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EMSAM
Overview
What is EMSAM?
EMSAM contains selegiline, a MAOI antidepressant. When applied to intact skin, EMSAM is designed to transdermally deliver selegiline over a 24-hour period.
Selegiline base is a colorless to yellow liquid, chemically described as (-)-()-Methyl--[(1)-1-methyl-2-phenylethyl]prop-2-yn-1-amine. It has a molecular formula of CHN and a molecular weight of 187.30. The structural formula is:
EMSAM transdermal systems are available in three strengths that deliver approximately 6 mg, 9 mg, or 12 mg of selegiline over 24 hours. Each corresponding system has an active surface area of 20 cm, 30 cm, or 40 cm containing 20, 30, or 40 mg of selegiline, respectively. The composition of the systems per unit area is identical.
EMSAM is a matrix-type transdermal system composed of three layers as illustrated in Figure 1 below. Layer 1 is the Backing Film that provides occlusivity, 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. The inactive ingredients are acrylic adhesive, ethylene vinyl acetate/polyethylene, polyester, polyurethane, and silicone coated polyester.
What does EMSAM look like?
What are the available doses of EMSAM?
Transdermal System: 6 mg per 24 hours, 9 mg per 24 hours and 12 mg per 24 hours ().
What should I talk to my health care provider before I take EMSAM?
How should I use EMSAM?
EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD)
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Clinical Studies (14)
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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 per 24 hours. EMSAMhas been systematically evaluated and shown to be effective in a dose range of 6 mg per 24 hours to 12 mg per 24 hours. However, the trials were not designed to assess if higher doses are more effective than the lowest effective dose of 6 mg per 24 hours. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur in dose increments of 3 mg per 24 hours (up to a maximum dose of 12 mg per 24 hours) at intervals of no less than 2 weeks. 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 per 24 hours or 12 mg per 24 hours treatment and should continue to be avoided for 2 weeks after a dose reduction to EMSAM 6 mg per 24 hours or following the discontinuation of EMSAM 9 mg per 24 hours or 12 mg per 24 hours .
What interacts with EMSAM?
Sorry No Records found
What are the warnings of EMSAM?
Sorry No Records found
What are the precautions of EMSAM?
Sorry No Records found
What are the side effects of EMSAM?
Sorry No records found
What should I look out for while using EMSAM?
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What might happen if I take too much EMSAM?
How should I store and handle EMSAM?
Store olanzapine orally disintegrating tablets, USP at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [ USP Controlled Room Temperature].Protect olanzapine orally disintegrating tablets from light and moisture. Store olanzapine orally disintegrating tablets, USP at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [ USP Controlled Room Temperature].Protect olanzapine orally disintegrating tablets from light and moisture. How SuppliedEMSAM (selegiline transdermal system) is a transdermal system with the following strengths, sizes, color, backing film printing and presentation:Storage and HandlingStore 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.How SuppliedEMSAM (selegiline transdermal system) is a transdermal system with the following strengths, sizes, color, backing film printing and presentation:Storage and HandlingStore 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.How SuppliedEMSAM (selegiline transdermal system) is a transdermal system with the following strengths, sizes, color, backing film printing and presentation:Storage and HandlingStore 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.How SuppliedEMSAM (selegiline transdermal system) is a transdermal system with the following strengths, sizes, color, backing film printing and presentation:Storage and HandlingStore 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.How SuppliedEMSAM (selegiline transdermal system) is a transdermal system with the following strengths, sizes, color, backing film printing and presentation:Storage and HandlingStore 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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of selegiline (the drug substance of EMSAM) as an antidepressant is not fully understood, but is presumed to be linked to potentiation of monoamine neurotransmitter activity in the central nervous system (CNS) resulting from its irreversible inhibition of the enzyme monoamine oxidase (MAO).
Non-Clinical Toxicology
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Drug Interactions:
In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1.
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.
It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing EMSAM, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
The following adverse reactions are discussed in greater detail in other sections of the label.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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