Amitriptyline
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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Suicidality and Antidepressant Drugs
See full prescribing information for complete Boxed Warning.
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 amitriptyline hydrochloride tablets 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. Amitriptyline hydrochloride is not approved for use in pediatric patients.
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Overview
Amitriptyline is a Tricyclic antidepressant that is FDA approved for the {{{indicationType}}} of depression. There is a Black Box Warning for this drug as shown here. Common adverse reactions include M.
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: American Association
- Class of Recommendation: Class 1(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
- Hypersensitivity to tricyclic antidepressants or to any of its recipients
- History of myocardial infarction
- History of arrhythmias, and heart block to any degree
- Congestive heart failure
- Coronary artery insufficiency
- Mania
- Severe liver disease
- Children under 7 years
- Breast feeding
- Patients who are taking monoamine oxidase inhibitors (MAOIs) or have taken them within the last 14 days.[1]
Warnings
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Suicidality and Antidepressant Drugs
See full prescribing information for complete Boxed Warning.
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 amitriptyline hydrochloride tablets 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. Amitriptyline hydrochloride is not approved for use in pediatric patients.
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Condition 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
Mechanism of Action
There is limited information regarding Amitriptyline Mechanism of Action in the drug label.
Structure
Amitriptyline HCl, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol.
It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d] cycloheptene-Δ5, γ-propylamine hydrochloride. It has the following structural formula: amitriptyline HCl chemical structure
Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn) and titanium dioxide. The 10 mg also includes D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; 25 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake; 50 mg – FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake; 75 mg – D&C Red #7 Calcium Lake and FD&C Blue #2 Aluminum Lake; 100 mg – D&C Red #30 Aluminum Lake and D&C Yellow #10 Aluminum Lake; 150 mg – D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake.
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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