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The dataset generation failed because of a cast error
Error code: DatasetGenerationCastError
Exception: DatasetGenerationCastError
Message: An error occurred while generating the dataset
All the data files must have the same columns, but at some point there are 1 new columns ({'text'}) and 5 missing columns ({'length', 'version_number', 'xml_id', 'indication_cleaned', 'set_id'}).
This happened while the json dataset builder was generating data using
/tmp/hf-datasets-cache/heavy/datasets/34660962318080-config-parquet-and-info-um-ids-dailymed-annotatio-72290ab7/downloads/315be291f24341428ed6dd6485b0ddd67363f3303041555e6cf4bb3840dcbeeb
Please either edit the data files to have matching columns, or separate them into different configurations (see docs at https://hf.co/docs/hub/datasets-manual-configuration#multiple-configurations)
Traceback: Traceback (most recent call last):
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/builder.py", line 2011, in _prepare_split_single
writer.write_table(table)
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/arrow_writer.py", line 585, in write_table
pa_table = table_cast(pa_table, self._schema)
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 2302, in table_cast
return cast_table_to_schema(table, schema)
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/table.py", line 2256, in cast_table_to_schema
raise CastError(
datasets.table.CastError: Couldn't cast
text: string
to
{'set_id': Value(dtype='string', id=None), 'xml_id': Value(dtype='string', id=None), 'version_number': Value(dtype='int64', id=None), 'indication_cleaned': Value(dtype='string', id=None), 'length': Value(dtype='int64', id=None)}
because column names don't match
During handling of the above exception, another exception occurred:
Traceback (most recent call last):
File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 1321, in compute_config_parquet_and_info_response
parquet_operations = convert_to_parquet(builder)
File "/src/services/worker/src/worker/job_runners/config/parquet_and_info.py", line 935, in convert_to_parquet
builder.download_and_prepare(
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/builder.py", line 1027, in download_and_prepare
self._download_and_prepare(
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/builder.py", line 1122, in _download_and_prepare
self._prepare_split(split_generator, **prepare_split_kwargs)
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/builder.py", line 1882, in _prepare_split
for job_id, done, content in self._prepare_split_single(
File "/src/services/worker/.venv/lib/python3.9/site-packages/datasets/builder.py", line 2013, in _prepare_split_single
raise DatasetGenerationCastError.from_cast_error(
datasets.exceptions.DatasetGenerationCastError: An error occurred while generating the dataset
All the data files must have the same columns, but at some point there are 1 new columns ({'text'}) and 5 missing columns ({'length', 'version_number', 'xml_id', 'indication_cleaned', 'set_id'}).
This happened while the json dataset builder was generating data using
/tmp/hf-datasets-cache/heavy/datasets/34660962318080-config-parquet-and-info-um-ids-dailymed-annotatio-72290ab7/downloads/315be291f24341428ed6dd6485b0ddd67363f3303041555e6cf4bb3840dcbeeb
Please either edit the data files to have matching columns, or separate them into different configurations (see docs at https://hf.co/docs/hub/datasets-manual-configuration#multiple-configurations)Need help to make the dataset viewer work? Make sure to review how to configure the dataset viewer, and open a discussion for direct support.
set_id
string | xml_id
string | version_number
int64 | indication_cleaned
string | length
int64 |
|---|---|---|---|---|
f3114cff-d638-4562-9e11-88130677363c | 6feb059d-5153-42a5-9306-6b05429ca86d | 7 | 1 INDICATIONS AND USAGE
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age [see Use in Special Population (8.4)]
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is a combination of codeine phosphate, an opiate agonist antitussive, and chlorpheniramine maleate, a histamine-1 (H1) receptor antagonist indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold. (
1
)
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age (8.4)) | 740 |
fff41159-af99-94bf-4327-8a6a7ee77b36 | 8ada4dd5-ebb4-7ae5-e9c3-69ab78d8509e | 4 | INDICATIONS AND USAGE
Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
Unlike penicillamine, trientine hydrochloride capsules are not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.
Trientine hydrochloride capsules are not indicated for treatment of biliary cirrhosis. | 1,119 |
a3294d91-4aa9-4a94-be6a-28ccf2d74326 | bc38c309-978f-47ec-9357-aa73b81f9c39 | 1 | 1.1 Hypertension
Amlodipine besylate tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. | 168 |
a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36 | 7ba834b5-8d04-429c-bd83-71e895634521 | 2 | INDICATIONS AND USAGE
Promethazine Hydrochloride, is useful orally for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amelioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of post-operative pain.
Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients. | 977 |
c714974b-766f-42f2-a846-b0c1f5a60560 | 42a9bee3-8d03-4f87-b55c-fbcb84a8ab8d | 5 | 1 INDICATIONS AND USAGE
The Estradiol Transdermal System is indicated for:
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
[Enter Generic Section here]
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
1.3 Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure
[Enter Generic Section here]
1.4 Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis | 848 |
467e464b-bbaf-4053-9136-39e47a92fa05 | 42600718-075b-481b-8fec-cb6cbadab7de | 12 | 1 INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (
1
). | 315 |
4eb71151-241a-476e-a495-4a021bc55bda | 4eb71151-241a-476e-a495-4a021bc55bda | 1 | 1 INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults
[see Clinical Studies (
14)]
.
Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults
(
1)
. | 292 |
74566251-958d-4e50-aaa9-a7eb91d350f3 | be7751d6-036f-4f05-bbfb-58b674f6576f | 4 | For cauterization of skin or mucous membrane and for removing warts and granulated tissue. | 90 |
81243f47-bd25-bd02-518a-087badcca755 | 649d8760-81df-13da-6556-14a0fdbc8b02 | 4 | 1 INDICATIONS AND USAGE
Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
Neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery (1). | 383 |
17b570e7-3cf8-2f20-e054-00144ff8d46c | 60a1c32b-70e4-332b-e053-2a91aa0a3fd8 | 4 | INDICATIONS AND USAGE:
This product is indicated for the topical treatment and removal of common warts and plantar warts. | 121 |
b946c396-34fc-1845-1944-f16028a8447d | 4a27a35f-574e-e0d4-f083-ed2b34d5b939 | 3 | 1 INDICATIONS AND USAGE
Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following:
- Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic braintumors.
- Multiple myeloma in combination withprednisone.
- Relapsed or refractory Hodgkin's lymphoma in combination with other approveddrugs.
- Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approveddrugs.
Carmustine for injection is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:
Brain tumors glioblastoma, brainstem glioma, medulloblastoma,
astrocytoma, ependymoma, and metastatic brain tumors (1)
Multiple myeloma-in combination with prednisone (1)
Relapsed or refractory Hodgkin's lymphoma in combination with other
approved drugs (1)
Relapsed or refractory Non-Hodgkin's lymphomas in combination with
other
approved drugs (1) | 1,041 |
020d34eb-9560-4218-9d87-dfdeff705c3a | 2ba7e0fa-a7ca-4cc9-a6e8-5929d5dfe73c | 1 | 1 INDICATIONS AND USAGE
Bicalutamide 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)].
Bicalutamide 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide 150 mg daily is not approved for use alone or with other treatments. (1) | 638 |
50a46bd0-d57e-4685-a027-622f63bfcf80 | 73f867a1-3da9-4c6f-8f57-d337d237af2c | 3 | Panic Disorder:
Clonazepam is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see
CLINICAL PHARMACOLOGY
:
Clinical Trials
).
Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2)sweating; (3)trembling or shaking; (4)sensations of shortness of breath or smothering; (5)feeling of choking; (6)chest pain or discomfort; (7)nausea or abdominal distress; (8)feeling dizzy, unsteady, lightheaded or faint; (9)derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11)fear of dying; (12)paresthesias (numbness or tingling sensations); (13)chills or hot flushes.
The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION
). | 1,686 |
cde9fb09-e5af-434d-8874-e4f9f974d893 | 7d63504d-5cb7-504f-e053-2991aa0aec29 | 6 | INDICATIONS AND USAGE
LOMAIRA tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in patients with an initial body mass index greater than or equal to 30 kg/m
2, or greater than or equal to 27 kg/m
2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m
2
The limited usefulness of agents of this class, including phentermine (see
Clinical Pharmacology
), should be measured against possible risk factors inherent in their use such as those described below.
table | 963 |
b60d2cb0-f2c3-4ad5-8060-5179d5b94256 | b58c8fbf-c7b3-4b9c-84a9-e19bd76904ac | 1 | INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets, USPare indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets, USPare indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets, USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets, USP therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION
,
CONTRAINDICATIONS
, and
WARNINGS
). | 827 |
6bb510c8-2ae2-4159-b4c6-0aec5e64b4c9 | 6bb510c8-2ae2-4159-b4c6-0aec5e64b4c9 | 1 | INDICATIONS AND USAGE
RELPAX is indicated for the acute treatment of migraine with or without aura in adults.
RELPAX is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of RELPAX Tablets have not been established for cluster headache, which is present in an older, predominantly male population. | 413 |
fa22943c-27d3-4419-be9b-ffe7de1a2416 | fed449e4-9657-4ca1-a8bc-7e14535d854b | 3 | INDICATIONS AND USAGE
Edema
Furosemide tablets, USP is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.
Hypertension
Furosemide tablets, USP may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone. | 632 |
6b577898-b36a-425c-8cf3-36230347b2d2 | 9abd651c-3fc9-4426-9392-6e2a783d3d8e | 1 | 1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, USP and other antibacterial drugs, amoxicillin tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Amoxicillin tablets, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin tablets, USP are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract.(1.1- 1.5)
In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.6, 1.7)
1.1 Infections of the Ear, Nose, and Throat
Due to Streptococcus species (- and -hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract
Due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure
Due to Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4 Infections of the Lower Respiratory Tract
Due to Streptococcus spp. (- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections)
due to Neisseria gonorrhoeae.Because of high rates of amoxicillin resistance, amoxicillin tablets, USP are not recommended for empiric treatment of gonorrhea. Amoxicillin tablets, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.
1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole
Amoxicillin tablets, USP, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.7 Dual Therapy for H. pylori with Lansoprazole
Amoxicillin tablets, USP, in combination with lansoprazole delayed-release capsules as dual therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. | 3,058 |
ab8118dc-aca8-478b-8290-a468cbe36ae1 | 5bfd44d1-e5fd-46c6-b172-37af53fdd38e | 8 | 1 INDICATIONS AND USAGE
Enoxaparin Sodium Injection is a low molecular weight heparin [LMWH] indicated for:
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1)
Inpatient treatment of acute DVT with or without pulmonary embolism (1.2)
Outpatient treatment of acute DVT without pulmonary embolism (1.2)
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] (1.3)
Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI] (1.4)
1.1 Prophylaxis of Deep Vein Thrombosis
Enoxaparin Sodium Injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies 14.1
].
in patients undergoing hip replacement surgery, during and following hospitalization.
in patients undergoing knee replacement surgery.
in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
1.2 Treatment of Acute Deep Vein Thrombosis
Enoxaparin Sodium Injection is indicated for:
the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium.
the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.
1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction
Enoxaparin Sodium Injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
1.4 Treatment of Acute ST-Segment Elevation Myocardial Infarction
Enoxaparin Sodium Injection, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI). | 2,337 |
bfc817db-ab65-5cd7-e053-2995a90a8ee8 | ed8510e5-ad24-5a93-e053-2995a90ab601 | 2 | INDICATIONS AND USAGE
Flucytosine Capsules USP is indicated only in the treatment of serious infections caused by susceptible strains of
Candida and/or
Cryptococcus.
Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.
Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.
Flucytosine Capsules USP should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules USP (See
MICROBIOLOGY). | 756 |
0a7c1ae6-4878-43e7-9026-073f74af64c0 | 13f549e6-797d-42e9-a2b2-510c41315ae2 | 6 | 1INDICATIONS AND USAGE
Ursodiol tablets, USP 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cirrhosis (PBC).
Ursodiol tablets, USP 250 mg and 500 mg are bile acids indicated for the treatment of patients with primary biliary cirrhosis (1) | 274 |
82e7d9d8-bad8-4dac-8e2c-29e834fc6dbf | ee2c519b-e285-4bde-81ed-f109f64088a7 | 2 | INDICATIONS AND USAGE
LIGNOSPAN Solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques.
Only accepted procedures for these techniques as described in standard textbooks are recommended. | 257 |
abc1d07f-91ee-4421-bc9b-457d0ed41f4c | 0db13470-fcc5-4378-86ab-20f36277ab3c | 5 | INDICATIONS AND USAGE: Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2. | 197 |
e673c84f-d3cc-4e61-bdc7-5679cde9f359 | cca757b4-55c2-4d0f-b578-e4d658c6db2f | 3 | INDICATIONS AND USAGE
Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial super-infections of fungal or viral infections. Please Note: Gentamicin sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. Gentamicin sulfate is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers , infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be treated with gentamicin sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin sulfate cream is recommended for wet, oozing primary infections, and greasy, secondary infections, such as pustular acne or infected seborrheic dermatitis. If a water-washable preparation is desired, the cream is preferable. Gentamicin sulfate cream has been used successfully in infants over one year of age, as well as in adults and children. | 1,572 |
f673387f-0b94-42e5-9747-60bc80de93e5 | 32b15c85-9ca5-4528-b43e-eb773d64786e | 1 | 1 INDICATIONS AND USAGE
Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
Meclizine hydrochloride is indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults (1). | 295 |
5c02665d-05d2-4e99-b403-c270de543ebe | df64082c-a5c5-4d74-adc5-065cf9b0b061 | 4 | 1 INDICATIONS AND USAGE
MOVANTIK (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
MOVANTIK (naloxegol) is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain (1) | 321 |
b39aaacb-f429-4cb4-b88b-341b8b8b217c | db958941-32f2-47ba-8b8f-a9fcf6560edb | 5 | 1 INDICATIONS AND USAGE
Clindamycin phosphate and benzoyl peroxide gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. (1.1)
Limitation of Use:
Clindamycin phosphate and benzoyl peroxide gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. (1.2)
1.1 Indication
Clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older.
1.2 Limitations of Use
Clindamycin phosphate and benzoyl peroxide gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. | 896 |
9050af7a-19c6-4670-937a-9445605de995 | f125fb04-5043-5367-e053-2a95a90aa73b | 34 | INDICATIONS AND USAGE:
AZASAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms.
Renal Homotransplantation: AZASAN is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of AZASAN on these variables has not been tested in controlled trials.
Rheumatoid Arthritis: AZASAN is indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, nonsteroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with AZASAN. The combined use of AZASAN with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of AZASAN with these agents cannot be recommended. | 1,103 |
d6fa7f20-5125-ff79-4e8d-00542a13472a | 4995ef74-5377-6fdf-5a0a-0ea1925c35fb | 1 | INDICATIONS AND USAGE
Meprobamate tablets are indicated for the management of anxietydisorders or for the short-term relief of the symptoms of anxiety.Anxiety or tension associated with the stress of everyday life usuallydo not require treatment with an anxiolytic.
