um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Testosterone gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.
Limitations of Use:
Safety and efficacy of testosterone gel in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
Safety and efficacy of testosterone gel in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Dosage and Administration (2) and Clinical Pharmacology (12.3)].
Testosterone gel is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired). (1)
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of Use:
Safety and efficacy of testosterone gel in men with age-related hypogonadism have not been established (1)
Safety and efficacy of testosterone gel in males less than 18 years old have not been established (8.4)
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure (1, 12.3)
1 INDICATIONS AND USAGE
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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
Testosterone Gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.
Limitations of use:
Safety and efficacy of Testosterone Gel 1% in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of Testosterone Gel 1% in males less than 18 years old have not been established [see Use in Specific Populations (8.4)].
Topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure (1, 12.3).
Testosterone Gel 1% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired). (1)
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of use:
Safety and efficacy of Testosterone Gel 1% in men with age-related hypogonadism have not been established. (1)
Safety and efficacy of Testosterone Gel 1% in males less than 18 years old have not been established. (8.4)
Topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure. (1, 12.3)
1 INDICATIONS AND USAGE
FUZEON in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
FUZEON is an HIV-1 gp41 fusion inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with HIV-1 replication despite ongoing antiretroviral therapy. (1)
1 INDICATIONS AND USAGE
NORDITROPINis a recombinant human growth hormone indicated for:
Pediatric: Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated withNoonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome (1.1)
Adult: Replacement of endogenous GH in adults with growth hormone deficiency (1.2)
1.1 Pediatric Patients
NORDITROPIN is indicated for the treatment of pediatric patients with:
growth failure due to inadequate secretion of endogenous growth hormone (GH),
short stature associated with Noonan syndrome,
short stature associated with Turner syndrome,
short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age,
Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range,
growth failure due to Prader-Willi syndrome (PWS).
1.2 Adult Patients
NORDITROPINis indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)
INDICATIONS AND USAGE
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
INDICATIONS AND USAGE
Cordran Lotion is indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses.
1 INDICATIONS AND USAGE
RYTHMOL SR is 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.
Usage Considerations:
The use of RYTHMOL SR in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use RYTHMOL SR 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 effect of propafenone on mortality has not been determined [see Boxed Warning].
RYTHMOL SR is 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)
Usage Considerations:
Use in patients with permanent atrial fibrillation or with atrial flutter or paroxysmal supraventricular tachycardia (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 RYTHMOL SR with drugs that increase the atrioventricular nodal refractory period. (1)
The effect of propafenone on mortality has not been determined. (1)
INDICATIONS AND USAGE
Hypertension Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Coronary Artery Disease (CAD)
Chronic Stable Angina
Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina)
Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal drugs.
Angiographically Documented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.
1	INDICATIONS AND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet (1.3)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5)
Limitations of use (1.8): Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1.3 Hypertriglyceridemia
Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1 INDICATIONS AND USAGE
Pantoprazole is a proton pump inhibitor indicated (PPI) 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)
Pantoprazole sodium delayed-release tablets are indicated for:
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 AND USAGE
Oxandrin is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or tomaintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis (See DOSAGE AND ADMINISTRATION).
INDICATIONS & USAGE
Zaleplon is indicated for the short-term treatment of insomnia. Zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trialsunder CLINICAL PHARMACOLOGY). It has not been shown to increase total sleep time or decrease the number of awakenings.
The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.
1 INDICATIONS AND USAGE
Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
Busulfan injection is an alkylating drug indicated for:
Use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML). (1)
1 INDICATIONS AND USAGE
Prasugrel tablets is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows:
Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) (1.1).
Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (1.1).
1.1 Acute Coronary Syndrome
Prasugrel tablets is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
Prasugrel tablets has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablet is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (
1)
1 INDICATIONS AND USAGE
XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. (1.1)
1.1 Relapsed or Refractory Acute Myeloid Leukemia
XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
INDICATIONS AND USAGE
Lidocaine and prilocaine cream, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
- normal intact skin for local analgesia.
- genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and prilocaine cream, 2.5%/2.5% is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).
1 INDICATIONS AND USAGE
Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
[see
Clinical Studies (14)].
Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (
1)
Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important.
1 INDICATIONS AND USAGE
Clobazam is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Clobazam is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older (1)
1 INDICATIONS AND USAGE
Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. (1.1)
Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Do not use if atrophy is present at the treatment site. (1.2)
Do not use for rosacea or perioral dermatitis. (1.2)
1.1 Indication
Clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
Patients should be instructed to use clobetasol propionate spray, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2)].
Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations formulations [see Use in Specific Populations (8.4)].
1.2 Limitations of Use
Clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.