The active ingredient in KALYDECO tablets is ivacaftor which
has the following chemical name: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4oxoquinoline-3-carboxamide.
Its molecular formula is C24H28N2O3
and its molecular weight is 392.49. Ivacaftor has the following structural
Ivacaftor is a white to off-white
powder that is practically insoluble in water (<0.05 microgram/mL). KALYDECO
is available as a light blue capsule-shaped, film-coated tablet for oral
administration containing 150 mg of ivacaftor. Each tablet contains the
inactive ingredients colloidal silicon dioxide, croscarmellose sodium,
hypromellose acetate succinate, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and sodium lauryl sulfate. The tablet film coat
contains carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and
titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide
black, propylene glycol, and shellac.
Last reviewed on RxList: 10/10/2012
This monograph has been modified to include the generic and brand name in many instances.