RX ITEM-Emsam 24Hr 9Mg 24 Hr Selegiline Transdermal Patch 30 By Mylan

Clinical Information
Gen. Code and Des.
60454 selegiline TRANSDERM PATCH TD24 9 MG/24 HR
GCN and Des.
26613 selegiline TRANSDERM PATCH TD24 9 MG/24 HR
Strength
9MG
Dose Form
PATCH, TRANSDERMAL 24 HOURS
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
28363200 MONOAMINE OXIDASE B INHIBITORS
28160412 MONOAMINE OXIDASE INHIBITORS
Active Ingredients
4599 selegiline 14611519
Inactive Ingredients
3245 adhesive






EMSAM- selegiline patch
Mylan Specialty

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)].


In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)].

EMSAM is contraindicated in patients less than 12 years of age because of an increased risk of hypertensive crisis [see Contraindications (4) and Use in Specific Populations (8.4)].

1 INDICATIONS AND USAGE

EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD). The efficacy of EMSAM in the treatment of major depressive disorder was established in two short term (6-week and 8-week) trials of outpatients with major depressive disorder. Efficacy was studied in two short term studies and one maintenance study [see Clinical Studies (14.1)].

2 DOSAGE AND ADMINISTRATION

2.1 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 per 24 hours. EMSAM has 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 [see Warnings and Precautions (5.3)].

RX ITEM-Emsam 24Hr 9Mg 24 Hr Patch 30 By
Item No.:RX062796 NDC No.49502090130 UPC No.:349502901302 NDC No. 49502-0901-30 UPC/GTIN No. 3-49502-90130-2 MPN 90130

Emsam 24Hr 9Mg 24 Hr Patch 30 By Mylan S
Item No.:RX062796 NDC No.49502090130 UPC No.:349502901302 NDC No. 49502-0901-30 UPC/GTIN No. 3-49502-90130-2 MPN 90130

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