um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Endocrine DisordersPrimary 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 hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancerRheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy):Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis or osteoarthritisEpicondylitisCollagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditisSystemic dermatomyositis (polymyositis)Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitisAllergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactionsOphthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmiaRespiratory DiseaseSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapyAspiration pneumonitisHematologic DisorderIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemiaNeoplastic DiseaseFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhoodEdematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosusGastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritisMiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement
1 INDICATIONS AND USAGE
Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
Donepezil hydrochloride tablet, is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease (
1).
1 INDICATIONS AND USAGE
PEXEVA is indicated in adults for the treatment of:
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Generalized anxiety disorder (GAD)
PEXEVA is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of:
Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder (PD)
Generalized Anxiety Disorder (GAD)
INDICATIONS AND USAGE
Ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur
or
M. orbiculare).
Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
INDICATIONS & USAGE
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.)
ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING).
1 INDICATIONS AND USAGE
Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
INDICATIONS AND USAGE
Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
1 INDICATIONS AND USAGE
Levocetirizine dihydrochloride is a histamine H1-receptor antagonist indicated for:
The relief of symptoms associated with seasonal and perennial allergic rhinitis (1.1, 1.2)
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.3)
1.1
Seasonal Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.
1.2
Perennial Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older.
1.3
Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children
6 months of age and older.
INDICATIONS AND USAGE
Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to:
help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic.
prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. Amiloride HCl has little additive diuretic or antihypertensive effect when added to a thiazide diuretic.
Amiloride HCl should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including amiloride HCl, result in an increased risk of hyperkalemia (approximately 10% with amiloride). Amiloride HCl should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes.
1 INDICATIONS AND USAGE
Benazepril hydrochloride tablets are 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.
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 mm Hg 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.
It may be used alone or in combination with thiazide diuretics.
Benazepril hydrochloride is an angiotensin-converting enzyme (ACE) inhibitor 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)
1 INDICATIONS AND USAGE
Propafenone hydrochloride tablets are indicated to:
prolong
the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF)
associated with disabling symptoms in patients without structural heart
disease.
prolong
the time to recurrence of paroxysmal supraventricular tachycardia (PSVT)
associated with disabling symptoms in patients without structural heart
disease.
treat
documented ventricular arrhythmias, such as sustained ventricular
tachycardia that, in the judgment of the physician, are life-threatening.
Initiate treatment in the hospital.
Usage Considerations:
The
use of propafenone hydrochloride tablets in patients with permanent atrial
fibrillation (AF) or in patients exclusively with atrial flutter or PSVT
has not been evaluated. Do not use propafenone hydrochloride tablets to
control ventricular rate during AF.
Some
patients with atrial flutter treated with propafenone have developed 1:1
conduction, producing an increase in ventricular rate. Concomitant
treatment with drugs that increase the functional atrioventricular (AV)
nodal refractory period is recommended.
The
use of propafenone hydrochloride tablets in patients with chronic atrial
fibrillation has not been evaluated.
Because
of the proarrhythmic effects of propafenone hydrochloride tablets, its use
with lesser ventricular arrhythmias is not recommended, even if patients
are symptomatic, and any use of the drug should be reserved for patients
in whom, in the opinion of the physician, the potential benefits outweigh
the risks.
The
effect of propafenone on mortality has not been determined [see Boxed Warning] .
Propafenone hydrochloride tablets are an antiarrhythmic indicated to:
prolong
the time to recurrence of symptomatic atrial fibrillation (AF) in patients
with episodic (most likely paroxysmal or persistent) AF who do not have
structural heart disease. (1)
prolong
the time to recurrence of paroxysmal supraventricular tachycardia (PSVT)
associated with disabling symptoms in patients who do not have structural
heart disease. (1)
treat
documented life-threatening ventricular arrhythmias. (1)
Usage Considerations:
Use
in patients with permanent atrial fibrillation or with atrial flutter or
PSVT has not been evaluated. Do not use to control ventricular rate during
atrial fibrillation. (1)
In
patients with atrial fibrillation and atrial flutter, use propafenone
hydrochloride tablets with drugs that increase the atrioventricular nodal
refractory period. (1)
Because
of proarrhythmic effects, use with lesser ventricular arrhythmias is not
recommended, even if patients are symptomatic. (1)
The
effect of propafenone on mortality has not been determined. (1)
1 INDICATIONS AND USAGE
Tacrolimus capsules are calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney or heart transplants and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants. (
1.1
)
1.1 Prophylaxis of Organ Rejection in Kidney, Liver and Heart Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [
see Clinical Studies (14.1)
], liver transplants [
see Clinical Studies (14.2)
] and heart transplant [
see
Clinical Studies (14.3)
], and pediatric patients receiving allogeneic liver transplants [
see
Clinical Studies (14.2)
] in combination with other immunosuppressants.
Additional pediatric use information is approved for Astellas Pharma US, Inc.s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
INDICATIONS AND USAGE
Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see
CLINICAL PHARMACOLOGY-Susceptibility Test Methods
).
Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistantStaphylococcus sp., therapy with Nafcillin for Injection, USP should be discontinued and alternative therapy provided.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection, USPand other antibacterial drugs, Nafcillin for Injection, USPshould 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.
INDICATIONS AND USAGE
Terconazole Vaginal Cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
1 INDICATIONS AND USAGE
Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older.
Clindamycin phosphate and tretinoin gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older. (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 hyperlipidemia. Niacin 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.
Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Niacin extended-release tablets in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
Limitations of Use
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see
Warnings and Precautions
(5.1)
].
Niacin extended-release tablets contain extended-release niacin (nicotinic acid), and are indicated:
To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. (1)
To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. (1)
In combination with a bile acid binding resin:
Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. (1)
As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. (1)
To reduce TG in adult patients with severe hypertriglyceridemia. (1)
Limitations of use:
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial. (5.1)
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are indicated for:
Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). (
1.1)
Maintenance of Healing of Erosive Esophagitis. (
1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome. (
1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
INDICATIONS & USAGE
Herpes Zoster Infections:
Acyclovir Oral Suspension, USP is indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes:
Acyclovir Oral Suspension, USP is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox:
Acyclovir Oral Suspension, USP is indicated for the treatment of chickenpox (varicella).
1 INDICATIONS AND USAGE
Promethazine Hydrochloride 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) and Use in Specific Populations (8.4)].
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) and 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride 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.
1.5 Urinary Tract Infections
caused by betalactamaseproducing isolates of E. coli, Klebsiellaspecies, and Enterobacter species.
1 INDICATIONS AND USAGE
Omega-3-acid ethyl esters is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia (HTG).
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl esters.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use:
The effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined.
The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined.
Omega-3-acid ethyl esters is a combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia (HTG).
Limitations of Use:
The effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. (1)
The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined. (1)