Mofelet 500mg (Mycophenolate Mofetil)

Description

Mofelet (mycophenolate mofetil) is the 2 – morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent, inosine mono-phosphate dehydrogenase (IMPDH) inhibitor.

Pharmacokinetics:

Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA. Oral absorption of the drug is rapid and essentially complete. Mean apparent half life of MPA, the active metabolite is 17.9 (+6.5) hours. A negligible amount of drug (<1% of dose) is excreted as MPA in the urine. 93% of the dose recovered in the urine and 6% recovered in the feces.

Indications and Dosage:

A dose of 1 g orally administered twice a day (daily dose of 2 g) is recommended for use in renal transplant patients. A dose of 1.5 g bid orally administered twice a day (daily dose of 3 g) is recommended for use in cardiac and hepatic transplant patients.

Contraindications:

Patients with hypersensitivity to mycophenolate mofetil or mycophenolic acid or any component of the drug product.

Warnings and precautions:

Gastrointestinal bleeding has been observed in approx.3% of renal, in 1.7% cardiac and 5.4% hepatic transplant patients treated with mycophenolate mofetil. Patients should be monitored for neutropenia. It should be not administered concomitantly with azathioprine because both have the potential to cause bone marrow suppres- sion. During treatment the use of live attenuated vaccines should be avoided. It should be avoided in pregnant women unless the potential benefit outweighs the potential risk to the fetus.safety and effectiveness in pediatric patients have not been established. Patients receiving immunosuppressive regimens involving combinations of drugs, including mycophenolate mofetil as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin.

Adverse Reactions:

Abdominal pain, fever, headache, infection, sepsis, asthenia, chest pain, anemia, leucopenia, thrombocytopenia, urinary tract infection, peripheral edema, hypertension, hypotension, anorexia, cholangitis, nausea, vomiting, acne, alopecia, fungal dermatitis, colitis.