Mycophenolate-Mofetil 500 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Mycophenolate mofetil |
| Company | Sandoz a novartis division |
Indications
- Prophylaxis of acute organ rejection and treatment of first or refractory organ rejection in patients receiving allogeneic renal transplants
- Prophylaxis of acute organ rejection in patients receiving allogeneic cardiac transplants
- Prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants
- Induction and maintenance therapy of patients with Class III-V lupus nephritis
Description
Immunosuppressive agent, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), cytostatic effects on lymphocytes, prevents acute rejection of kidney and heart allotransplantation, decreases antibody production
Mechanism of Action
Potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), inhibits de novo pathway of guanosine nucleotide synthesis, structurally mimics nicotinamide adenine dinucleotide cofactor and a catalytic water molecule, more potent cytostatic effects on lymphocytes than on other cells
Pharmacodynamics
Non-competitive, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), blocks de novo synthesis of guanosine nucleotides, decreases intracellular pools of guanosine triphosphate (GTP) and deoxyguanosine triphosphate (dGTP) in mitogen-stimulated human peripheral blood monocytes or T lymphocytic cell lines
Dosage & Administration
- Standard dosage for prophylaxis of renal rejection in adults: A dose of 1 g administered orally twice a day (daily dose of 2 g)
- Standard dosage for prophylaxis of renal rejection in children: Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed Mycophenolate Mofetil Tablets at a dose of 750 mg twice daily (1.5 g daily dose)
- Standard dosage for prophylaxis of cardiac rejection in adults: A dose of 1.5 g administered orally twice a day (daily dose of 3 g)
- Standard dosage for treatment of first or refractory renal rejection in adults: A dose of 1.5 g administered orally twice a day (daily dose of 3 g)
- Standard Dosage for Induction Therapy in adults: A dose of 750 mg-1.5 g administered orally twice a day (daily dose of up to 3 g)
- Standard Dosage for Maintenance Therapy in adults: A dose of 500 mg-1 g administered orally twice a day
Interaction
Caution with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration
Contraindications
Hypersensitivity to mycophenolic acid or any of its excipients, pregnancy, breastfeeding
Side Effects
- Diarrhea
- Leukopenia
- Sepsis
- Gastrointestinal candidiasis
- Urinary tract infection
- Herpes simplex
- Vomiting
- Higher frequency of certain types of infections eg. opportunistic infections
Pregnancy & Lactation
Contraindicated in pregnancy and during breastfeeding, safe use during labor and delivery not established
Precautions & Warnings
- Can increase new or reactive viral infections
- Can cause blood dyscrasias including pure red cell aplasia (PRCA)
- Can cause serious GI tract complications
- May increase the risk of developing lymphomas and other malignancies
- Use of live vaccines should be avoided
- Patients should not donate blood during therapy
Use in Special Populations
Geriatric patients may be at an increased risk of adverse events such as certain infections and possibly gastrointestinal hemorrhage and pulmonary edema
Overdose Effects
Could result in over suppression of the immune system, increase susceptibility to infections and bone marrow suppression, neutropenia may develop, dosing should be interrupted or reduced
Therapeutic Class
Immunological Chemotherapy, Immunosuppressant
Storage Conditions
Store in a cool (below 30°C), dry place and away from light, keep out of the reach of children