PRODUCT DETAILS
Brand Name : Mofilet-s
Composition : Mycophenolate Mofetil
Strength availability : 360mg
Manufactured by : Emcure pharmaceuticals
Tab Count : 10 Tablets in 1 strip
for MORE INFORMATION !!!
Mycophenolic acid is belonging to immunosuppressive drug. Mofilet-s 360mg is an inactive form of mycophenolic acid (MPA). Following oral administration, Mofilet-s 360mg is fastly absorbed and hydrolysed change into MPA. MPA is the effective metabolite which has pharmacological action.
Mofilet-s 360mg which is used as prescription drug provided under the guidance of doctors.
INDICATION
Mofilet-s 360mg is an immunosuppressant drug which is;
Prescribed for the prophylaxis of organ refusal in patients getting allogeneic renal, cardiac or hepatic transplants.
DOSAGE
Mofilet-s is primarily necessary for inhibition of organ transplant of kidney, heart and liver, the dosage as follows
Kidney transplantation :
For Adult the recommended dose for kidney transplantation is 1 g given orally or intravenously (over no less than 2 hours) twice a day.
For paediatric (3 months to 18 years of age) the recommended dose of the oral suspension is 600 mg/m2 given twice daily (maximum daily dose of 2 g/10 ml).
Dosage also calculated according to body surface area
Capsule dose of 750 mg twice daily administers to Patients with a body surface area of 1.25 m2 to 1.5 m2.
Capsules or tablets at a 1 g dose twice daily is administrated to Patients with a body surface area >1.5 m2.
Heart transplantation :
For Adults the prescribed dose for heart transplantation is 1.5 g given twice daily intravenously over no less than 2 hours or 1.5 g administrated orally twice daily.
Liver Transplantation :
For Adults the prescribed dose for Liver Transplantation is 1 g twice daily given via intravenously over no less than 2 hours or 1.5 g orally twice daily.
For Geriatrics (elderly patients) the recommended orally is 1 g dose twice daily for renal transplant patients, 1.5 g
dose given twice daily for heart transplant patients, and 1 g dose twice in a day administered intravenously or 1.5 g dose twice in a day given orally in liver transplant patients.
MECHANISM
Mycophenolate Mofetil consist of morpholino ethyl ester of mycophenolic acid (MPA) with effective immunosuppressive properties mycophenolic blocks T-cell and B-cell multiplication via selective prohibition of the de novo pathway of purine biosynthesis. In vivo, the effective metabolite, MPA, reversibly prevents inosine 5’-monophosphate dehydrogenase, an enzyme contains in the de novo synthesis of guanine nucleotides. MPA show high lymphocyte specificity and cytotoxicity because of higher dependence of stimulation lymphocytes on both salvage and de novo synthesis of guanine nucleotides relative to other cell types. (NCI04).
ADME
Rapidly absorbed and bioavailability are 94% for oral Mycophenolate mofetil
the active metabolite MPA bounded to plasma protein is 98%.
Primarily metabolised by glucuronic transferase to form inactive phenolic glucuronide of MPA.
Mofilet-s 360mg is totally recovered with 93% dose in urine and 6% via feces and 87% administrated dose eliminated via urine as MPAG
Half-life of Mofilet-s is 13-17 hours
PRECAUTION
Embryofoetal Toxicity :
Mofilet-s 360mg can leads foetal harm when given to a pregnant female. While Use of Mofilet-s during pregnancy is along with an high risk of first trimester pregnancy loss and increased risk of congenital malformations
Lymphoma and Malignancy :
When Patients getting immunosuppressive drug including co administration of drugs, contains Mofilet-s 360mg, as part of an immunosuppressive regimen have increase of developing lymphomas and other malignancies, especially effect the skin
Pregnancy Exposure Prevention and Planning :
Females of reproductive possible should be made aware of the high risk of lack of first trimester pregnancy and congenital malformations and must be advise about pregnancy stopping and planning.
DRUG INTERACTION
Concomitant use of Mofilet-s 360mg with acyclovir or ganciclovir may causes high blood levels Mofilet-s and interacting drugs elimination through kidneys the drugs complete with each other
Mofilet-s 360mg concomitant use with antacid may reduce MPA blood levels
Combination with proton pump may reduce blood levels by binding in the intestine.
Mofilet-s 360mg concomitant use with birth control pills may reduce the effectiveness of some oral contraceptives
CONTRAINDICATION
Mofilet-s 360mg is contraindicated to the patients having with
Hypersensitivity to mycophenolate mofetil
Allergic to polysorbate 80 (tween)
Pregnant women
Breastfeeding women
MISSED DOSE
If dose is not taken, have immediately before next dose reaches or skip the dose and follow normal timing
Please Consult with the doctor
STORAGE
Mofilet-s 360mg Stored at 20℃-25℃
Avoid using if blister is torn or broken.
SIDE EFFECTS
Mofilet-s 360mg Common side effects :
Diarrhoea
Vomiting
Pain
Abdominal pain
Hypertension
Swelling of the ankles or feet, lower legs.
Serious side effects :
Infection
Infection in blood
Pharyngitis
Low RBC, and WBC