United States - English - NLM (National Library of Medicine)

strides pharma science limited - ethacrynic acid (unii: m5dp350vzv) (ethacrynic acid - unii:m5dp350vzv) - ethacrynic acid tablets are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. - treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. - short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. - short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. - intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable. all diuretics, including ethacrynic acid, are contraindicated in anuria. if increasing electrolyte imbalance, azotemia, and/or oliguria occur during treatment of severe, progressive renal disease, the diuretic should be discontinued. in a few patients this diuretic has produced severe, watery diar

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - oseltamivir phosphate, quantity: 98.5 mg - capsule, hard - excipient ingredients: gelatin; croscarmellose sodium; purified water; iron oxide yellow; titanium dioxide; sodium stearylfumarate; pregelatinised maize starch; purified talc; iron oxide red; povidone; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - oseltamivir strides is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,oseltamivir strides is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - oseltamivir phosphate, quantity: 39.4 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; purified talc; gelatin; povidone; croscarmellose sodium; iron oxide yellow; titanium dioxide; sodium stearylfumarate; purified water; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - oseltamivir strides is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,oseltamivir strides is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

Australia - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - oseltamivir phosphate, quantity: 59.1 mg - capsule, hard - excipient ingredients: pregelatinised maize starch; gelatin; titanium dioxide; povidone; purified water; croscarmellose sodium; purified talc; sodium stearylfumarate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - oseltamivir strides is indicated for the treatment of infections due to influenza a and b viruses in adults and children including full-term neonates. treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.,oseltamivir strides is indicated for the prevention of influenza in adults and children aged 1 year and older. vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

United States - English - NLM (National Library of Medicine)

strides pharma science limited - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsule 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 patients 18 years of age and older. pediatric use information is approved for novartis pharmaceuticals corporation's gilenya (fingolimod) capsules. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, tia, decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1)] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with clas

United States - English - NLM (National Library of Medicine)

strides pharma science limited - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast tablets are indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. the use of roflumilast is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in specific populations (8.6)] . risk summary there are no randomized clinical studies of roflumilast in pregnant women. in animal reproductive toxicity studies, roflumilast administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest roflumilast dose in these studies was approximately 30 and 26 times, respectively, the maximum recommended human dose (mrhd). roflumilast induced post-implantation loss in rats at doses greater than or equal to approximately 10 times the mrhd

United States - English - NLM (National Library of Medicine)

strides pharma science limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets, usp 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 tablets, usp 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)] . nevirapine tablets, usp are contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)] . pregnancy exposure registry th

United States - English - NLM (National Library of Medicine)

strides pharma science limited - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - meloxicam tablets, usp is indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1) ]. meloxicam tablets, usp is indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1) ]. meloxicam tablets, usp is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [see dosage and administration (2.4) and clinical studies (14.2) ]. meloxicam tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7,5.8) ] - in the setting

United States - English - NLM (National Library of Medicine)

strides pharma science limited - mefenamic acid (unii: 367589pj2c) (mefenamic acid - unii:367589pj2c) - carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation ). mefenamic acid is indicated: - for relief of mild to moderate pain in patients ≥ 14 years of age, when therapy will not exceed one week (7 days). - for treatment of primary dysmenorrhea. mefenamic acid is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to mefenamic acid or any components of the drug product (see warnings; anaphylactic reactions, serious skin reactions) . - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients (see warnings; anaphylactic reaction, exacerbation of ast

United States - English - NLM (National Library of Medicine)

strides pharma science limited - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial  [ see clinical studies (14.1)] .   when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [ see warnings and precautions  (5.5)]. monotherapy — oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with manic or