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

a-s medication solutions - 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)]. risk summary tamsulosin hydrochloride is not indicated for use in women. there are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride in pregnant women. no adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (gd 7 to 17 in the rat and gd 6 to 18 in the rabbit) [see data ]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data administration of tamsulosin hydrochloride to pregnant female rats during the period of organogenesis 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 during the period of organogenesis at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydrochloride is not indicated for use in women. there are no data on the presence of tamsulosin hydrochloride in human milk, the effects of tamsulosin hydrochloride on the breastfed infant, or the effects of tamsulosin hydrochloride on milk production. tamsulosin hydrochloride is present in the milk of lactating rats [see data ]. data oral administration of radiolabeled tamsulosin hydrochloride to rats demonstrated that tamsulosin hydrochloride and/or its metabolites are excreted into the milk of rats. infertility males abnormal ejaculation including ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation decrease has been associated with tamsulosin hydrochloride [see clinical trials experience (6.1) ]. studies in rats revealed significantly reduced fertility in males considered to be due to impairment of ejaculation, which was reversible [see nonclinical toxicology (13.1) ]. females tamsulosin hydrochloride is not indicated for use in women. female fertility in rats was significantly reduced, considered to be due to impairment of fertilization [see nonclinical toxicology (13.1) ]. 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 h2 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 h2 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 (clcr <10 ml/min/1.73 m2 ) 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 has not been studied in patients with severe hepatic impairment [see clinical pharmacology (12.3)] .

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

mckesson corporation dba sky packaging - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules usp are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)]. tamsulosin hydrochloride capsules usp are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules usp are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules usp. 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 usp are not indicated for use in women. tamsulo

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

st. mary’s medical park pharmacy - 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 hydroch

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

bryant ranch prepack - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules, usp 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)]. risk summary tamsulosin hydrochloride capsules are not indicated for use in women. there are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride capsules in pregnant women. no adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (gd 7 to 17 in the rat and gd 6 to 18 in the rabbit) [see data] . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data administration of tamsulosin hydrochloride to pregnant female rats during the period of organogenesis 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 during the period of organogenesis 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. there are no data on the presence of tamsulosin hydrochloride in human milk, the effects of tamsulosin hydrochloride on the breastfed infant, or the effects of tamsulosin hydrochloride on milk production. tamsulosin hydrochloride is present in the milk of lactating rats [see data] . data oral administration of radiolabeled tamsulosin hydrochloride to rats demonstrated that tamsulosin hydrochloride and/or its metabolites are excreted into the milk of rats. infertility males abnormal ejaculation including ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation decrease has been associated with tamsulosin hydrochloride [see clinical trials experience (6.1)]. studies in rats revealed significantly reduced fertility in males considered to be due to impairment of ejaculation, which was reversible [see nonclinical toxicology (13.1)]. females tamsulosin hydrochloride capsules are not indicated for use in women. female fertility in rats was significantly reduced, considered to be due to impairment of fertilization [see nonclinical toxicology (13.1)] . 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 h2 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 h2 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 (clcr < 10 ml/min/1.73 m2 ) 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 has not been studied in patients with severe hepatic impairment [see clinical pharmacology (12.3)] .

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

synthon b.v. - tamsulosin hydrochloride 0,4 mg - modified-release capsule, hard - 0,4 mg - tamsulosin hydrochloride 0.4 mg - tamsulosin

Canada - English - Health Canada

teva canada limited - tamsulosin hydrochloride - capsule (sustained-release) - 0.4mg - tamsulosin hydrochloride 0.4mg - selective alfa-1-adrenergic blocking agents

Canada - English - Health Canada

ranbaxy pharmaceuticals canada inc. - tamsulosin hydrochloride - capsule (sustained-release) - 0.4mg - tamsulosin hydrochloride 0.4mg - selective alfa-1-adrenergic blocking agents

Canada - English - Health Canada

pro doc limitee - tamsulosin hydrochloride - tablet (extended-release) - 0.4mg - tamsulosin hydrochloride 0.4mg - selective alfa-1-adrenergic blocking agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - tamsulosin hydrochloride - modified release capsules - tamsulosin hydrochloride 0.4 mg - tamsulosin - treatment of functional symptoms of benign prostatic hyperplasia (bph).