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.