Yhdysvallat - englanti - NLM (National Library of Medicine)

novadoz pharmaceuticals llc - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin capsule, 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 capsule is 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 [see adverse reactions (6.2) and description (11)] 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 reversibl

Yhdysvallat - englanti - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin capsule, 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 capsule is 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 capsule is not indicated for use in females. silodosin capsule 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 reversibl

Yhdysvallat - englanti - NLM (National Library of Medicine)

alembic pharmaceuticals limited - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin capsule, 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 capsule is 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) ] pregnancy category b. silodosin capsule is not indicated for use in women. an embryo/fetal study in rabbits showed decreased maternal body weight at 200 mg/kg/day (approximately 13 to 25 times the maximum recommended human exposure or mrhe of silodosin via auc). no statistically significant teratogenicity was observed at this dos

Yhdysvallat - englanti - NLM (National Library of Medicine)

actavis pharma, inc. - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin 8 mg - rapaflo, 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 ) ]. rapaflo is 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 rapaflo [see adverse reactions ( 6.2 )  and description ( 11 )] pregnancy category b. rapaflo is not indicated for use in women. an embryo/fetal study in rabbits showed decreased maternal body weight at 200 mg/kg/day (approximately 13 to 25 times the maximum recommended human exposure or mrhe of silodosin via auc). no statistically significant teratogenicity was observed at this dose. silodosin was not teratoge

Yhdysvallat - englanti - NLM (National Library of Medicine)

allergan, inc. - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin 8 mg - rapaflo® , 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 ) ] . rapaflo is 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 rapaflo [ see adverse reactions ( 6.2 )  and  description ( 11 )] risk summary rapaflo is not indicated for use in females. rapaflo 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 )] . rapaflo 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 rapaflo, 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 rapaflo patients < 65 years of age (1.2% for placebo), 2.9% of rapaflo 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. rapaflo should be reduced to 4 mg per day in patients with moderate renal impairment. exercise caution and monitor patients for adverse events. rapaflo has not been studied in patients with severe renal impairment. rapaflo 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. rapaflo has not been studied in patients with severe hepatic impairment. rapaflo is contraindicated in patients with severe hepatic impairment [ see contraindications ( 4 ), warnings and precautions ( 5.3 )  and  clinical pharmacology ( 12.3 ) ] .

Australia - englanti - 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

Australia - englanti - 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

Yhdysvallat - englanti - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - 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 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). t

Yhdysvallat - englanti - NLM (National Library of Medicine)

avera mckennan hospital - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin 4 mg

Yhdysvallat - englanti - NLM (National Library of Medicine)

physicians total care, inc. - silodosin (unii: cuz39luy82) (silodosin - unii:cuz39luy82) - silodosin 8 mg - rapaflo, 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) ]. rapaflo is not indicated for the treatment of hypertension. - severe renal impairment (ccr < 30 ml/min) severe renal impairment (ccr < 30 ml/min) - severe hepatic impairment (child-pugh score > 10) 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) ] concomitant administration with strong cytochrome p450 3a4 (cyp3a4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see drug interactions (7.1) ] pregnancy category b. rapaflo is not indicated for use in women. an embryo/fetal study in rabbits showed decreased maternal body weight at 200 mg/kg/day (approximately 13-25 times the maximum recommended human exposure or mrhe of silod