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Flibanserin (trade names include Addyi, Fili, Fliban, Pink Viagra) is a gynecological medication for systemic use. It is used for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD). This medicine works related to the Kinsey dual control model of sexual response.
Atosiban (Antocin, Tractocile)
Cyproterone, Ethinyl Estradiol (Diane-35)
Desogestrel, Ethinyl Estradiol (Desogen)
Estrogens conjugated (Premarin)
Ethinyl Estradiol, Levonorgestrel (Alesse)
Sildenafil (Female Viagra)
Pharmacological and medical categories:
Central nervous system agents
Sexual dysfunction medications
Treatment of hypoactive sexual desire disorder among women
G - Genito urinary system and sex hormones
G02 - Other gynecologicals
G02C - Other gynecologicals
G02CX - Other gynecologicals
G02CX02 - Flibanserin
Sexual dysfunction not due to a substance or known physiological condition - F52
Hypoactive sexual desire disorder - F52.0
Indications and usage:
Addyi (Flibanserin) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOTdue to:
A co-existing medical or psychiatric condition,
Problems within the relationship, or
The effects of a medication or other drug substance.
Limitations of use:
Addyi (Flibanserin) is not indicated for the treatment of HSDD in postmenopausal women or in men.
This medication is not indicated to enhance sexual performance.
Dosage and administration:
Recommended dosage is 100 mg taken once daily at bedtime.
Flibanserin (Addyi) is dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression.
Discontinue treatment after 8 weeksif no improvement.
Dosage forms and strengths:
Addyi (Flibanserin) oral tablets 100 mg.
Overdosage of flibanserin may cause an increase in the incidence or severity of any of the reported adverse reactions. In the event of overdosage, treatment should address the symptoms and supportive measures, as needed. There is no known specific antidote for Addyi.
Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors.
Warnings and precautions:
Hypotension and syncope with ADDYI alone: patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve.
Central nervous system (CNS) depression (e.g., somnolence, sedation): can occur with flibanserin alone. Exacerbated by other CNS depressants, and in settings where Addyi concentrations are increased. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least 6 hours after each dose and until they know how this medication affects them.
Adverse reactions, side effects:
Most common adverse reactions (incidence >= 2%) are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.
Oral contraceptives and other weak CYP3A4 inhibitors: increases flibanserin exposures and incidence of adverse reactions.
Strong CYP2C19 inhibitors: increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression.
CYP3A4 inducers: use of Addyi not recommended; flibanserin concentrations substantially reduced.
Digoxin: increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.
Use in specific populations:
Nursing Mothers: flibanserin is not recommended.
CYP2C19 poor metabolizers: increases Addyi exposure which may increase risk of hypotension, syncope, and CNS depression.
B3 - Australia
C - United States (Risk cannot be ruled out)
Salts and other forms:
Synonyms, international and chemical names:
Brands, generics, trade names:
Addyi - Sprout Pharmaceuticals
Fili - RSM Enterprises
Fliban - Centurion Laboratories
Pink Viagra - Pfizer
Flibanserin main article on Wikipedia: https://en.wikipedia.org/wiki/Flibanserin
Flibanserin compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Flibanserin
Flibanserin Hydrochloride compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Flibanserin-hydrochloride
Flibanserin on DrugBank: https://www.drugbank.ca/drugs/DB04908
Flibanserin Hydrochloride on DrugBank: https://www.drugbank.ca/salts/DBSALT001321
Flibanserin FAQ on MedlinePlus (revised 11/15/2019): https://medlineplus.gov/druginfo/meds/a615040.html
Addyi (Flibanserin) film-coated tablets drug label info on DailyMed (revised October 10, 2019): https://dailymed.nlm.nih.gov/dailymed/drugInfo...
Flibanserin for sale on Pharma Doctor: https://pharma-doctor.com/flibanserin.html
Flibanserin international drug names on Drugs.com: https://www.drugs.com/international/flibanserin.html
Addyi (Flibanserin) oral tablets 100 mg official prescribing information and medication guide from the U.S. FDA (revised 8/2015): https://www.accessdata.fda.gov/drugsatfda_docs/label...
Addyi (Flibanserin) tablets for oral use full prescribing and patient counseling information from Sprout Pharmaceuticals, Inc. (revised 10/2019): https://addyi.com/wp-content/uploads/2019/11/Full-Prescribing-Information-1.pdf
Addyi (Flibanserin) tablets official website: https://addyi.com/
Sprout Pharmaceuticals, Inc. (manufacturer and distributor of Addyi) official website: https://sproutpharmaceuticals.com/
Addyi (Flibanserin) product monograph and patient medication information from canadian drug and health product register (revised February 27, 2018): https://pdf.hres.ca/dpd_pm/00044049.PDF
Addyi (Flibanserin) health fact sheet on NWHN: https://nwhn.org/addyi-health-fact-sheet/
Fili (Flibanserin, Addyi generic) 100 mg tablets medication guide from RSM Enterprises pharmaceutical company: https://www.rsmenterprises.in/product/viewdetail/fili-100mg-229
Revised: April 2021
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