Addyi
Addyi, known as the "female Viagra", increases sexual desire in women. Unlike Viagra, Addyi is believed to work by restoring brain chemical balance.
Addyi Overview
Addyi, known as the "female Viagra", is a prescription medication used to enhance sexual desire and decrease emotional distress in premenopausal women with hypoactive sexual desire disorder (HSDD). HSDD is the most commonly reported sexual dysfunction in women.
Although Addyi has been called "the female Viagra", the way in which it works is distinctly different from Viagra. Viagra works by increasing blood flow to the genitals, whereas Addyi may work more like an antidepressant by correcting an imbalance of neurotransmitters in the brain to help restore sexual desire. It has effects on dopamine, norepinephrine, and serotonin levels in the brain.
Addyi comes in tablet form and is typically taken daily, at bedtime.
Common side effects include dizziness, nausea, and sleepiness. Addyi can also cause fainting, especially when used with alcohol.
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Addyi Cautionary Labels
Uses of Addyi
Addyi, known as the "female Viagra", is a prescription medication used to enhance sexual desire and decrease emotional distress in premenopausal women with hypoactive sexual desire disorder (HSDD).
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Manufacturer
Generic
Flibanserin
For more information on this medication choose from the list of selections below.
Side Effects of Addyi
Serious side effects have been reported with Addyi. See the “Addyi Precautions” section.
Common side effects of Addyi include the following:
- dizziness
- nausea
- tiredness
- difficulty falling asleep or staying asleep
- dry mouth
This is not a complete list of Addyi side effects. Ask your doctor or pharmacist for more information.
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Addyi Interactions
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- certain medicines used to treat HIV-1 infection, such as amprenavir, atazanavir (REYATAZ), fosamprenavir (LEXIVA), ritonavir (NORVIR), saquinavir (INVIRASE), nelfinavir (VIRACEPT), and indinavir (CRIXIVAN)
- certain medicines that you take by mouth used to treat fungal infections, such as fluconazole (DIFLUCAN), ketoconazole, itraconazole (ONMEL, SPORANOX), and posaconazole (NOXAFIL)
- certain antibiotics, such as ciprofloxacin (CIPRO, CIPRO XR), erythromycin (ERY-TAB, ERYC ,PCE), telithromycin (KETEK), and clarithromycin (BIAXIN)
- medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
- medications that block a protein in the body (CYP2C19) such as Proton pump inhibitors [omeprazole (Prilosec) and esomeprazole (Nexium)], selective serotonin reuptake inhibitors [escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa)], and benzodiazepines [Alprazolam (Xanax) and Lorazepam (Ativan)]
- certain medicines used to treat Hepatitis C infection, such as boceprevir (VICTRELIS) and telaprevir
- certain medicines used to treat high blood pressure, chest pain (angina), or other heart problems, such as diltiazem (CARDIZEM,CARDIZEM CD, CARDIZEM LA, CARTIA XT, DILT CD, DILTZAC, TAZTIA XT, Tiazac), verapamil (CALAN, CALAN SR, COVERA-HS, Verelan, Verelan PM), and conivaptan (Vaprisol)
- nefazodone which is a medicine used to treat depression
- Birth control pills
- St. John’s Wort
- ginkgo
- resveratrol
- cimetidine
- Digoxin
This is not a complete list of Addyi drug interactions. Ask your doctor or pharmacist for more information.
Addyi Precautions
Serious side effects have been reported with Addyi including the following:
- Sleepiness is a common side effect of Addyi and can be serious. Taking Addyi can increase your risk of sleepiness if taken during waking hours, if you drink alcohol, or take certain medicines or herbal supplements.
- Low blood pressure and fainting (loss of consciousness). It can happen when you take Addyi even if you do not drink alcohol or take other medicines or herbal supplements. If you take Addyi and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you faint (lose consciousness). If you faint (lose consciousness), tell your doctor as soon as you can. Your risk of severe low blood pressure and fainting (loss of consciousness) is increased if you take Addyi and:
- drink alcohol. Do not drink alcohol if you take Addyi.