The effectiveness of meprobamate tablets in long-term use, that is,more than 4 months, has not been assessed by systematic clinicalstudies. The physician should periodically reassess the usefulness ofthe drug for the individual patient. | 502 |
01f1f478-5493-439f-9b99-f4f82023781c | 857dd673-6ba8-485c-b96b-14291666b852 | 11 | INDICATIONS AND USAGE
Hydrochlorothiazide tablets, USPare indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Hydrochlorothiazide tablets, USPhave also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Hydrochlorothiazide tablets, USPare indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Use in Pregnancy
Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see
PRECAUTIONS, Pregnancy
). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease.However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate. | 1,913 |
c6c845b3-8f22-454e-b0f8-ed2cdd59e8dd | eaa6c757-097c-4e9a-84b4-e4dfc403e18a | 1 | 1 INDICATIONS AND USAGE
ZENPEP (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
ZENPEP is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions (1) | 346 |
be8ec971-c4f1-3e53-77e1-8337d9d506eb | b6d4150a-3849-e804-02cb-468a6593dd71 | 3 | 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy. | 228 |
8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 | 252ba2ed-d4cf-456a-84f9-cb253621e1c1 | 29 | INDICATIONS AND USAGE
Epilepsy
Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:
Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.
Generalized tonic-clonic seizures (grand mal).
Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Tegretol (see PRECAUTIONS, General).
Trigeminal Neuralgia
Tegretol is indicated in the treatment of the pain associated with true trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal neuralgia.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. | 949 |
54f28743-bb66-4234-8d20-8502a5ffdc26 | 05653083-535e-473b-bd53-e17df9ddc1dd | 3 | INDICATIONS AND USAGE
Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other
information, FDA has classified the following indications as possibly effective:
For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis)
and acute enterocolitis.
May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN
CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A
DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS. | 612 |
60b85eab-17ad-4482-87d6-ca9720ca06e0 | 62a34e85-f86f-407b-9809-8b33c073b33c | 2 | INDICATIONS AND USAGE
I. Vasospastic Angina
Nifedipine extended release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended release may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.
II. Chronic Stable Angina (Classical Effort-Associated Angina)
Nifedipine extended release tablets are indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents.
In chronic stable angina (effort-associated angina), nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete.
Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely, since severe hypotension can occur from the combined effects of the drugs. (See
WARNINGS
.)
III. Hypertension
Nifedipine extended release tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents. | 2,391 |
174cc098-fe49-4f1a-87e2-601c7573f0db | 81f11e22-8d19-4974-87d5-aa983d5ea945 | 6 | 1.2 Acute Bacterial Otitis Media
caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis. | 111 |
f6623154-ae05-44c3-b7f8-e1fde35fa311 | 3d359b53-9006-4c31-ab1d-1606f50642da | 6 | 1 INDICATIONS AND USAGE
Aripiprazole Tablets are an atypical antipsychotic.The oral formulations are indicated for:
Schizophrenia (
14.1)
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (
14.2)
Adjunctive Treatment of Major Depressive Disorder (
14.3)
Irritability Associated with Autistic Disorder (
14.4)
Treatment of Tourette's disorder (
14.5)
Aripiprazole Oral Tablets are indicated for the treatment of:
Schizophrenia
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder
Adjunctive Treatment of Major Depressive Disorder
Irritability Associated with Autistic Disorder
Treatment of Tourette's Disorder | 654 |
532d40b2-c05c-4d4f-b7ee-e6434c4c27fc | 49a9efb3-9bea-431c-8ec5-15a85cd1e293 | 11 | 1 INDICATIONS AND USAGE
Indomethacin extended-release capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Indomethacin extended-release capsules are a nonsteroidal anti-inflammatory drug indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
(1) | 601 |
983ce15f-cd37-4f3a-9e51-205860e80976 | f849b89b-f428-48c3-a779-463e444ec8ce | 3 | INDICATIONS AND USAGE
OsmoPrep Tablets are indicated for cleansing of the colon as a
preparation for colonoscopy in adults 18 years of age or older. | 148 |
8593f7fc-eabe-44ae-bb05-b3d7d408e4f7 | f8fa3869-95ff-42a2-9658-8641a30e9eec | 1 | INDICATIONS AND USAGE
Neoplastic Diseases
Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole.
In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is also indicated in the treatment of meningeal leukemia.
Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkins lymphomas.
Methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor.
Psoriasis:
Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by a biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis flare is not due to an undiagnosed concomitant disease affecting immune responses.
Rheumatoid Arthritis including Polyarticular-Course Juvenile Rheumatoid Arthritis:
Methotrexate is indicated in the management of selected adults with severe, active rheumatoid arthritis (ACR criteria), or children with active polyarticular-course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non- steroidal anti-inflammatory agents (NSAIDs).
Aspirin, (NSAIDs), and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. (See
PRECAUTIONS, Drug Interactions
.)
Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued. | 2,512 |
499f9dfd-b533-4021-a3ed-308f0f956c79 | f62f5875-c0f1-4892-95c4-a811d8b6f1de | 5 | INDICATIONS AND USAGE
Nitrofurantoin Oral Suspension, USP is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin oral suspension, USP are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin oral suspension, USP, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin oral suspension, USP, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized. | 1,226 |
e2b2cc16-c33c-4b04-bf2d-6bd59a71df01 | f952403a-8a6c-4106-81f0-d931b214c24a | 1 | Clopidogrel tablets USP are a P2Y12 platelet inhibitor indicated for:
Acute coronary syndrome
- For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], clopidogrel tablets USP have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets USP have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown. (1.1)
Recent (MI), recent stroke, or established peripheral arterial disease. Clopidogrel tablets USP have been shown to reduce the combined endpoint of new ischemic stroke, new MI, and other vascular death. (1.2)
1.1 Acute Coronary Syndrome (ACS)
For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablets USP have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets USP have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.
The optimal duration of clopidogrel tablets USP therapy in ACS is unknown.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablets USP have been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. | 2,237 |
90f0c351-3977-2b84-0a6a-e9cb091430ca | 7fc09e55-b28d-9197-a808-a6b341102f06 | 5 | 1 INDICATIONS AND USAGE
ALBUMIN (HUMAN) 20% is indicated for the restoration and maintenance of circulating blood volume for:
Hypovolemia. (1.1)
Hypoalbuminemia. (1.2)
Prevention of central volume depletion after paracentesis due to cirrhotic ascites. (1.3)
Ovarian hyperstimulation syndrome (OHSS). (1.4)
Adult respiratory distress syndrome (ARDS). (1.5)
Acute nephrosis. (1.6)
Hemolytic Disease of the Newborn (HDN). (1.7)
1.1 Hypovolemia
ALBUMIN (HUMAN) 20% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [1, 2]
When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [
1
]
1.2 Hypoalbuminemia
For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, ALBUMIN (HUMAN)20% infusions may be indicated. [
3
] When albumin deficit is the result of excessive protein loss, the effect of administration of ALBUMIN (HUMAN) 20% will be temporary unless the underlying disorder is reversed.
