mycophenolic acid
Drug Details
- Generic Name
- mycophenolic acid
- Brand Names
- Myfortic, mycophenolic acid
- Application Number
- NDA050791
- Sponsor
- Novartis Pharmaceuticals Corporation
- NDC Codes
- 12
- Dosage Forms
- TABLET, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- MYCOPHENOLATE SODIUM
Indications and Usage
1 INDICATIONS AND USAGE Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1) Use in combination with cyclosporine and corticosteroids. (1.1) Limitations of Use: Mycophenolic acid delayed release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. (1.2) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Mycophenolic acid are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Mycophenolic acid are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. Mycophenolic acid are to be used in combination with cyclosporine and corticosteroids. 1.2 Limitations of Use Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.