um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Tobramycin inhalation solution, USP is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa.
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14)].
Tobramycin inhalation solution, USP is an aminoglycoside antibacterial indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. (1)
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >75% predicted, or patients colonized with Burkholderia cepacia. (1)
Technology
Ombrelles patented filtering system with Mexoryl technology and other sunscreen filters provides effective broad-spectrum UVA/UVB protection and helps prevent sunburns.
1 INDICATIONS AND 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, USP 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, USP are indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir Phosphate Capsules, USP 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, USP [
see
Microbiology (12.4)
]
Oseltamivir Phosphate Capsules, USP 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)
].
1 INDICATIONSAND USAGE
Oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Oxybutynin chloride extended-release tablets is 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 is 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 AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, USP and other treatment options before deciding to use diclofenac sodium delayed-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac sodium delayed-release tablets are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1 INDICATIONS AND USAGE
Zidovudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated for:
Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1)
Prevention of maternal-fetal HIV-1 transmission. (1.2)
1.1 Treatment of HIV-1
Zidovudine tablets, a nucleoside reverse transcriptase inhibitor,are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
1.2 Prevention of Maternal-Fetal HIV-1 Transmission
Zidovudinetablets areindicated for the prevention of maternal-fetal HIV-1 transmission
[see Dosage and Administration (2.2)].
The indication is based on a dosing regimen that included 3 components:
antepartum therapy of HIV-1 infected mothers
intrapartum therapy of HIV-1 infected mothers
post-partum therapy of HIV-1 exposed neonate.
Points to consider prior to initiating zidovudine tabletsinpregnant women for the prevention of maternal-fetal HIV-1 transmission include:
In most cases, zidovudine tabletsfor prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs.
Prevention of HIV-1 transmission in women who have received zidovudine tabletsfor a prolonged period before pregnancy has not been evaluated.
Because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of gestation and the risks of therapy with zidovudine tabletsduring that period are not fully known, women in the first trimester of pregnancy who do not require immediate initiation of antiretroviral therapy for their own health may consider delaying use; this indication is based on use after 14 weeks gestation.
1 INDICATIONS AND USAGE
Montelukast sodium is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 12 months of age and older (
1.1).
Acute prevention of exercise-induced
bronchoconstriction (EIB) in patients 6 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 6
months 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 patients 12 months of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years 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 patients 6 months of age and older.
INDICATIONS AND USAGE
Magnesium sulfate in 5% dextrose injection, USP is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.
INDICATIONS: Sodium Sulfacetamide 10% - Sulfur 4% Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
INDICATIONS AND USAGE
Triamcinolone acetonide cream USP,0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
1.1 Monotherapy
Finasteride tablets 5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
Improve symptoms
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2 Combination with Alpha-Blocker
Finasteride tablets 5 mg administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score).
1.3 Limitations of Use
Finasteride is not approved for the prevention of prostate cancer.
INDICATIONS AND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal states.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
INDICATIONS AND USAGE
Desipramine hydrochloride tablets, USP are indicated for the treatment of depression.
1 INDICATIONS AND USAGE
Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1)
INDICATIONS AND USAGE
Major Depressive Disorder
Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder.
The efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure 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 efficacy of venlafaxine hydrochloride tablets (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4 week controlled trial (see Clinical Trials). The safety and efficacy of venlafaxine hydrochloride extended-release capsules in hospitalized depressed patients have not been adequately studied.
The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine hydrochloride tablets (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use venlafaxine hydrochloride tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE:
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitises is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drugs in this product is active against the following common bacterial eye pathogens:
Staphylococcus
aureus
, Escherichia coli,
Haemophilus
influenzae
,
Klebsiella
/
Enterobacter
species,
Niesseria
species, and
Pseudomonas
aeruginosa.
This product does not provide adequate coverage against:
Serratia
marcescens
and Streptococci, including
Streptococcus
pneumoniae.
1 INDICATIONS AND USAGE
Nevirapine is an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. (1)
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in:
adult females with CD4+cell counts greater than 250 cells/mm3
adult males with CD4+cell counts greater than 400 cells/mm3(1, 5.1)
Nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2].
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in:
adult females with CD4+ cell counts greater than 250 cells/mm3 or
adult males with CD4+cell counts greater than 400 cells/mm3
[see Warnings and Precautions (5.1)] .
Pneumocystis Carinii Pneumonia:
For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis cariniipneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis cariniipneumonia.
INDICATION AND USAGE
Fluocinolone Acetonide Topical Oil, 0.01% is a low to medium potency corticosteroid indicated:
In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).
1 INDICATIONS AND USAGE
Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the:
short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
short-term treatment (4 to 8 weeks) of active benign gastric ulcer.
treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.
short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.
oThe efficacy of Omeprazole and Sodium Bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate may be considered.
maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.
Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for the:
reduction of risk of upper GI bleeding in critically ill adult patients.
Omeprazole and Sodium Bicarbonate is a proton pump inhibitor (PPI).
Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules are indicated in adults for:
Treatment of active duodenal ulcer (1)
Treatment of active benign gastric ulcer (1)
Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) (1)
Maintenance of healing of EE (1)
Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for:
Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients (1)
INDICATIONS AND USAGE
Etoposide Injection, USPis indicated in the management of the following neoplasms:
Refractory Testicular Tumors
Etoposide injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.
Small Cell Lung Cancer
Etoposide injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
1 INDICATIONS AND USAGE
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. (1)
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. (1)
1 INDICATIONS AND USAGE
Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to
Epidermophyton floccosum,
Trichophyton mentagrophytes, and
Trichophyton rubrum in patients 17 years and older.
Clotrimazole and Betamethasone Dipropionate Cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to
Epidermophyton floccosum,
Trichophyton mentagrophytes, and
Trichophyton rubrum in patients 17 years and older. (
1)
INDICATIONS & USAGE
Lidocaine HCl injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
1	INDICATIONS AND USAGE
Zolpidem Tartrate Extended-Release Tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)].
Zolpidem Tartrate Extended-Release Tablets, a gamma-aminobutyric acid (GABA) A agonist, are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (1)
1 INDICATIONS AND USAGE
Montelukast sodium tablets area leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients15 years of age and older, and perennial allergic rhinitis (PAR) in patients15 years of age and older (1.3).
1.1 Asthma
Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corps montelukast tablet products.However, due to Merck Sharp & Dohme Corps marketing exclusivity rights, this drug productis not labeled with that pediatric information.
1.3 Allergic Rhinitis
Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients15 years of age and older and perennial allergic rhinitis in patients15 years of age and older.
2. INDICATIONS
Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intraoral radiographs.