Zulresso

Generic name: Brexanolone
Drug class: Miscellaneous antidepressants

Usage of Zulresso

Zulresso is a prescription medicine used to treat postpartum depression.

Zulresso 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 this medicine.

Zulresso is given as a continuous intravenous infusion over a total of 60 houts.

Zulresso side effects

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

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 Zulresso side effects 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 Zulresso

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

To make sure Zulresso is safe for you, 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 this medicine. Ask your doctor about any risk.

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How to use Zulresso

Usual Adult Dose for Depression:

Hours 0 to 4: 30 mcg/kg/hr IV via continuous infusion Hours 4 to 24: 60 mcg/kg/hr IV via continuous infusion Hours 24 to 52:90 mcg/kg/hr IV via continuous infusion Hours 52 to 56: 60 mcg/kg/hr IV via continuous infusion Hours 56 to 60: 30 mcg/kg/hr IV via continuous infusion Duration of therapy: 60 hours Comments: -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

Zulresso 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 Zulresso

Using Zulresso 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 interact with 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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