Kalydeco

DRUG DESCRIPTION

The active ingredient in KALYDECO tablets is ivacaftor which has the following chemical name: W-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide. Its molecular formula is C24H28N2O3 and its molecular weight is 392.49. Ivacaftor has the following structural formula:

Kalydeco (ivacaftor) structural formula illustration

Ivacafftor 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 ivacafftor. 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.



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