Emsam
Encyclopedia
Monoamine oxidase inhibitor
Monoamine oxidase inhibitors are a class of antidepressant drugs prescribed for the treatment of depression. They are particularly effective in treating atypical depression....
(MAOI) class. Emsam is a transdermal patch
Transdermal patch
A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream. Often, this promotes healing to an injured area of the body. An advantage of a transdermal drug delivery route over other types of...
containing the MAOI selegiline
Selegiline
Selegiline is a drug used for the treatment of early-stage Parkinson's disease, depression and senile dementia. In normal clinical doses it is a selective irreversible MAO-B inhibitor, however in larger doses it loses its specificity and also inhibits MAO-A...
. Selegiline, in small doses, is most commonly used in the treatment of Parkinson's disease
Parkinson's disease
Parkinson's disease is a degenerative disorder of the central nervous system...
. It is also effective in higher doses for the treatment of major depressive disorder. On February 28, 2006 the U.S. Food and Drug Administration (FDA) approved EMSAM for the treatment of major depression.
Inception and development
Emsam's development was spearheaded by J. Alexander Bodkin, M.D., Director of the Clinical Psychopharmacology Research Program at McLean Hospital
McLean Hospital
McLean Hospital is a psychiatric hospital in Belmont, Massachusetts.It is noted for its clinical staff expertise and ground-breaking neuroscience research...
in Belmont MA, in conjunction with Harvard Medical School
Harvard Medical School
Harvard Medical School is the graduate medical school of Harvard University. It is located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts....
.
Currently, it is the only MAOI on the market used in the treatment of depression that is absorbed through the skin into the blood stream and thereby to the central nervous system
Central nervous system
The central nervous system is the part of the nervous system that integrates the information that it receives from, and coordinates the activity of, all parts of the bodies of bilaterian animals—that is, all multicellular animals except sponges and radially symmetric animals such as jellyfish...
.
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." 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).
"Despite long-standing concerns over hypertensive reactions,... (MAOIs) have grown in popularity... (and) the risk of hypertensive episodes is less than 1%."
Emsam advantages
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 psychiatristPsychiatrist
A psychiatrist is a physician who specializes in the diagnosis and treatment of mental disorders. All psychiatrists are trained in diagnostic evaluation and in psychotherapy...
s have avoided prescribing MAOIs
because of the possibility of hypertensive crisis. With Emsam, taken at the lowest dose of 6 mg. every 24 hours, no dietary modifications are required by the FDA, and the chance of such a side effect due to diet is eliminated. 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.
In addition to the lack of dietary restrictions at the 6 mg/24h dose, Emsam offers another benefit. 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. Generally, oral medication can not keep a steady dose in the blood stream.
Emsam is also valuable in the treatment of atypical depression, which is not alleviated by the more commonly used selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reupatake inhibitors (SNRIs) and 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, especially 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 depressions are characterized by an increased need for sleep and increased appetite.
Usage
The patch is changed once daily. There may be a reaction to the adhesiveAdhesive
An adhesive, or glue, is a mixture in a liquid or semi-liquid state that adheres or bonds items together. Adhesives may come from either natural or synthetic sources. The types of materials that can be bonded are vast but they are especially useful for bonding thin materials...
on the skin at the site of application. Patients are encouraged to use an adhesive remover: usually mineral oil
Mineral oil
A mineral oil is any of various colorless, odorless, light mixtures of alkanes in the C15 to C40 range from a non-vegetable source, particularly a distillate of petroleum....
, Vaseline
Vaseline
Vaseline is a brand of petroleum jelly based products owned by Anglo-Dutch company Unilever. Products include plain petroleum jelly and a selection of skin creams, soaps, lotions, cleansers, deodorants and personal lubricants....
or an over-the-counter
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
product such. 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
Rubbing alcohol
Rubbing alcohol, USP / B.P. is a liquid prepared and used primarily for topical application. It is prepared from a special denatured alcohol solution and contains 97.5-100% by volume of pure, concentrated ethanol or isopropyl alcohol...
or hydrogen peroxide
Hydrogen peroxide
Hydrogen peroxide is the simplest peroxide and an oxidizer. Hydrogen peroxide is a clear liquid, slightly more viscous than water. In dilute solution, it appears colorless. With its oxidizing properties, hydrogen peroxide is often used as a bleach or cleaning agent...
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 currently required by the FDA, as a precaution, at the higher 9 mg/24h and 12 mg/24h doses of Emsam.
