Mycophenolate Mofetil Tecnigen

Mycophenolate Mofetil Tecnigen

mycophenolic acid






Concise Prescribing Info
Mycophenolate mofetil
Prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants in combination w/ ciclosporin & corticosteroids.
Dosage/Direction for Use
Adult Renal transplant 1 g bid (2 g daily dose) initiated w/in 72 hr following transplantation. Cardiac transplant 1.5 g bid (3 g daily dose) initiated w/in 5 days following transplantation. Hepatic transplant 1.5 g bid (3 g daily dose). Administer IV mycophenolate mofetil for the first 4 days following hepatic transplant, w/ oral mycophenolate mofetil initiated as soon after as this it can be tolerated. Elderly ≥65 yr Renal transplant 1 g bid. Cardiac or hepatic transplant 1.5 g bid.
May be taken with or without food: Swallow whole, do not crush/open. In stable renal transplant patients, may be administered w/ meals if necessary.
Hypersensitivity to mycophenolate mofetil or mycophenolic acid. Pregnancy & lactation.
Special Precautions
Risk of lymphomas & other malignancies, opportunistic infections (eg, bacterial, fungal, viral & protozoal), fatal infections & sepsis. Monitor for neutropenia, & perform CBC wkly during the 1st mth, twice mthly for the 2nd & 3rd mth of treatment, then mthly through the 1st yr. Interrupt or discontinue use if neutropenia develops (absolute neutrophil count <1.3 x 103/microL). Pure red cell aplasia. Avoid live attenuated vaccines. Active serious digestive system disease. Hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) deficiency (eg, Lesch-Nyhan & Kelley-Seegmiller syndrome). Concomitant use w/ azathioprine & drugs that interfere w/ enterohepatic recirculation; tacrolimus or sirolimus. Limit exposure to sunlight & UV light. Childn <2 yr.
Adverse Reactions
Sepsis, GI candidiasis, UTI, herpes simplex, herpes zoster; leucopenia, thrombocytopenia, anemia; vomiting, abdominal pain, diarrhoea, nausea. Pneumonia, influenza, resp tract infection, resp moniliasis, GI infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vag candidiasis, rhinitis; skin cancer, benign neoplasm of skin; pancytopenia, leucocytosis; acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia; agitation, confusional state, depression, anxiety, abnormal thinking, insomnia; convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia; tachycardia; hypotension, HTN, vasodilation; pleural effusion, dyspnoea, cough; GI haemorrhage, peritonitis, ileus, colitis, gastric & duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation; hepatitis, jaundice, hyperbilirubinaemia; skin hypertrophy, rash, acne, alopecia; arthralgia; renal impairment; oedema, pyrexia, chills, pain, malaise, asthenia; increased hepatic enzyme, increased blood creatinine, increased blood lactate dehydrogenase, increased blood urea, increased blood alkaline phosphatase, decreased wt.
Drug Interactions
Decreased absorption w/ antacids. Reduced efficacy w/ cholestyramine & drugs that interfere enterohepatic circulation. Increased AUC w/ ciclosporin A & probenecid. Decreased MPA exposure w/ rifampicin, sirolimus, & norfloxacin & metronidazole combination. Decreased Cmax, AUC0-12 w/ sevelamer. Reduced pre-dose (trough) MPA conc w/ ciprofloxacin & amoxicillin plus clavulanic acid.
MIMS Class
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Mycophenolate Mofetil Tecnigen FC tab 500 mg
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