Selegiline (oral)

Selegiline (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

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Black Box Warning

TITLE See full prescribing information for complete Boxed Warning. Condition Name: (Content)

Overview

Selegiline (oral) is a MAOI that is FDA approved for the {{{indicationType}}} of major depressive disorder. There is a Black Box Warning for this drug as shown here. Common adverse reactions include decreased systolic arterial pressure, orthostatic hypotension, application site reaction, weight loss, greater than of equal to 5% in body weight, diarrhea, indigestion, headache, insomnia, xerostomia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Major depressive disorder

• Initial, 6 mg/24 hr
• (20 mg/20 cm) patch tropically every 24 hr
• Maintenance 6 mg/24 hr patch tropically every 24 hr
• Increase at increments of 3 mg/24 hr at 2 week intervals up to 12 mg/24 hr

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Selegiline in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Selegiline in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety is not established in children

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Selegiline in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Selegiline in pediatric patients.

Contraindications

• Contraindicated in patients with a known hypersensitivity to this drug.

• Contraindicated for use with meperidine (DEMEROL & other trade names). This contraindication is often extended to other opioids. (See Drug Interactions.)

Warnings

TITLE See full prescribing information for complete Boxed Warning. Condition Name: (Content)

Selegiline should not be used at daily doses exceeding those recommended (10 mg/day) because of the risks associated with non-selective inhibition of MAO.

The selectivity of selegiline for MAO-B may not be absolute even at the recommended daily dose of 10 mg a day. Rare cases of hypertensive reactions associated with ingestion of tyramine-containing foods have been reported in patients taking the recommended daily dose of selegiline. The selectivity is further diminished with increasing daily doses. The precise dose at which selegiline becomes a non-selective inhibitor of all MAO is unknown, but may be in the range of 30 to 40 mg a day. Severe CNS toxicity associated with hyperpyrexia and death have been reported with the combination of tricyclic antidepressants and non-selective MAOIs (Nardil, Parnate). A similar reaction has been reported for a patient on amitriptyline and selegiline. Another patient receiving protriptyline and selegiline developed tremors, agitation, and restlessness followed by unresponsiveness and death two weeks after selegiline was added. Related adverse events including hypertension, syncope, asystole, diaphoresis, seizures, changes in behavioral and mental status, and muscular rigidity have also been reported in some patients receiving selegiline and various tricyclic antidepressants. Serious, sometimes fatal, reactions with signs and symptoms that may include hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuations of the vital signs, and mental status changes that include extreme agitation progressing to delirium and coma have been reported with patients receiving a combination of fluoxetine hydrochloride and non-selective MAOIs. Similar signs have been reported in some patients on the combination of selegiline (10 mg a day) and selective serotonin re-uptake inhibitors including fluoxetine, sertraline and paroxetine. Since the mechanisms of these reactions are not fully understood, it seems prudent, in general, to avoid this combination of selegiline and tricyclic antidepressants as well as selegiline and selective serotonin re-uptake inhibitors. At least 14 days should elapse between discontinuation of selegiline and initiation of treatment with a tricyclic antidepressant or selective serotonin re-uptake inhibitors. Because of the long half-lives of fluoxetine and its active metabolite, at least five weeks (perhaps longer, especially if fluoxetine has been prescribed chronically and/or at higher doses) should elapse between discontinuation of fluoxetine and initiation of treatment with selegiline.

General precautions

Some patients given selegiline may experience an exacerbation of levodopa associated side effects, presumably due to the increased amounts of dopamine reaction with super sensitive, post-synaptic receptors. These effects may often be mitigated by reducing the dose of levodopa/carbidopa by approximately 10 to 30%. The decision to prescribe selegiline should take into consideration that the MAO system of enzymes is complex and incompletely understood and there is only a limited amount of carefully documented clinical experience with selegiline. Consequently, the full spectrum of possible responses to selegiline may not have been observed in pre-marketing evaluation of the drug. It is advisable, therefore, to observe patients closely for atypical responses.

