um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Adults
Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening
[
see Clinical Studies (14)]
.
Pediatric Patients (1 to 17 Years old)
Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability
and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise
[
see Clinical Studies (14)].
Adults
Sildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.
(1)
Pediatric Patients (1 to17 years old)
Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise (
1,
14)
1 INDICATIONS AND USAGE
Carglumic acid tablets for oral suspension is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as:
Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. (1.1)
Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. (1.1)
1.1 Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency
Carglumic acid tablets for oral suspension is indicated in pediatric and adult patients as:
Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency.
Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.
1 INDICATIONS AND USAGE
AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has 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 45 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
AMBIEN, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. (1)
1 INDICATIONS & USAGE
PLAQUENIL is an antimalarial and antirheumatic indicated for the:Treatment of uncomplicated malaria due toPlasmodium falciparum, Plasmodium malariae, Plasmodium ovale, andPlasmodium vivaxin adult and pediatric patients.(1.1)
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients(1.1)
Treatment of rheumatoid arthritis in adults.(1.2)
Treatment of systemic lupus erythematosus in adults.(1.3)
Treatment of chronic discoid lupus erythematosus in adults.(1.4)
Limitations of Use(1.1):
PLAQUENIL isnotrecommended for the:Treatment of complicated malaria.Treatment of chloroquine or hydroxychloroquine-resistant strains ofPlasmodiumspecies.Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when thePlasmodiumspecies has not been identified.Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.Prevention of relapses ofP. vivaxorP. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivaxandP. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary.
1.1 Malaria
PLAQUENIL is indicated in adult and pediatric patients for the: Treatment of uncomplicated malaria due toPlasmodium falciparum, Plasmodium malariae, Plasmodium vivax,andPlasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use:
PLAQUENIL isnotrecommended for: Treatment of complicated malaria. Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains ofPlasmodiumspecies[seeMicrobiology (12.4)]
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when thePlasmodiumspecies has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses ofP. vivaxorP. ovalebecause it is not active against the hypnozoite liver stage forms of these parasites. For radical cure ofP. vivaxandP. ovaleinfections, concomitant therapy with an 8-aminoquinoline drug is necessary[seeMicrobiology (12.4)].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1 .
1.2 Rheumatoid Arthritis
PLAQUENIL is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus Erythematosus
PLAQUENIL is indicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus Erythematosus
PLAQUENIL is indicated for the treatment of chronic discoid lupus erythematosus in adults.
1 INDICATIONS AND USAGE
BETASERON 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.
BETASERON is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. (1)
1 INDICATIONS AND USAGE
Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant patients.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.2)], reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
1 INDICATIONSAND USAGE
Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride is a biguanide indicated as an adjunct to diet and exe rcise to
i m p rove gl yc e mic cont rol in adults with t ype 2 diabetes
m ellitus.
(1)
1INDICATIONS AND USAGE
READI-CAT 2 and READI-CAT 2 SMOOTHIES are indicated
for use in computed tomography (CT)of the abdomen to delineate the
gastrointestinal (GI) tract in adult and pediatric patients.
READI-CAT 2 and READI-CAT 2 SMOOTHIE
are radiographic contrast agents, indicated for use in computed tomography
(CT)of the abdomen to delineate the gastrointestinal (GI) tract in
adult and pediatric patients (1)
1 INDICATIONS AND USAGE
Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
Nateglinide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Nateglinide is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
(1)
Limitations of Use: Not for treating type 1 diabetes mellitus or diabetes ketoacidosis
(1)
1 INDICATIONS AND USAGE
LAMOTRIGINE is an antiepileptic drug (AED) indicated for:
Epilepsyadjunctive therapy in patients 2 years of age: (1.1)
partial seizures.
generalized seizures of Lennox-Gastaut syndrome.
Epilepsymonotherapy in patients 16 years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single AED. (1.1)
Bipolar Disorder in patients 18 years of age: maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2)
1.1 Epilepsy
Adjunctive Therapy: LAMOTRIGINE is indicated as adjunctive therapy for the following seizure types in patients 2 years of age:
partial seizures
generalized seizures of Lennox-Gastaut syndrome
Monotherapy: LAMOTRIGINE is indicated for conversion to monotherapy in adults (16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of LAMOTRIGINE have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
LAMOTRIGINE is indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (18 years of age) treated for acute mood episodes with standard therapy. The effectiveness of LAMOTRIGINE in the acute treatment of mood episodes has not been established.
