Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MYCOPHENOLATE MOFETIL
Ascend Laboratories Sdn Bhd
MYCOPHENOLATE MOFETIL
10capsule Capsules; 100capsule Capsules
Alkem Laboratories Limited
MYCOKEM CAPSULE 250 MG (MYCOPHENOLATE MOFETIL CAPSULES USP) Mycophenolate Mofetil (250 mg) _Con_ _sumer_ _ Medicine Information Leaflet (RiMUP)_ Page 1 WHAT IS IN THIS LEAFLET 1. What Mycokem is used for 2. How Mycokem works 3. Before you use Mycokem 4. How to use Mycokem 5. While you are using it 6. Side effects 5. Storage and disposal of Mycokem 6. Product description 7. Manufacturer and Product Registration Holder 8. Date of revision WHAT MYCOKEM IS USED FOR MYCOKEM CAPSULE are used to prevent your body rejecting a transplanted kidney, heart or liver. MYCOKEM CAPSULE is used together with other medicines known as ciclosporin and corticosteroids. HOW MYCOKEM WORKS These hard gelatin capsules contain 250mg of the active ingredient Mycophenolate Mofetil. This belongs to a group of medicines called “immunesuppressants”. These medication works by lowering your body's immune system activity. BEFORE YOU USE MYCOKEM _When you must not use it_: -MYCOKEM CAPSULE should not be given to women of child bearing potential who are not using highly effective contraception -MYCOKEM CAPSULE treatment should not be initiated in women of child bearing potential without providing a pregnancy test result to rule out unintended use in pregnancy -MYCOKEM CAPSULE should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection -MYCOKEM CAPSULE should not be given to women who are breastfeeding. If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking MYCOKEM CAPSULE. _Taking other medicines_ Please inform your doctor or pharmacist if you are taking/using other medicines or have recently taken/used other medicines, even if these were obtained without a prescription. Are you taking medicines that contains -Acyclovir, Ganciclovir (for treatment of viral infection) -colestyramine (for the treatment of patients with high blood cholesterol) - rifampicin, norfloxacin, metronidazole, ciprofloxacin, amoxicillin + clavulanic acid (antibiotic) Soma hati kamili
MYCOKEM CAPSULES 250 mg MYCOPHENOLATE MOFETIL CAPSULES USP NAME OF PRODUCT MYCOKEM CAPSULES 250 MG DESCRIPTION AND COMPOSITION: MYCOKEM CAPSULES 250 MG: White to off white granular powder filled in size "1" blue coloured cap, brown coloured body hard gelatin capsules imprinted "266" on body with black ink. Each hard gelatin capsule contains: Mycophenolate Mofetil Ph. Eur. .... 250 mg PHARMACODYNAMICS Pharmacotherapeutic group: immunosuppressive agents ATC code L04AA06 Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA. MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells. PHARMACOKINETICS Absorption Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA. As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of Mycokem is correlated with MPA concentration. The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to IV mycophenolate mofetil. Mycophenolate mofetil is not measurable systemically in plasma following oral administration. Distribution As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are usually observed at approximately 6 – 12 hours post-dose. A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating that there is a significant amount of enterohepatic recirculation. MPA at clinically relevant concentrations is 97% bound to plasma albumin. Biotransformation MPA is metabolised principally by gl Soma hati kamili