Medication interactions
Over-the-counterOver-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
items that can not be used while on Emsam include: St. John's Wort; products containing dextromethorphan
Dextromethorphan
Dextromethorphan is an antitussive drug. It is one of the active ingredients in many over-the-counter cold and cough medicines, such as Robitussin, NyQuil, Dimetapp, Vicks, Coricidin, Delsym, and others, including generic labels. Dextromethorphan has also found other uses in medicine, ranging...
such as cough and cold preparations; decongestant
Decongestant
A decongestant or nasal decongestant is a type of drug that is used to relieve nasal congestion.-Pharmacology:The vast majority of decongestants act via enhancing norepinephrine and epinephrine or adrenergic activity by stimulating the α-adrenergic receptors...
medicines; and diet pills or herbal weight loss products. Caffeine
Caffeine
Caffeine is a bitter, white crystalline xanthine alkaloid that acts as a stimulant drug. Caffeine is found in varying quantities in the seeds, leaves, and fruit of some plants, where it acts as a natural pesticide that paralyzes and kills certain insects feeding on the plants...
and chocolate
Chocolate
Chocolate is a raw or processed food produced from the seed of the tropical Theobroma cacao tree. Cacao has been cultivated for at least three millennia in Mexico, Central and South America. Its earliest documented use is around 1100 BC...
can only be consumed in small amounts.
There are prescription medications that can not be taken while using Emsam, and for 2 weeks after stopping Emsam. Some medications must not be taken for 1 week (or more) before an individual can start using Emsam.
Medications that can not be taken because they can cause serotonin syndrome
Serotonin syndrome
Serotonin syndrome is a potentially life-threatening adverse drug reaction that may occur following therapeutic drug use, inadvertent interactions between drugs, overdose of particular drugs, or the recreational use of certain drugs...
include: (SSRIs), (SNRIs), (TCAs), other MAOIs, mirtazapine
Mirtazapine
Mirtazapine is a tetracyclic antidepressant used primarily in the treatment of depression. It is also sometimes used as a hypnotic, antiemetic, and appetite stimulant, and for the treatment of anxiety, among other indications...
, analgesics such as meperidine, tramadol
Tramadol
Tramadol hydrochloride is a centrally acting synthetic opioid analgesic used in treating moderate pain. The drug has a wide range of applications, including treatment for restless legs syndrome and fibromyalgia...
, methadone
Methadone
Methadone is a synthetic opioid, used medically as an analgesic and a maintenance anti-addictive for use in patients with opioid dependency. It was developed in Germany in 1937...
, propoxyphene, cyclobenzaprine
Cyclobenzaprine
Cyclobenzaprine is a muscle relaxant medication used to relieve skeletal muscle spasms and associated pain in acute musculoskeletal conditions. It is the most well-studied drug for this application, and it also has been used off-label for fibromyalgia treatment.- Mechanism of action :The mechanism...
, and oral selegiline.
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
Pseudoephedrine
Pseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It is used as a nasal/sinus decongestant and stimulant, or as a wakefulness-promoting agent....
, phenylephrine
Phenylephrine
Phenylephrine is a selective α1-adrenergic receptor agonist used primarily as a decongestant, as an agent to dilate the pupil, and to increase blood pressure...
, phenylpropanolamine
Phenylpropanolamine
Phenylpropanolamine , also known as the stereoisomers norephedrine and norpseudoephedrine, is a psychoactive drug of the phenethylamine and amphetamine chemical classes which is used as a stimulant, decongestant, and anorectic agent. It is commonly used in prescription and over-the-counter cough...
, and ephedrine
Ephedrine
Ephedrine is a sympathomimetic amine commonly used as a stimulant, appetite suppressant, concentration aid, decongestant, and to treat hypotension associated with anaesthesia....
). Carbamazepine
Carbamazepine
Carbamazepine is an anticonvulsant and mood-stabilizing drug used primarily in the treatment of epilepsy and bipolar disorder, as well as trigeminal neuralgia...
and oxcarbazepine
Oxcarbazepine
Oxcarbazepine is a anticholinergic anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy. It is also used to treat anxiety and mood disorders, and benign motor tics...
are also contraindicated.
Patients taking Emsam should not undergo elective surgery requiring general anesthesia or be given local anesthesia containing sympathomimetic vasoconstrictors.
Name origin, manufacturer and distributor
The acronym Emsam is derived from the names Emily and Samuel. They are two of the children of Mel Sharoky, M.D., CEO of Emsam's manufacturer, Somerset Pharmaceuticals, Inc., The prescription medication is distributed by Bristol-Myers SquibbBristol-Myers Squibb
Bristol-Myers Squibb , often referred to as BMS, is a pharmaceutical company, headquartered in New York City. The company was formed in 1989, following the merger of its predecessors Bristol-Myers and the Squibb Corporation...
out of Princeton, NJ.
External links
- Everything You Ever Wanted to Know about EMSAM and more.
- FDA Approves Emsam (selegiline) as First Drug Patch for Depression.
- Andrew Bridges, Associated Press (2006). "Skin patch for mood disorders approved". The Boston Globe March 1, 2006
- Bristol-Myers Squibb Company EMSAM information for U.S. residents only.
- Tong TG, Saklad SR (1994). "What foods you should avoid on MAOIs" (MAO-I's Dietary Restrictions)
- William J. Cromie (November 7, 2002). "Bodkin is patching up depression". Harvard University Gazette (photo of Dr. Bodkin displaying patch.)
- NIH Medication Information: EMSAM.