Emsam

EMSAM (selegiline transdermal system) is a groundbreaking monoamine oxidase inhibitor (MAOI) delivered through a transdermal patch, designed for patients with major depressive disorder (MDD) who have not achieved satisfactory improvement from other antidepressant therapies. By bypassing the gastrointestinal tract, it offers a unique mechanism of action with a potentially improved side effect profile compared to oral MAOIs. Its transdermal delivery allows for continuous, steady-state drug delivery, making it a valuable option in the psychiatric armamentarium for managing treatment-resistant cases.

Features

• Active Ingredient: Selegiline, a selective monoamine oxidase-B (MAO-B) inhibitor.
• Delivery System: A multi-layer transdermal patch providing controlled release over 24 hours.
• Available Strengths: 6 mg/24 hr, 9 mg/24 hr, and 12 mg/24 hr patches.
• Mechanism: Inhibits monoamine oxidase, increasing levels of neurotransmitters such as serotonin, norepinephrine, and dopamine in the brain.
• Prescription Status: Available by prescription only; not available over-the-counter.

Benefits

• Effective for Treatment-Resistant Depression: Demonstrated efficacy in patients who have not responded adequately to other antidepressant classes.
• Minimized Dietary Restrictions: At the 6 mg/24 hr dose, no tyramine dietary modifications are required, unlike traditional oral MAOIs.
• Improved Tolerability: Transdermal administration reduces first-pass metabolism, potentially lowering the incidence of certain side effects like nausea and orthostatic hypotension.
• Steady Drug Delivery: Provides consistent plasma concentrations, supporting stable mood management.
• Dosing Flexibility: Multiple strengths allow for individualized titration based on patient response and tolerability.
• Non-Oral Route: Beneficial for patients with gastrointestinal sensitivities or compliance issues with oral medications.

Common use

EMSAM is indicated for the treatment of major depressive disorder (MDD) in adults. It is particularly considered for patients who have had an inadequate response to other antidepressant treatments, such as SSRIs or SNRIs. It is not intended for initial therapy and is typically reserved for cases where the benefits outweigh potential risks associated with MAOI use. Off-label uses are not well-established, and it should be used strictly per approved indications under specialist supervision.

Dosage and direction

• Initial Dose: Usually starts with the 6 mg/24 hr patch applied once daily.
• Titration: May be increased to 9 mg/24 hr or 12 mg/24 hr after a minimum of 2 weeks, based on efficacy and tolerability.
• Application: Apply to dry, intact skin on the upper torso (below the neck and above the waist), upper thigh, or outer surface of the upper arm. Avoid areas with hair, cuts, or irritation.
• Rotation: Rotate application sites to prevent skin irritation; do not apply to the same site for 14 days.
• Duration: Each patch is worn for 24 hours and should be replaced at the same time each day.
• Discontinuation: Taper dose gradually under medical supervision to avoid withdrawal symptoms.

Precautions

• Hypertensive Crisis Risk: Although dietary restrictions are not required at the 6 mg/24 hr dose, caution is advised with tyramine-rich foods at higher doses. Patients should be educated on symptoms of hypertension (e.g., severe headache, palpitations).
• Serotonin Syndrome: Monitor for signs such as agitation, hallucinations, tachycardia, and hyperthermia, especially when used with other serotonergic drugs.
• Suicidal Thoughts: Antidepressants may increase the risk of suicidal thinking and behavior in children, adolescents, and young adults; close supervision is advised.
• Skin Reactions: Local skin reactions (e.g., redness, rash) may occur; advise patients on proper application and rotation.
• Pregnancy and Lactation: Use only if potential benefit justifies potential risk to the fetus or infant; insufficient human data.
• Elderly Patients: Dose cautiously due to potential increased sensitivity.

Contraindications

• Concomitant use with other MAOIs or within 14 days of discontinuing MAOI therapy.
• Use with meperidine, tramadol, methadone, pentazocine, dextromethorphan, St. John’s wort, cyclobenzaprine, or other contraindicated serotonergic agents.
• Pheochromocytoma.
• History of hypersensitivity to selegiline or any component of the patch.
• Concomitant use with sympathomimetic amines (e.g., pseudoephedrine).

Possible side effects

• Common: Application site reactions (redness, rash, itching), headache, insomnia, dry mouth.
• Less Common: Dizziness, orthostatic hypotension, gastrointestinal disturbances, anxiety.
• Rare but Serious: Hypertensive crisis, serotonin syndrome, suicidal ideation, severe skin reactions, mania/hypomania.
• Long-Term Use: Monitor for changes in weight, libido, or sleep patterns.

Drug interaction

• Serotonergic Drugs: Risk of serotonin syndrome with SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tryptophan, and buspirone.
• ** sympathomimetics:** Avoid decongestants (e.g., pseudoephedrine) due to risk of hypertensive crisis.
• CNS Depressants: Enhanced sedative effects with alcohol, benzodiazepines, or opioids.
• Other MAOIs: Absolutely contraindicated.
• Carbamazepine, Oxcarbazepine: May reduce selegiline levels.
• Tyramine-Containing Foods: Risk increases with higher doses; avoid aged cheeses, cured meats, tap beer, and fermented products.

Missed dose

If a dose is missed, apply the patch as soon as possible. However, if it is almost time for the next dose, skip the missed dose and resume the regular schedule. Do not apply extra patches to make up for a missed dose.

Overdose

Symptoms may include severe hypertension, agitation, hallucinations, hyperthermia, and seizures. Management involves immediate removal of the patch, symptomatic and supportive care, and close monitoring of vital signs. Hypertension should be controlled with rapid-acting antihypertensives (e.g., phentolamine). Avoid serotonin antagonists in cases of suspected serotonin syndrome. Seek emergency medical attention immediately.

Storage

Store at room temperature (20°C to 25°C/68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep in the original pouch until use. Do not freeze. Keep out of reach of children and pets. Dispose of used patches by folding adhesive sides together and discarding in household trash away from children or 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 treatment. Do not disregard professional medical advice or delay in seeking it because of something you have read here. Individual patient responses to EMSAM may vary.

Reviews

Clinical studies and patient reports indicate that EMSAM is effective in reducing depressive symptoms in treatment-resistant cases, with many users appreciating the convenience of transdermal delivery and reduced dietary concerns at lower doses. Some users report mild skin irritation, which often resolves with proper site rotation. Overall, it is regarded as a valuable option for those who have not benefited from first-line antidepressants. Long-term satisfaction often correlates with adequate dosing and adherence to application guidelines.