Amitriptyline

Amitriptyline
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

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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 Amitriptyline 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 Amitriptyline in pediatric patients.

Contraindications

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

Warnings

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

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

There is limited information regarding Amitriptyline 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 Amitriptyline Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Amitriptyline 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 Amitriptyline Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Amitriptyline 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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