1.3 Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites (Treatment Adjunct)
ALBUMIN (HUMAN) 20% may be used to maintain cardiovascular function following the removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites. [
2
]
1.4 Ovarian Hyperstimulation Syndrome (OHSS)
ALBUMIN (HUMAN) 20% may be used as a plasma expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome (OHSS). [7, 8]
1.5 Adult Respiratory Distress Syndrome (ARDS) (Treatment Adjunct)
ALBUMIN (HUMAN) 20% infusions may be indicated in conjunction with diuretics to correct the fluid volume overload associated with ARDS. [
5
]
1.6 Acute Nephrosis (Treatment Adjunct)
ALBUMIN (HUMAN) 20% may be used to treat edema in patients with acute nephrosis who are refractory to cyclophosphamide and corticosteroid therapy. [
1
]
1.7 Hemolytic Disease of the Newborn (HDN)
ALBUMIN (HUMAN) 20% is indicated in the treatment of hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free and to enhance its removal. [
6
] | 2,473 |
429e98d2-6da4-559f-e054-00144ff88e88 | d60cbdb0-5a89-8335-e053-2995a90a948f | 5 | 1 INDICATIONS AND USAGE
Ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.
1.1 Urinary Tract Infections
Ciprofloxacin is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.
1.2 Acute Uncomplicated Cystitis
Ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.
1.3 Chronic Bacterial Prostatitis
Ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.
1.4 Lower Respiratory Tract Infections
Ciprofloxacin is indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Also, ciprofloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis [see INDICATIONS AND USAGE (1.15)].
1.5 Acute Sinusitis
Ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.
1.6 Skin and Skin Structure Infections
Ciprofloxacin is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.
1.7 Bone and Joint Infections
Ciprofloxacin is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
1.8 Complicated Intra-Abdominal Infections
Ciprofloxacin is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
1.9 Infectious Diarrhea
Ciprofloxacin is indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii
, Shigella dysenteriae, Shigella flexneri or Shigella sonnei when antibacterial therapy is indicated.
Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
1.10 Typhoid Fever (Enteric Fever)
Ciprofloxacin is indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.
1.11 Uncomplicated Cervical and Urethral Gonorrhea
Ciprofloxacin is indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see WARNINGS AND PRECAUTIONS (5.16)].
1.12 Complicated Urinary Tract Infections and Pyelonephritis
Ciprofloxacin is indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [see INDICATIONS AND USAGE (1.15) and USE IN SPECIFIC POPULATIONS (8.4)].
1.13 Inhalational Anthrax (post-exposure)
Ciprofloxacin is indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001. [See CLINICAL STUDIES (14.2).]
1.14 Plague
Ciprofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see CLINICAL STUDIES (14.3) ].
1.15 Limitation of Use
Use in Pediatric Patients
Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see WARNINGS AND PRECAUTIONS (5.11), ADVERSE REACTIONS (6.1), USE IN SPECIFIC POPULATIONS (8.4)and NONCLINICAL TOXICOLOGY (13.2)].
Lower Respiratory Tract Infections
Ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae [see INDICATIONS AND USAGE (1.4)].
1.16 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance. | 7,194 |
bbd6c0d4-110c-4bda-9d9f-89ab7ce4c18e | 069eec8b-6cca-435c-9d3f-fbdc75a813a0 | 3 | INDICATIONS AND USAGE
Tramadol hydrochloride tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see
WARNINGS
), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
Have not been tolerated, or are not expected to be tolerated.
Have not provided adequate analgesia, or are not expected to provide adequate analgesia. | 618 |
49f82130-6f8a-412c-b625-e75906e74675 | ee144ff6-87c4-0dc9-e053-2a95a90a4329 | 10 | INDICATIONS AND USAGE
Doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Hyclate Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. | 784 |
28bc9ec9-b8db-4ece-a14a-8bcf618cbf7e | dc165fc0-baa8-f182-e053-2995a90aef3d | 3 | INDICATIONS AND USAGE
Macrobid is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of
Escherichia coli or
Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
Macrobid and other antibacterial drugs,
Macrobid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with
Macrobid are predisposed to persistence or reappearance of bacteriuria. (See
CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with
Macrobid, other therapeutic agents with broader tissue distribution should be selected. In considering the use of
Macrobid, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized. | 1,618 |
e3de56de-b707-405e-bf97-837070e5c744 | b26a83fd-322b-d988-e053-2a95a90a35e3 | 1 | INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets, USPare indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets, USPare indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets, USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral metoprolol tartrate tablets, USP therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION
,
CONTRAINDICATIONS
, and
WARNINGS
). | 827 |
58acf5fd-078d-0737-f8fe-178b4026da0f | c1d8c6eb-50e0-8e92-7179-4c281be4804e | 3 | 1 INDICATIONS AND USAGE
Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for:
Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1)
Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1)
Treatment of esophageal candidiasis. (1)
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1)
1.1 Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients
Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.1, 14.5)].
1.2 Treatment of Candidemia and Other Candida Infections
Caspofungin acetate for injection is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.2, 14.5)].
Limitations of Use: Caspofungin acetate for injection has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.
1.3 Treatment of Esophageal Candidiasis
Caspofungin acetate for injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.3, 14.5)].
Limitations of Use: Caspofungin acetate for injection has not been approved for the treatment of oropharyngeal candidiasis (OPC). In the study that evaluated the efficacy of caspofungin in the treatment of esophageal candidiasis, patients with concomitant OPC had higher relapse rate of the OPC [see Clinical Studies (14.3)].
1.4 Treatment of Invasive Aspergillosis in Patients Who Are Refractory to or Intolerant of Other Therapies
Caspofungin acetate for injection is indicated for the treatment of invasive aspergillosis in adult and pediatric patients (3 months of age and older) who are refractory to or intolerant of other therapies [see Clinical Studies (14.4, 14.5)].
Limitations of Use: Caspofungin acetate for injection has not been studied as initial therapy for invasive aspergillosis. | 2,341 |
6785cf30-360f-409b-a4b2-fc910728f01f | 5af5d3b5-1a03-4717-b828-97589f278992 | 1 | INDICATIONS AND USAGE:
Intravenous adenosine injection, USPis indicated for the following:
Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection, USPadministration.
It is important to be sure the adenosine injection, USPsolution actually reaches the systemic circulation (see
DOSAGE AND ADMINISTRATION
).
Adenosine injection, USPdoes not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection, USPadministration. | 858 |
8a0f252d-0a5b-4fa1-91db-21525b2ed2b0 | 40e5d119-b44e-4d48-afe6-8406fb57c488 | 1 | INDICATIONS AND USAGE
Hypertension
Losartan potassium and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION).
Hypertensive Patients with Left Ventricular Hypertrophy
Losartan potassium and hydrochlorothiazide tablets USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See
PRECAUTIONS, Race, CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke, Race
, and DOSAGE AND ADMINISTRATION.) | 962 |
a34d3c72-ce91-47c7-86a1-f32caaed2c47 | 6fe42517-aec2-4203-9574-2576c6472a94 | 4 | 1 INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.
Atorvastatin calcium tablet is an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to:
Reduce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors (1.1).
Reduce the risk of MI and stroke in patients with type 2 diabetes without CHD, but with multiple risk factors (1.1).
Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with CHD (1.1).
Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (1.2).
Reduce elevated TG in patients with hypertriglyceridemia and primary dysbetalipoproteinemia (1.2).
Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) (1.2).
Reduce elevated total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy (1.2).
Limitations of Use
Atorvastatin calcium tablets has not been studied in Fredrickson Types I and V dyslipidemias.
