Usual Adult Dose for Parkinson's Disease

Oral capsule and tablet: 5 mg orally twice a day taken at breakfast and lunch
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 before breakfast
Maximum dose: 2.5 mg orally once a day

Comments:

• Two to 3 days after initiating therapy with this drug, an attempt may be made to reduce the dose of levodopa-carbidopa; typically a 10% to 30% reduction is needed; further reductions may be possible during continued concomitant use.
• There is no evidence that this drug has beneficial effect in the absence of concurrent levodopa therapy.

Use: As an adjunct in the management of Parkinson's disease in patients being treated with levodopa-carbidopa who exhibit deterioration in the quality of their response to this therapy.

Usual Adult Dose for Depression

Transdermal System:
Initial dose: 6 mg/24 hours patch applied topically once a day

• Based on clinical judgement, doses may be increased in increments of 3 mg/24 hours at intervals of no less than 2 weeks

Maintenance dose: 6 mg/24 hours to 12 mg/24 hours patch applied topically once a day
Maximum dose: 12 mg/24 hours

Comments:

• Full antidepressant effect may be delayed.
• Tyramine-rich food should be avoided beginning on the first day of therapy with a dose of 9 mg/24 hours or 12 mg/24 hours and continued to be avoided for 2 weeks after these doses are reduced to 6 mg/24 hours or less.

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

Transdermal patch:

• 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

Transdermal patch:

• Mild to moderate liver dysfunction (Child-Pugh 5 to 9): No adjustment recommended
• Severe liver dysfunction (Child-Pugh 10 to 15): Data not available

Precautions

US BOXED WARNING (transdermal patch):

• Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies.
• Closely monitor all patients treated with antidepressants for clinical worsening, and for emergence of suicidal thoughts and behaviors
• This drug is contraindicated in patients less than 12 years of age because of an increased risk of hypertensive crisis.

CONTRAINDICATIONS:
ORAL USE:

• Hypersensitivity to the active substance or any of the product ingredients
• Concomitant use with opioids; at least 14 days should elapse between discontinuation of this drug and initiating treatment with opioids
• Concomitant use of other drugs in the monoamine oxidase inhibitor (MAOI) class or other drugs that are potent inhibitors of monoamine oxidase including linezolid; at least 14 days should elapse between discontinuation of this drug and initiating treatment with any MAOI
• Concomitant use of St. John's wort or cyclobenzaprine
• Concomitant use of dextromethorphan

TRANSDERMAL USE:

• Patients younger than 12 years
• Patients with pheochromocytoma
• Concomitant use with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), clomipramine, imipramine, meperidine (pethidine), tramadol, methadone, pentazocine, propoxyphene (dextropropoxyphene), dextromethorphan, and carbamazepine:
• Use of any of these contraindicated drugs within at least 2 weeks of ceasing therapy with selegiline
• Use of selegiline within 4 to 5 half-lives (approximately 1 week) of ceasing therapy with the contraindicated drugs above
• Use of selegiline within at least 5 weeks of ceasing fluoxetine

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Oral capsule/tablet:

• Take orally twice a day with food, at breakfast and lunch

Orally disintegrating tablets:

• Take orally once a day before breakfast and without liquid; avoid ingesting food or liquids for 5 minutes before and after taking a dose
• Patients should be instructed to peel the backing of the blister pack with dry hands to remove tablets and then place immediately on top of tongue; patients should not attempt to push the tablet through the foil backing

Transdermal patch:

• Patients should be instructed to 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

Storage requirements:

• Orally disintegrating tablet: Once opened, unused tablets must be disposed of after 3 months

General:

• Treatment should be periodically reevaluated.
• This drug interacts with other drugs; prescribers should be aware for the potential for interactions and observe washout periods required between stopping this drug 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.

Monitoring:

• Cardiovascular: Blood pressure, tyramine-induced hypertensive crisis
• Nervous system: Exacerbation of dyskinesia
• Oncologic: Melanoma in patients with PD
• Psychiatric: Prior to initiation of transdermal patch, screen for bipolar disorder (screen for a personal or family history of bipolar disorder, mania, or hypomania)
• 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

Patient advice:

• Patients prescribed the transdermal patch should be instructed to read the US FDA-approved patient labeling (Instructions for Use and Medication Guide ).
• 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 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).