Zenocept Tablets / Film-coated

Mycophenolate Mofetil

500mg

ZEINO PHARMA FZ LLC

Pack size	50's (10's Blister x 5)
Dispensing mode	POM
Source	UAE
Agent	ALPHAMED DRUG STORE
Retail Price	322.50 AED

Indications

Zenocept Tablets / Film-coated is used for: Prophylaxis of acute renal graft rejection, Prophylaxis of cardiac graft rejection, Liver 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.

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. 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

Pregnancy-Lactation

Pregnancy Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems Consider alternative immunosuppressants with less potential for embryofetal toxicity; risks and benefits of therapy should be discussed with the pregnant woman; the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear Animal data Oral administration of mycophenolate to rats and rabbits during period of organogenesis produced congenital malformations and pregnancy loss at doses less than recommended clinical dose (0.02 to 0.1 times the recommended clinical doses in kidney and heart transplant patients) Lactation There are no data on presence of drug in human milk, or effects on milk production; there are limited data in the National Transplantation Pregnancy Registry on effects of mycophenolate on a breastfed child; studies in rats treated with MMF have shown mycophenolic acid (MPA) to be present in milk Because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from the underlying maternal condition

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

Zenocept 500mg Tablets / Film-coated manufactured by ZEINO PHARMA FZ LLC. Its generic name is Mycophenolate Mofetil. Zenocept is availble in United Arab Emirates. Farmaco UAE drug index information on Zenocept Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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