Avoprost Capsules (Silodosin)

• Composition :
  Each capsule contains Silodosin 8 mg.
• Indications :
  Indicated for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only.
• Pharmacodynamics :
  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.
• Dosage and administration :
  8 mg capsules taken orally once daily with a meal.
• Contraindications :
  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. Patients with a history of hypersensitivity to silodosin or any of the ingredients.
• Precautions and warnings :
  Postural hypotension, with or without symptoms (e.g., dizziness), may develop when beginning Silodosin treatment. In patients with moderate renal impairment, Silodosin dose should be reduced to 4 mg once daily. 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)
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category B. AVAPROST is not indicated for use in women. Avaprost is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.
• Drug interactions :
  Strong P-glycoprotein inhibitors (e.g. cyclosporine): Co-administration may increase plasma silodosin concentration. Concomitant use is not recommended. Alpha blockers: Interactions involving concomitant use have not been determined. However, due to expected interactions, concomitant use is not recommended. Concomitant use of PDE5 inhibitors (e.g. sildenafil) with alpha-blockers can potentially cause symptomatic hypotension.
• Adverse reactions :
  The most common adverse reactions include retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion.
• Therapy Area :
  Urologicals