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)

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

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

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

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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