EMSAM: A Transdermal MAOI for Treatment-Resistant Depression
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Synonyms | |||
EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) delivered through a transdermal patch, offering a novel mechanism of action for adults with major depressive disorder (MDD) who have not achieved an adequate response from other antidepressant therapies. By bypassing first-pass metabolism, EMSAM provides targeted delivery of selegiline, a potent and irreversible inhibitor of monoamine oxidase, while potentially mitigating the need for the strict dietary tyramine restrictions historically associated with oral MAOIs at its lowest dosage. This unique delivery system represents a significant advancement in the pharmacological management of treatment-resistant depression, providing clinicians with a valuable tool for patients who have struggled with other therapeutic options.
Features
- Active Ingredient: Selegiline, an irreversible inhibitor of monoamine oxidase (MAO).
- Delivery System: A transdermal patch for continuous 24-hour delivery.
- Available Strengths: 6 mg/24 hr, 9 mg/24 hr, and 12 mg/24 hr.
- Mechanism of Action: Increases the levels of monoamine neurotransmitters (norepinephrine, dopamine, and serotonin) in the brain by inhibiting their breakdown by the MAO enzyme.
- Prescription Status: Available by prescription only.
Benefits
- Novel Mechanism for Treatment Resistance: Provides a distinct pharmacological approach for patients who have not responded adequately to more commonly prescribed antidepressants like SSRIs or SNRIs.
- Potential for Reduced Dietary Restrictions: At the 6 mg/24 hr dosage, the transdermal delivery minimizes inhibition of intestinal MAO-A, which may eliminate the need for a tyramine-restricted diet for many patients, as demonstrated in clinical trials. (Dietary modifications are required at the 9 mg/24 hr and 12 mg/24 hr dosages).
- Bypasses First-Pass Metabolism: The transdermal route avoids the gastrointestinal tract and liver, leading to more consistent plasma drug levels and potentially reducing certain side effects.
- Once-Daily Dosing: The 24-hour patch application supports patient adherence by simplifying the dosing regimen.
- Continuous Drug Delivery: Provides stable, around-the-clock neurotransmitter modulation, avoiding the peaks and troughs associated with oral dosing.
Common use
EMSAM is indicated for the treatment of major depressive disorder (MDD) in adults. It is particularly considered for patients who have exhibited an inadequate response to initial antidepressant therapy, a condition often referred to as treatment-resistant depression. Its use is predicated on a confirmed diagnosis of MDD by a qualified healthcare professional.
Dosage and direction
Initial Dose: The recommended starting dose is 6 mg/24 hr applied once daily. Dose Titration: The dose may be increased in increments of 3 mg/24 hr (e.g., to 9 mg/24 hr or 12 mg/24 hr) at intervals of no less than 2 weeks, based on clinical response and tolerability. Maximum Dose: The maximum recommended dose is 12 mg/24 hr. Application Instructions:
- Apply the patch to dry, intact skin on the upper torso (below the neck and above the waist), upper thigh, or the outer surface of the upper arm.
- Do not apply to irritated skin or where cuts are present.
- Press the patch firmly in place with the palm of the hand for approximately 30 seconds.
- Change the application site every day to minimize the potential for skin reaction. A new site should be selected that has not been used for several days.
- Do not cut the patch.
Precautions
- Hypertensive Crisis: As an MAOI, EMSAM can potentiate a sudden, severe increase in blood pressure (hypertensive crisis) if taken with certain medications or high amounts of tyramine. Patients must be thoroughly educated on the signs and symptoms (e.g., sudden severe headache, nausea, vomiting, sweating, photophobia, tachycardia).
- Serotonin Syndrome: There is a risk of serotonin syndrome, a potentially life-threatening condition, especially when EMSAM is used concomitantly with other serotonergic drugs (e.g., other antidepressants, tramadol, triptans). Symptoms include mental status changes, autonomic hyperactivity, and neuromuscular abnormalities.
