Emsam

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Skeletal formula of selegiline

Emsam (selegiline transdermal system) is the trade name of an antidepressant of the monoamine oxidase inhibitor (MAOI) class. Emsam is a transdermal patch containing the MAOI selegiline. Selegiline, in small doses, is most commonly used in the treatment of Parkinson's disease. Emsam is also used, in higher doses, for the treatment of major depressive disorder.[1] On February 28, 2006, the U.S. Food and Drug Administration (FDA) approved Emsam for the treatment of major depression. [2] [3] [4]

Inception and development[edit]

Emsam's development was spearheaded by J. Alexander Bodkin, M.D. ,[5] Director of the Clinical Psychopharmacology Research Program at McLean Hospital in Belmont, Massachusetts, in conjunction with Harvard Medical School.[4] [6] [7] [8] Currently, it is the only MAOI on the market used in the treatment of depression that is absorbed through the skin into the bloodstream and thereby to the central nervous system.[citation needed]

The patch "is a matrix containing three layers consisting of a backing, an... adhesive drug layer, and a release liner that is placed against the skin."[1] The primary advantage of delivering selegiline in this manner is to bypass the gastrointestinal tract and liver, specifically the small intestine, thereby limiting the chance of hypertensive crisis (very high spike in blood pressure possibly leading to stroke).[1] [9] [10]

"Despite long-standing concerns over hypertensive reactions,... (MAOIs) have grown in popularity... (and) the risk of hypertensive episodes is less than 1%."[11]

Emsam advantages[edit]

Due mainly to the availability of the newer SSRIs and SNRIs, which are viewed to have more medically benign side effects in the treatment of depression, psychopharmacologists and psychiatrists have avoided prescribing monoamine oxidase inhibitors (MAOIs)[1][11] [12] [13] because of the possibility of hypertensive crisis and other troublesome side effects such as medication and diet interactions. With Emsam, taken at the lowest dose of 6 mg every 24 hours, no dietary modifications are required by the Food and Drug Administration, and the chance of such a side effect due to diet is reportedly eliminated.[6] The FDA requirement for dietary modifications for the 9 mg and 12 mg doses are based on theoretical concerns, as no adverse events due to diet have ever been reported.[14]

In addition to the lack of dietary restrictions at the 6 mg/24h dose, Emsam offers another benefit.[10] It is a continuous delivery system, keeping the medication at a steady level in the body over time, although there is no evidence that this makes a difference in terms of the efficacy or side effects of this medication.[15] Generally, oral medication cannot keep a steady dose in the blood stream.

Emsam may be valuable in the treatment of some cases of atypical depression when the depression is not alleviated by the more commonly used selective serotonin reuptake inhibitors (SSRIs), serotonin–norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs).

Somewhat surprisingly, clinical trials done with MAOIs do not find that they are more effective than other antidepressants when they are tested in large groups of people. However, for certain individuals, maybe individuals who have not done well on other antidepressants, an MAOI may be best. MAOIs are thought to be particularly effective in what has been called "atypical" depression. Atypical depression is characterized by an increased need for sleep, increased appetite, weight gain, mood reactivity, leaden paralysis, and sensitivity to rejection.

Usage[edit]

6mg/24hr dose

The patch is changed once daily. There may be a reaction to the adhesive on the skin at the site of application.[6] Patients are encouraged to use an adhesive remover: usually mineral oil, Vaseline or an over-the-counter product. A new patch is placed on a different site. The combination of adhesive remover and placing each patch on a new area of skin is to discourage any dermatological reason for discontinuance of the patch.

Using rubbing alcohol or hydrogen peroxide to clean the skin of oils and dirt before applying a patch can increase the likelihood of proper attachment for the duration of each 24 hour period. Immediately after applying a patch it can be helpful to use the pressure and body heat of the palm of the hand to enhance proper adhesive contact.

All of the dietary restrictions are required, at the higher 9 mg/24h and 12 mg/24h doses of Emsam but not at the 6 mg/24hr dose.[16]

Medication interactions[edit]

At high doses selegiline may also inhibit MAO-A which means it is subject to many of the same medication restrictions as MAO-A inhibitors to prevent serotonin syndrome.[17]

There are prescription medications that cannot be taken while using Emsam, and for 2 weeks after stopping Emsam.[4] Some medications must not be taken for 1 week (or more) before an individual can start using Emsam.

