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2189. Epub 2013 May 14.ounces of distilled spirits/shot 40% alcohol after taking the medication, patients should not use alcohol until the following day The use in patients with any degree of hepatic impairment is contraindicated; hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension flibanserin pre o syncope Malignant mammary tumors in female mice were observed at exposures 3 and 10 times the recommended clinical dose; no increases were seen in male mice or in male or female rats; clinical significance of this observations is unknown Coadministration with moderate or strong CYP3A4 inhibitors significantly increases flibanserin concentrations, which can lead to hypotension and syncope also see Contraindications, Black Box Warnings, and Dosage Modifications Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements eg, ginkgo, resveratrol or nonprescription drugs eg, cimetidine could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope Coadministration with strong CYP2C19 inhibitors may increase flibanserin exposure, which may increase risk of hypotension, syncope, and CNS depression Causes CNS flibanserin pre o eg, somnolence, sedation risk of CNS depression is increased if taken during waking hours, with alcohol or other CNS depressants, or with medications that increase flibanserin concentrations eg, CYP3A4 inhibitors Flibanserin may increase blood concentrations of P-gp substrates eg, digoxin, sirolimus There are no studies in pregnant women to inform whether there is a drug-associated risk in humans In animals, fetal flibanserin pre o only occurred in the presence of significant maternal toxicity, including reductions in weight gain and flibanserin pre o reproductive and developmental effects consisted of decreased fetal weight, structural anomalies, and increases in fetal loss at exposures greater than 15 times exposures achieved with the recommended human dosage Unknown if distributed in flibanserin pre o breast milk Excreted in rat milk Unknown whether flibanserin has effects on the breastfed infant or if it affects milk production Because of the potential for serious adverse reactions, including sedation, in a breastfed infant, breastfeeding is not recommended during treatmentA: Generally acceptable.
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You may report side effects to FDA at 1-800-FDA-1088. Store at room temperature between 15 and 30 degrees C 59 and 86 degrees F Throw away any unused medicine after the expiration date.Table 1. Adverse Reactions* Leading to Discontinuation in Randomized, Double-blind, Placebo-controlled Trials in Premenopausal Women with HSDD Adverse reactions leading to discontinuation of 1% of flibanserin approved receiving 100 mg Table 2 summarizes the most common flibanserin approved reactions reported in four flibanserin approved of premenopausal women with HSDD.
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