Zuranolone
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Black Box Warning
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Impaired ability to engage in potential hazardous activity
See full prescribing information for complete Boxed Warning.
Patients are advised to avoid potential hazardous activity like driving for 12 hours after taking zuranolone during the 14 day treatment regimen.
Zuranolone causes driving impairment as it results in CNS depressing effects. Patients are also advised that they may not be able to assess their own driving competence, or the degree of driving impairment caused by ZURZUVAE. |
Overview
Zuranolone is a gamma-aminobutyric acid (GABA) A receptor positive modulator that is FDA approved for the treatment of postpartum depression (PPD) in adults. There is a Black Box Warning for this drug as shown here. Common adverse reactions include somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Zuranolone FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Zuranolone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Zuranolone Contraindications in the drug label.
Warnings
|
Impaired ability to engage in potential hazardous activity
See full prescribing information for complete Boxed Warning.
Patients are advised to avoid potential hazardous activity like driving for 12 hours after taking zuranolone during the 14 day treatment regimen.
Zuranolone causes driving impairment as it results in CNS depressing effects. Patients are also advised that they may not be able to assess their own driving competence, or the degree of driving impairment caused by ZURZUVAE. |
There is limited information regarding Zuranolone Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Zuranolone Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Zuranolone Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Zuranolone Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Zuranolone in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Zuranolone in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Zuranolone during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Zuranolone in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Zuranolone in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Zuranolone in geriatric settings.
Gender
There is no FDA guidance on the use of Zuranolone with respect to specific gender populations.
Race
There is no FDA guidance on the use of Zuranolone with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Zuranolone in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Zuranolone in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Zuranolone in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Zuranolone in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Zuranolone Administration in the drug label.
Monitoring
There is limited information regarding Zuranolone Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Zuranolone and IV administrations.
Overdosage
There is limited information regarding Zuranolone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Zuranolone Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Zuranolone Mechanism of Action in the drug label.
Structure
There is limited information regarding Zuranolone Structure in the drug label.
Pharmacodynamics
There is limited information regarding Zuranolone Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Zuranolone Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Zuranolone Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Zuranolone Clinical Studies in the drug label.
How Supplied
There is limited information regarding Zuranolone How Supplied in the drug label.
Storage
There is limited information regarding Zuranolone Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Zuranolone Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Zuranolone interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Zuranolone Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Zuranolone Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.