Siloflo (Silodosin)

Therapeutic Group : AntiBPH

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:

– 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)

Side effects:

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.