Avobi Tablet (Bicalutamide)

• Composition :
  Each tablet contains Bicalutamide 50mg.
• Indications :
  Advanced prostatic cancer in combination with LHRH analogue on surgical castration.
• Pharmacodynamics :
  Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.
• Dosage and administration :
  One tablet, once daily.
• Contraindications :
  Patients with hypersensitivity to bicalutamide, women and pregnancy.
• Precautions and warnings :
  Potential of severe hepatic injury and fatal hepatic failure- Monitor serum transaminase levels prior to starting treatment with bicalutamide. Potential of causing gynecomastia and breast pain. Glucose tolerance in males when used along with LHRH analogue- monitor blood glucose levels periodically.
• Use in pregnancy, lactation & pediatrics :
  Contraindicated in pregnancy and lactation. Male subjects should use effective contraception with female partners of reproductive potential, as antiandrogen therapy may cause morphological changes in spermatozoa. The safety and effectiveness of bicalutamide in paediatric patients has not been established.
• Drug interactions :
  R-bicalutamide is an inhibitor of CYP 3A4; therefore, caution should be used when Bicalutamide is co-administered with CYP 3A4 substrates. PT/INR should be closely monitored in patients already receiving coumarin anticoagulants who are started on bicalutamide.
• Adverse reactions :
  Hot flashes, pain (including general, back, pelvic and abdominal), asthenia, constipation, infection, nausea, peripheral edema, dyspnoea, diarrhoea, haematuria, nocturia, and anaemia.
• Therapy Area :
  Urologicals