- take certain prescription medicines, over-the-counter medicines, or herbal supplements. Do not take or start taking any prescription medicines, over-the-counter medicines, or herbal supplements while taking Addyi until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking Addyi.
- have liver problems. Do not take Addyi if you have liver problems.
Do not drink alcohol when taking Addyi. Addyi can cause drowsiness, dizziness, and fainting, especially when used with alcohol. Do not drive or operate heavy machinery until you know how Addyi affects you.
Addyi is only available through the Addyi risk evaluation and mitigation strategy (REMS) Program because of the increased risk of severe low blood pressure and fainting (loss of consciousness) with alcohol use. You can only get Addyi from pharmacies that are enrolled in the Addyi REMS Program. For more information about the Program and a list of pharmacies that are enrolled in the Addyi REMS Program, go to www.AddyiREMS.com or call 1-844-PINK-PILL (1-844-746-5745).
Do not take Addyi if you:
- are allergic to Addyi or to any of its ingredients
- drink alcohol
- have liver problems
- take medications that are strong CYP3A4 inhibitors such as clarithromycin, telithromycin, indinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir, ketoconazole, itraconazole, posaconazole, voriconazole, conivaptan (Vaprisol), delaviridine (Rescriptor), and nefazadone
Addyi Food Interactions
Grapefruit and grapefruit juice may interact with Addyi and lead to potentially dangerous effects. Do not drink grapefruit juice if you take Addyi. Drinking grapefruit juice during your treatment with Addyi increases your risk of severe low blood pressure and fainting (loss of consciousness).
Inform MD
Before taking Addyi tell your doctor about all of your medical conditions. Especially tell your doctor if you:
- are allergic to Addyi or to any of its ingredients
- drink alcohol, use drugs, or have a history of alcohol or drug abuse
- have ever had depression or other mental health problems
- have low blood pressure or a medical condition that can cause low blood pressure
- are pregnant or plan to become pregnant. It is not known if Addyi will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Addyi passes into your breast milk. You and your doctor should decide if you will take Addyi or breastfeed. You should not do both
- have liver problems
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Addyi and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
It is not known if Addyi will harm your unborn baby. There are no well-done studies that have been done in humans with Addyi. In animal studies, pregnant animals were given Addyi, and some babies had problems but were given high doses of Addyi. Animal studies cannot rule out the potential for fetal harm.
Addyi and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known if Addyi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, breastfeeding is not recommended during treatment with Addyi.
Addyi Usage
Take Addyi exactly as prescribed.
Addyi comes in tablet form and is taken once daily, at bedtime.
Take 1 Addyi tablet one time a day at bedtime.
Take Addyi only at bedtime. Taking Addyi at a time other than bedtime can increase your risk of low blood pressure, fainting (loss of consciousness), accidental injury, and sleepiness.
If you miss a dose of Addyi, skip your missed dose. Take your next dose at bedtime the next day. Do not take Addyi the next morning or double your next dose. If you take too much Addyi, call your doctor.
Tell your doctor if your symptoms of HSDD have not improved after you have taken Addyi for 8 weeks.
Addyi Dosage
Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
Recommended dosage is 100 mg taken once daily at bedtime.
Addyi Overdose
If you take too much Addyi, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
Other Requirements
- Store Addyi at room temperature between 68°F to 77°F (20°C to25°C).
- Keep this and all medicines out of the reach of children.
Addyi FDA Warning
WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS
Use of Addyi and alcohol increases the risk of severe hypotension and syncope; therefore, alcohol use is contraindicated.
Do NOT drink alcohol while taking Addyi.
Severe hypotension and syncope can oalso ccur when Addyi is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, Addyi use in these settings is contraindicated.
Addyi is only available through the Addyi risk evaluation and mitigation strategy (REMS) Program because of the increased risk of severe low blood pressure and fainting (loss of consciousness) with alcohol use. You can only get Addyi from pharmacies that are enrolled in the Addyi REMS Program. For more information about the Program and a list of pharmacies that are enrolled in the Addyi REMS Program, go to www.AddyiREMS.com or call 1-844-PINK-PILL (1-844-746-5745).