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

physicians total care, inc. - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2)]. teratogenic effects, pregnancy category b. administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic auc exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydrochloride capsules are not indicated for use in women. tamsulosin hydrochloride

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

lake erie medical dba quality care products llc - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2)]. teratogenic effects, pregnancy category b. administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic auc exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydrochloride capsules are not indicated for use in women. tamsulosin hydrochl

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

avpak - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [ see clinical studies (14) ]. tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus,angioedema, and respiratory symptoms [ see adverse reactions (6.2) ]. teratogenic effects, pregnancy category b. administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic auc exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydrochloride capsules are not indicated for use in women. tamsulosin hydrochloride capsules are not indicated for use in women. tamsulosin hydrochloride capsules are not indicated for use in pediatric populations. efficacy and positive benefit/risk of tamsulosin hydrochloride was not demonstrated in two studies conducted in patients 2 years to 16 years of age with elevated detrusor leak point pressure (>40 cm h 2 o) associated with known neurological disorder (e.g., spina bifida). patients in both studies were treated on a weight-based mg/kg schema (0.025 mg, 0.05 mg, 0.1 mg, 0.2 mg, or 0.4 mg tamsulosin hydrochloride) for the reduction in detrusor leak point pressure below 40 cm h 2 o. in a randomized, double-blind, placebo controlled, 14-week, pharmacokinetic, safety and efficacy study in 161 patients, no statistically significant difference in the proportion of responders was observed between groups receiving tamsulosin hydrochloride and placebo. in an open-label, 12-month safety study, 87 patients were treated with tamsulosin hydrochloride. the most frequently reported adverse events (<5%) from the pooled data of both studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation. of the total number of subjects (1783) in clinical studies of tamsulosin, 36% were 65 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [ see clinical pharmacology (12.3) ]. patients with renal impairment do not require an adjustment in tamsulosin hydrochloride capsules dosing. however, patients with end-stage renal disease (cl cr <10 ml/min/1.73 m 2 ) have not been studied [ see clinical pharmacology (12.3) ]. patients with moderate hepatic impairment do not require an adjustment in tamsulosin hydrochloride capsules dosage. tamsulosin hydrochloride capsules has not been studied in patients with severe hepatic impairment [ see clinical pharmacology (12.3) ].

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

ncs healthcare of ky, inc dba vangard labs - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14) ]. tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema and respiratory symptoms [see adverse reactions (6.2) ]. teratogenic effects , pregnancy category b. administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic auc exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydrochloride capsules are not indicated for use in women. tamsulosin hydrochloride

Malta - English - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - tamsulosin hydrochloride - prolonged-release capsule - tamsulosin hydrochloride 0.4 mg - urologicals

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - tamsulosin hydrochloride - capsules modified release - 400 microgram - tamsulosin

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

sandoz pty ltd - tamsulosin hydrochloride, quantity: 400 microgram - tablet, modified release - excipient ingredients: quinoline yellow; purified talc; polyethylene oxide; cochineal; microcrystalline cellulose; magnesium stearate; hyprolose; butylated hydroxytoluene; macrogol 400; titanium dioxide; iron oxide black; hypromellose; colloidal anhydrous silica - for the relief of lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph).

Israel - English - Ministry of Health

inovamed ltd - tamsulosin hydrochloride - tablets prolonged release - tamsulosin hydrochloride 0.4 mg - tamsulosin - lower urinary tract symptoms ( luts) associated with benign prostatic hyperplasia (bph).

Malta - English - Medicines Authority

pharmaceutical works polpharma sa 19 pelplinska steet, 83-200 starogard gdanski, poland - dutasteride, tamsulosin hydrochloride - hard capsule - tamsulosin hydrochloride 0.4 mg dutasteride 0.5 mg - urologicals

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - tamsulosin hydrochloride - modified-release capsule, hard - 400 microgram(s) - alpha-adrenoreceptor antagonists; tamsulosin