MYFORTIC Tablet
Mycophenolate Mofetil
360mg
Novartis India Ltd.
| Pack size | 120's |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 161.00 NPR |
Available as:
Indications
MYFORTIC Tablet is used for:
Prophylaxis of acute renal graft rejection, Prophylaxis of cardiac graft rejection, Liver Transplant
Adult Dose
Oral
Prophylaxis of acute renal graft rejection
Adult: 1 g bid starting within 72 hr of transplantation. Max: 2 g/day.
Prophylaxis of cardiac graft rejection, Liver Transplant
Adult: 1.5 g bid starting within 5 days after transplantation.
Child Dose
Kidney Transplant
<3 months
Safety and efficacy not established
>3 months
Prophylaxis of organ rejection in patients receiving allogeneic renal transplants
MMF (suspension): 600 mg/m² PO q12hr; not to exceed 2 g/day
MMF: BSA 1.25-1.5 m²: 750 mg capsule PO q12hr
MMF: BSA >1.5 m²: 1 g capsule/tablet PO q12hr
Renal Dose
Renal impairment
MMF: In severe renal impairment (glomerular filtration rate [GFR] <25 mL/min/1.73 m²), not to exceed 1 g q12hr
No dosage adjustment needed in renal transplant patients experiencing delayed graft function postoperatively
Administration
Drug is taken on empty stomach 1 hour before or 2 hours after meals
Once dosage is stabilized, MMF can be taken with food after kidney transplant
Contra Indications
Pregnancy, lactation. Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT), including Kelley-Seegmiller or Lesch-Nyhan syndrome.
Precautions
Teratogenic in animals; avoid inhalation or direct skin contact. Monitor patients for lymphoproliferative disorders; advise patient to limit exposure to sunlight/UV light. Active peptic ulcer disease. Severe renal impairment. Mycophenolate mofetil and mycophenolate sodium are not interchangeable. Perform CBCs; monitor for neutropenia.
Lactation: Unknown whether drug is excreted in breast milk; avoid using, or do not nurse
Pregnancy-Lactation
Interactions
Increased plasma levels of both drugs when combined with aciclovir, valaciclovir, ganciclovir and valganciclovir. Reduced absorption with colestyramine, magnesium- and aluminium hydroxide-containing products, sevelamer and other calcium-free phosphate binders. Reduced plasma levels with ciclosporin, metronidazole, quinolones, rifamycins. May reduce plasma levels of progestins; may reduce efficacy of oral contraceptives. Increased plasma levels with probenecid. May reduce efficacy of live vaccines.
Adverse Effects
Side effects of Mycophenolate Mofetil :
>10%
Hyperglycemia (44%),Hypercholesterolemia (41%),Hypomagnesemia (39%),Dyspnea (37%),Back pain (35%),Increased blood urea nitrogen (BUN) (35%),Leukopenia (34%),Pleural effusion (34%),Urinary tract infection (34%),Increasing frequency of cough (31%),Hypocalcemia (30%),Hypertension (28%),Abdominal pain (27%),Peripheral edema (27%),Anemia (26%),Fever (23%),Nausea (23%),Hyperkalemia (22%),Diarrhea (21%),Infection (21%),Headache (16%)
1-10%
Melanoma (1.6-4.2%),Other malignancies (0.7-2.1%),Lymphoma (0.4-1%),Opportunistic infection (including herpes),Neutropenia,GI bleeding,Pulmonary fibrosis,Progressive multifocal leukoencephalopathy
Potentially Fatal: Angioedema, anaphylaxis, fatal pulmonary fibrosis.
Mechanism of Action
Mycophenolic acid acts by blocking purine synthesis of human lymphocytes through reversible inhibition of inosine monophosphate dehydrogenase. It also inhibits proliferation of both T- and B- lymphocytes.
Note
MYFORTIC 360mg Tablet manufactured by Novartis India Ltd.. Its generic name is Mycophenolate Mofetil. MYFORTIC is availble in Nepal.
Farmaco Nepal drug index information on MYFORTIC Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.