Myfortic
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FDA Labeling Changes
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Uses
Myfortic® (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Myfortic is 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.
Myfortic is to be used in combination with cyclosporine and corticosteroids.
Myfortic 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.
History
There is currently no drug history available for this drug.
Other Information
Myfortic® (mycophenolic acid) delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Myfortic is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt.
Its empirical formula is C17H19O6Na. The molecular weight is 342.32 and the structural formula is:
Myfortic, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid.
Myfortic is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, povidone (K-30), and starch. The enteric coating of the tablet consists of hypromellose phthalate, titanium dioxide, iron oxide yellow, and indigotine (180 mg) or iron oxide red (360 mg).
Sources
Myfortic Manufacturers
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Novartis Pharmaceuticals Corporation
![Myfortic (Mycophenolic Acid) Tablet, Delayed Release [Novartis Pharmaceuticals Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Myfortic | Novartis Pharmaceuticals Corporation
2.1 Dosage in Adult Kidney Transplant PatientsThe recommended dose of Myfortic is 720 mg administered twice daily (1440 mg total daily dose).
2.2 Dosage in Pediatric Kidney Transplant PatientsThe recommended dose of Myfortic in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily).
2.3 AdministrationMyfortic tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake [see Clinical Pharmacology (12.3)].
Myfortic tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating.
Pediatric patients with a BSA of 1.19 to 1.58 m2 may be dosed either with three Myfortic 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet twice daily (1080 mg daily dose). Patients with a BSA of >1.58 m2 may be dosed either with four Myfortic 180 mg tablets, or two Myfortic 360 mg tablets twice daily (1440 mg daily dose). Pediatric doses for patients with BSA <1.19 m2 cannot be accurately administered using currently available formulations of Myfortic tablets.
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