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.
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Presentation:
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Siloflo 4 Capsule: Each capsule contains Silodosin INN 4 mg. Siloflo 8 Capsule: Each capsule contains Silodosin INN 8 mg.
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Indication:
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Silodosin is indicated for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH).
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Dosage & Administration:
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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) 30-50 mL/min].
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Contrainidications:
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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.
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Warning & Precautions:
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- Postural 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)
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Side effects:
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Most common adverse reactions are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis and nasal congestion.
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Drug interaction:
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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.
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Use in special groups:
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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.
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Packing:
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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.