FDA label
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BOXED WARNING Suicidal thoughts and behaviors: increased risk in pediatric and young adult patients; monitor closely. Contraindicated in patients less than 12 years of age due to increased risk of hypertensive crisis.
| FDA dosing | Population | Start | Target | Max |
| Major depressive disorder | Adults | 6 mg/24 h once daily | 6 mg/24 h | 12 mg/24 h |
| Major depressive disorder | Elderly (≥65 y) | 6 mg/24 h once daily | 6 mg/24 h | 6 mg/24 h |
Titration Increase in 3 mg/24 h increments at intervals of no less than 2 weeks
Renal No adjustment needed (mild, moderate, or severe); not studied in ESRD/dialysis
Hepatic No adjustment needed (mild or moderate Child-Pugh); not studied in severe
Observe washout intervals when switching to/from contraindicated drugs (≥2 weeks after stopping EMSAM; ~1 week (or 5 weeks for fluoxetine) before starting EMSAM)
Instructions
- Apply to dry, intact skin on upper torso, upper thigh, or outer upper arm once every 24 hours; rotate sites
- Avoid tyramine-rich foods/beverages at doses of 9 mg/24 h and 12 mg/24 h (and 2 weeks after reducing/stopping those doses)
- Avoid external heat (heating pads, saunas, hot tubs, prolonged sunlight) at application site
- Screen for bipolar disorder before starting
Contraindications
- Serotonergic drugs: SSRIs, SNRIs, clomipramine and imipramine, meperidine, tramadol, methadone, pentazocine, and propoxyphene; and the antitussive agent dextromethorphan — because of a risk of serotonin syndrome
- Carbamazepine (possible increased risk of hypertensive crisis)
- Patients less than 12 years of age (potential for hypertensive crisis)
- Pheochromocytoma
Cautions
- Tyramine-induced hypertensive crisis (dietary modification at 9 and 12 mg/24 h)
- Blood pressure elevation with concomitant sympathomimetics/buspirone
- Activation of mania/hypomania
- External heat may increase selegiline absorption
- Serotonin syndrome
Adverse reactions
- Application site reaction
- Headache
- Insomnia
- Diarrhea
- Dry mouth
- Dyspepsia
- Rash
- Pharyngitis
- Sinusitis
Pregnancy Insufficient human data; animal studies show malformations and developmental toxicity — potential fetal harm; weigh MAOI risks
Lactation No human data; breastfeeding not recommended during treatment and for 5 days after final dose