BOXED WARNING Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients; monitor closely.
FDA dosing
Population
Start
Target
Max
Major depressive disorder
adults
25 mg QD
25 mg QD
62.5 mg QD
Panic disorder
adults
12.5 mg QD
titrate to response
75 mg QD
Social anxiety disorder
adults
12.5 mg QD
titrate to response
37.5 mg QD
Premenstrual dysphoric disorder
adults
12.5 mg QD (continuous or luteal-phase)
12.5 mg QD
25 mg QD
Titration Increase in 12.5 mg/day increments at intervals of at least 1 week.
Renal Severe impairment: start 12.5 mg/day; max 50 mg/day (MDD, PD) or 37.5 mg/day (SAD).
Hepatic Severe impairment: start 12.5 mg/day; max 50 mg/day (MDD, PD) or 37.5 mg/day (SAD).
Instructions
Administer as a single morning dose, with or without food.
Swallow tablets whole; do not chew or crush.
Reduce dose gradually when discontinuing.
Contraindications
Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome
Taking thioridazine because of risk of QT prolongation
Taking pimozide because of risk of QT prolongation
Cautions
Serotonin syndrome
Embryofetal toxicity (cardiovascular malformations with first-trimester exposure)
Increased risk of bleeding
Activation of mania/hypomania
Seizures
Angle-closure glaucoma
Hyponatremia
Sexual dysfunction
Discontinuation syndrome
Adverse reactions
Abnormal ejaculation
Nausea
Somnolence
Dry mouth
Constipation
Dizziness
Insomnia
Decreased libido
Sweating
Tremor
Asthenia
Abnormal vision
Pregnancy Associated with a less than 2-fold increase in cardiovascular malformations with first-trimester exposure; late exposure linked to postpartum hemorrhage and neonatal complications.
Lactation Undefined
⚠ BOXED WARNING
Suicidal thoughts and behaviors in patients under 25