Mycophenolic Acid 180 mg/1
Mycophenolic Acid · TABLET, DELAYED RELEASE · Accord Healthcare Inc.
Mycophenolic Acid is a tablet, delayed release containing mycophenolic acid at 180 mg/1, taken oral. Manufactured by Accord Healthcare Inc..
Key Facts
- Brand Name
- Mycophenolic Acid
- Generic Name
- Mycophenolic Acid
- NDC Code (Product)
16729-261- Manufacturer
- Accord Healthcare Inc.
- Strength
- 180 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202555
- Marketing Start
- 09/11/2017
Recall History
Aidapak Services, LLC
Labeling: Label Mixup: MYCOPHENOLIC ACID DR, Tablet, 180 mg may have potentially been mislabeled as the following drug: METHAZOLAMIDE, Tablet, 50 mg, NDC 00781107101, Pedigree: AD37072_11, EXP: 5/13/2014.
Ascend Laboratories, LLC
Failed Dissolution Specifications
Mylan Lab Inc
Failed Dissolution Specifications: Low out of specification dissolution results.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 administrati…
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-release tablets are 720 mg administered twice daily (1,440 mg total daily dose). 2.2 Dosage in Pediatric Kidney Transplant Patients The recommended dose of mycophenolic acid in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m 2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily). 2.3 Administration Mycophenolic acid delayed-release tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake [see Clinical Pharmacology (12.3) ]. Mycophenolic acid delayed-release tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in …
Contraindications
4 CONTRAINDICATIONS Known hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. (4.1) 4.1 Hypersensitivity Reactions Mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. Reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing reports [see Adverse Reactions (6) ].
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; concomitant use is not recommended. (7.4) Cyclosporine: May decrease MPA concentrations; exercise caution when switching from cyclosporine to other drugs or from other drugs to cyclosporine. (7.5) Norfloxacin and Metronidazole: May decrease MPA concentrations; concomitant use with both drugs is not recommended. (7.6) Rifampin: May decrease MPA concentrations; concomitant use is not recommended unless the benefit outweighs the risk. (7.7) Hormonal Contraceptives: May reduce the effectiveness of oral contraceptives. Additional barrier contraceptive methods must be used. (5.1 , 7.8) Acyclovir, Valacyclovir, Ganciclovir, Valganciclovir, and Other Drugs that Undergo Renal Tubular Secretion: May increa…
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 Precautions (5.6) ] Serious GI Tract Complications [see Warnings and Precautions (5.7) ] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.8) ] Rare Hereditary Deficiencies [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥ 20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rat…
Frequently Asked Questions
What is Mycophenolic Acid used for?
Mycophenolic Acid contains Mycophenolic Acid. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.
Is Mycophenolic Acid a controlled substance?
Mycophenolic Acid is not classified as a controlled substance by the DEA.
What is the generic name for Mycophenolic Acid?
The generic name for Mycophenolic Acid is Mycophenolic Acid. There are 5 other brand versions of Mycophenolic Acid.
What is the NDC code for Mycophenolic Acid 180 mg/1?
The NDC (National Drug Code) for Mycophenolic Acid 180 mg/1 is 16729-261, listed by Accord Healthcare Inc..