Melanoma

Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, is unclear. For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using selegiline for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).

Adverse Reactions

Clinical Trials Experience

Central Nervous System

Motor/Coordination/Extrapyramidal-increased tremor, chorea, loss of balance, restlessness, blepharospasm, increased bradykinesia, facial grimace, falling down, heavy leg, muscle twitch*, myoclonic jerks*, stiff neck, tardive dyskinesia, dystonic symptoms, dyskinesia, involuntary movements, freezing, festination, increased apraxia, muscle cramps.

Mental Status/Behavioral/Psychiatric-hallucinations, dizziness, confusion, anxiety, depression, drowsiness, behavior/mood change, dreams/nightmares, tiredness, delusions, disorientation, lightheadedness, impaired memory*, increased energy*, transient high*, hollow feeling, lethargy/malaise, apathy, overstimulation, vertigo, personality change, sleep disturbance, restlessness, weakness, transient irritability.

Pain/Altered Sensation-headache, back pain, leg pain, tinnitus, migraine, supraorbital pain, throat burning, generalized ache, chills, numbness of toes/fingers, taste disturbance.

Autonomic Nervous System

dry mouth, blurred vision, sexual dysfunction.

Cardiovascular

orthostatic hypotension, hypertension, arrhythmia, palpitations, new or increased angina pectoris, hypotension, tachycardia, peripheral edema, sinus bradycardia, syncope.

Gastrointestinal

nausea/vomiting, constipation, weight loss, anorexia, poor appetite, dysphagia, diarrhea, heartburn, rectal bleeding, bruxism*, gastrointestinal bleeding (exacerbation of preexisting ulcer disease).

Genitourinary/Gynecologic/Endocrine

slow urination, transient anorgasmia*, nocturia, prostatic hypertrophy, urinary hesitancy, urinary retention, decreased penile sensation*, urinary frequency.

Skin and Appendages

increased sweating, diaphoresis, facial hair, hair loss, hematoma, rash, photosensitivity.

Miscellaneous

asthma, diplopia, shortness of breath, speech affected.

Postmarketing Experience

There is limited information regarding Selegiline (oral) Postmarketing Experience in the drug label.

Drug Interactions

• Meperidine and MAOIs.

The occurrence of stupor, muscular rigidity, severe agitation, and elevated temperature has been reported in some patients receiving the combination of selegiline and meperidine.

Symptoms usually resolve over days when the combination is discontinued. This is typical of the interaction of meperidine and MAOIs.

Other serious reactions (including severe agitation, hallucinations, and death) have been reported in patients receiving this combination (see CONTRAINDICATIONS).

• Tricyclic antidepressants & selective serotonin re-uptake inhibitors

Severe toxicity has also been reported in patients receiving the combination of tricyclic antidepressants and selegiline and selective serotonin re-uptake inhibitors and selegiline. (See WARNINGS for details.)

• Sympathomimetic medication

One case of hypertensive crisis has been reported in a patient taking the recommended doses of selegiline and a sympathomimetic medication (ephedrine).

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Selegiline (oral) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Selegiline (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Selegiline (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Selegiline (oral) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Selegiline (oral) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Selegiline (oral) in geriatric settings.

Gender

There is no FDA guidance on the use of Selegiline (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Selegiline (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Selegiline (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Selegiline (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Selegiline (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Selegiline (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Selegiline (oral) Administration in the drug label.

Monitoring

There is limited information regarding Selegiline (oral) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Selegiline (oral) and IV administrations.

Overdosage

There is limited information regarding Selegiline (oral) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mechanism of Action

There is limited information regarding Selegiline (oral) Mechanism of Action in the drug label.

Structure

There is limited information regarding Selegiline (oral) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Selegiline (oral) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Selegiline (oral) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Selegiline (oral) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Selegiline (oral) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Selegiline (oral) How Supplied in the drug label.

Storage

There is limited information regarding Selegiline (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Selegiline (oral) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Selegiline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Selegiline (oral) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Selegiline (oral) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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