Silodosin

Silodosin capsules, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsule is not indicated for the treatment of hypertension. ( 1 ) 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.

Patients with severe renal impairment [Creatinine Clearance (CCr < 30 mL/min)]. ( 4 ) Patients with severe hepatic impairment (Child-Pugh score ≥ 10). ( 4 ) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir). ( 4 ) Patients with a history of hypersensitivity to silodosin or any of the ingredients of silodosin capsules. ( 4 ) 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 )]

Postural hypotension, with or without symptoms (e.g., dizziness), may develop when beginning silodosin treatment. ( 5.1 ) In patients with moderate renal impairment, silodosin dose should be reduced to 4 mg once daily. ( 5.2 ) Silodosin should not be used in combination with other alpha-blockers. ( 5.5 ) Examine patients thought to have BPH prior to starting therapy with silodosin to rule out the presence of carcinoma of the prostate.

( 5.6 ) Inform patients planning cataract surgery to notify their ophthalmologist that they are taking silodosin because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS). ( 5.7 )

5.1Orthostatic Effects

Postural hypotension, with or without symptoms (e.g., dizziness) may develop when beginning silodosin treatment. As with other alpha-blockers, there is potential for syncope. Patients should be cautioned about driving, operating machinery, or performing hazardous tasks when initiating therapy [ see ADVERSE REACTIONS ( 6 ), USE IN SPECIFIC POPULATIONS ( 8.5 ), CLINICAL PHARMACOLOGY ( 12.2 ), and PATIENT COUNSELING INFORMATION ( 17 ) ] .