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.

• 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]
• 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 ]
• Dosage Adjustment in Special Populations Renal impairment: Silodosin capsule is contraindicated in patients with severe renal impairment (CCr < 30 mL/min)
• In patients with moderate renal impairment (CCr 30 mL/min 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 mL/min to 80 mL/min) [see CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS , USE IN SPECIFIC POPULATIONS and CLINICAL PHARMACOLOGY ]. …

Capsules: 8 mg and 4 mg. ( 3 ) The 8 mg, size '1' capsules with white opaque cap and white opaque body imprinted with "LU" on the cap and "Q72" on the body in green ink. The 4 mg, size '3' capsules with white opaque cap and white opaque body imprinted with "LU" on the cap and "Q71" on the body in gold ink.

• Silodosin 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 silodosin, 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 silodosin patients < 65 years of age (1.2% for placebo), 2.9% of silodosin patients ≥ 65 years of age (1.9% for placebo), and 5.0% of patients ≥ 75 years of age (0% for placebo) …

• Advise patients to take silodosin capsules once daily with a meal [see DOSAGE AND ADMINISTRATION ]
• Advise patients about the possible occurrence of symptoms related to postural hypotension (such as dizziness), and should be cautioned about driving, operating machinery, or performing hazardous tasks until they know how silodosin capsules will affect them
• This is especially important for those with low blood pressure or who are taking antihypertensive medications [see WARNINGS AND PRECAUTIONS ]
• Counsel patients on that the most common side effect seen with silodosin capsules is an orgasm with reduced or no semen. …

• 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. …

Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma silodosin concentration. Concomitant use is not recommended. ( 7.2 ) Alpha-blockers: Interactions involving concomitant use have not been determined. However, interactions are expected and concomitant use is not recommended. ( 7.3 ) Concomitant use of PDE5 inhibitors with alpha-blockers including silodosin can potentially cause symptomatic hypotension. …

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). …

Most common adverse reactions (incidence ≥ 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In U.S. …

8.1 Pregnancy Risk Summary Silodosin is not indicated for use in females.

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 used, and renal function should be monitored and supported as needed. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.