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

• It is highly effective in managing BPH symptoms
• and has high uroselectivity for alpha-1 adrenergic receptors.
• It is an effective option for patients who do not respond adequately to Tamsulosin.
• Silodosin does not commonly cause orthostatic hypotension
• and is administered conveniently as a once-daily dose.

Silodosin is a selective antagonist of post-synaptic alpha-1 adrenergic receptors located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra. By blocking these receptors, Silodosin relaxes smooth muscle in these tissues, leading to improved urinary flow and relief of symptoms associated with benign prostatic hyperplasia (BPH).

The recommended dose is Silodosin 8 mg orally once daily with a meal. 4 mg capsules taken orally once daily with a meal for those with moderate renal impairment (CrCl 30-50 mL/min).

Strong P-glycoprotein inhibitors (e.g., cyclosporine) may increase plasma concentrations of Silodosin when used together. Concomitant use of PDE5 inhibitors with alpha-blockers, including Silodosin, may lead to symptomatic hypotension such as dizziness or fainting due to additive blood pressure–lowering effects.

Silodosin is contraindicated in patients with severe renal or hepatic impairment. It is also contraindicated with strong CYP3A4 inhibitors such as ketoconazole, clarithromycin, itraconazole, and ritonavir. Patients with known hypersensitivity to Silodosin should not use this medicine.

The most commonly reported adverse effects include retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion.

Pregnancy Category B. Silodosin is not indicated for use in women. Animal studies in rabbits showed reduced maternal body weight at high doses, but no significant teratogenic effects were observed. In rats, no embryotoxic or teratogenic effects were seen during organogenesis. Silodosin is not considered teratogenic in animal studies, and no adverse effects on offspring development were observed during pregnancy and lactation studies in rats.

Postural hypotension with or without symptoms such as dizziness may occur at the start of treatment. Silodosin should not be used with other alpha-blockers. Patients planning cataract surgery should inform their ophthalmologist due to the risk of Intraoperative Floppy Iris Syndrome (IFIS).

Pediatric Use: Not indicated for use in children.

Geriatric Use: Clinical studies showed a slightly higher incidence of orthostatic hypotension in elderly patients, especially those above 75 years. Overall safety and effectiveness were similar between older and younger patients.

Renal Impairment: Contraindicated in severe renal impairment (CCr <30 mL/min). In moderate impairment (CCr 30–50 mL/min), dose should be reduced to 4 mg once daily with food. No adjustment is required in mild impairment.

Hepatic Impairment: Contraindicated in severe hepatic impairment (Child-Pugh >10). No dose adjustment is required in mild to moderate hepatic impairment.

In studies up to 48 mg/day, postural hypotension was the main dose-limiting effect. If overdose occurs, cardiovascular support is essential. The patient should be placed in a supine position to restore blood pressure. If needed, intravenous fluids and vasopressors may be administered. Renal function should be monitored. Dialysis is unlikely to be effective due to high protein binding (~97%).

Treatment for benign prostatic hyperplasia (BPH), urinary retention, and urinary incontinence.

Store below 30°C in a dry place, protected from light. Keep out of reach of children.