Bedaquiline description: Difference between revisions
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SIRTURO (bedaquiline) contains 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).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1534c9ae-4948-4cf4-9f66-222a99db6d0e#nlm34089-3 | publisher = | date = | accessdate = | SIRTURO (bedaquiline) contains 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).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SIRTURO (BEDAQUILINE FUMARATE) TABLET [JANSSEN PRODUCTS, LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1534c9ae-4948-4cf4-9f66-222a99db6d0e#nlm34089-3 | publisher = | date = | accessdate = }}</ref> | ||
==References== | ==References== | ||
Latest revision as of 02:11, 26 December 2013
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Description
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-2-methoxy-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:
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SIRTURO (bedaquiline) contains 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).[1]
References
Adapted from the FDA Package Insert.