FULYZAQ (crofelemer) delayed-release tablets is an anti-diarrheal, enteric-coated drug product for oral administration. It contains 125 mg of crofelemer, a botanical drug substance that is derived from the red latex of Croton lechleri Mull. Arg. Crofelemer is an oligomeric proanthocyanidin mixture primarily composed of (+)-catechin, (-)-epicatechin, (+)-gallocatechin, and (-)-epigallocatechin monomer units linked in random sequence, as represented below. The average degree of polymerization for the oligomers ranges between 5 and 7.5, as determined by phloroglucinol degradation.

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.

Coating ingredients: ethylacrylate and methylacrylate copolymer dispersion, talc, triethyl citrate, and white dispersion which contains xanthan gum, titanium idoxide, propyl paraben, and methyl paraben.

Last reviewed on RxList: 1/10/2013
This monograph has been modified to include the generic and brand name in many instances.