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ADDYI
Miscellaneous Ob/Gyn conditions
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Drug Name:

ADDYI Rx

Generic Name and Formulations:
Flibanserin 100mg; tabs.

Company:
Valeant Pharmaceuticals, Inc

Therapeutic Use:

Indications for ADDYI:

Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women and is not due to a coexisting medical or psychiatric condition, problems within the relationship, or adverse effect of a medication or other drug substance.

Limitations Of use:

Not for HSDD in postmenopausal women or men. Not for sexual performance enhancement.

Adult:

100mg daily at bedtime. Discontinue if no improvement after 8 weeks.

Children:

Not recommended.

Contraindications:

Concomitant alcohol, moderate or strong CYP3A4 inhibitors (eg, azole antifungals, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan, amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fosamprenavir, verapamil, grapefruit juice). Hepatic impairment.

Warnings/Precautions:

Increased risk of severe hypotension and syncope with concomitant alcohol use. Assess patient's likelihood of alcohol abstinence prior to prescribing. Increased risk of CNS depression if taken during waking hours. Conditions that predispose to hypotension. CYP2C19 poor metabolizers; monitor. Pregnancy. Nursing mothers: not recommended.

Interactions:

See Contraindications. Increased risk of hypotension and syncope with concomitant moderate or strong CYP3A4 inhibitors, if use necessary, discontinue Addyi at least 2 days before starting the CYP3A4 inhibitor; discontinue the CYP3A4 inhibitor for 2 weeks before restarting Addyi. Increased risk of CNS depression with alcohol, other CNS depressants (eg, diphenhydramine, opioids, hypnotics, benzodiazepines), or strong CYP2C19 inhibitors (eg, PPIs, SSRIs, antifungals). Potentiated by weak CYP3A4 inhibitors (eg, oral contraceptives cimetidine, fluoxetine, ginkgo, resveratrol, ranitidine). Antagonized by CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. Johns wort): not recommended. Potentiates digoxin, sirolimus, other P-gp substrates: monitor levels.

Pharmacological Class:

5-HT1A agonist/5-HT2A antagonist.

Adverse Reactions:

Dizziness, somnolence, nausea, fatigue, insomnia, dry mouth; hypotension, syncope.

REMS:

YES

Generic Availability:

NO

How Supplied:

Tabs—30

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