Phenocept

Phenocept500mg

Type:10 Tablets

Generic Name:Mycophenolate Mofetil

Manufacturer:Renata Limited

Price:680.00

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Indication

Prophylaxis of acute renal graft rejection, Prophylaxis of cardiac graft rejection, Liver Transplant

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

Adult Dose

Oral Adult Prophylaxis of acute renal graft rejection As Mycophenolate Mofetil (MMF): 1 g twice daily starting w/in 72 hr of transplantation. Max: 2 g/day. Prophylaxis of cardiac graft rejection, Liver Transplant Adult: As Mycophenolate Mofetil (MMF):1.5 g bid starting within 5 days after transplantation.

Child Dose

<3 months Safety and efficacy not established >3 months Prophylaxis of organ rejection in patients receiving allogeneic renal transplants As Mycophenolate Mofetil (MMF): 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 post-operatively.

Contraindication

Pregnancy, lactation. Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT), including Kelley-Seegmiller or Lesch-Nyhan syndrome.

Mode 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.

Precaution

Teratogenic in animals; avoid inhalation or direct skin contact. Monitor patients for lymphoproliferative disorders; advise patient to limit exposure to sunlight/UV light. Perform CBCs; monitor for neutropenia. Mycophenolate mofetil and mycophenolate sodium are not interchangeable. Lactation: Unknown whether drug is excreted in breast milk; avoid using, or do not nurse

Side Effect

>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.

Interaction

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.

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