Japani - englanti - すりの適正使用協議会 RAD-AR Council, Japan

nihon generic co.,ltd - silodosin - white to faint yellowish white oval tablet, major axis: 11.2 mm, minorr axis: 6.2 mm, thickness: 3.9mm

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 ) ] .

Kanada - englanti - Health Canada

sandoz canada incorporated - silodosin - capsule - 4mg - silodosin 4mg - selective alfa-1-adrenergic blocking agents

Kanada - englanti - Health Canada

sandoz canada incorporated - silodosin - capsule - 8mg - silodosin 8mg - selective alfa-1-adrenergic blocking agents

Kanada - englanti - Health Canada

apotex inc - silodosin - capsule - 4mg - silodosin 4mg - selective alfa-1-adrenergic blocking agents

Kanada - englanti - Health Canada

jamp pharma corporation - silodosin - capsule - 4mg - silodosin 4mg

Kanada - englanti - Health Canada

jamp pharma corporation - silodosin - capsule - 8mg - silodosin 8mg

Japani - englanti - すりの適正使用協議会 RAD-AR Council, Japan

kyosomirai pharma co., ltd. - silodosin - pale yellowish red tablet, diameter: 6.5 mm, thickness: 3.0 mm

Japani - englanti - すりの適正使用協議会 RAD-AR Council, Japan

sanwa kagaku kenkyusho co.,ltd. - silodosin - pale yellowish red tablet, diameter: 6.5 mm, thickness: 3.0 mm

Japani - englanti - すりの適正使用協議会 RAD-AR Council, Japan

kyosomirai pharma co., ltd. - silodosin - pale yellowish red tablet, diameter: 8.0 mm, thickness: 3.9 mm