1.1 Prevention of Cardiovascular Disease
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets is indicated to:
1.Reduce the risk of myocardial infarction
2.Reduce the risk of stroke
3.Reduce the risk for revascularization procedures and angina
In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to:
1.Reduce the risk of myocardial infarction
2.Reduce the risk of stroke
In patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to:
1.Reduce the risk of non-fatal myocardial infarction
2.Reduce the risk of fatal and non-fatal stroke
3.Reduce the risk for revascularization procedures
4.Reduce the risk of hospitalization for CHF
5.Reduce the risk of angina
1.2 Hyperlipidemia
Atorvastatin calcium tablets are indicated:
1.As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
2.As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV);
3.For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
4.To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;
5.As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
a. LDL-C remains
190 mg/dL or
b. LDL-C remains
160 mg/dL and:
1.there is a positive family history of premature cardiovascular disease or
2.two or more other CVD risk factors are present in the pediatric patient
1.3 Limitations of Use
Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V). | 4,271 |
8fd7b5d8-f6b1-4d0a-9ec6-446c5f89762a | 4f15e43e-2be6-4f49-bf18-cfe8c8106f17 | 2 | INDICATIONS AND USAGE
Acetylcysteine, administered orally, is indicated as an antidote to prevent or lessen hepatic injury which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen. It is essential to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of ingestion. | 343 |
af9ce58c-3cd7-769f-e053-2a95a90a5385 | ed21864f-7e96-1977-e053-2995a90a0f22 | 7 | 1. Indications and Usage
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh 60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)]. | 636 |
90e0e508-75f7-4c8b-bb38-898aa4c531c3 | c68712f0-976b-49b0-a8bb-8801ed5462b6 | 9 | 1INDICATIONS AND USAGE
Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron tablets are a 5-HT3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. (1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. (1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. (1)
postoperative nausea and/or vomiting. (1) | 1,078 |
ee828a36-7f94-4106-8c4d-c61ba7e2f308 | e97e6623-9454-4d2f-8cbc-d84db5f0b5ce | 13 | 1 INDICATIONS AND USAGE
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of olmesartan medoxomil, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker, and hydrochlorothiazide, a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1).
Limitations of Use
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are not indicated for initial therapy (1).
Limitations of Use
This fixed combination drug is not indicated for the initial therapy of hypertension. | 3,412 |
b89656fc-6917-434c-bec2-a4e064e6682a | b466e9af-1a1d-5026-e053-2995a90a92a3 | 3 | 1 INDICATIONS AND USAGE
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia
[see
CLINICAL STUDIES (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY
(aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic. The oral formulationis indicated for:
Schizophrenia
(14.1) | 487 |
18dc6cc7-ec64-4730-941c-8a9ad5dcb252 | 24150f6d-980b-4a8f-bf76-6308c091ed56 | 1 | 1 INDICATIONS AND USAGE
Abacavir, lamivudine and zidovudine tablet, a combination of abacavir, lamivudine, and zidovudine, each nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.(1)
Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Limitations of Use:
Limited data exist on the use of abacavir, lamivudine and zidovudine
tablets alone in patients with higher
baseline viral
load levels (greater than
100,000 copies per
mL) [see CLINICAL STUDIES (14)] . | 693 |
6aae700d-1cb4-4e66-9b6b-eb1a255d2660 | 285d06b8-f0f0-4bb6-95bb-1512d385ec15 | 2 | 1 INDICATIONSANDUSAGE
Esomeprazole magnesium delayed-release capsule, is a proton pump inhibitor indicated for the following:
Treatment of gastroesophageal reflux disease (GERD). (1.1)
Risk reduction of NSAID-associated gastric ulcer. (1.2)
H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (1.4)
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin): Esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Dosage and Administration (2) and Clinical Studies (14)].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the prescribing information for clarithromycin].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. | 2,888 |
1acfb8cc-6faf-4b3e-9304-4819c42de0a6 | 155f6c9e-77e8-4597-a05c-d5a92bbd8b35 | 3 | 1 INDICATIONS AND USAGE
Naproxen Tablets are indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
Naproxen tablets are non-steroidal anti-inflammatory drugs indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea | 573 |
715433dc-cb2b-43ea-b6df-c5b4177adc6c | 650ce9da-73d0-4335-b8f4-dabb12672108 | 4 | 1 INDICATIONS AND USAGE
BREZTRI AEROSPHERE is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Limitations of Use:
BREZTRI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see Warnings and Precautions
(5.1
,
5.2)
].
BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1)
Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma. (1, 5.1, 5.2) | 733 |
e6611157-4a8f-4de3-a858-b4f518cad7c4 | 27f2d683-bf04-43f9-b431-2bb80adab6fa | 1 | 1. INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.
Simvastatin tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (
1.1)
Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (
1.2)
Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbeta-lipoproteinemia. (
1.2)
Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (
1.2
)
Reduce elevated total-C, LDL-C, and ApoB in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (
1.2,
1.3)
Limitations of Use
Simvastatin tablets have not been studied in Fredrickson TypesI andV dyslipidemias. (
1.4)
1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets are indicated to:
Reduce the risk of total mortality by reducing CHD deaths.
Reduce the risk of non-fatal myocardial infarction and stroke.
Reduce the need for coronary and non-coronary revascularization procedures.
1.2 Hyperlipidemia
Simvastatin tablets are indicated to:
Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson typeIIb).
Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson typelV hyperlipidemia).
Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson typeIII hyperlipidemia).
Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3 Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH)
Simvastatin tablets are indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present:
LDL cholesterol remains 190mg/dL; or
LDL cholesterol remains 160mg/dL and
There is a positive family history of premature cardiovascular disease (CVD) or
Two or more other CVD risk factors are present in the adolescent patient.
The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined.
1.4 Limitations of Use
Simvastatin tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson typesI andV). | 3,913 |
d4bfba33-9f4d-4c43-ae6c-bcf67ef8fe51 | a8bc8f3d-05f0-43f7-aa9b-024158d9aae6 | 1 | 1 INDICATIONS AND USAGE
Baclofen injection is indicated for use in the management of severe spasticity in adult and pediatric patients age 4 years and above. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injection is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the Medtronic SynchroMed II Programmable Pump or other pumps labeled for intrathecal administration of baclofen injection [see Clinical Studies (14)].
Prior to implantation of a device for chronic intrathecal infusion of baclofen injection, patients must show a response to baclofen injection in a screening trial [see Dosage and Administration (2.2)].
Baclofen injection is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above (1)
Baclofen injection should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses (1)
Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. (1)
Spasticity due to traumatic brain injury: wait at least one year after injury before considering baclofen injection therapy (1) | 1,905 |
4fedeb6a-d99f-43e1-89f3-75818ce919aa | b6b00292-9230-43f4-8d2b-7aa1f13d734d | 2 | INDICATIONS AND USAGE
OCELLA is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.
Oral contraceptives are highly effective. TABLE II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE II Percentage of women experiencing an unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage continuing use at the end of the first year: United States.
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
% of Women Experiencing an
Accidental PregnancyWithin the First Year of Use
% of Women
Continuing Use
At One Year
Method(1)
Typical Use
(2)
Perfect Use
(3)
(4)
Chance
85
85
Spermicides
26
6
40
Periodic abstinence
25
63
Calendar
9
Ovulation method
3
Sympto-thermal
2
Post-ovulation
1
Withdrawal
19
4
CapWith spermicidal cream or jelly.
