Selegiline transdermal
EMSAM
Pronunciation: se-LE-ji-leen (EM-sam)
“YosEmite Sam Seals gills”
On patch: Mao Zedong → monoamine oxidase (MAO) inhibitor
What it isTransdermal selegiline, an MAOI; major depressive disorder in adults.
Why this oneAt 6 mg/24 h no tyramine diet is needed, because skin delivery spares gut MAO-A.
What limits itTyramine restriction from the first day of 9 or 12 mg/24 h and for 2 weeks after stepping down. Contraindicated with SSRIs, SNRIs, clomipramine, imipramine, meperidine, tramadol, methadone, dextromethorphan and carbamazepine.
FDA label
Read the full label on DailyMed ↗
| 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
Available strengths
- patch 6, 9, 12 mg/24 hr
- cap 5 mg
- tab 5 mg
- ODT 1.25 mg
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
Cost
| Strength | #/mo | generic $/unit | brand $/unit | CostPlus | |
|---|---|---|---|---|---|
| 6 mg/24 hr | patch | per unit | — | $75.00/ea | not offered |
| 9 mg/24 hr | patch | per unit | — | $75.18/ea | not offered |
| 12 mg/24 hr | patch | per unit | — | $75.40/ea | not offered |
Other forms: Selegiline (ELDEPRYL)
⚠ BOXED WARNINGS
- Suicidal thoughts and behaviors
- Hypertensive crisis in patients under 12 years
Classes and tags
Clinical profile
Serotonin and MAOI
Provisional washout figures
Elevating mechanismMAO-A inhibitor (dose-dependent)
Evidence confidenceHigh
InterpretationEMSAM label 12.2: "at antidepressant doses, selegiline inhibits both isoenzymes... as selegiline concentration increases, this selectivity is lost with resulting dose-related inhibition of MAO-A." A tyramine-modified diet is not required at 6 mg/24 h but IS required at 9 and 12 mg/24 h. No modified diet does not establish SRI compatibility.
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