Tamsulosin Hcl.,DUTASTERIDE - Meklēšanas rezultāti

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

dutasteride capsule, liquid filled

humanwell puracap pharmaceutical (wuhan), ltd. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - dutasteride 0.5 mg - dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (bph) in men with an enlarged prostate to: dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride capsules are not approved for the prevention of prostate cancer. dutasteride capsules are contraindicated for use in: pregnancy category x. dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. dutasteride are a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (dht), a hormone necessary for normal development of male genitalia. in animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male fetuses. therefore, dutasteride may cause fetal harm when administered to a pregnant woman. if dutasteride is used during pregnancy or if the patient becomes

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

tamsulosin hydrochloride capsule

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) ].