Silodosin capsule is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2 R )-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl}amino) propyl]-2,3-dihydro-1 H -indole-7-carboxamide and the molecular formula is C 25 H 32 F 3 N 3 O 4 with a molecular weight of 495.53. The structural formula of silodosin is: Silodosin is a white to pale yellowish white powder that melts at approximately 105°C to 109°C. It is freely soluble in acetic acid, freely s...

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8 mg capsules taken orally once daily with a meal. 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30 mL/min to 50 mL/min]. 2.1 Dosing Information The recommended dose is 8 mg orally once daily with a meal. Patients who have difficulty swallowing pills and capsules may carefully open the silodosin capsule and sprinkle the powder inside on a tablespoonful of applesauce. The applesauce should be swallowed immediately (within 5 minu...

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

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Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse event was postural hypotension. Should overdose of silodosin lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by maintaining the patient in the supine position. If this measure is inadequate, administration of intravenous fluid should be considered. If necessary, vasopressors could be...

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

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Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma silodosin concentration. Concomitant use is not recommended. Alpha-blockers: Interactions involving concomitant use have not been determined. However, interactions are expected and concomitant use is not recommended. Concomitant use of PDE5 inhibitors with alpha-blockers including silodosin can potentially cause symptomatic hypotension. 7.1 Moderate and Strong CYP3A4 Inhibitors In a clinical metabolic inhibit...

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