Immucept 250/Immucept 500

Immucept 250/Immucept 500

mycophenolic acid

Manufacturer:

Intas Pharmaceuticals

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Concise Prescribing Info
Contents
Mycophenolate mofetil
Indications/Uses
Prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants in combination w/ ciclosporine & corticosteroids. Refractory acute transplant rejection in patients receiving allogeneic renal. Induction & maintenance therapy in patients w/ class III-IV lupus nephritis.
Dosage/Direction for Use
Renal transplant Adult 1 g bid initiated w/in 72 hr following transplantation. Childn & adolescents 2-18 yr 600 mg/m2 bid. Max: 2 g daily. BSA 1.25-1.5 m2 750 mg bid (1.5 g daily dose), >1.5 m2 1 g bid (2 g daily dose). Elderly ≥65 yr 1 g bid. Cardiac transplant Adult 1.5 g bid (3 g daily dose). Elderly ≥65 yr 1.5 g bid. Hepatic transplant Adult 1.5 g bid (3 g daily dose). Elderly ≥65 yr 1.5 g bid. Lupus nephritis Induction therapy: 750 mg to 1.5 g bid (up to 3 g daily dose). Maintenance therapy: 500 mg to 1 g bid (2 g daily dose).
Administration
May be taken with or without food: In stable renal transplant patients, may be administered w/ meals if necessary.
Contraindications
Hypersensitivity to mycophenolate mofetil, mycophenolic acid. Lactation.
Special Precautions
Increased risk of developing lymphomas & other malignancies, risk for opportunistic infections (bacterial, fungal, viral & protozoal), fatal infections & sepsis. Limit exposure to sunlight or UV light. Monitor patients for neutropenia & ensure to have CBC wkly during the 1st mth, twice mthly for 2nd & 3rd mth of treatment, then mthly through the 1st yr. Pure red cell aplasia (PRCA). Avoid use of live attenuated vaccines & w/ rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Patients w/ active serious digestive system disease. Pregnancy.
Adverse Reactions
Diarrhea, leukopenia, sepsis & vomiting. Lymphomas & other malignancies; candida mucocutaneous, CMV viraemia/syndrome & herpes simplex; abdominal pain, anemia, fever, HTN, infection, pain, pharyngitis, resp tract infection; GI haemorrhage, pulmonary oedema.
Drug Interactions
Increase plasma conc of acyclovir, ganciclovir, valacyclovir. Decreased absorption w/ antacids (Mg & Al hydroxides). Potential reduction of efficacy w/ cholestyramine & drugs that interfere w/ enterohepatic recirculation. Reduced enterohepatic recirculation w/ cyclosporine A. Decreased MPA exposure w/ rifampin, norfloxacin & metronidazole. Decreased MPA plasma conc w/ sevelamer. Elevated MPA trough plasma conc w/ tacrolimus & sirolimus. Reduced pre-dose (trough) MPA conc w/ ciprofloxacin & amoxicillin plus clavulanic acid. Decrease plasma conc of levonogestrel. Live vaccines. Raised plasma AUC w/ probenecid.
MIMS Class
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Immucept 250 cap 250 mg
Packing/Price
10 × 10's
Form
Immucept 500 tab 500 mg
Packing/Price
5 × 10's
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