May 25, 2017
Recommended Topic Related To:

Addyi

"Multidrug-resistant (MDR) Shigella infections may be spreading among your adult patients in a way that you might not have considered: through sexual transmission. Although shigellosis is most commonly transmitted from person to person amon"...

A A A

Addyi

ADDYI
(flibanserin) Tablets, for Oral Use

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 WARNINGS AND PRECAUTIONS].

Contraindicated with Strong or Moderate CYP3A4 Inhibitors

The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope [see WARNINGS AND PRECAUTIONS]. Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see CONTRAINDICATIONS].

Contraindicated in Patients with Hepatic Impairment

The use of ADDYI in patients with hepatic impairment increases flibanserin concentrations, which can cause severe hypotension and syncope [see WARNINGS AND PRECAUTIONS]. Therefore, ADDYI is contraindicated in patients with hepatic impairment [see CONTRAINDICATIONS].

DRUG DESCRIPTION

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:

ADDYI (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.

Last reviewed on RxList: 8/31/2015
This monograph has been modified to include the generic and brand name in many instances.

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.


Sex & Relationships

Get tips to boost your love life.