Medically reviewed by Drugs.com. Last updated on Oct 15, 2018.
Applies to the following strengths: 100 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Hypoactive Sexual Desire Disorder
100 mg orally once per day at bedtime
Duration of therapy: This drug should be discontinued after 8 weeks if the patient does not report an improvement in symptoms.
Comments: This drug is not indicated to enhance sexual performance, and is not indicated for treatment in postmenopausal women or in men.
Use: 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 not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.
Renal Dose Adjustments
Data not available.
Liver Dose Adjustments
Contraindicated in patients with hepatic impairment.
If Initiating this Drug Following Use of Moderate or Strong CYP450 3A4 Inhibitor:
-Start this drug 2 weeks after the last dose of the CYP450 3A4 inhibitor.
If Initiating a Moderate or Strong CYP450 3A4 Inhibitor Following Use of This Drug:
-Start the CYP450 3A4 inhibitor 2 days after the last dose of this drug.
US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Addyi. It includes elements to assure safe use and an implementation system. For additional information: www.fda.gov/REMS
US BOXED WARNING:
HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS:
-Contraindicated with Alcohol: Concomitant use of this drug with alcohol increases the risk of severe hypotension and syncope. Patients should be counseled about the importance of abstaining from alcohol, and their current and past drinking behavior as well as other pertinent social and medical history should be assessed before this drug is prescribed.
-Contraindicated with Strong or Moderate CYP450 3A4 Inhibitors: Concomitant use of this drug with strong or moderate CYP450 3A4 inhibitors increases the concentration of this drug, which can result in severe hypotension and syncope.
-Contraindicated in Patients with Hepatic Impairment: The concentration of this drug is increased when used in patients with hepatic impairment, which can result in severe hypotension and syncope.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available.
-This drug should be taken at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and CNS depression (e.g., somnolence and sedation).
-If a dose is missed, that dose should be skipped and the next dose should be taken as usual at bedtime on the next day; the next dose should not be doubled.
-There is no known specific antidote for this drug; supportive measures and treatment of symptoms are recommended if overdosage occurs.
-Cardiovascular: Hypotension, syncope
-Nervous: CNS depression (e.g., somnolence, sedation, fatigue)
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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Other brands: Addyi