Silodosin

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

• 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 )]
• 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. ( 4 )

• 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 ) ].