Brexanolone

Generic name: Brexanolone
Brand names: Zulresso
Dosage form: intravenous solution (5 mg/mL)
Drug class: Miscellaneous antidepressants

Usage of Brexanolone

Brexanolone is used to treat postpartum depression.

Brexanolone is available only under a special program because it can cause excessive drowsiness or sudden loss of consciousness. You must be registered in the program and understand the risks and benefits of brexanolone.

Brexanolone may also be used for purposes not listed in this medication guide.

Brexanolone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Brexanolone may cause serious side effects. Call your doctor at once if you have:

excessive drowsiness (feeling like you cannot stay awake, or feeling like you might pass out);

sudden changes in mood or behavior;

new or worsening depression; or

thoughts of hurting yourself.

Common side effects of brexanolone may include:

drowsiness;

feeling like you might pass out;

dry mouth; or

flushing (sudden warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Brexanolone

Brexanolone is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

kidney disease; or

if you drink large amounts of alcohol.

Some young people have thoughts about suicide while using an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Brexanolone may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of brexanolone on the baby.

It may not be safe to breastfeed while using brexanolone. Ask your doctor about any risk.

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How to use Brexanolone

Usual Adult Dose for Depression:

Hours 0 to 4: 30 mcg/kg/hr IV via continuous infusionHours 4 to 24: 60 mcg/kg/hr IV via continuous infusionHours 24 to 52:90 mcg/kg/hr IV via continuous infusionHours 52 to 56: 60 mcg/kg/hr IV via continuous infusionHours 56 to 60: 30 mcg/kg/hr IV via continuous infusionDuration of therapy: 60 hoursComments:-To allow for proper monitoring of excessive sedation, treatment should begin early enough during the day.-Patients should be constantly monitored by a healthcare provider for the duration of the infusion.Use: Treatment of postpartum depression

Warnings

Brexanolone is given in a hospital or clinic setting where you can be watched closely for side effects.

Brexanolone can make you very drowsy, and may cause you to pass out. Tell your caregivers if you feel light-headed or feel like you cannot stay awake.

What other drugs will affect Brexanolone

Using brexanolone with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect brexanolone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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