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

mayne pharma international pty ltd - silodosin, quantity: 4 mg - capsule, hard - excipient ingredients: mannitol; sodium lauryl sulfate; magnesium stearate; gelatin; titanium dioxide; iron oxide yellow; pregelatinised maize starch - urorec is indicated for the relief of lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia in adult men

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

mayne pharma international pty ltd - silodosin, quantity: 8 mg - capsule, hard - excipient ingredients: mannitol; sodium lauryl sulfate; magnesium stearate; gelatin; titanium dioxide; pregelatinised maize starch - urorec is indicated for the relief of lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia in adult men

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - silodosin - capsule, hard - 4 milligram(s) - silodosin

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - silodosin - capsule, hard - 8 milligram(s) - silodosin

Malta - English - Medicines Authority

rontis hellas medical and pharmaceutical products s.a. 38, sorou str., athens, maroussi, 15125, greece - silodosin - hard capsule - silodosin 4 mg - urologicals

Malta - English - Medicines Authority

rontis hellas medical and pharmaceutical products s.a. 38, sorou str., athens, maroussi, 15125, greece - silodosin - hard capsule - silodosin 8 mg - urologicals

European Union - English - EMA (European Medicines Agency)

recordati ireland ltd - silodosin - prostatic hyperplasia - urologicals, alpha-adrenoreceptor antagonists - treatment of the signs and symptoms of benign prostatic hyperplasia (bph) in adult men.

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

sandoz inc - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin capsules, a selective alpha-1 adrenergic receptor antagonist, are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . silodosin capsules are not indicated for the treatment of hypertension. risk summary silodosin is not indicated for use in females. silodosin is not indicated for use in females. infertility males possible effects on male fertility could be observed based on findings in rats at exposures that were at least two times higher than at the mrhd (based on auc). these findings may be reversible, and the clinical relevance is unknown [see nonclinical toxicology (13.1)]. silodosin is not indicated for use in pediatric patients. safety and effectiveness in pediatric patients have not been established. in double-blind, placebo-controlled, 12-week clinical studies of silodosin, 259 (55.6%) were under 65 years of age, 207 (44.4%) patients were 65 years of age and over, while 60 (12.9%) patients were 75 years of age and over. or

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

amneal pharmaceuticals ny llc - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . silodosin capsules are not indicated for the treatment of hypertension. - severe renal impairment (ccr < 30 ml/min) - severe hepatic impairment (child-pugh score ≥ 10) - concomitant administration with strong cytochrome p450 3a4 (cyp3a4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see drug interactions (7.1)] - patients with a history of hypersensitivity to silodosin or any of the ingredients of silodosin capsules [see adverse reactions (6.2) and description (11)] risk summary silodosin capsules are not indicated for use in females. silodosin capsules are not indicated for use in females. infertility males possible effects on male fertility could be observed based on findings in rats at exposures that were at least two times higher than at the mrhd (based on auc). these findings may be reversible, and the clinical relevance is unknown [see nonclinical toxicology (13.1)] . silodosin capsules are not indicated for use in pediatric patients. safety and effectiveness in pediatric patients have not been established. in double-blind, placebo-controlled, 12-week clinical studies of silodosin, 259 (55.6%) were under 65 years of age, 207 (44.4%) patients were 65 years of age and over, while 60 (12.9%) patients were 75 years of age and over. orthostatic hypotension was reported in 2.3% of silodosin patients < 65 years of age (1.2% for placebo), 2.9% of silodosin patients ≥ 65 years of age (1.9% for placebo), and 5.0% of patients ≥ 75 years of age (0% for placebo). there were otherwise no significant differences in safety or effectiveness between older and younger patients [see clinical pharmacology (12.3)] . the effect of renal impairment on silodosin pharmacokinetics was evaluated in a single dose study of six male patients with moderate renal impairment and seven male subjects with normal renal function. plasma concentrations of silodosin were approximately three times higher in subjects with moderate renal impairment compared with subjects with normal renal function. silodosin should be reduced to 4 mg per day in patients with moderate renal impairment. exercise caution and monitor patients for adverse events. silodosin has not been studied in patients with severe renal impairment. silodosin is contraindicated in patients with severe renal impairment [see contraindications (4) , warnings and precautions (5.2) and clinical pharmacology (12.3)] . in a study comparing nine male patients with moderate hepatic impairment (child-pugh scores 7 to 9), to nine healthy male subjects, the single dose pharmacokinetics of silodosin were not significantly altered in patients with hepatic impairment. no dosing adjustment is required in patients with mild or moderate hepatic impairment. silodosin has not been studied in patients with severe hepatic impairment. silodosin is contraindicated in patients with severe hepatic impairment [see contraindications (4) , warnings and precautions (5.3)  and clinical pharmacology (12.3)] .

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

amneal pharmaceuticals ny llc - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . silodosin capsules are not indicated for the treatment of hypertension. - severe renal impairment (ccr < 30 ml/min) - severe hepatic impairment (child-pugh score ≥ 10) - concomitant administration with strong cytochrome p450 3a4 (cyp3a4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see drug interactions (7.1)] - patients with a history of hypersensitivity to silodosin or any of the ingredients of silodosin capsules [see adverse reactions (6.2) and description (11)] risk summary silodosin capsules are not indicated for use in females. silodosin capsules are not indicated for use in females. infertility males possible effects on male fertility could be observed based on findings in rats at exposures that were at least two times higher than at the mrhd (based on auc). these findings may be reversible, and the clinical relevance is unknown [see nonclinical toxicology (13.1)] . silodosin capsules are not indicated for use in pediatric patients. safety and effectiveness in pediatric patients have not been established. in double-blind, placebo-controlled, 12-week clinical studies of silodosin, 259 (55.6%) were under 65 years of age, 207 (44.4%) patients were 65 years of age and over, while 60 (12.9%) patients were 75 years of age and over. orthostatic hypotension was reported in 2.3% of silodosin patients < 65 years of age (1.2% for placebo), 2.9% of silodosin patients ≥ 65 years of age (1.9% for placebo), and 5.0% of patients ≥ 75 years of age (0% for placebo). there were otherwise no significant differences in safety or effectiveness between older and younger patients [see clinical pharmacology (12.3)] . the effect of renal impairment on silodosin pharmacokinetics was evaluated in a single dose study of six male patients with moderate renal impairment and seven male subjects with normal renal function. plasma concentrations of silodosin were approximately three times higher in subjects with moderate renal impairment compared with subjects with normal renal function. silodosin should be reduced to 4 mg per day in patients with moderate renal impairment. exercise caution and monitor patients for adverse events. silodosin has not been studied in patients with severe renal impairment. silodosin is contraindicated in patients with severe renal impairment [see contraindications (4) , warnings and precautions (5.2) and clinical pharmacology (12.3)] . in a study comparing nine male patients with moderate hepatic impairment (child-pugh scores 7 to 9), to nine healthy male subjects, the single dose pharmacokinetics of silodosin were not significantly altered in patients with hepatic impairment. no dosing adjustment is required in patients with mild or moderate hepatic impairment. silodosin has not been studied in patients with severe hepatic impairment. silodosin is contraindicated in patients with severe hepatic impairment [see contraindications (4) , warnings and precautions (5.3)  and clinical pharmacology (12.3)] .