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 MAO 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

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

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

Selegiline (oral)

Clinical data
Trade names	Eldepryl
AHFS/Drugs.com	Monograph
MedlinePlus	a697046
[[Regulation of therapeutic goods |Template:Engvar data]]	US FDA: Selegiline
Pregnancy category	US: C (Risk not ruled out)
Routes of administration	Oral, transdermal, buccal
ATC code	N04BD01 (WHO) Template:ATCvet
Legal status
Legal status	US: RX-only, POM (UK)
Pharmacokinetic data
Bioavailability	4.4% (oral, fasted), 20% (oral, after food), 18% (patch)
Protein binding	90%
Metabolism	liver
Elimination half-life	1.5 hours (oral, single dose), 9 hours (oral, chronic)
Excretion	urine
Identifiers
IUPAC name (R)-N-methyl-N-(1-phenylpropan-2-yl)prop-1-yn-3-amine
CAS Number	14611-51-9 Y 14611-52-0 (HCl)
PubChem CID	26757
DrugBank	DB01037 Y
ChemSpider	24930 Y
UNII	2K1V7GP655
KEGG	D03731 Y
ChEBI	CHEBI:9086 Y
ChEMBL	ChEMBL972 Y
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C13H17N
Molar mass	187.281 g/mol
3D model (JSmol)	Interactive image
SMILES C#CCN([C@@H](Cc1ccccc1)C)C
InChI InChI=1S/C13H17N/c1-4-10-14(3)12(2)11-13-8-6-5-7-9-13/h1,5-9,12H,10-11H2,2-3H3/t12-/m1/s1 Y Key:MEZLKOACVSPNER-GFCCVEGCSA-N Y
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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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