Parous women
40
26
42
Nulliparous women
20
9
56
Sponge
Parous women
40
20
42
Nulliparous women
20
9
56
Diaphragm
20
6
56
Condom
Female (Reality)
21
5
56
Male
14
3
61
Pill
5
71
progestin only
0.5
combined
0.1
IUD
Progesterone T:
2
1.5
81
Copper T 380A
0.8
0.6
78
Lng 20
0.1
0.1
81
Depo Provera
0.3
0.3
70
Norplant and Norplant-2
0.05
0.05
88
Female Sterilization
0.5
0.5
100
Male Sterilization
0.15
0.1
100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%
Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception
In clinical efficacy studies of OCELLA of up to 2 years duration, 2,629 subjects completed 33,160 cycles of use without any other contraception. The mean age of the subjects was 25.5
4.7 years. The age range was 16 to 37 years. The racial demographic was: 83% Caucasian, 1% Hispanic, 1% Black, <1% Asian, <1% other, <1% missing data, 14% not inquired and <1% unspecified. Pregnancy rates in the clinical trials were less than one per 100 woman-years of use. | 2,372 |
b8f4d730-fd8e-4692-aabd-e2b7e63fabe1 | b119c7cd-d261-41ca-94a4-d01ace9e4929 | 6 | INDICATIONS AND USAGE
Lisinopril and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
In using lisinopril and hydrochlorothiazide tablets, USP, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (See WARNINGS).
In considering the use of lisinopril and hydrochlorothiazide tablets, USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril). | 3,216 |
b38fc681-6bc7-473b-b381-af0c9b42abe0 | 0e6315f2-49bd-471a-ab04-2949077728d0 | 1 | INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain.
Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted. | 706 |
6b9c2d73-866b-44c4-8718-e7e4a9a0fb55 | 168a74a5-392a-4677-8188-2cc73f28437d | 6 | 1. INDICATIONS AND USAGE
Fluoxetine is indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].
Fluoxetine and Olanzapine in Combination is indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder in adult.
Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
When using
Fluoxetine
and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbya.
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD)(1)
Acute and maintenance treatment of Bulimia Nervosa (1)
Acute treatment of Panic Disorder, with or without agoraphobia(1)
Fluoxetine and olanzapine in combination for treatment of:
Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1) | 1,497 |
0ded3105-b962-4748-bf5b-fca7a4557562 | 0ded3105-b962-4748-bf5b-fca7a4557562 | 1 | 1 INDICATIONS & USAGE
Metoprolol succinate extended-release tablets, metoprolol succinate,
beta-adrenergic blocker indicated for the treatment of:
Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.(1.1)
Angina Pectoris. (1.2)
Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure(1.3)
1.1 Hypertension
Metoprolol succinate extended-release tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Metoprolol succinate extended-release tablets may be administered with other antihypertensive agents.
1.2 Angina Pectoris
Metoprolol succinate extended-release tablets is indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance.
1.3 Heart Failure
Metoprolol succinate extended-release tablets is indicated to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure. | 3,437 |
8b2641eb-4d92-ab67-e053-2995a90a76ed | ea4e5146-9c7b-ecaa-e053-2a95a90a2de7 | 2 | Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. | 165 |
763958a2-6952-4c0d-8a4a-9c04acb62229 | eb938c77-194c-7a22-e053-2995a90a9f4a | 15 | 1.2 Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in
patients with coronary artery disease and left ventricular dysfunction, when used together with
myocardial perfusion imaging. | 271 |
4a5b43f6-a5ea-4d6f-941f-3c19f242c896 | fad5d266-a87f-413a-b644-8ebbe93e7534 | 2 | 1 INDICATIONS AND USAGE
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1) | 1,276 |
2b678081-29cd-4311-a9fa-d884734778e2 | 98141f3a-5e93-4b6f-8a8a-3f7f43ab30bb | 12 | INDICATIONS AND USAGE:
Topical application of APF gel is indicated in the prevention of dental caries. | 102 |
acf5dbe5-ca75-4300-816f-b3f4625f6e7d | be02ec53-e514-4779-841b-22c6af4771af | 5 | 1.4 Limitations of Use
Tigecycline for injection is not indicated for the treatment of diabetic foot infections. A clinical trial failed to demonstrate non-inferiority of tigecycline for injection for treatment of diabetic foot infections.
Tigecycline for injection is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia. In a comparative clinical trial, greater mortality and decreased efficacy were reported in tigecycline-treated patients [see Warnings and Precautions (5.2)]. | 515 |
f06a91eb-5aa0-4722-8644-c56bbd975f02 | 1c49c40e-091d-45ac-afdc-fbc7172c3e5c | 1 | 1.3 Irritability Associated with Autistic Disorder
Risperidone tablets USP are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see
Clinical Studies (14.4)
]. | 411 |
7a7cc017-fc08-3118-e053-2991aa0ad7af | e5486dc8-d5a8-7aa6-e053-2a95a90a5248 | 4 | 1 INDICATIONS AND USAGE
Ciprofloxacin tablet is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:
Skin and Skin Structure Infections (
1.1)
Bone and Joint Infections (
1.2)
Complicated Intra-Abdominal Infections (
1.3)
Infectious Diarrhea (
1.4)
Typhoid Fever (Enteric Fever) (
1.5)
Uncomplicated Cervical and Urethral Gonorrhea (
1.6)
Inhalational Anthrax post-exposure in adult and pediatric patients (
1.7)
Plague in adult and pediatric patients (
1.8)
Chronic Bacterial Prostatitis (
1.9)
Lower Respiratory Tract Infections (
1.10)
Acute Exacerbation of Chronic Bronchitis
Urinary Tract Infections (
1.11)
Urinary Tract Infections (UTI)
Acute Uncomplicated Cystitis
Complicated UTI and Pyelonephritis in Pediatric Patients
Acute Sinusitis (
1.12)
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
1.13)
1.1 Skin and Skin Structure Infections
Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible
Staphylococcus aureus, methicillin-susceptible
Staphylococcus epidermidis, or
Streptococcus pyogenes.
1.2 Bone and Joint Infections
Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by
Enterobacter cloacae, Serratia marcescens, or
Pseudomonas aeruginosa.
1.3 Complicated Intra-Abdominal Infections
Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by
Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or
Bacteroides fragilis.
1.4 Infectious Diarrhea
Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by
Escherichia coli (enterotoxigenic isolates),
Campylobacter jejuni, Shigella boydii
,
Shigella dysenteriae, Shigella flexneri or
Shigella sonnei
when antibacterial therapy is indicated.
Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
1.5 Typhoid Fever (Enteric Fever)
Ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by
Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.
1.6 Uncomplicated Cervical and Urethral Gonorrhea
Ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to
Neisseria gonorrhoeae
[see
Warnings and Precautions (5.16)]
.
1.7 Inhalational Anthrax (Post-Exposure)
Ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized
Bacillus anthracis.
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.
1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001
[see
Clinical Studies (14.2)]
.
1.8 Plague
Ciprofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to
Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only
[see
Clinical Studies (14.3)]
.
1.9 Chronic Bacterial Prostatitis
Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by
Escherichia coli or
Proteus mirabilis.
1.10 Lower Respiratory Tract Infections
Ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or
Streptococcus pneumoniae.
Ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to
Streptococcus pneumoniae.
Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by
Moraxella catarrhalis.
Because fluoroquinolones, including ciprofloxacin tablets, have been associatedwith serious adverse reactions
[see
Warnings and Precautions (5.1 to
5.15)]
and for some patients AECB is self-limiting, reserve ciprofloxacin tablets for treatment of AECB in patients who have no alternative treatment options.
1.11 Urinary Tract Infections
Urinary Tract Infections in Adults
Ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible
Staphylococcus epidermidis, Staphylococcus saprophyticus, or
Enterococcus faecalis.
Acute Uncomplicated Cystitis
Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by
Escherichia coli or
Staphylococcus saprophyticus.
Because fluoroquinolones, including ciprofloxacin tablets,have been associated with serious adverse reactions
[see
Warnings and Precautions (5.1 to
5.15)]
and for some patients acute uncomplicated cystitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.