Medications that cannot be taken because they can cause serotonin syndrome[18] include: SSRI medications such as sertraline, paroxetine, and fluoxetine; SNRI medications such as venlafaxine and duloxetine; Tricyclic antidepressants such as nortriptyline; other MAOIs; mirtazapine; analgesics such as meperidine, tramadol, methadone, propoxyphene, cyclobenzaprine; and oral selegiline.[4] The use of Emsam is contraindicated for use with sympathomimetic amines, including amphetamines as well as cold products and weight-reducing preparations that contain vasoconstrictors (e.g., pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine). Carbamazepine and oxcarbazepine are also contraindicated.[4]

Patients taking Emsam should not undergo elective surgery requiring general anesthesia or be given local anesthesia containing sympathomimetic vasoconstrictors.[4]

Name origin, manufacturer and distributor[edit]

The acronym Emsam is derived from the names Emily and Samuel, two of the children of Mel Sharoky, M.D., CEO of Emsam's manufacturer, Somerset Pharmaceuticals, Inc.[19]

Emsam is distributed by Mylan out of Pittsburgh, Pennsylvania.

External links[edit]

References[edit]

  1. ^ a b c d Patkar AA, Pae CU (May 2006). "Transdermal selegiline: the new generation of monoamine oxidase inhibitors". CNS Spectrum 11 (5): 363–75. PMID 16641841. 
  2. ^ Cruzan, Suzanne (28 February 2006). "FDA Approves EMSAM (Selegiline) as First Drug Patch for Depression". U.S. Food and Drug Administration, FDA News. P06-31. 
  3. ^ Andrew Bridges, Associated Press (March 1, 2006). "Skin Patch for Mood Disorders Approved". The Boston Globe. 
  4. ^ a b c d e f "FDA Approves EMSAM(R) (selegiline Transdermal System), The First Transdermal Patch For The Treatment Of Major Depressive Disorder". Medical News Today. 6 March 2006. 
  5. ^ "Alexander J. Bodkin, M.D.". Retrieved 2007-09-08. 
  6. ^ a b c Frampton JE, Plosker GL (2007). "Selegiline transdermal system: in the treatment of major depressive disorder". Drugs 67 (2): 257–67, discussion 266–7. doi:10.2165/00003495-200767020-00006. PMID 17284087. 
  7. ^ Tong TG, Saklad SR (1994). "What foods you should avoid on MAOIs (MAO-I's Dietary Restrictions)". 
  8. ^ William J. Cromie (2002-11-07). "Bodkin is Patching up Depression". Harvard University Gazette. Retrieved 2007-09-08. 
  9. ^ "Hypertensive Crisis". Retrieved 2007-09-15. 
  10. ^ a b Rapaport MH (2007). "Dietary restrictions and drug interactions with monoamine oxidase inhibitors: the state of the art". Journal of Clinical Psychiatry 68 (8): 42–6. PMID 17640157. 
  11. ^ a b Lavin MR, Mendelowitz A, Kronig MH (August 1, 1993). "Spontaneous hypertensive reactions with monoamine oxidase inhibitors". Biological Psychiatry 34 (3): 146–51. doi:10.1016/0006-3223(93)90384-p. PMID 8399806. 
  12. ^ Fiedorowicz JG, Swartz KL (July 2004). "The role of monoamine oxidase inhibitors in current psychiatric practice". Journal of Psychiatric Practice 10 (4): 239–48. doi:10.1097/00131746-200407000-00005. PMC 2075358. PMID 15552546. 
  13. ^ Krishnan KR (2007). "Revisiting monoamine oxidase inhibitors". Journal of Clinical Psychiatry 68 (8): 35–41. PMID 17640156. 
  14. ^ Cascade EF, Kalali AH (June 2007). "EMSAM: The First Year". Psychiatry 2007. Retrieved 2009-11-30. 
  15. ^ Patkar AA, Pae CU, Zarzar M (June 2007). "Transdermal selegiline". Drugs of today (Barcelona, Spain : 1998) 43 (6): 361–77. doi:10.1358/dot.2007.43.6.1050794. PMID 17612708. 
  16. ^ Feiger AD, Rickels K, Rynn MA, Zimbroff DL, Robinson DS (September 2006). "Selegiline transdermal system for the treatment of major depressive disorder: an 8-week, double-blind, placebo-controlled, flexible-dose titration trial". Journal of Clinical Psychiatry 67 (9): 1354–61. doi:10.4088/JCP.v67n0905. PMID 17017821. 
  17. ^ Laine, K.; Anttila, M.; Helminen, A.; Karnani, H.; Huupponen, R. (2001). "Dose linearity study of selegiline pharmacokinetics after oral administration: Evidence for strong drug interaction with female sex steroids". British Journal of Clinical Pharmacology 47 (3): 249–254. doi:10.1046/j.1365-2125.1999.00891.x. PMC 2014223. PMID 10215747.  edit
  18. ^ "Serotonin Syndrome". Retrieved 2007-09-15. 
  19. ^ Somerset Pharmaceuticals, Inc. Tampa FL 33607 USA