"The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis
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(ivacaftor) Film-coated Tablets
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 formula:
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: 3/10/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Kalydeco Information
- Kalydeco Drug Interactions Center: ivacaftor oral
- Kalydeco Side Effects Center
- Kalydeco FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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