um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Nitroglycerin sublingual tablets, USP are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
1 INDICATIONS AND USAGE
Fenofibrate tablets are a are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (
1.1
).
For treatment of adult patients with severe hypertriglyceridemia (
1.2
).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (
5.1
).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (
5.1
)].
1 INDICATIONS AND USAGE
Nicardipine hydrochloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible.
1.1 Hypertension
Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.6)].
INDICATIONS AND USAGE
Desoximetasone cream, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Posaconazole delayed-release tablets is an azole antifungal agent indicated as follows: (
1)
Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive
Aspergillus and
Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graftversushost disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (
1.2)
Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older (
1)
1.2 Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole is indicated for the prophylaxis of invasive
Aspergillus and
Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
[see Clinical Studies (
14.2)]
as follows:
Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
KEPPRA is indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
KEPPRA injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible (1.4)
1.1
Partial-Onset Seizures
KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2
Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
KEPPRA is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3
Primary Generalized Tonic-Clonic Seizures
KEPPRA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1.4	Limitations of Use
KEPPRA injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
INDICATIONS AND USAGE
Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infec- tion in the following settings:
Acute Exposure to Blood Containing HBsAg:
Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum.
Perinatal Exposure of Infants Born to HBsAg-positive Mothers:
Infants born to mothers positive for HBsAg with or without HBeAg
12.
Sexual Exposure to HBsAg-positive Persons:
Sexual partners of HBsAg-positive persons.
Household Exposure to Persons with Acute HBV Infection:
Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg. Other household contacts with an identifiable blood exposure to the index patient.
Nabi-HB is indicated for intramuscular use only.
1 INDICATIONS AND USAGE
Fluoxetine tablets are indicated for the treatment of:
Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5 week trial, three 6 week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8 to 9 week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)].
Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13 week trials in adults and one 13 week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)].
Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8 week trials and one 16 week trial in adults [see Clinical Studies (14.3)].
Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12 week trials in adults [see Clinical Studies (14.4)].
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of:
Major Depressive Disorder (MDD) (1)
Adults: Efficacy was established in one 5 week trial, three 6-week trials, and one maintenance study (14.1)
Pediatrics: Efficacy was established in two 8 to 9 week trials of patients 8 to 18 years of age (14.1)
Obsessive Compulsive Disorder (OCD) (1)
Adults: Efficacy was established in two 13 week trials (14.2)
Pediatrics: Efficacy was established in one 13 week trial in patients 7 to 17 years of age (14.2)
Bulimia Nervosa (1)
Adults: Efficacy was established in two 8 week trials and one 16 week trial (14.3)
Panic Disorder, with or without agoraphobia (1)
Adults: Efficacy was established in two 12 week trials (14.4)
1.1 Acute Bacterial Exacerbation of Chronic Bronchitis
Clarithromycin tablets, USP are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae,
Haemophilus parainfluenzae,
Moraxella catarrhalis, or
Streptococcus pneumoniae[see Indications and Usage
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]
.
1 INDICATIONS AND USAGE
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney
[see
Clinical Studies (14.1)],
heart
[see
Clinical Studies (14.2)]
or liver transplants
[see
Clinical Studies (14.3)]
, in combination with other immunosuppressants.
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (
1)
INDICATIONS AND USAGE
Hypertension
Ramipril is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.In using ramipril, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that ramipril does not have a similar risk. (See WARNINGS.)In considering use of ramipril, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (see WARNINGS, Angioedema.)
1 INDICATIONS AND USAGE
Teriparatide injection is a parathyroid hormone analog (PTH 1-34) indicated for:
Treatment of postmenopausal women with osteoporosis at high risk for fracture (1.1)
Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture (1.2)
Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture (1.3)
1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Teriparatide injection is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures [see Clinical Studies (14.1)].
1.2 Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture
Teriparatide injection is indicated to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies (14.2)].
1.3 Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture
Teriparatide injection is indicated for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies (14.3)].
INDICATIONS AND USAGE
Oxycodone and acetaminophen tablets are indicated for the management of
pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Migraine
Propranolol hydrochloride tablets USP are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
1 INDICATIONS AND USAGE
PREVDUOTM, a fixed dose combination of cholinesterase inhibitor and antimuscarinic agent, is indicated in patients age two years and above for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration.
PREVDUOTM, a fixed dose combination of a cholinesterase inhibitor and antimuscarinic agent, is indicatedin patients age two years and above for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibitionfollowing NMBA reversal administration (1).
1 INDICATIONS AND USAGE
Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m
2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron orally disintegrating tablets are a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50mg/m
2.
(1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
(1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
(1)
postoperative nausea and/or vomiting.
(1)
1 INDICATIONS AND USAGE
INSPRA is an aldosterone antagonist indicated for:
Improving survival of stable patients with LV systolic dysfunction (LVEF 40%) and CHF after an acute myocardial infarction. (1.2)
Hypertension, alone or combined with other agents. (1.3)
1.1 Patient Selection Considerations
Serum potassium levels should be measured before initiating INSPRA therapy, and INSPRA should not be prescribed if serum potassium is >5.5 mEq/L. [See CONTRAINDICATIONS (4)].
1.2 Congestive Heart Failure Post-Myocardial Infarction
INSPRA is indicated to improve survival of stable patients with left ventricular (LV) systolic dysfunction (ejection fraction 40%) and clinical evidence of congestive heart failure (CHF) after an acute myocardial infarction (MI).
1.3 Hypertension
INSPRA is indicated for the treatment of hypertension. INSPRA may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
1 INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
Hypertension (1.3)
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol tablets, USP areindicated 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 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].
1.3 Hypertension
Carvedilol tablets, USP 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)].
1 INDICATIONS AND USAGE
Sincalide for Injection is indicated in adults to:
stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals;
stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology;
accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract.
Sincalide for Injection is a cholecystokinin (CCK) analog indicated in adults to:
stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals. (1)
stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology. (1)
accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. (1)
INDICATIONS & USAGE
Ethacrynic Acid Tablets USP, are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required.
Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.
Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema.
Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome.
Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion 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)]
.
The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial
[see Clinical Studies (
14)]
.
Bupropion hydrochloride extended-release tablets, (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (
1)
1 INDICATIONS AND USAGE
Hypothyroidism
UNITHROID is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
UNITHROID is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
UNITHROID is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with UNITHROID may induce hyperthyroidism [see Warnings and Precautions (
5.4
)].
UNITHROID is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
UNITHROID is L-thyroxine (T4) indicated in pediatric and adult patients for:
Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)
Limitations of Use:
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (1)
Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (1)
1 INDICATIONS AND USAGE
Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (
1)
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)].