Avoprost D Capsules (Silodosin + Dutasteride)

• Composition :
  Each capsule contains 8mg of silodosin and 0.5mg of dutasteride.
• Indications :
  Indicated for the treatment of the signs and symptoms of BPH in men with an enlarged prostate.
• Pharmacodynamics :
  Silodosin is a selective antagonist of post-synaptic alpha-1A adrenoreceptors, which are located in the human prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra. Blockade of these alpha-1A adrenoreceptors can cause smooth muscle in these tissues to relax, resulting in an improvement in urine flow and a reduction in BPH symptoms. Dutasteride is a competitive and specific inhibitor of both type I and type II 5-alpha-reductase isoenzymes, with which it forms a stable enzyme complex.
• Dosage and administration :
  One capsule daily approximately 30 minutes after the same meal each day. Swallow capsule as a whole.
• 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.Dutasteride is contraindicated for use in women and children.
• Precautions and warnings :
  Postural hypotension, with or without symptoms (e.g., dizziness), may develop when beginning Avoprost D treatment. In patients with moderate renal impairment, Avoprost D dose modification is required. Should not be used in combination with other alpha-blockers. Inform patients planning cataract surgery to notify their ophthalmologist that they are taking Avoprost D because of the possibility of Intraoperative Floppy Iris Syndrome (IFIS)
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category B. Avaprost D is not indicated for use in women. Avaprost D 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. Dutasteride is metabolized by human CYP 450 enzymes CYP3A4 and CYP3A5, hence to be used in caution when used with CYP3A4 inhibitors (e.g. ritonavir).
• Adverse reactions :
  The most common adverse reactions include retrograde ejaculation disorders, headache, diarrhoea, orthostatic hypotension, nasopharyngitis, nasal congestion, impotence and decreased libido.
• Therapy Area :
  Urologicals