"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
(cysteamine bitartrate) Delayed-release Capsules
PROCYSBI (cysteamine bitartrate) delayed-release capsules for oral administration, is a cystine depleting agent which lowers the cystine content of cells in patients with nephropathic cystinosis, an inherited defect of lysosomal transport.
PROCYSBI contains the bitartrate salt of cysteamine. The chemical name for cysteamine bitartrate is ethanethiol, 2-amino, (2R,3R)-2,3-dihydroxybutanedioate (1:1) (salt). Cysteamine bitartrate is a highly water soluble white powder with a molecular weight of 227.24 and the molecular formula C2H7NS • C4H6O6. It has the following chemical structure:
Each 25 mg delayed-release capsule contains 74 mg cysteamine bitartrate, equivalent to 25 mg cysteamine. Each 75 mg delayed-release capsule contains 221 mg cysteamine bitartrate, equivalent to 75 mg cysteamine. PROCYSBI (cysteamine bitartrate) delayed-release capsules contain the following inactive ingredients: microcrystalline cellulose, Eudragit® L 30 D-55, hypromellose, talc, triethyl citrate, sodium lauryl sulfate, and purified water. Capsule shell ingredients are gelatin, titanium dioxide, blue ink and white ink.
Last reviewed on RxList: 8/28/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Procysbi Information
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