SILODOSIN
These highlights do not include all the information needed to use SILODOSIN CAPSULES safely and effectively. See full prescribing information for SILODOSIN CAPSULES. SILODOSIN capsules, for oral use Initial U.S. Approval: 2008
5e5038ea-9214-469b-8174-e5787be7a801
HUMAN PRESCRIPTION DRUG LABEL
Jul 23, 2021
Aurobindo Pharma Limited
DUNS: 650082092
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SILODOSIN
PRODUCT DETAILS
INGREDIENTS (12)
SILODOSIN
PRODUCT DETAILS
INGREDIENTS (12)
Drug Labeling Information
INDICATIONS & USAGE SECTION
1 INDICATIONS AND USAGE
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.
Silodosin, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsules are not indicated for the treatment of hypertension. (1)
DOSAGE & ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
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 minutes) without chewing and followed with an 8 oz glass of cool water to ensure complete swallowing of the powder. The applesauce used should not be hot, and it should be soft enough to be swallowed without chewing. Any powder/applesauce mixture should be used immediately (within 5 minutes) and not stored for future use. Subdividing the contents of a silodosin capsule is not recommended [see CLINICAL PHARMACOLOGY (12.3)].
2.2 Dosage Adjustment in Special Populations
Renal impairment: Silodosin capsules are contraindicated in patients with severe renal impairment (CCr < 30 mL/min). In patients with moderate renal impairment (CCr 30 to 50 mL/min), the dose should be reduced to 4 mg once daily taken with a meal. No dosage adjustment is needed in patients with mild renal impairment (CCr 50 to 80 mL/min) [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2), USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].
Hepatic impairment: Silodosin capsules have not been studied in patients with severe hepatic impairment (Child-Pugh score ≥ 10) and is therefore contraindicated in these patients. No dosage adjustment is needed in patients with mild or moderate hepatic impairment [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.3), USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].
- 8 mg capsules taken orally once daily with a meal. (2.1)
- 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment [Creatinine Clearance (CCr) 30 to 50 mL/min]. (2.2)
DOSAGE FORMS & STRENGTHS SECTION
3 DOSAGE FORMS AND STRENGTHS
The 8 mg capsules are size ‘1’ capsules with white opaque hard gelatin cap imprinted with “SIL” and white opaque hard gelatin body imprinted with “8 mg” in black ink containing white to off‑white powder.
The 4 mg capsules are size ‘3’ capsules with white opaque hard gelatin cap imprinted with “SIL” and white opaque hard gelatin body imprinted with “4 mg” in black ink containing white to off‑white powder.
Capsules: 8 mg and 4 mg. (3)