Mycophen S Tablets (Mycophenolic Acid )

• Composition :
  Each tablet contains Mycophenolate acid 360 mg.
• Indications :
  For the prophylaxis of acute organ rejection and for the treatment of refractory organ rejection in patients receiving allogeneic renal transplants increased graft and patient ssurvival receiving allogeneic cardiac transplants.
• Pharmacodynamics :
  MPA is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines, whereas other cell types can utilize salvage pathways, MPA has potent cytostatic effects on lymphocytes.
• Dosage and administration :
  The recommended dose of Mycophenolic acid is 720 mg administered twice daily (1440 mg total daily dose) on an empty stomach, one hour before or two hours after food intake.
• Contraindications :
  In patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or to any of its excipients.
• Precautions and warnings :
  New or Reactivated Viral Infections: Consider reducing immunosuppression. Blood Dyscrasias, including Pure Red Cell Aplasia (PRCA): Monitor for neutropenia or anemia; consider treatment interruption or dose reduction. Serious GI Tract Complications (gastrointestinal bleeding, perforations and ulcers): Administer with caution to patients with active digestive system disease. Immunizations: Avoid live attenuated vaccines. Patients with Hereditary Deficiency of Hypoxanthine-guanine Phosphoribosyl-transferase (HGPRT): May cause exacerbation of disease symptoms; avoid use. Blood Donation: Avoid during therapy and for 6 weeks thereafter. Semen Donation: Avoid during therapy and for 90 days thereafter.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy category D. There are no data on the presence of mycophenolate in human milk, or the effects on milk production. Safety and effectiveness in paediatric patients receiving allogeneic cardiac or hepatic transplants have not been established.
• Drug interactions :
  Mycophen may be administered to patients who are also taking antacids containing magnesium and aluminum hydroxides; however, it is recommended that Mycophen and the antacid not be administered simultaneously. It is recommended that sevelamer and other calcium free phosphate binders preferentially 20 could be given 2 hours after Mycophen intake to minimize the impact on the absorption of MPA.
• Adverse reactions :
  Most common adverse reactions (≥20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain
• Therapy Area :
  Immunosuppresants