The effectiveness of LAMOTRIGINE as maintenance treatment was established in 2 placebo-controlled trials in patients with Bipolar I Disorder as defined by DSM-IV [see Clinical Studies (14.2)]. The physician who elects to prescribe LAMOTRIGINE for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated:
in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). (1.1)
in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. (1.2)
1.1 Hepatocellular Carcinoma
IMJUDO in combination with durvalumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
1.2 Non-Small Cell Lung Cancer (NSCLC)
IMJUDO, in combination with durvalumab and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
1 INDICATIONS AND USAGE
Fenofibric acid delayed-release capsule is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to:
Reduce TG in patients with severe hypertriglyceridemia (1.1).
Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDLC in patients with primary hypercholesterolemia or mixed dyslipidemia (1.2).
Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsule did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Treatment of Severe Hypertriglyceridemia
Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied.
1.2 Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibric acid delayed-release capsules 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 cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
1.3 Limitations of Use
Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see
Warnings and Precautions
(5.1)].
1.4 General Considerations for Treatment
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsules therapy.
Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.
1 INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients2 yearsof age and older ( ).
1.1
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients6 years of age and older ( ).
1.2
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2years of age and older ( ).
1.3
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients2 yearsof age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients6years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients2 yearsof age and older.
1 INDICATIONS AND USAGE
Levetiracetam is indicated for adjunctive therapy, as an alternative when oral administration is temporarily not feasible, in the treatment of:
Partial onset seizures in patients 1 month of age and older with epilepsy (
1.1)
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)
1.1 Partial Onset Seizures
Levetiracetamis indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
1.2
Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetamis indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
1.3
Primary Generalized Tonic-Clonic Seizures
Levetiracetamis indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
INDICATIONS AND USAGE
This solution is indicated for parenteral replacement of
extracellular losses of fluid and electrolytes, with or without minimal
carbohydrate calories, as required by the clinical condition of the
patient.
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.
Ezetimibe and simvastatin tablets, which contains a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet to:
reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. (1.1)
reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. (1.2)
Limitations of Use (1.3)
No incremental benefit of ezetimibe and simvastatin tablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
Ezetimibe and simvastatin tablets have not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1.1 Primary Hyperlipidemia
Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
1.2 Homozygous Familial Hypercholesterolemia (HoFH)
Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3 Limitations of Use
No incremental benefit of ezetimibe and simvastatin tablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
Ezetimibe and simvastatin tablets have not been studied in Fredrickson type I, III, IV, and V dyslipidemias.
1 INDICATIONS AND USAGE
Testosterone gel 1.62% 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 1.62% in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of testosterone gel 1.62% 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
Indications and Usage (
1
),
and
Clinical Pharmacology (
12.3
)
].
Testosterone gel 1.62% 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 1.62% in men with age-related hypogonadism have not been established. (1)
Safety and efficacy of testosterone gel 1.62% in males less than 18 years old have not been established. (1, 8.4)
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1, 12.3)
INDICATIONS AND USAGE
Status Epilepticus
Lorazepam Injection is indicated for the treatment of status epilepticus.
Preanesthetic
Lorazepam Injection is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery (see
PRECAUTIONS, Information for Patients
).
1
INDICATIONS AND USAGE
Modafinil Tabletsare indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
Limitations of Use
In OSA, Modafinil Tabletsare indicated to treat excessive sleepiness and not as treatment for the underlyingobstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, amaximal effort to treat with CPAP for an adequate period of time should be made prior to initiating andduring treatment with Modafinil Tablets for excessive sleepiness.
Modafinil Tabletsare indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy,obstructive sleep apnea (OSA), or shift work disorder (SWD). (1)
Limitations of Use
In OSA, Modafinil Tabletsare indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
INDICATIONS AND USAGE
Paromomycin sulfate is indicated for intestinal amebiasisacute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic comaas adjunctive therapy.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of HUMATIN Capsules and other antibacterial drugs, HUMATIN Capsules 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.