Renodapt-S 360mg (Mycophenolate Mofetil)

Mycophenolate Mofetil
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Biocon Ltd.

Renodapt-S 360mg (Mycophenolate Mofetil)

ManufacturerBiocon Ltd.Brand nameRenodapt-SActive substanceMycophenolate MofetilStrength360mgCategoryNephrologyManufacturerBiocon Ltd

Description of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

Mycophenolic acid is belonging to immunosuppressive medicine.
Renodapt-S 360mg (Mycophenolate Mofetil 360mg) is an inactive form of mycophenolic acid (MPA). Following oral administration, Renodapt-S 360mg (Mycophenolate Mofetil 360mg) is fastly absorbed and hydrolysedchange into MPA.
MPA is the effective metabolite which has pharmacological action.
Renodapt-S 360mg (Mycophenolate Mofetil 360mg) which is used as prescription medicine provided under the guidance of doctors.

Medical use /Indication of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

Renodapt-S 360mg (Mycophenolate Mofetil 360mg) is an immunosuppressant medicine which is prescribed for the prophylaxis of organ refusal in patients getting allogeneic renal, cardiac or hepatic transplants.

Mechanism of Action Renodapt-S 360mg (Mycophenolate Mofetil 360mg)  

Mycophenolate Mofetil consist ofmorpholino ethyl ester of mycophenolic acid (MPA) with effective immunosuppressive properties mycophenolic blocks T-cell and B-cell multiplicationvia 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 of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

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.

Renodapt-S 360mg (Mycophenolate Mofetil 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 Renodapt-S 360mg (Mycophenolate Mofetil 360mg) is 13-17 hours

Side effects of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

Renodapt-S 360mg (Mycophenolate Mofetil 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

Precautions of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

Embryofoetal Toxicity Renodapt-S 360mg (Mycophenolate Mofetil 360mg) can leads fetal harm when given to a pregnant female.

While Use of Renodapt-S 360mg (Mycophenolate Mofetil 360mg) 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 medicine including co administration of medicines, contains Renodapt-S 360mg (Mycophenolate Mofetil 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 of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

  • Concomitant use of Renodapt-S 360mg (Mycophenolate Mofetil 360mg) with acyclovir or ganciclovir may causes high blood levels
  • Renodapt-S 360mg (Mycophenolate Mofetil 360mg) and interacting medicines elimination through kidneys the medicines complete with each other
  • Renodapt-S 360mg (Mycophenolate Mofetil 360mg) concomitant use with antacid may reduce MPA blood levels
  • Combination with proton pump may reduce blood levels by binding in the intestine.
  • Renodapt-S 360mg (Mycophenolate Mofetil 360mg) concomitant use with birth control pills may reduce the effectiveness of some oral contraceptives

Contraindication of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

Renodapt-S 360mg (Mycophenolate Mofetil 360mg) is contraindicated to the patients having with;

  • Hypersensitivity to mycophenolate mofetil
  • Allergic to polysorbate 80 (tween)
  • Pregnant women
  • Breastfeeding women

Pregnancy of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

Pregnancy category D

When use of Renodapt-S 360mg (Mycophenolate Mofetil 360mg) during pregnancy will have high risk of 1st trimester loss and congenital malformations occurred.

Lactation of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

Do not use Renodapt-S 360mg (Mycophenolate Mofetil 360mg) during breast feeding to infants.

Dosage of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

Renodapt-S 360mg (Mycophenolate Mofetil 360mg)  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 pediatric (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.

Storage of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

Renodapt-S 360mg (Mycophenolate Mofetil 360mg) Stored at 20℃-25℃

Avoid using if blister is torn or broken.

Missed dose of Renodapt-S 360mg (Mycophenolate Mofetil 360mg)

If dose is not taken, have immediately before next dose reaches or skip the dose and follow normal timing

Please Consult with the doctor

Brand name:
Renodapt-S
Active substance:
Mycophenolate Mofetil
Strength:
360mg
Category:
Nephrology
Manufacturer:
Biocon Ltd
Packaging:
10 tablets
Product form:
Tablet

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