um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Fenofibrate tablets are a peroxisome proliferator receptor alpha (PPAR) activator 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)
to treat adult patients with severe hypertriglyceridemia. (1.2)
Important Limitation 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 and 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 (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein (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 reduce fasting triglycerides and eliminate chylomicronemia thereby obviating 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 tablets therapy on reducing this risk has not been adequately studied.
1.3	Important Limitations of Use
Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
1. Indications and Usage Section
INDICATIONS AND USAGE
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see CLINICAL STUDIES (14)].
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to
2
or
3
weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
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 Tests
).
Nafcillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. 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 an organism other than a resistant Staphylococcus, therapy should not be continued with Nafcillin for Injection, USP.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs, Nafcillin for Injection 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.
1 INDICATIONS AND USAGE
Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. (1)
Teriflunomide is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
1 INDICATIONS AND USAGE
Rocuronium Bromide Injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Rocuronium Bromide is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
1 INDICATIONS AND USAGE
VASCEPA (icosapent ethyl) is indicated:
as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels ( 150 mg/dL) and
established cardiovascular disease or
diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.
as an adjunct to diet to reduce TG levels in adult patients with severe ( 500 mg/dL) hypertriglyceridemia.
Limitations of Use:
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated:
as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels( 150 mg/dL) and
established cardiovascular disease or
diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. (1)
as an adjunct to diet to reduce TG levels in adult patients with severe ( 500 mg/dL) hypertriglyceridemia. (1)
Limitations of Use:
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. (1)
1 INDICATIONS AND USAGE
Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) (1).
1.1	Obsessive-Compulsive Disorder
Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.
The efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 to 17), and one maintenance trial in adults [see Clinical Studies (14)].
INDICATIONS AND USAGE
Calcipotriene ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
1 INDICATIONS & USAGE
Atovaquone oral suspension is a quinone antimicrobial drug indicated for:
Prevention of
Pneumocystisjirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).(
1.1)
Treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX
.(1.2)
Limitations of Use
(1.3):
Treatment of severe PCP (alveolar arterial oxygen diffusion gradient [(A-a)DO
2] >45 mm Hg) with atovaquone oralsuspension has not been studied.
The efficacy of atovaquone oral suspension in subjects who are failing therapy with TMP-SMX has also not been studied.
1.1 Prevention of Pneumocystis jiroveci Pneumonia
Atovaquone oral suspension is indicated for the prevention of
Pneumocystisjirovecii pneumonia (PCP) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
1.2 Treatment of Mild-to-Moderate Pneumocystis jirovecii Pneumonia
Atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate PCP in adults and adolescents (aged 13 years and older) who cannot tolerate TMP-SMX.
1.3 Limitations of Use
Clinical experience with atovaquone for the treatment of PCP has been limited to subjects with mild-to-moderate PCP (alveolar-arterial oxygen diffusion gradient [(A-a)DO
2] 45 mm Hg). Treatment of more severe episodes of PCP with atovaquone has not been studied. The efficacy of atovaquone in subjects who are failing therapy with TMP-SMX has also not been studied.
1 Indications and Usage
Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of:
active duodenal ulcer.
active gastric ulcer.
symptomatic non-erosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
Famotidine tablets are indicated in adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-
Ellison Syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcer recurrence.
Famotidine is a histamine-2 (H2) receptor antagonist indicated (1):
In adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer.
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
In adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison
syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
1 INDICATIONS AND USAGE
Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks.
Sumatriptan tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.
Sumatriptan tablets are a serotonin (5-HT
1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. (
1)
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. (
1)
Not indicated for the prophylactic therapy of migraine attacks. (
1)
Not indicated for the treatment of cluster headache. (
1)
1 INDICATIONS AND USAGE
Isoproterenol hydrochloride injection is indicated:
To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output
For bronchospasm occurring during anesthesia
Isoproterenol hydrochloride injection is a beta-adrenergic agonist indicated:
To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output (1)
For treatment of bronchospasm occurring during anesthesia (1)
1 INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of:
Major Depressive Disorder (MDD) [see Clinical Studies (14.1)]
Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)]
Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)]
Panic Disorder (PD) [see Clinical Studies (14.4)]
Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder(GAD) (1)
Social Anxiety Disorder (SAD) (1)
Panic Disorder (PD) (1)
1 INDICATIONS AND USAGE
Anastrozole tablets are an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1) First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2) Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets ( 1.3)
1.1. Adjuvant Treatment
Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
1.2. First-Line Treatment
Anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
1.3. Second-Line Treatment
Anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets.
1 INDICATIONS AND USAGE
ZEMPLAR is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.
ZEMPLAR is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis (1).
1 INDICATIONS AND USAGE
Risperidone tabletsare anatypical antipsychotic indicated for:
Treatment of schizophrenia (1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2)
Treatment of irritability associated with autistic disorder (1.3)
1.1 Schizophrenia
Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)].
1.2 Bipolar Mania
Monotherapy
Risperidone tabletsare indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years)[see Clinical Studies (14.2)].
Adjunctive Therapy
Risperidone tablets adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Risperidone tabletsare indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4)].
1 INDICATIONS AND USAGE
Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for:
Immunocompetent Adult Patients
(1.1)
Herpes labialis (cold sores)
Treatment of recurrent episodes
Genital herpes
Treatment of recurrent episodes
Suppressive therapy of recurrent episodes
Herpes zoster (shingles)
Human Immunodeficiency Virus (HIV)-Infected Adult Patients
(1.2)
Treatment of recurrent episodes of orolabial or genital herpes
Limitation of Use
The efficacy and safety of famciclovir have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1.1 Immunocompetent Adult Patients
Herpes labialis (cold sores)
Famciclovir tablets are indicated for the treatment of recurrent herpes labialis in adult patients.
Genital herpes
Recurrent episodes
Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established.
Suppressive therapy
Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients.
The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established.
Herpes zoster (shingles)
Famciclovir tablets are indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir when initiated more than 72 hours after onset of rash has not been established.
1.2 HIV-Infected Adult Patients
Recurrent orolabial or genital herpes
Famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established.
Limitation of Use
The efficacy and safety of famciclovir tablets have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1 INDICATIONS AND USAGE
Pemetrexed for Injection is a folate analog metabolic inhibitor indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. (1.1)
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1)
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1)
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1) Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1)
initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2)
1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed for Injection is indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies (14.1)].
1.2 Mesothelioma
Pemetrexed for Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
INDICATIONS AND USAGE
Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
INDICATIONS
ENLON is recommended for the differential diagnosis of myasthenia gravis and as an adjunct in the evaluation of treatment
requirements in this disease. It may also be used for evaluating emergency treatment in myasthenic crises. Because of its brief duration of action, it is not recommended for maintenance
therapy in myasthenia gravis.ENLON is also useful whenever a curare antagonist is needed to reverse the neuromuscular block produced by curare, tubocurarine,
gallamine triethiodide or dimethyl-tubocurarine. It is not effective against decamethonium bromide and succinylcholine chloride. It may be used adjunctively in the treatment of
respiratory depression caused by curare overdosage.
1 INDICATIONS AND USAGE
Naratriptan tablets areindicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks.
Naratriptan tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness ofnaratriptan tablets have not been established for cluster headache.
Naratriptan tablets area serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine has been established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)