um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
AmBisome is indicated for the following:
Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
Treatment of Cryptococcal Meningitis in HIV-infected patients (see
DESCRIPTION OF CLINICAL STUDIES
).
Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.
Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with AmBisome, relapse rates were high following initial clearance of parasites (see
DESCRIPTION OF CLINICAL STUDIES
).
See
DOSAGE AND ADMINISTRATION
for recommended doses by indication.
INDICATIONS AND USAGE
Atenolol and chlorthalidone tablets 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 atenolol and chlorthalidone.
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 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 (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.
1 INDICATIONS AND USAGE
Cinacalcet is a positive modulator of the calcium sensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (
1.1)
Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis
Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (
1.2)
Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (
1.3)
1.1
Secondary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis
[see Clinical Studies (
14.1)].
Limitations of Use:
Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia
[see Warnings and Precautions (
5.1)].
1.2	Parathyroid Carcinoma
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma
[see Clinical Studies (
14.2)].
1.3	Primary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy
[see Clinical Studies (
14.3)].
INDICATIONS AND USAGE
Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by Streptococcuspneumoniae and Streptococcuspyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to Streptococcuspneumoniae, Haemophilusinfluenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxellacatarrhalis
Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes
Bone infections caused by Staphylococcus aureus and/or Proteusmirabilis
Genitourinary tract infections, including acute prostatitis, caused by Escherichiacoli, Proteusmirabilis, and Klebsiellapneumoniae
Note
Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, 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.
INDICATIONS AND USAGE
Catapres-TTS (clonidine) transdermal therapeutic system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
Hydrocodone bitartrate and acetaminophen tablets USP are, indicated for the relief of moderate to moderately severe pain.
Please review the manufacturer's complete drug information available from the FDA at:
www.fda.gov
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=60f43308-1deb-4f05-8f17-aa49ebdcf498
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.
1.1 Treatment of Influenza
Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1 INDICATIONS AND USAGE
Rizatriptanbenzoate orally disintegrating tablets are indicated for the acute treatment ofmigraine with or without aura in adults and in pediatric patients 6 to 17 yearsold.
Limitations of Use
Rizatriptan benzoate orally disintegrating 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 orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate orally disintegrating 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 INDICATIONS AND USAGE
Methadone Hydrochloride Oral Solution is indicated for the:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [
see Warnings and Precautions (5.2)
], reserve Methadone Hydrochloride Oral Solution for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone Hydrochloride Oral Solution is not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject tothe conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)
].
Methadone Hydrochloride Oral Solution is an opioid agonist indicated for the:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve Methadone Hydrochloride Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone Hydrochloride Oral Solution is not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 (2.1).
1
INDICATIONS AND USAGE
TARPEYO is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) 1.5 g/g.
This indication is approved under accelerated approval based on a reduction in proteinuria. It has not been established whether TARPEYO slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
TARPEYO is a corticosteroid indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR)
1.5 g/g. (1)
This indication is approved under accelerated approval based on a reduction in proteinuria.
It has not been established whether TARPEYO slows kidney function decline in patients with IgAN.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. (1)
INDICATIONS AND USAGE
Norethindrone Acetate Tablets USP are indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norethindrone Acetate Tablets USP are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
1INDICATIONS AND USAGE
Pravastatin sodium tablets are indicated:
1.To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD).
2.To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.
3.As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.
4.As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
5. As an adjunct to diet for the treatment of adults with:
1.2.Primary dysbetalipoproteinemia.
2.2.Hypertriglyceridemia.
Pravastatin sodiumtablets are an HMG-CoA reductase inhibitor (statin) indicated (1):
To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD).
To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.
As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.
As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to diet for the treatment of adults with:
3.2.Primary dysbetalipoproteinemia.
4.2.Hypertriglyceridemia.
1 INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of major depressive disorder (MDD) in adult and pediatric patients aged 8 to 18 years. (1.1)
Acute and maintenance treatment of obsessive compulsive disorder (OCD) in adult and pediatric patients aged 7 to 17 years. (1.2)
Acute and maintenance treatment of bulimia nervosa in adult patients. (1.3)
Acute treatment of panic disorder, with or without agoraphobia, in adult patients. (1.4)
Fluoxetine and olanzapine in combination for:
Acute treatment of depressive episodes associated with bipolar I disorder in adults. (1.5)
1.1 Major Depressive Disorder
Fluoxetine capsules are indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to18 years [see Clinical Studies (14.1)].
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be reevaluated [see
Dosage and Administration (2.1)
].
1.2 Obsessive Compulsive Disorder
Fluoxetine capsules are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder (OCD) [see Clinical Studies (14.2)].
The effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules for extended periods, should periodically reevaluate the long-term usefulness of the drug for the individual patient [see
Dosage and Administration (2.2)
].
1.3 Bulimia Nervosa
Fluoxetine capsules are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe bulimia nervosa [see Clinical Studies (14.3)].
The physician who elects to use fluoxetine capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].
1.4 Panic Disorder
Fluoxetine capsules are indicated for the acute treatment of panic disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)].
The effectiveness of fluoxetine in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules for extended periods, should periodically reevaluate the long-term usefulness of the drug for the individual patient [see
Dosage and Administration (2.4)
].
1.5 Fluoxetine and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I Disorder
When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Fluoxetine and olanzapine in combination is indicated for the acute treatment of depressive episodes associated with bipolar I disorder in adult patients.
Fluoxetine capsule monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.
1 INDICATIONS AND USAGE
CALDOLOR is indicated in adults and pediatric patients aged 3 months and older for the:
management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics
reduction of fever
CALDOLOR is a nonsteroidal anti-inflammatory drug indicated in adults and pediatric patients aged 3 months and older for the:
Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics (1)
Reduction of fever (1)
1 INDICATIONS AND USAGE
Solifenacin Succinate Tabletsare indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Solifenacin Succinate Tablets area muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. (
1)
INDICATIONS AND USAGE
Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see
Warnings
). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.
If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
1 INDICATIONS & USAGE
Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].
Tobramycin inhalation solution is an aminoglycoside antibacterial indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. (1)
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonized with Burkholderia cepacia. (1)
INDICATIONS
Chlorhexidine Gluconate Oral Rinse, 0.12% is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine Gluconate Oral Rinse, 0.12% has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see
PRECAUTIONS.