- Activation of Mania/Hypomania: Antidepressants can precipitate a manic or hypomanic episode in patients with bipolar disorder. EMSAM should be used with caution in patients with a history of bipolar disorder.
- Suicidal Thoughts and Behaviors: All antidepressants, including EMSAM, carry a black box warning for an increased risk of suicidal thinking and behavior in children, adolescents, and young adults. Patients of all ages should be closely monitored for clinical worsening, suicidality, or unusual changes in behavior.
- Orthostatic Hypotension: MAOIs can cause a significant drop in blood pressure upon standing.
- Local Skin Reactions: Application site reactions (e.g., redness, rash, itching) are common. Rotating application sites is crucial.
Contraindications
EMSAM is contraindicated in patients with:
- Pheochromocytoma.
- Concomitant use with other MAOIs or within 14 days of stopping an MAOI.
- Concomitant use with serotonergic agents (e.g., SSRIs, SNRIs, TCAs, tramadol, meperidine, methadone, dextromethorphan, St. John’s Wort, triptans, buspirone) or within 14 days of stopping such agents.
- Concomitant use with sympathomimetic amines (e.g., amphetamines, cold products containing phenylephrine or pseudoephedrine).
- Concomitant use with bupropion, carbamazepine, or oxcarbazepine.
- Known hypersensitivity to selegiline or any component of the transdermal system.
Possible side effect
Common side effects may include:
- Application site reactions (e.g., redness, rash, itching, swelling).
- Headache.
- Insomnia.
- Diarrhea.
- Dry mouth.
- Dyspepsia.
- Pharyngitis.
- Sinusitis.
Less common but more serious side effects require immediate medical attention and include symptoms of hypertensive crisis or serotonin syndrome (as described above).
Drug interaction
EMSAM has numerous potentially dangerous drug interactions. It is absolutely contraindicated with:
- Other Antidepressants: SSRIs, SNRIs, TCAs, nefazodone, trazodone, mirtazapine.
- Other MAOIs: Isocarboxazid, phenelzine, tranylcypromine, linezolid, intravenous methylene blue.
- Certain Analgesics: Meperidine, methadone, tramadol, propoxyphene.
- Dextromethorphan: Found in many over-the-counter cough suppressants.
- Sympathomimetics: Amphetamines, phenylephrine, pseudoephedrine (found in cold and allergy medications).
- Bupropion
- Buspiro ne
- Carbamazepine, Oxcarbazepine A thorough medication review, including all prescription, over-the-counter, and herbal products, is mandatory before initiating therapy and during treatment.
Missed dose
If a dose is missed, the patient should apply the patch as soon as possible. However, if it is almost time for the next application, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not apply two patches at the same time to make up for a missed dose.
Overdose
Overdose with MAOIs is serious and potentially fatal. Symptoms may include drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonos, seizures, coma, tachycardia, bradycardia, hypotension, hypertension, and cardiovascular collapse. In the event of a suspected overdose, immediate medical attention is critical. Treatment is symptomatic and supportive.
Storage
Store EMSAM patches at room temperature, 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F). Keep the patch in its sealed pouch until immediately before use. Keep out of reach of children and pets. Dispose of used patches by folding them in half with the sticky sides together and discarding them in a secure container out of the reach of children and pets.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.
Reviews
- “As a psychiatrist specializing in treatment-resistant cases, EMSAM has been a game-changer for several of my patients who failed multiple SSRIs. The transdermal delivery is a key advantage, and the 6 mg dose offers efficacy without the dietary burden for many.” – Dr. A., Psychiatrist
- “Introducing EMSAM required careful patient education, but the payoff has been significant for appropriate candidates. It fills a crucial niche in our antidepressant arsenal.” – Dr. B., MD
- “The potential for serious drug and food interactions cannot be overstated and requires meticulous management. However, for the right patient, it is an incredibly effective option.” – Clinical Pharmacist Specialist
- “While application site reactions are common, they are generally manageable with site rotation. The benefits of a novel mechanism often outweigh this manageable side effect in my practice.” – Nurse Practitioner