Miscellaneous Ob/Gyn conditions:
Indications for: ZULRESSO
Postpartum depression.
Adult Dosage:
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 Dosage:
<15yrs: not established.
Boxed Warning:
Excessive sedation and sudden loss of consciousness.
ZULRESSO 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.
ZULRESSO Classification:
GABAA receptor modulator.
ZULRESSO Interactions:
May increase the likelihood or severity of sedation with concomitant antidepressants or other CNS depressants (eg, opioids, benzodiazepines, alcohol).
Adverse Reactions:
Sedation/somnolence, dry mouth, dizziness, presyncope, vertigo, loss of consciousness, flushing/hot flush.
Note:
Register pregnant patients exposed to antidepressants by calling the National Pregnancy Registry for Antidepressants at (844) 405-6185.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
Mood disorders:
Indications for: ZULRESSO
Postpartum depression.
Adult Dosage:
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 Dosage:
<15yrs: not established.
Boxed Warning:
Excessive sedation and sudden loss of consciousness.
ZULRESSO 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.
ZULRESSO Classification:
GABAA receptor modulator.
ZULRESSO Interactions:
May increase the likelihood or severity of sedation with concomitant antidepressants or other CNS depressants (eg, opioids, benzodiazepines, alcohol).
Adverse Reactions:
Sedation/somnolence, dry mouth, dizziness, presyncope, vertigo, loss of consciousness, flushing/hot flush.
Note:
Register pregnant patients exposed to antidepressants by calling the National Pregnancy Registry for Antidepressants at (844) 405-6185.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
