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Flibanserin (Addyi)

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Flibanserin 100 mg

 

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WARNING

HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS

Contraindicated with Alcohol

 

The use of ADDYI and alcohol increases the risk of severe hypotension and syncope [see WARNINGS AND PRECAUTIONS]. Therefore, alcohol use is contraindicated in patients taking ADDYI [see CONTRAINDICATIONS]. Before prescribing ADDYI, assess the likelihood of the patient abstaining from alcohol, taking into account the patient's current and past drinking behavior, and other pertinent social and medical history. Counsel patients who are prescribed ADDYI about the importance of abstaining from alcohol use. Because of the increased risk of hypotension and syncope due to an interaction with alcohol, ADDYI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADDYI REMS Program [see Addyi.com for WARNINGS AND PRECAUTIONS].

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ADDYI (flibanserin) is a tablet for oral administration. The chemical name of flibanserin is 2H­Benzimidazol-2-one, 1,3-dihydro-1-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl]. Its empirical formula is C20H21F3N4O and its molecular weight is 390.41.

 

The structural formula is:

 

Flibanserin Structural Formula Illustration

Flibanserin is a white to off-white powder, insoluble in water, sparingly soluble in methanol, ethanol, acetonitrile and toluene, soluble in acetone, freely soluble in chloroform, and very soluble in methylene chloride.

 

Each ADDYI tablet contains 100 mg of flibanserin. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate, talc, macrogol, and the coloring agents, titanium dioxide and iron oxide.