SIRTURO (bedaquiline) for oral administration is
available as 100 mg strength tablets. Each tablet contains 120.89 mg of
bedaquiline fumarate drug substance, which is equivalent to 100 mg of
bedaquiline. Bedaquiline is a diarylquinoline antimycobacterial drug.
Bedaquiline fumarate is a white to almost white powder
and is practically insoluble in aqueous media. The chemical name of bedaquiline
fumarate is (1R, 2S)-1-(6-bromo-2methoxy-3-quinolinyl)-4-(dimethylamino)-2-(1-naphthalenyl)-1-phenyl-2-butanol
compound with fumaric acid (1:1). It has a molecular formula of C32H31BrN2O2•C4H4O4
and a molecular weight of 671.58 (555.50 + 116.07). The molecular
structure of bedaquiline fumarate is the following:
the following inactive ingredients: colloidal silicon dioxide, corn starch,
croscarmellose sodium, hypromellose 2910 15 mPa.s, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, polysorbate 20, purified water
(removed during processing).
Last reviewed on RxList: 1/10/2013
This monograph has been modified to include the generic and brand name in many instances.