Refrat

Refrat

mycophenolic acid

Manufacturer:

Strides Pharma Science

Distributor:

Unimed
Concise Prescribing Info
Contents
Mycophenolate mofetil
Indications/Uses
Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac & hepatic transplants in combination w/ cyclosporine & corticosteroids. Induction & maintenance treatment of lupus nephritis in combination w/ corticosteroids.
Dosage/Direction for Use
Renal transplant, induction & maintenance treatment of lupus nephritis 1 g bd. Cardiac & hepatic transplant 1.5 g bd.
Administration
Should be taken on an empty stomach: Do not open/crush.
Contraindications
Hypersensitivity to mycophenolate mofetil, mycophenolic acid.
Special Precautions
Increased risk of lymphomas & other malignancies. Bone marrow depression; active digestive system disease. Immunosuppressed patients. Post-transplant patients w/ delayed renal graft function. Monitor complete blood count & neutrophil during therapy. Avoid use in patients w/ hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase eg, Lesch-Nyhan & Kelley-Seegmiller syndrome. Avoid sunlight & UV exposure. Not to be used w/ azathioprine. Avoid use of live attenuated vaccines. Concomitant use w/ drugs known to interfere enterohepatic circulation. Avoid doses >1 g in patients w/ severe chronic renal impairment. Women of childbearing potential should use effective contraception prior to, during & for 6 wk after treatment. Avoid use during pregnancy. Lactation. Paed patients. Elderly.
Adverse Reactions
Diarrhoea, leukopenia, sepsis, vomiting, higher frequency of infections; abdominal, chest & back pain, fever, headache, anaemia, thrombocytopenia, leukocytosis, UTI, abnormal renal & hepatic function, HTN, hypotension, CV disorder, tachycardia, oedema, hypercholesterolemia, hypo-, hyperkalemia, hyperglycemia, increased BUN, serum creatinine conc & lactic dehydrogenase, hypomagnesemia, hypocalcemia, constipation, dyspepsia, nausea, anorexia, cough, dyspnoea, lung disorder, sinusitis, pleural effusion, rash, tremor, insomnia, anxiety, paraesthesia.
Drug Interactions
Higher MPAG & acyclovir plasma conc. Decreased absorption w/ antacids eg, Mg & Al hydroxide. Reduced AUC w/ cholestyramine. Increased MPAG & ganciclovir conc. Reduced MPAG Cmax w/ tacrolimus. Raised MPAG plasma AUC w/ probenecid. Diminished Ab response w/ live vaccines.
MIMS Class
ATC Classification
L04AA06 - mycophenolic acid ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Refrat cap 250 mg
Packing/Price
10 × 10's;5 × 10's
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