Selegiline (oral)
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
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See full prescribing information for complete Boxed Warning.
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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
There is limited information regarding Selegiline (oral) Contraindications in the drug label.
Warnings
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See full prescribing information for complete Boxed Warning.
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There is limited information regarding Selegiline (oral) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Selegiline (oral) Clinical Trials Experience in the drug label.
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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