Mycophenolic acid is the generic equivalent of the brand-name drug Mycophenolic Acid. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Mycophenolic acid through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Mycophenolic acid is 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 delayed release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney tr…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label. Embryo-fetal Toxicity [see Boxed Warning , Warnings and Precautions (5.1) ] Lymphomas and Other Malignancies [see Boxed Warning , Warnings and Precautions (5.3) ] Serious Infections [see Boxed Warning , Warnings and Precautions (5.4) ] New or Reactivated Viral Infections [see Warnings and Precautions (5.5) ] Blood Dyscrasias, Including Pure Red Cell Aplasia [see Warnings and Precau…
Drug Interactions
7 DRUG INTERACTIONS Antacids with Magnesium and Aluminum Hydroxides: Decreases concentrations of MPA; concomitant use is not recommended. ( 7.1 ) Azathioprine: Competition for purine metabolism; concomitant administration is not recommended. ( 7.2 ) Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal, and Other Drugs that Interfere with Enterohepatic Recirculation: May decrease MPA concentrations; concomitant use is not recommended. ( 7.3 ) Sevelamer: May decrease MPA concentrations;…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION In adults: 720 mg by mouth, twice daily (1,440 mg total daily dose) on an empty stomach, 1 hour before or 2 hours after food intake. ( 2.1 ) In children: 5 years of age and older (who are at least 6 months post kidney transplant), 400 mg/m 2 by mouth, twice daily (up to a maximum of 720 mg twice daily). ( 2.2 ) Do not crush, chew, or cut tablet prior to ingestion. ( 2.3 ) 2.1 Dosage in Adult Kidney Transplant Patients The recommended dose of mycophenolic acid delayed…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity Pregnancy loss and malformations Inform pregnant women and females of reproductive potential that use of mycophenolic acid delayed release tablets in pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Advise patients that they must use an acceptable form of contraception[see Warnings and Precautions ( 5.1 ), Use in Specific Polpulations ( 8.1 , 8.3 ) ] Encourage pregnant women to…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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