Complicated Urinary Tract Infection and Pyelonephritis in Pediatric Patients
Ciprofloxacin tablets are indicated in pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to
Escherichia coli [see
Use in Specific Populations (8.4)].
Although effective in clinical trials, ciprofloxacin tablets are not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. Ciprofloxacin tablets, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals
[see
Warnings and Precautions (5.12),
Adverse Reactions (6.1),
Use in Specific Populations (8.4) and
Nonclinical Toxicology (13.2)]
.
1.12 Acute Sinusitis
Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by
Haemophilus influenzae, Streptococcus pneumoniae, or
Moraxella catarrhalis.
Because fluoroquinolones, including ciprofloxacin tablets,have been associated with serious adverse reactions
[see
Warnings and Precautions (5.1 to
5.15)]
and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute sinusitis in patients who have no alternative treatment options.
1.13 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin tablets may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.
As with other drugs, some isolates of
Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance. | 9,233 |
67c74737-6c8b-9aeb-e053-2a91aa0adf09 | f7972e5c-9e4b-45fa-e053-6394a90a5a4a | 5 | CitraNatal Medley is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. | 241 |
cd8d188a-fa5d-4580-bcb1-ac8617118cbb | 771cf601-8f92-4e4f-a29f-b18e71b1ba96 | 5 | INDICATIONS AND USAGE
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:
Addisonian (pernicious) anemia
Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy
Fish tapeworm infestation
Malignancy of pancreas or bowel
Folic acid deficiency
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin.
Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.
Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test). | 1,146 |
dfe36c38-51c7-4d58-953e-ce2d6b73ade8 | 1acd7149-8581-42b2-910d-a8b4cdf75020 | 6 | INDICATIONS AND USAGE:
Triamcinolone Acetonide Lotion USP, 0.025% and 0.1% are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. | 188 |
5b453bcb-b110-4993-e053-2991aa0a8779 | f2133373-5541-7bb7-e053-2a95a90ac3fc | 3 | Major Depressive Disorder Sertraline hydrochloride tablets USP are indicated for the treatment of major depressive disorder in adults.
The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied.
The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY).
Obsessive-Compulsive Disorder Sertraline hydrochloride tablets USP are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
The efficacy of sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY).
Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.
The efficacy of sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Panic Disorder Sertraline hydrochloride tablets USP are indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.
The efficacy of sertraline hydrochloride was established in three 10 to 12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
The efficacy of sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Posttraumatic Stress Disorder (PTSD) Sertraline hydrochloride tablets USP are indicated for the treatment of posttraumatic stress disorder in adults.
The efficacy of sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY).
PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.
The efficacy of sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Premenstrual Dysphoric Disorder (PMDD) Sertraline hydrochloride tablets USP are indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults.
The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III-R/IV category of PMDD (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY).
The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant.
The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Social Anxiety Disorder Sertraline hydrochloride tablets USP are indicated for the treatment of social anxiety disorder, also known as social phobia in adults.
The efficacy of sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY).
Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress.
The efficacy of sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe sertraline hydrochloride tablets USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL TRIALS UNDER CLINICAL PHARMACOLOGY). | 10,169 |
78d87bc5-be86-4429-8ca3-e0a883108f9b | a706be2f-5593-485d-8791-b7aa923e2dfd | 2 | INDICATIONS AND USAGE
Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma,
furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin
infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis,
infected seborrheic dermatitis, infected contact dermatitis (including poison
ivy), infected excoriations, and bacterial super-infections of fungal or viral
infections. Please Note: Gentamicin sulfate is a bactericidal agent that is not
effective against viruses or fungi in skin infections. Gentamicin sulfate is
useful in the treatment of infected skin cysts and certain other skin abscesses
when preceded by incision and drainage to permit adequate contact between the
antibiotic and the infecting bacteria. Good results have been obtained in the
treatment of infected stasis and other skin ulcers , infected superficial burns,
paronychia, infected insect bites and stings, infected lacerations and
abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be
treated with gentamicin sulfate, although regular observation of patients
sensitive to topical antibiotics is advisable when such patients are treated
with any topical antibiotic. Gentamicin Sulfate Ointment helps retain moisture
and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin
Sulfate Ointment may be used in children over one year of age as well as in
adults. | 1,431 |
e518dfc6-7e93-4fee-a66c-51e1ab71c056 | ece2f47a-8151-4f84-80ec-16cc3a7dec6a | 31 | 1 INDICATIONS AND USAGE
CAMPTOSAR is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.
CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
CAMPTOSAR is a topoisomerase inhibitor indicated for:
First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. (1)
Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. (1) | 719 |
3a3047f2-0155-4a07-955f-839a312cf879 | e0dedd11-7ac9-0344-e053-2995a90a80fe | 3 | 1 INDICATIONS AND USAGE
Eplerenone Tablets are an aldosterone antagonist indicated for:
the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (
1.2).
1.2 Hypertension
Eplerenone Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and MI. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Control of high blood pressure should be part of comprehensive CV risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce CV morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent CV outcome benefit has been a reduction in the risk of stroke, but reductions in MI and CV mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased CV risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. | 2,624 |
d42f2e61-f65a-42f2-bec5-2d248d788e78 | 6108ef1e-ac59-4a0b-bce3-bd07415ac79e | 2 | INDICATIONS AND USAGE
Hydromorphone hydrochloride tablets USP are indicated for the management of pain in patients where an opioid analgesic is appropriate. | 156 |
dd6b6088-943e-413b-9886-88dd9c622be4 | 7a3de2bf-32a1-465e-ae85-bd7e1ad1b205 | 5 | 1 INDICATIONS AND USAGE
Quetiapine is an atypical antipsychotic indicated for the treatment of:
Schizophrenia (1.1)
Bipolar I disorder manic episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
1.1 Schizophrenia
Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)].
1.2 Bipolar Disorder
Quetiapine is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see Clinical Studies (14.2)].
Quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies (14.2)].
Quetiapine is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)].
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions. | 2,472 |
24a08a93-df23-474b-873e-c59ec8855f9f | 7a6642e8-d304-47fc-acd9-0dcac4650f88 | 8 | INDICATIONS AND USAGE
0.9% Sodium Chloride Injection USP is indicated as pharmaceutic aid and diluent for the infusion of compatible drug additives. Refer to prescribing information accompanying additive drugs. | 210 |
9f87f620-e576-4a51-91d3-9a9e6819c638 | 6ef21e8d-473a-4a1c-a9a2-ecc0e7dbc0ce | 1 | Indications and Usage
Levothyroxine sodium is used for the following indications:
Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. | 1,100 |
de40cc65-f955-423f-9cbd-bc2245c4f982 | 9cea1bb9-ec9a-4d12-aec1-c6e83e01baaa | 3 | INDICATION AND USAGE
PSORCON
(diflorasone diacetate cream USP), 0.05% is a high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. | 216 |
f3b8e18e-d26e-4ae2-90f5-c01cc660ea4c | f1ec1cd7-3ef0-27bf-e053-2a95a90a3db0 | 9 | 1 INDICATIONS AND USAGE
Warfarin Sodium Tablets USP are indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin sodium tablets USP have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
Warfarin sodium tablets USP are a vitamin K antagonist indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (
1)
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement (
1)
Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction (
1)
Limitation of Use
Warfarin sodium tablets USP have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. (
1) | 1,439 |
fe1eaaea-0697-4790-8f14-b9db08d42257 | 68dd17af-8dcd-48f2-8af2-4ad02200bd19 | 102 | 1 INDICATIONS AND USAGE
Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia.
