um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (BSA) of 1.17 m2 or greater [see Clinical Studies (14.1, 14.2)].
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in:
adult females with CD4+ cell counts greater than 250 cells/mm3 or
adult males with CD4+ cell counts greater than 400 cells/mm3[see Warnings and Precautions (5.1)].
Nevirapine extended-release tablets are an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 6 years of age or older with a BSA of 1.17 m2 or greater. (1)
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in:
adult females with CD4+ cell counts greater than 250 cells/mm3
adult males with CD4+ cell counts greater than 400 cells/mm3 (1, 5.1)
INDICATIONS & USAGE SECTION
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, 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 for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
1.1 Infections of the Ear, Nose, and Throatdue 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 Structuredue to Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.1.4 Infections of the Lower Respiratory Tractdue 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 for oral suspension, USP is not recommended for empiric treatment of gonorrhea. Amoxicillin for oral suspension, 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 for oral suspension, USP, in combination with clarithromycin plus lansoprazole as triple therapy, is 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 for oral suspension, USP, in combination with lansoprazole delayed-release capsules as dual therapy, is 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.
1. INDICATIONS AND USAGE
Hydroxychloroquine sulfate tablets is an antimalarial and antirheumatic indicated for the:
Treatment of uncomplicated malaria due to
Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients.
(1.1)
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients.
(1.1)
Treatment of rheumatoid arthritis in adults.
(1.2)
Treatment of systemic lupus erythematosus in adults.
(1.3)
Treatment of chronic discoid lupus erythematosus in adults.
(1.4)
Limitations of Use
(1.1):
Hydroxychloroquine sulfate Tablets is
not recommended for the:
Treatment of complicated malaria.
Treatment of chloroquine or hydroxychloroquine-resistant strains of
Plasmodium species.
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the
Plasmodium species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of
P. vivax or
P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of
P. vivax and
P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.
1.1 Malaria
Hydroxychloroquine sulfate tablet in indicated in adult and pediatric patients for the:
Treatment of uncomplicated malaria due to
Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and
Plasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:
Hydroxychloroquine sulfate tablet is
not recommended for:
Treatment of complicated malaria.
Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of
Plasmodium species
[see
Microbiology (12.4)].
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the
Plasmodium species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of
P. vivax or
P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of
P. vivax and
P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary
[see
Microbiology (12.4)].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention
1.
1.2 Rheumatoid Arthritis
Hydroxychloroquine sulfate tablet is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus Erythematosus
Hydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults.
Duloxetine delayed-release capsules USP are indicated for the treatment of:
Major Depressive Disorder [see Clinical Studies (14.1)]
Generalized Anxiety Disorder [see Clinical Studies (14.2)]
Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]
Chronic Musculoskeletal Pain [see Clinical Studies (14.5)]
1 INDICATIONS AND USAGE
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. (
1)
1 INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated in adults for:
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (1.1).
Maintenance of Healing of Erosive or Ulcerative GERD (1.2).
Treatment of Symptomatic GERD (1.3).
Healing of Duodenal Ulcers (1.4).
Helicobacter pyloriEradication to Reduce Risk of Duodenal Ulcer Recurrence (1.5).
Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (1.6).
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD (1.7).
1.1 Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Rabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
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 [seeClinical Pharmacology (12.2)
and the full prescribing information for clarithromycin].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
1 INDICATIONS & USAGE
Pantoprazole Sodium Delayed-Release Tablets are indicated for:
Pantoprazole sodium delayed-release tablet is a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated withGastroesophageal 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 Tablet is 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 Syndrome
Pantoprazole Sodium Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) syndrome.
1 INDICATIONS AND USAGE
ULTRAVIST Injection is an iodinated contrast agent indicated for:
ULTRAVIST (iopromide) Injection is a radiographic contrast agent indicated for:
Cerebral arteriography and peripheral arteriography (300 mg Iodine per mL) (1.1)
Coronary arteriography and left ventriculography, visceral angiography and aortography (370 mg Iodine per mL) (1.1)
Excretory urography (300 mg Iodine per mL) (1.2)
Contrast computed tomography (CT) imaging of head and body (300 mg Iodine per mL and 370 mg Iodine per mL) (1.2)
1.1 Intra-Arterial Procedures*
300 mg Iodine per mL for cerebral arteriography and peripheral arteriography
370 mg Iodine per mL for coronary arteriography and left ventriculography, visceral angiography, and aortography
1.2 Intravenous Procedures*
300 mg Iodine per mL for excretory urography
300 mg Iodine per mL and 370 mg Iodine per mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.
*For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration (2.3) and Use in Specific Populations (8.4)].
1 INDICATIONS AND USAGE
Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine extended-release capsules are an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults. (1)
1 INDICATIONS AND USAGE
Pregabalin capsules are indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pediatric use information is approved for Pfizers LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizers marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Pregabalin is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatment options before deciding to use naproxen tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Naproxen, USP as naproxen tablets, USP is indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritis
For relief of the signs and symptoms of tendonitis
For relief of the signs and symptoms of bursitis
For relief of the signs and symptoms of acute gout
For the management of pain
For the management of primary dysmenorrhea
1 INDICATIONS AND USAGE
Gabapentin capsules, USP are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin is indicated for:
Postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization in adults and pediatric patients 3 years and older with epilepsy
1 INDICATIONS AND USAGE
Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of:
mild to
severe chronic heart failure (
1.1)
left
ventricular dysfunction following myocardial infarction in clinically
stable patients(
1.2)
hypertension(
1.3)
1.1 Heart Failure
Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [
see Drug Interactions (
7.4) and Clinical Studies (14.1)
].
1.2 Left Ventricular Dysfunction following Myocardial Infarction
Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [
see
Clinical Studies (
14.2)
].
1.3 Hypertension
Carvedilol tablets are indicated for the management of essential hypertension [
see
Clinical Studies (
14.3,
14.4)]
. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [
see
Drug Interactions (
7.2)]
.
INDICATIONS AND USAGE
For Dermatologic Use: Salicylic Acid 6% Foam is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses,
keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris and psoriasis.
For Podiatric Use: Salicylic Acid 6% Foam is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.
1.2 Adenocarcinoma of the Breast
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.
Ezetimibe Tablet is 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 has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1.1 Primary Hyperlipidemia
Monotherapy
Ezetimibe Tablets, administered alone, is 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, is 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 Tablet is 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 has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
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.
1.1 Prevention of Cardiovascular Disease
In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets USP are indicated to:
reduce the risk of myocardial infarction (MI).
reduce the risk of undergoing myocardial revascularization procedures.
reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.
1.2 Hyperlipidemia
Pravastatin sodium tablets USP are indicated:
as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb).1
as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV).
for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.
as an adjunct to diet and lifestyle modification for treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescent patients ages 8 years and older if after an adequate trial of diet the following findings are present:
a. LDL-C remains 190 mg/dL or
b. LDL-C remains 160 mg/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 patient.
1.3 Limitations of Use
Pravastatin sodium tablets USP have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).