um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS & USAGE
Oseltamivir phosphate is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (1.2)
Limitations of Use:
Not a substitute for annual influenza vaccination. (1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use.(1.3)
Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3)
1.1 Treatment of Influenza
Oseltamivir phosphate capsules are 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.
1.2 Prophylaxis of Influenza
Oseltamivir phosphate capsules are indicated for the prophylaxis of influenza A and B in patients1 year and older.
1.3 Limitations of Use
Oseltamivir phosphate capsules are not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate capsules [see Microbiology (
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Oseltamivir phosphate capsules are not recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration(2.4) and Use in Specific Populations (8.6)].
INDICATIONS AND USAGE
For use as an adjunct in the therapy of all forms of parkinsonism.
Useful also in the control of extrapyramidal disorders (except tardive dyskinesia
see
PRECAUTIONS
) due to neuroleptic drugs (e.g., phenothiazines).
INDICATIONS AND USAGE
Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
INDICATIONS AND USAGE
Ketoconazole Cream 2% is indicated for the topical treatment of
tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea
(pityriasis) versicolor caused by Malassezia furfur
(Pityrosporum orbiculare); in the treatment of cutaneous candidiasis
caused by Candida spp. and in the treatment of
seborrheic dermatitis.
1 INDICATIONS AND USAGE
Formoterol fumarate inhalation solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for:
Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1)
Important limitations of use:
Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2)
Formoterol fumarate inhalation solution is not indicated to treat asthma. (1.2)
1.1
Maintenance Treatment of COPD
Formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
1.2
Important Limitations of Use
Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see Warnings and Precautions (5.2)].
Formoterol fumarate inhalation solution is not indicated to treat asthma. The safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established.
INDICATIONS AND USAGE
Postherpetic Neuralgia
Gabapentin tablets, USP are indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin tablets, USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin tablets, USPare also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.
1 INDICATIONS AND USAGE
Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
Oxybutynin chloride extended-release tabletsare a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)
Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). (1)
INDICATIONS & USAGE
INDICATIONS AND USAGE: NP Thyroid tablets (thyroid tablets, USP) are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism (See WARNINGS). 2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic Iymphocytic thyroiditis (Hashimotos), multinodular goiter, and in the management of thyroid cancer. 3. As diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.
Indications and Usage Section
INDICATIONS AND USAGE
Diazepam Tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, Diazepam Tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam Tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of Diazepam Tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Palonosetron hydrochloride injection is a serotonin-3 (5-HT3) receptor antagonist indicated in:
Adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1)
acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1)
postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1)
Pediatric patients aged 1 month to less than 17 years for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (HEC). (1)
Palonosetron hydrochloride injection is indicated in adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC).
postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low.
Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.
1 INDICATIONS AND USAGE
Topiramate tablets are indicated for:
Epilepsy:
initial monotherapy for the
treatment of partial-onset or primary generalized tonic-clonic seizures in
patients 2 years of age and older (1.1); adjunctive therapy for the
treatment of partial-onset seizures, primary generalized tonic-clonic
seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2
years of age and older (
1.2)
Preventive treatment of migraine in
patients 12 years of age and older (
1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
1.3 Migraine
Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.
1 INDICATIONS AND USAGE
Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated:
in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. (1.1)
for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. (1.2)
1.1 HIV-1 Infection
Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg.
1.2 Chronic Hepatitis B
Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 2 years of age and older weighing at least 10 kg.
1 INDICATIONS AND USAGE
Dactinomycin for injection is an actinomycin indicated for the treatment of:
adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen. (1.1)
adult and pediatric patients with rhabdomyosarcoma, as part of a multiphase, combination chemotherapy regimen. (1.2)
adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. (1.3)
adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. (1.4)
post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. (1.5)
adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion. (1.6)
1.1 Wilms Tumor
Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen.
1.2 Rhabdomyosarcoma
Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen.
1.3 Ewing Sarcoma
Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen.
1.4 Metastatic Nonseminomatous Testicular Cancer
Dactinomycin for injection is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen.
1.5 Gestational Trophoblastic Neoplasia
Dactinomycin for injection is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen.
1.6 Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies
Dactinomycin for injection is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion.
1 INDICATIONS AND USAGE
CARISOPRODOL is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
CARISOPRODOL should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see Dosage and Administration (2)].
CARISOPRODOL is a muscle relaxant indicated for the relief of discomfort associated withacute, painful musculoskeletal conditions in adults. (1)
Limitation of Use
Should only be used for acute treatment periods up to two or three weeks(1)
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.
Pravastatin sodium tablets USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. (
1.1)
Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. (
1.2)
Reduce elevated serum TG levels in patients with hypertriglyceridemia. (
1.2)
Treat patients with primary dysbetalipoproteinemia who are not responding to diet. (
1.2)
Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (
1.2)
Limitations of use:
Pravastatin sodium tablets USP have not been studied in
Fredrickson Types I and V dyslipidemias. (
1.3)
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:
LDL-C remains 190 mg/dL or
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).
1 INDICATIONS AND USAGE
Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (
1).
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
INDICATIONS AND USAGE
Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.3 mEq/L) or elevated.
In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.
Magnesium sulfate injection is also indicated for the prevention and control of seizures in a pre-eclampsia and eclampsia, respectively.
INDICATIONS AND USAGE
Vitafol-One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Vitafol-One does not contain fish, fish oils, fish proteins or fish byproducts.
Pheochromocytoma
Propranolol hydrochloride tablets USP are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
INDICATIONS AND USAGE
Carboprost tromethamine injection, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:
1.Failure of expulsion of the fetus during the course of treatment by another method; 2.Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3.Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4.Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.
Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.
INDICATIONS AND USAGE
Promethazine Hydrochloride Tablets are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amelioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled.
Preoperative, postoperative and obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.
Sedation in both children and adults as well as relief of apprehension and production of
light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
1 INDICATIONS AND USAGE
Risperidone is an atypical 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 oral solution is 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 oral solution is 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 oral solution 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 oral solution is 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
Aripiprazole is indicated for the treatment of: Schizophrenia
[see CLINICAL STUDIES (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic indicated as oral formulations for the: Schizophrenia (14.1)
1 INDICATIONS AND USAGE
Durezol (difluprednate ophthalmic emulsion) 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.
Durezol is a topical corticosteroid that is indicated for the treatment of inflammation and pain associated with ocular surgery. (1)