Protriptyline

Protriptyline
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

Suicidality and Antidepressant Drugs See full prescribing information for complete Boxed Warning. Condition Name: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of protriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Protriptyline hydrochloride is not approved for use in pediatric patients. (See Warning: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use.)

Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1

• Dosing Information

(Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

• Developed by: (Organization)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

• Dosing Information

(Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1

• Developed by: (Organization)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

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

Contraindications

• Condition 1
• Condition 2
• Condition 3
• Condition 4
• Condition 5

Warnings

Suicidality and Antidepressant Drugs See full prescribing information for complete Boxed Warning. Condition Name: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of protriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Protriptyline hydrochloride is not approved for use in pediatric patients. (See Warning: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use.)

Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Postmarketing Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Drug Interactions

• (Drug 1)

• (Description)

• (Drug 2)

• (Description)

• (Drug 3)

• (Description)

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Protriptyline during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Protriptyline in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Protriptyline in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Protriptyline in geriatric settings.

Gender

There is no FDA guidance on the use of Protriptyline with respect to specific gender populations.

Race

There is no FDA guidance on the use of Protriptyline with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Protriptyline in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Protriptyline in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Protriptyline in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Protriptyline in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Protriptyline Administration in the drug label.

Monitoring

There is limited information regarding Protriptyline Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Protriptyline and IV administrations.

Overdosage

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

Pharmacology

There is limited information regarding Protriptyline Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Protriptyline Mechanism of Action in the drug label.

Structure

There is limited information regarding Protriptyline Structure in the drug label.

Pharmacodynamics

There is limited information regarding Protriptyline Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Protriptyline Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Protriptyline Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Protriptyline Clinical Studies in the drug label.

How Supplied

There is limited information regarding Protriptyline How Supplied in the drug label.

Storage

There is limited information regarding Protriptyline Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

For patient information, please click here.

Precautions with Alcohol

Alcohol-Protriptyline 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 Protriptyline Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Protriptyline 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.