um-ids/dailymed-annotations huggingface dataset:
INDICATIONS & USAGE
In Anesthesia
Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
In Peptic Ulcer
For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
INDICATIONS & USAGE
Amiodarone HCl injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Amiodarone HCl injection also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone HCl injection, patients may be transferred to oral amiodarone therapy (see
DOSAGE & ADMINISTRATION).
Amiodarone HCl injection should be used for acute treatment until the patients ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone HCl injection may be safely administered for longer periods if necessary.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam oral solution, USP is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
Limitations of Use
:
Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets.
It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients.
Tolvaptan tablets are a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) (1)
Limitations of Use:
Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets (1)
It has not been established that tolvaptan tablets provides a symptomatic benefit to patients (1)
1 INDICATIONS AND USAGE
Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
Adenosine injection, USP, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in
patients unable to exercise adequately (1)
1 INDICATIONS AND USAGE
Levetiracetam tablets are indicated for the treatment of partial- onset seizures in patients 1 month of age and older
(1.1)
Levetiracetam tablets are indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
(1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy
(1.3)
1.1 Partial-Onset Seizures
Levetiracetam tablets are indicated for the treatment of partial- onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
Indications and Usage
Duloxetine is indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients 7 years of age and older.
Diabetic peripheral neuropathic pain in adults
Fibromyalgia in adults
Chronic musculoskeletal pain in adults
Additional pediatric use information is approved for Eli Lilly and Company, Inc.s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Mesalamine delayed-release tablets is an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. (1)
Limitation of Use: Safety and effectiveness of Mesalamine delayed-release tablets beyond 6 weeks have not been established (1)
Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Safety and effectiveness of Mesalamine delayed-release tablets beyond 6 weeks have not been established.
1 INDICATIONS AND USAGE
HIV-1 Treatment (
1.1)
Emtricitabine and tenofovir disoproxil fumarate tablet is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:
in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
HIV-1 PrEP (
1.2):
Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablet for HIV-1 PrEP.
1.1 Treatment of HIV-1 Infection
Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg
[see Clinical Studies (
14)]
.
1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP)
Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP
[see Dosage and Administration (
2.2), Warnings and Precautions (
5.2)]
.
1 INDICATIONS AND USAGE
THIOLA is indicated, in combination
with high fluid intake, alkali, and diet modification, for the prevention
of cystine stone formation in adults and pediatric patients 20 kg
and greater with severe homozygous cystinuria, who are not responsive
to these measures alone.
THIOLA is a reducing and complexing
thiol indicated, in combination with high fluid intake, alkali, and
diet modification, for the prevention of cystine stone formation in
adults and pediatric patients 20 kg and greater with severe homozygous
cystinuria, who are not responsive to these measures alone. (1)
INDICATIONS AND USAGE
Seromycin
is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, Seromycin
should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent.
Seromycin
may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram- positive and gram-negative bacteria. Use of Seromycin
in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug.
1 INDICATIONS AND USAGE
Quetiapine is anatypical antipsychotic indicated for the treatment of:
Schizophrenia (1.1)
Bipolar I disorder manic episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
1.1 Schizophrenia
Quetiapine tablets USP are indicated for the treatment of schizophrenia. The efficacy of quetiapine tabletsUSPin schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tabletsUSPfor the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [
see Clinical Studies (14.1)
].
1.2 Bipolar Disorder
Quetiapine tabletsUSP are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see Clinical Studies (14.2)].
QuetiapinetabletsUSPare indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies (14.2)].
QuetiapinetabletsUSPare indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness ofquetiapinetabletsUSPas monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)].
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
1 INDICATIONS AND USAGE
TAMIFLU is an influenza neuraminidase inhibitor indicated for:
Treatment of influenza in patients 1 year and older who have been symptomatic for no more than 2 days. (1.1)
Prophylaxis of influenza in patients 1 year and older. (1.2)
Important Limitations of Use:
Efficacy not established in patients who begin therapy after 48 hours of symptoms. (1.3)
Not a substitute for annual influenza vaccination. (1.3)
No evidence of efficacy for illness from agents other than influenza viruses types A and B. (1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3)
1.1 Treatment of Influenza
TAMIFLU is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days.
1.2 Prophylaxis of Influenza
TAMIFLU is indicated for the prophylaxis of influenza in patients 1 year and older.
1.3 Limitations of Use
The following points should be considered before initiating treatment or prophylaxis with TAMIFLU:
Efficacy of TAMIFLU in patients who begin treatment after 48 hours of symptoms has not been established.
TAMIFLU is 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.
There is no evidence for efficacy of TAMIFLU in any illness caused by agents other than influenza viruses types A and B.
Influenza viruses change over time. Emergence of resistance mutations 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 TAMIFLU.
INDICATIONS AND USAGE
Phytonadione tablets are indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.
Phytonadione tablets are indicated in:
anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
hypoprothrombinemia secondary to antibacterial therapy;
hypoprothrombinemia secondary to administration of salicylates;
hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed.
1 INDICATIONS AND USAGE
SUTENT is a kinase inhibitor indicated for:
treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1)
treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2)
adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3)
treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4)
1.1	Gastrointestinal Stromal Tumor
SUTENT is indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
1.2	Advanced Renal Cell Carcinoma
SUTENT is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC).
1.3	Adjuvant Treatment of Renal Cell Carcinoma
SUTENT is indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
1.4	Advanced Pancreatic Neuroendocrine Tumors
SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.
1 INDICATIONS AND USAGE
Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (
1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (
1.2)
1.1 Major Depressive Disorder
Escitalopram tablets, USP are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [
see
Clinical Studies (14.1)
].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram tablets are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [
see
Clinical Studies (14.2)
].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least three of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension and sleep disturbance.
INDICATIONS AND USAGE
Herpes Zoster Infections: Acyclovir capsules, USP are indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes: Acyclovir capsules, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox: Acyclovir capsules, USP are indicated for the treatment of chickenpox (varicella).
INDICATIONS AND USAGE
Mirtazapine tablets are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders
3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The effectiveness of mirtazapine tablets in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine tablets in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see CLINICAL PHARMACOLOGY).
Hypertension
Metoprolol Tartrate Tablets USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Disopyramide Phosphate Extended-release Capsules, USP are indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.Initiation of disopyramide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The extended-release capsules 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 and Usage:
This is a prescription fluoride treatment gel used to help prevent dental decay.
For Professional Use Only. This product is not intended for home or unsupervised consumer use.
INDICATIONS AND USAGE
Hypertension
Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules is not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Migraine
Propranolol hydrochloride extended-release capsules are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
Hypertrophic Subaortic Stenosis
Propranolol hydrochloride extended-release capsules improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
1	INDICATIONS AND USAGE
ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. (1.1)
1.1	Acute Lymphoblastic Leukemia
ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
INDICATIONS AND USAGE
Sevoflurane, USP is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.
Sevoflurane, USP should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane, USP should be used.
1 INDICATIONS AND USAGE
Deferasirox tablets are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1)
Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2)
Limitations of Use
The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. (1.3)
1.1 Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)
Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
1.2 Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes
Deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.
1.3 Limitations of Use
The safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established.