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Emsam (Selegiline Transdermal) - Indications and Dosage

 
 



INDICATIONS AND USAGE

EMSAM (selegiline transdermal system) is indicated for the treatment of major depressive disorder.

The efficacy of EMSAM in the treatment of major depressive disorder was established in 6- and 8-week placebo-controlled trials of outpatients with diagnoses of DSM-IV category of major depressive disorder (see Clinical Efficacy Trials).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempt or suicidal ideation.

The benefit of maintaining patients with major depressive disorder on therapy with EMSAM after achieving a responder status for an average duration of about 25 days was demonstrated in a controlled trial (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). The physician who elects to use EMSAM for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

The antidepressant action of EMSAM in hospitalized depressed patients has not been studied.

DOSAGE AND ADMINISTRATION

Initial Treatment

EMSAM should be applied 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 once every 24 hours. The recommended starting dose and target dose for EMSAM is 6 mg/24 hours. EMSAM has been systematically evaluated and shown to be effective in a dose range of 6 mg/24 hours to 12 mg/24 hours. However, the trials were not designed to assess if higher doses are more effective than the lowest effective dose of 6 mg/24 hours. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur in dose increments of 3 mg/24 hours (up to a maximum dose of 12 mg/24 hours) at intervals of no less than 2 weeks. As with all antidepressant drugs, full antidepressant effect may be delayed.

Patients should be informed that tyramine-rich foods and beverages should be avoided beginning on the first day of EMSAM 9 mg/24 hours or 12 mg/24 hours treatment and should continue to be avoided for 2 weeks after a dose reduction to EMSAM 6 mg/24 hours or following the discontinuation of EMSAM 9 mg/24 hours or 12 mg/24 hours (see WARNINGS).

Special Populations

EMSAM at any dose should not be used in children under the age of 12 years even when administered with dietary modifications. EMSAM is not approved for use in pediatric patients.

No dosage adjustment is required for patients with mild to moderate renal or hepatic impairment. The recommended dose for elderly patients (≥ 65 years) is EMSAM 6 mg/24 hours daily. Dose increases, in the elderly, should be made with caution and patients should be closely observed for postural changes in blood pressure throughout treatment.

How to Use EMSAM

  1. EMSAM should be applied 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. A new application site should be selected with each new patch to avoid re-application to the same site on consecutive days. Patches should be applied at approximately the same time each day.
  2. Apply the patch to an area of skin that is not hairy, oily, irritated, broken, scarred or calloused. Do not place the patch where your clothing is tight, which could cause the patch to rub off.
  3. After you have selected the site for your patch, wash the area gently and thoroughly with soap and warm water. Rinse until all soap is removed. Dry the area with a clean dry towel.
  4. Just before you apply the patch, remove it from the pouch. Remove half of the protective backing and throw it away. Try not to touch the exposed side (sticky side) of the patch, because the medicine could come off on your fingers.
  5. Press the sticky side of the patch firmly against the skin site that was just washed and dried. Remove the second half of the protective liner and press the remaining sticky side firmly against your skin. Make sure that the patch is flat against the skin (there should be no bumps or folds in the patch) and is sticking securely. Be sure the edges are stuck to the skin surface.
  6. After you have applied the patch, wash your hands thoroughly with soap and water to remove any medicine that may have gotten on them. Do not touch your eyes until after you have washed your hands.
  7. After 24 hours, remove the patch. Do not touch the sticky side. As soon as you have removed the patch, fold it so that the sticky side sticks to itself.
  8. Throw away the folded patch so that children and/or pets cannot reach it.
  9. Wash your hands with soap and water.
  10. If your patch falls off, apply a new patch to a new site and resume your previous schedule.
  11. Only one EMSAM patch should be worn at a time.
  12. Avoid exposing the EMSAM application site to external sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.

Maintenance Treatment

It is generally agreed that episodes of depression require several months or longer of sustained pharmacologic therapy. The benefit of maintaining depressed patients on therapy with EMSAM at a dose of 6 mg/24 hours after achieving a responder status for an average duration of about 25 days was demonstrated in a controlled trial (see Clinical Efficacy Trials and INDICATIONS AND USAGE). The physician who elects to use EMSAM for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

HOW SUPPLIED

EMSAM (selegiline transdermal system) is supplied as 6 mg/24 hours (20 mg/20 cm2), 9 mg/24 hours (30 mg/30 cm2) and 12 mg/24 hours (40 mg/40 cm2) transdermal systems.

They are available as:
NDC 49502-900-30: 6 mg/24 hours (20 mg/20 cm2) box of 30 transdermal systems.
NDC 49502-901-30: 9 mg/24 hours (30 mg/30 cm2) box of 30 transdermal systems.
NDC 49502-902-30: 12 mg/24 hours (40 mg/40 cm2) box of 30 transdermal systems.

STORAGE AND DISPOSAL

Store at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature.] Do not store outside of the sealed pouch. Apply immediately upon removal from the protective pouch. Discard used EMSAM in household trash in a manner that prevents accidental application or ingestion by children, pets or others.

DISTRIBUTED BY:

Dey, L.P.
Napa, CA 94558

MANUFACTURED FOR:

Somerset
Pharmaceuticals, Inc.
Morgantown, WV 26505

MAY 2009
EMSAM:PIR7
03-943-00

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