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Zulresso Generic Name & Formulations
Legal Class
CIV
General Description
Brexanolone 100mg/20mL (5mg/mL); soln for IV infusion after dilution; preservative-free.
Pharmacological Class
GABAA receptor modulator.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Zulresso Indications
Indications
Postpartum depression.
Zulresso Dosage and Administration
Adult
Give as a continuous IV infusion over 60hrs (2.5 days). ≥15yrs: 0–4hrs: initially 30mcg/kg/hr; 4–24hrs: increase to 60mcg/kg/hr; 24–52hrs: increase to 90mcg/kg/hr (reduction to 60mcg/kg/hr may be considered if not tolerated at this time period); 52–56hrs: decrease to 60mcg/kg/hr; 56–60hrs: decrease to 30mcg/kg/hr.
Children
<15yrs: not established.
Zulresso Contraindications
Not Applicable
Zulresso Boxed Warnings
Boxed Warning
Excessive sedation and sudden loss of consciousness.
Zulresso Warnings/Precautions
Warnings/Precautions
Risk of excessive sedation or sudden loss of consciousness during therapy; must be monitored with continuous pulse oximetry. During infusion, monitor for sedative effects every 2hrs during planned, non-sleep periods. Discontinue infusion if signs/symptoms of excessive sedation; may resume after resolution at the same or lower dose. Suicidal thoughts and behaviors. Consider changing regimen or discontinuing therapy if depression worsens or persists. ESRD (eGFR <15mL/min/1.73m2): avoid. Pregnancy. Nursing mothers.
REMS
Zulresso Pharmacokinetics
See Literature
Zulresso Interactions
Interactions
May increase the likelihood or severity of sedation with concomitant antidepressants or other CNS depressants (eg, opioids, benzodiazepines, alcohol).
Zulresso Adverse Reactions
Adverse Reactions
Sedation/somnolence, dry mouth, dizziness, presyncope, vertigo, loss of consciousness, flushing/hot flush.
Zulresso Clinical Trials
See Literature
Zulresso Note
Notes
Register pregnant patients exposed to antidepressants by calling the National Pregnancy Registry for Antidepressants at (844) 405-6185.
Zulresso Patient Counseling
See Literature
Zulresso Generic Name & Formulations
Legal Class
CIV
General Description
Brexanolone 100mg/20mL (5mg/mL); soln for IV infusion after dilution; preservative-free.
Pharmacological Class
GABAA receptor modulator.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Zulresso Indications
Indications
Postpartum depression.
Zulresso Dosage and Administration
Adult
Give as a continuous IV infusion over 60hrs (2.5 days). ≥15yrs: 0–4hrs: initially 30mcg/kg/hr; 4–24hrs: increase to 60mcg/kg/hr; 24–52hrs: increase to 90mcg/kg/hr (reduction to 60mcg/kg/hr may be considered if not tolerated at this time period); 52–56hrs: decrease to 60mcg/kg/hr; 56–60hrs: decrease to 30mcg/kg/hr.
Children
<15yrs: not established.
Zulresso Contraindications
Not Applicable
Zulresso Boxed Warnings
Boxed Warning
Excessive sedation and sudden loss of consciousness.
Zulresso Warnings/Precautions
Warnings/Precautions
Risk of excessive sedation or sudden loss of consciousness during therapy; must be monitored with continuous pulse oximetry. During infusion, monitor for sedative effects every 2hrs during planned, non-sleep periods. Discontinue infusion if signs/symptoms of excessive sedation; may resume after resolution at the same or lower dose. Suicidal thoughts and behaviors. Consider changing regimen or discontinuing therapy if depression worsens or persists. ESRD (eGFR <15mL/min/1.73m2): avoid. Pregnancy. Nursing mothers.
REMS
Zulresso Pharmacokinetics
See Literature
Zulresso Interactions
Interactions
May increase the likelihood or severity of sedation with concomitant antidepressants or other CNS depressants (eg, opioids, benzodiazepines, alcohol).
Zulresso Adverse Reactions
Adverse Reactions
Sedation/somnolence, dry mouth, dizziness, presyncope, vertigo, loss of consciousness, flushing/hot flush.
Zulresso Clinical Trials
See Literature
Zulresso Note
Notes
Register pregnant patients exposed to antidepressants by calling the National Pregnancy Registry for Antidepressants at (844) 405-6185.
Zulresso Patient Counseling
See Literature
