Applies to the following strength(s): 5 mg ; 1.25 mg ; 6 mg/24 hr ; 9 mg/24 hr ; 12 mg/24 hr
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Parkinson's Disease
Recommended dose: 5 mg orally twice a day
Maximum dose: 10 mg orally per day
Oral disintegrating tablet:
Initial dose: 1.25 mg orally once a day for at least 6 weeks. After 6 weeks, the dose may be increased to 2.5 mg orally once a day if needed.
Maintenance dose: 1.25 to 2.5 mg orally once a day
Maximum dose: 2.5 mg orally once a day
-After two to three days of treatment, an attempt may be made to reduce the dose of concomitant levodopa-carbidopa by 10% to 30%. Further reductions may be possible during continued selegiline therapy.
Use: Adjunct in the management of Parkinson's disease patients being treated with levodopa-carbidopa who exhibit deterioration in the quality of their response to this therapy.
Usual Adult Dose for Depression
Initial dose: Apply one 6 mg/24 hours transdermal patch to intact skin once every 24 hours
Maintenance dose: One 6 mg/24 hours to 12 mg/24 hours transdermal patch applied to the skin once a day
Maximum dose: 12 mg/24 hours transdermal patch applied to the skin once a day
-Episodes of depression may require several months or more of sustained pharmacologic therapy
-If dose adjustments are necessary, they should be made in increments of 3 mg/24 hours at intervals of at least 2 weeks
-Full antidepressant effect may be delayed
Use: Treatment of major depressive disorder (MDD)
Renal Dose Adjustments
Oral tablets: Data not available
Orally disintegrating tablets:
-Mild to moderate renal dysfunction (CrCl 30 to 89 mL/min): No adjustment recommended
-Severe renal dysfunction and end-stage renal disease (CrCl less than 30 mL/min): Use is not recommended
-Mild to severe renal dysfunction (CrCl 15 to 89 mL/min/1.73 m3): No adjustment recommended
-End-stage renal disease (CrCl less than 15 mL/min/1.73 m3): Data not available
Liver Dose Adjustments
Oral tablets: Data not available
Orally disintegrating tablets:
-Mild to moderate liver dysfunction (Child-Pugh 5 to 9): 1.25 mg orally once a day
-Severe liver dysfunction (Child-Pugh greater than 9): Use is not recommended
-Mild to moderate liver dysfunction (Child-Pugh 5 to 9): No adjustment recommended
-Severe liver dysfunction (Child-Pugh 10 to 15): Data not available
US BOXED WARNING (Emsam (R) transdermal patch):
-Antidepressants increased the risk of suicidal thoughts and behaviors 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 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older.
-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.
-Selegiline is contraindicated in patients less than 12 years of age because of an increased risk of hypertensive crisis.
Oral tablet, orally disintegrating tablet, transdermal patch:
-Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Oral tablet: Doses should be taken with food, at breakfast and lunch
-Orally disintegrating tablets: Patients should avoid ingesting food or liquids for 5 minutes before and after taking a dose
-Transdermal patch: Follow the detailed instructions in the medication guide. Patches should be applied to dry intact skin on the upper torso, upper thigh, or the outer surface of the upper arm. Rotate application sites; avoid reapplication to the same site on consecutive days.
-Orally disintegrating tablet: Once opened, unused tablets must be disposed of after 3 months.
-Treatment should be periodically reevaluated
-This drug interacts with other drugs; prescribers should be aware for the potential for interactions. A washout period may be required between ceasing selegiline and commencing other medicines and vice versa.
-Dietary modifications are recommended in patients taking either selegiline transdermal 9 mg/24 hours or 12 mg/24 hours patches. Tyramine-rich foods and beverages should be avoided beginning on the first day of the 9 mg/24 hours or 12 mg/24 hours patch and for 2 weeks after either a dose reduction to 6 mg/24 hours or following discontinuation of the higher strength patches. Foods and drinks containing little to no tyramine are acceptable; the manufacturer product information should be consulted.
-Cardiovascular: Blood pressure, tyramine-induced hypertensive crisis
-Nervous system: Exacerbation of dyskinesia (if used concomitantly with levodopa)
-Psychiatric: Impulse disorders, falling asleep during activities of daily living, somnolence, emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
-Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.
-This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.
-There have been reports of patients experiencing intense urges to gamble, increased sexual urges, and other intense urges, and the inability to control these urges while taking one or more of the medicines used to treat Parkinson's disease. Be alert for the emergence of these urges. Report any behavior of concern to your healthcare provider as soon as possible.
-Tyramine-rich foods, beverages, and nutritional supplements should be avoided when using the 9 mg/24 hours or 12 mg/24 hours patch.
-Immediately contact your doctor if you experience severe headache, neck stiffness, heart racing or palpitations, or other sudden unusual symptoms.
-Avoid exposing the selegiline transdermal patch application site to external sources of direct heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.
-This medicine may cause drowsiness, impaired judgment, thinking, or motor skills; do not drive a car or operate dangerous machinery until you know how this drug affects you. Contact your doctor if you experience daytime sleepiness or episodes of falling asleep during activities that require participation (e.g., eating).
-Concomitant ingestion of alcohol is not advised.
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