um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Citalopram tablets, USP are indicated for the treatment of depression.
The efficacy of citalopram in the treatment of depression was established in 4 to 6 week; controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USP in hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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 non-pharmacologic measures alone has been inadequate.
Ezetimibe
tablets are an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to:
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) (
1.1)
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate (
1.1)
Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin (
1.2)
Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) (
1.3)
Limitations of Use (
1.4)
The effect of ezetimibe tablets on cardiovascular morbidity and mortality has not been determined.
Ezetimibe tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1.1	Primary Hyperlipidemia
Monotherapy
Ezetimibe tablets, administered alone, are indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Combination Therapy with HMG-CoA Reductase Inhibitors (Statins)
Ezetimibe tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Combination Therapy with Fenofibrate
Ezetimibe tablets administered in combination with fenofibrate, are indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia.
1.2	Homozygous Familial Hypercholesterolemia (HoFH)
The combination of ezetimibe tablets and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3	Homozygous Sitosterolemia
Ezetimibe tablets are indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
1.4	Limitations of Use
The effect of ezetimibe tablets on cardiovascular morbidity and mortality has not been determined.
Ezetimibe tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ibuprofen Oral Suspension and other treatment options before deciding to use Ibuprofen Oral Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
In Pediatric Patients, Ibuprofen Oral Suspension is indicated:
For reduction of fever in patients aged 6 months up to 2 years of age.
For relief of mild to moderate pain in patients aged 6 months up to 2 years of age.
For relief of signs and symptoms of juvenile arthritis.
In Adults, Ibuprofen Oral Suspension is indicated:
For treatment of primary dysmenorrhea.
For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see
PRECAUTIONS - Drug Interactions
).
INDICATIONS & USAGE SECTION
Tramadol Hydrochloride Extended-Release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
1 INDICATIONS AND USAGE
CIBINQO is indicated for the treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
CIBINQO is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. (1)
Limitation of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
Limitations of Use
CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
INDICATIONS & USAGE
Prednisone Tablets, USP are indicated in the following conditions:
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
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
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.
Dermatologic Diseases
Pemphigus, Bullous dermatitis herpetiformis, severe erythema multiforme (stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis.
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.
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.
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.
Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.
Neoplastic Diseases
For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
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
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis
Nervous System
Acute exacerbations of multiple sclerosis
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement
1 INDICATIONS AND USAGE
Eptifibatide injection is a platelet aggregation inhibitor indicated for:
Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI). (1.1)
Treatment of patients undergoing PCI (including intracoronary stenting). (1.2)
1.1 Acute Coronary Syndrome (ACS)
Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).
1.2 Percutaneous Coronary Intervention (PCI)
Eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new MI, or need for urgent intervention in patients undergoing PCI, including those undergoing intracoronary stenting [seeClinicalStudies(14.1, 14.2)].
1 INDICATIONS AND USAGE
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glipizide extended-release tablet is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis
1.1 Limitations of Use
Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
1 INDICATIONS AND USAGE
Frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Use only if a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks.
Frovatriptan succinate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache.
Frovatriptan succinate is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. (1)
Limitations of Use
Use only after a 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)
INDICATIONS AND USAGE
Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as:
Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung)Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis)Pulmonary complications of cystic fibrosisTracheostomy carePulmonary complications associated with surgeryUse during anesthesiaPost-traumatic chest conditionsAtelectasis due to mucous obstructionDiagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization)
1 INDICATIONS AND USAGE
Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD
[see Clinical Studies (
14)].
Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (
1)
1 INDICATIONS AND USAGE
Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)
].
Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)
].
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)
].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)
], reserve Promethazine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Promethazine HCl and Codeine Phosphate Oral Solution is a combination of codeine, an opioid agonist; and promethazine, a phenothiazine, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. (1)
Important Limitations of Use (
1
)
Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Promethazine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
1 INDICATIONS AND USAGE
Diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee(s). (1)
INDICATIONS AND USAGE
Clonidine hydrochloridetablets USP are indicated in the treatment of hypertension. Clonidine hydrochloridetablets USPmay be employed alone or concomitantly with other antihypertensive agents.
1
INDICATIONS AND USAGE
Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [
see Dosage and Administration (
2)
].
CARISOPRODOL Tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (
1)
Limitations of Use:
Should only be used for acute treatment periods up to two or three weeks (
1)
INDICATIONS AND USAGE
Vancomycin hydrochloride for injection is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin hydrochloride for injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by
S. viridans or S. bovis. For endocarditis caused by enterococci (e.g.,
E. faecalis), vancomycin hydrochloride for injection has been reported to be effective only in combination with an aminoglycoside.
Vancomycin hydrochloride for injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by
S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection and other antibacterial drugs, vancomycin hydrochloride 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.
The parenteral form of vancomycin hydrochloride for injection may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by
C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.
INDICATIONS AND USAGE
Angina Pectoris
Nadolol tablets, USP are indicated for the long-term management of patients with angina pectoris.
Hypertension
Nadolol is 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. 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 Nadolol.
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 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.
Nadolol may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
1 INDICATIONS AND USAGE
Nevirapine is indicated for combination antiretroviral treatment of HIV-1 infection in adults and in pediatrics patients 15 days and older [
see Clinical Studies (14.1)
, (14.2)
].
Additional important information regarding the use of nevirapine for the treatment of HIV-1 infection:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [
see Boxed Warning and Warnings and Precautions (5.1)
].The 14-day lead-in period with nevirapine 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [
see Dosage and Administration (2.4)
and
Warnings and Precautions (5.2)
].If rash persists beyond the 14-day lead-in period, do not dose escalate to 200 mg twice daily.The 200 mg once-daily dosing regimen should not be continued beyond 28 days, at which point an alternative regimen should be sought.
Nevirapine is an NNRTI indicated for combination antiretroviral treatment of HIV-1 infection in adults and in pediatric patients 15 days and older.
(1)
Important Considerations:
Initiation of treatment is not recommended in the following populations unless the benefits outweigh the risks
( 1
,
5.1)
adult females with CD4+ cell counts greater than 250 cells/mm3
adult males with CD4+ cell counts greater than 400 cells/mm3
The 14-day lead-in period must be strictly followed; it has been demonstrated to reduce the frequency of rash ( 2.4,
5.2 )