Immucept 250/Immucept 500

Immucept 250/Immucept 500 Dosage/Direction for Use

mycophenolic acid

Manufacturer:

Intas Pharmaceuticals

Distributor:

Berlin Pharm

Marketer:

Berlin Pharm
Full Prescribing Info
Dosage/Direction for Use
Recommended Doses: Treatment with mycophenolate mofetil should be initiated and maintained by appropriately qualified transplant specialists.
Use in renal transplant: Adults: Oral mycophenolate mofetil should be initiated within 72 hours following transplantation.
The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Children and adolescents (aged 2 to 18 years): The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to a maximum dose of 2 g daily). Mycophenolate mofetil should only be prescribed to patients with a body surface area of at least 1.25 m2. Patients with a body surface area of 1.25 m2 to 1.5 m2 may be prescribed mycophenolate mofetil at a dosed of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area greater than 1.5 m2 may be prescribed mycophenolate mofetil at a dose of 1 g twice daily (2 g daily dose). As some adverse reactions occur with greater frequency in this age group compared with adult, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Children (< 2 years): Safety and efficacy in renal transplantation children younger than 2 years of age have not been established.
Use in cardiac transplant: Adults: Oral mycophenolate mofetil should be initiated as soon as possible following transplantation. The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Children: No data available for paediatric cardiac transplant patients.
Use in hepatic transplant: Adults: Oral Mycophenolate Mofetil should be initiated as soon as possible following transplantation. The recommended dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Children: No data available for paediatric hepatic transplant patients.
Use in elderly (≥ 65 years): The recommended dose of 1 g administered twice a day for renal transplant patients and 1.5 g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
Use in renal impairment: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 ml/min/1.73 m2), outside the immediate post-transplant period, dose greater than 1 g administered twice a day should be avoided. These patients should also be carefully observed. No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively. No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Use in severe hepatic impairment: No data adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Lupus nephritis patients: Standard Dosage for Induction Therapy: A Dose of 750 mg - 1.5 g administered orally twice a day (daily dose of up to 3 g) is recommended.
Standard Dosage for Maintenance Therapy: A Dose of 500 mg - 1 g administered orally twice a day (daily dose of up to 2 g) is recommended.
Mycophenolate Mofetil should be used in combination with corticosteroids. Doses should be introduced gradually and adjusted according to clinical response. Therapeutic drug monitoring could help prevent sub-therapeutic exposure (Cmin ≥ 3.0 mg/L or inter-dose AUC ≥ 35 h*mg/L).
Mode of Administration: Capsule for oral use.
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