ADDYI

Flibanserin 100mg, Oral tablet

Grapefruit juice

· Severity: Severe

· Notes for Consumers: Grapefruit and Grapefruit juice should be avoided while taking Flibanserin. Grapefruit juice and grapefruit-containing foods may increase the effects of Flibanserin such as extreme drowsiness, dangerously low blood pressure, fainting, falls, and injury.

· Notes for Professionals: Grapefruit juice should be avoided during flibanserin administration. Moderate CYP3A4 inhibitors, such as grapefruit juice, can increase flibanserin concentrations, which can cause severe hypotension and syncope. In a study of 26 healthy female subjects, 240 mL of grapefruit juice increased flibanserin 100 mg single dose exposure (AUC) by 1.4-fold and Cmax 1.1-fold compared to flibanserin 100 mg alone.

Flibanserin 100mg, Oral tablet

Alcohol

· Severity: Moderate

· Notes for Consumers: If you drink Alcohol, you must wait at least 2 hours after you stop drinking Alcohol before taking your Flibanserin dose at bedtime. Taking Alcohol within 2 hours of Flibanserin will increase the risk for dangerously low blood pressure, fainting, falls, and injury. Additive drowsiness may also occur. If you choose to consume Alcohol in the evening, you may skip your dose of Flibanserin that night and resume your usual Flibanserin schedule the next night. After taking your bedtime dose of Flibanserin, you must avoid Alcohol until the following day. Avoid activities requiring full alertness, such as driving or operating machinery, for at least 6 hours after you take Flibanserin until you know how the medication affects you.

· Notes for Professionals: It is essential that the use of alcohol be separated from flibanserin by at least 2 hours. Patient should be counseled to wait at least 2 hours after ingestion of alcoholic beverages before taking their bedtime flibanserin dose. Alternatively, the patient may skip the flibanserin dose if alcohol is consumed that evening. Alcohol should not be consumed until the day following the bedtime flibanserin dose. Medications and dietary supplements should also be checked for alcohol content. The use of flibanserin and alcohol increases the risk of severe hypotension and syncope vs. the use of flibanserin or alcohol alone, and coadministration also increases the risk for CNS depression, such as sedation. In a study of 24 premenopausal women who consumed 0.4 g/kg alcohol (equivalent to 2 alcoholic drinks in a 70 kg person) during the evening meal 2.5 to 4 hours prior to taking flibanserin at bedtime, there were no cases of syncope, and the incidence of hypotension the following morning was higher in patients who received flibanserin alone than in those who had consumed alcohol alone or consumed alcohol at least 2.5 hours before their flibanserin dose.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>