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(selegiline transdermal) System
CONTINUOUS DELIVERY FOR ONCE-DAILY APPLICATION
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of EMSAM (selegiline transdermal system) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening,suicidality,or unusual changes in behavior.Families and caregivers should be advised for the need for close observation and communication with the prescriber. EMSAM (selegiline transdermal system) is not approved for use in pediatric patients.Furthermore,EMSAM (selegiline transdermal system) at any dose should not be used in children under the age of 12, even when administered with dietary modifications. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
EMSAM® (selegiline transdermal system) is a transdermally administered antidepressant. When applied to intact skin, EMSAM (selegiline transdermal system) is designed to continuously deliver selegiline over a 24-hour period. Selegiline base is a colorless to yellow liquid, chemically described as (-)-(N)-Methyl- N-[(1 R)-1-methyl-2- phenylethyl]prop-2-yn-1-amine. It has an empirical formula of C13H17N and a molecular weight of 187.30. The structural formula is:
EMSAM (selegiline transdermal system) systems are transdermal patches that contain 1 mg of selegiline per cm2 and deliver approximately 0.3 mg of selegiline per cm2 over 24 hours. EMSAM (selegiline transdermal system) systems are available in three sizes: 20 mg/20 cm2, 30 mg/30 cm2, and 40 mg/40 cm2 that deliver, on average, doses of 6 mg, 9 mg, or 12 mg, respectively, of selegiline over 24 hours.
EMSAM (selegiline transdermal system) is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below.Layer 1 is the Backing Film that provides the matrix system with occlusivity and physical integrity and protects the adhesive/drug layer.Layer 2 is the Adhesive/Drug Layer.Layer 3 consists of side-by-side release liners that are peeled off and discarded by the patient prior to applying EMSAM (selegiline transdermal system) .The inactive ingredients are acrylic adhesive, ethylene vinyl acetate/polyethylene,polyester,polyurethane,and silicon coated polyester.
Figure 1: Side view of EMSAM (selegiline transdermal system) system. (Not to scale.)
What are the possible side effects of selegiline transdermal (Emsam)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Remove the skin patch and get emergency medical help if you have any of these signs of...
What are the precautions when taking selegiline transdermal system (Emsam)?
Before using selegiline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal/family history of mental/mood disorders...
Last reviewed on RxList: 6/2/2008
This monograph has been modified to include the generic and brand name in many instances.
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