Limitation of Use:
Sodium polystyrene sulfonate for suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see
Clinical Pharmacology (12.2)
]
Sodium polystyrene sulfonate for suspension is a potassium binder indicated for thetreatment of hyperkalemia (1).
Limitation of Use:
Sodium polystyrene sulfonate for suspension should not be used an emergency treatment for life threatening hyperkalemia because of its delayed onset of action (1). | 629 |
c69e83a3-5217-ab76-e053-2995a90ae7c0 | cc330c63-1bb0-210d-e053-2995a90a2545 | 2 | Prednisone tablets are indicated in the following conditions:
1. Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)
Congenital adrenal hyperplasia
Hypercalcemia associated with cancer
Nonsuppurative thyroiditis
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Epicondylitis
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
4. Dermatologic Diseases
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Mycosis fungoides
Severe psoriasis
Severe seborrheic dermatitis
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Serum sickness
Drug hypersensitivity reactions
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Sympathetic ophthalmia
Allergic conjunctivitis
Keratitis
Chorioretinitis
Optic neuritis
Iritis and iridocyclitis
7. Respiratory Diseases
Symptomatic sarcoidosis
Loeffler's syndrome not manageable by other means
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
11. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12. Nervous System
Acute exacerbations of multiple sclerosis
13. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement | 3,094 |
2edaac6a-9fa2-48ba-bfae-3a79381482fb | c14d08c7-47b9-4209-9adb-0f8500f29564 | 6 | INDICATIONS AND USAGE
This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.
Triamterene and hydrochlorothiazide capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Triamterene and hydrochlorothiazide capsules are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.
Triamterene and hydrochlorothiazide may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide may enhance the action of these agents, dosage adjustments may be necessary.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate. | 2,112 |
abea62b3-6a55-40a4-9e68-1ee9801e0f2c | 5fdeb154-0e74-44b6-a493-ed377dd838e3 | 10 | 1 INDICATIONS AND USAGE
Simpesse (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy.
Simpesse is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1) | 364 |
cd12fae6-f277-4679-a7a8-b98719fe6fa9 | 28e0a855-0be8-480d-9aaf-bdf8be6d2df1 | 2 | 1INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.
LESCOL/LESCOL XL is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia ( )
1.1
Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy ( )
1.1
Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD( )
1.2
Slow the progression of atherosclerosis in patients with CHD ( )
1.2
Limitations of Use:
Neither LESCOL nor LESCOL XL have been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V)( )
1.3
1.1Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia
LESCOL and LESCOL XL are indicated
as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).
as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present:
LDL-C remains 190 mg/dL or
LDL-C remains
160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
two or more other cardiovascular disease risk factors are present
The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below.
Category
Total-C (mg/
dL
)
LDL-C (mg/
dL
)
Acceptable
<170
<110
Borderline
170-199
110-129
High
200
130
Children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals.
1.2Secondary Prevention of Cardiovascular Disease
In patients with clinically evident CHD, LESCOL and LESCOL XL are indicated to:
reduce the risk of undergoing coronary revascularization procedures
slow the progression of coronary atherosclerosis
1.3Limitations of Use
Neither LESCOL nor LESCOL XL have been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V). | 3,067 |
fafa4cf1-99c2-43d5-73ad-51f256de3be0 | 8dbc0210-6208-4895-b1fb-8304e5540f69 | 29 | 1 INDICATIONS AND USAGE
SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for:
Treatment of asthma in patients 6 years of age and older. (1.1)
Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. (1.2)
Important limitations:
Not indicated for the relief of acute bronchospasm. (1.1, 1.2)
1.1 Treatment of Asthma
SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older.
SYMBICORT should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA).
Important Limitations of Use:
SYMBICORT is NOT indicated for the relief of acute bronchospasm.
1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease
SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. SYMBICORT 160/4.5 is also indicated to reduce exacerbations of COPD. SYMBICORT 160/4.5 is the only strength indicated for the treatment of COPD.
Important Limitations of Use:
SYMBICORT is NOT indicated for the relief of acute bronchospasm. | 1,469 |
cde13809-a606-12ca-aece-f2ae594baa71 | c22646b3-ed67-5eb9-e053-2a95a90ab780 | 3 | INDICATIONS AND USAGE
Trianex
0.05%
(Triamcinolone Acetonide Ointment, USP
) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. | 193 |
a22a94bc-4fa7-8a4e-e053-2a95a90a6308 | b2a9ec04-4f1b-2767-e053-2995a90a7bc2 | 3 | 1
INDICATIONS & USAGE
Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting. | 560 |
ac75c6ee-e8eb-4bad-91d5-a58e64ba5d60 | eedca302-5a83-6a5c-e053-2a95a90a7144 | 25 | INDICATIONS AND USAGE
Colistimethate for Injection is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of
Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to
Proteus or
Neisseria. Colistimethate for Injection has proven clinically effective in treatment of infections due to the following gram-negative organisms:
Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, and
Pseudomonas Aeruginosa.
Colistimethate for Injection may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Colistimethate for Injection and other antibacterial drugs, Colistimethate for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. | 1,373 |
8d442b8c-97a8-40a9-8603-f9cd0542cedc | 91f49ac7-d683-4c63-9b79-355c13cc28e4 | 2 | 1 INDICATIONS AND USAGE
Ranexa is indicated for the treatment of chronic angina.
Ranexa may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
Ranexa is indicated for the treatment of chronic angina. (1) | 314 |
ec1be1bf-73bb-41c5-8fab-359a4cc53674 | 5c6c99d0-578e-49a1-847d-4b1f7cceaab6 | 2 | INDICATIONS AND USAGE
Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:
Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.
Respiratory tract infections caused by Mycoplasma pneumoniae.
Lymphogranuloma venereum caused by Chlamydia trachomatis.
Psittacosis (Ornithosis) due to Chlamydia psittaci.
Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.
Inclusion conjunctivitis caused by Chlamydia trachomatis.
Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis.
Relapsing fever due to Borrelia recurrentis.
Chancroid caused by Haemophilus ducreyi.
Plague due to Yersinia pestis.
Tularemia due to Francisella tularensis.
Cholera caused by Vibrio cholerae.
Campylobacter fetus infections caused by Campylobacter fetus.
Brucellosis due to Brucella species (in conjunction with streptomycin).
Bartonellosis due to Bartonella bacilliformis.
Granuloma inguinale caused by Calymmatobacterium granulomatis.
Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:
Escherichia coli.
Enterobacter aerogenes.
Shigella species.
Acinetobacter species.
Respiratory tract infections caused by Haemophilus influenzae.
Respiratory tract and urinary tract infections caused by Klebsiella species.
Minocycline hydrochloride capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:
Upper respiratory tract infections caused by Streptococcus pneumoniae.
Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)
When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:
Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.
Infections in women caused by Neisseria gonorrhoeae.
Syphilis caused by Treponema pallidum subspecies pallidum.
Yaws caused by Treponema pallidum subspecies pertenue.
Listeriosis due to Listeria monocytogenes.
Anthrax due to Bacillus anthracis.
Vincents infection caused by Fusobacterium fusiforme.
Actinomycosis caused by Actinomyces israelii.
Infections caused by Clostridium species.
In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides.
In severe acne, minocycline may be useful adjunctive therapy.
Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.
Oral minocycline is not indicated for the treatment of meningococcal infection.
Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. | 4,297 |
a83a55e8-58df-ac57-e053-2a95a90a9425 | a8af593b-e40f-5fad-e053-2a95a90ad5a2 | 2 | INDICATIONS & USAGE
Uses
For the treatment
and / or prevention of diaper rash temporarily and helps relieve chapped or cracked skin | 131 |
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