Description

Silodosin is a selective antagonist of post-synaptic alpha-1 adrenoreceptors, which are located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra. Blockade of these alpha-1 adrenoreceptors can cause smooth muscle in these tissues to relax, resulting in an improvement in urine flow and a reduction in BPH symptoms.

Presentation

    Siloflo 4 Capsule: Each capsule contains Silodosin INN 4 mg.
    Siloflo 8 Capsule: Each capsule contains Silodosin INN 8 mg.

Indications

    Silodosin is indicated for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH).

Dosage & Administration

    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) 30-50 mL/min].

Contrainidications

    Patients with severe renal & hepatic impairment, concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) and patients with a history of hypersensitivity to Silodosin.

Warning & Precautions

    • Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma Silodosin concentrationPostural hypotension with or without symptoms (e.g. dizziness) may develop when beginning Silodosin treatment
    • Silodosin should not be used in combination with other alpha-blockers
    • Inform patients planning cataract surgery to notify their ophthalmologist that they are taking Silodosin because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS)

Side effects

    The most common adverse reactions are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis and nasal congestion.

Drug interaction

    • Strong P-glycoprotein inhibitors (e.g., cyclosporine): Co-administration may increase plasma Silodosin concentration.
    • Concomitant use of PDE5 inhibitors with alpha-blockers including Silodosin can potentially cause symptomatic hypotension. 

Use in special groups

    Pregnancy: Silodosin is not indicated for use in women.
    Pediatric patients: Silodosin is not indicated for use in pediatric patients.
    Renal impairment: Silodosin should be reduced to 4 mg per day in patients with moderate renal impairment. Silodosin is contraindicated in patients with severe renal impairment.
    Hepatic impairment: No dosing adjustment is required in patients with mild or moderate hepatic impairment. Silodosin is contraindicated in patients with severe hepatic impairment.

Packing

    Siloflo 4 Capsule: Each box contains 20 capsules in alu-alu blister pack.
    Siloflo 8 Capsule: Each box contains 20 capsules in alu-alu blister pack.