Refrat

Refrat Dosage/Direction for Use

mycophenolic acid

Manufacturer:

Strides Pharma Science

Distributor:

Unimed
Full Prescribing Info
Dosage/Direction for Use
The initial dose of REFRAT should be given as soon as the patients can tolerate oral medication following renal, cardiac or hepatic transplantation.
Recommended dosage: For prophylaxis of renal rejection: A dose of 1 g administered twice a day (daily dose of 2 g) for use in renal transplant patients.
For prophylaxis of cardiac rejection: A dose of 1.5 g administered twice a day (daily dose of 3 g) for use in cardiac transplant patients.
For prophylaxis of hepatic rejection: A dose of 1.5 g administered twice a day (daily dose of 3 g) for use in hepatic transplant patients.
Induction and maintenance treatment of lupus nephritis: A dose of 1g administered twice a day (daily dose of 2g).
Special dosage instructions: Patients with neutropenia: If neutropenia develops (absolute neutrophil count <1.3x103/μl), dosing with mycophenolate mofetil should be interrupted or the dose reduced.
Patients with severe renal impairment: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate <25 mL/min/1.73m2), outside of the immediate post transplant period or after treatment of acute or refractory rejection, doses greater than 1 g administered twice a day should be avoided. No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
No data are available for cardiac transplant patients with severe chronic impairment.
Patients with delayed renal graft function post-transplant: No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively.
Patients with severe hepatic impairment: No dose adjustments are needed for renal patients with severe hepatic parenchymal disease. No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Elderly (≥65 years): The recommended oral dosage of 1 g twice daily for renal transplant patients and 1.5 g twice daily for cardiac transplant patients are appropriate for elderly patients.
Children: Safety and efficacy in paediatric patients have not been established. Very limited pharmacokinetic data are available for paediatric renal transplant patients. No data are available for paediatric patients receiving cardiac transplants.
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