Mycophenolic Acid Recall
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FDA Labeling Changes
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Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic acid 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.
Mycophenolic acid is to be used in combination with cyclosporine and corticosteroids.
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.
There is currently no drug history available for this drug.
Mycophenolic acid delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid 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 molecular formula is C17H19O6 Na. The molecular weight is 342.32 and the structural formula is
Mycophenolic acid, 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.
Mycophenolic acid is available for oral use as delayed-release tablets containing 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include methylcellulose, sodium lauryl sulfate, stearic acid, colloidal silicon dioxide, hypromellose and polyethylene glycol. The enteric coating of the tablet consists of triethyl citrate, talc, titanium dioxide, yellow ferric oxide (180 mg and 360 mg), indigotine al lake (180 mg), methacrylic acid and ethyl acrylate copolymer dispersion, and red ferric oxide (360 mg).