Nortriptyline

Nortriptyline
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. 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 nortriptyline 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. Nortriptyline hydrochloride is not approved for use in pediatric patients.

Overview

Nortriptyline is a Tricyclic antidepressant that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.

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 Nortriptyline 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 Nortriptyline 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. 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 nortriptyline 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. Nortriptyline hydrochloride is not approved for use in pediatric patients.

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

Nortriptyline
Systematic (IUPAC) name
3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-1-propanamine
Identifiers
CAS number	72-69-5 894-71-3 (hydrochloride)
ATC code	N06AA10
PubChem	4543
DrugBank	DB00540
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	263.38 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	High
Metabolism	Hepatic
Half life	16 and 90 hours
Excretion	Renal
Therapeutic considerations
Pregnancy cat.	C(AU)
Legal status	Prescription Only (S4)(AU) [[Prescription drug|Template:Unicode-only]](US)
Routes	Oral

Mechanism of Action

The mechanism of mood elevation by tricyclic antidepressants is at present unknown. Nortriptyline hydrochloride is not a monoamine oxidase inhibitor. It inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine, and acetylcholine. It increases the pressor effect of norepinephrine but blocks the pressor response of phenethylamine. Studies suggest that nortriptyline hydrochloride interferes with the transport, release, and storage of catecholamines. Operant conditioning techniques in rats and pigeons suggest that nortriptyline hydrochloride has a combination of stimulant and depressant properties.

Structure

Nortriptyline Hydrochloride, USP is 1-Propanamine, 3-(10, 11-dihydro-5H-dibenzo [a,d] cyclohepten-5-ylidene)-N-methyl, hydrochloride. Its molecular weight is 299.8, and its molecular formula is C19H21N•HCl. The structural formula is as follows:

This image is provided by the National Library of Medicine.

Chemical Structure Each capsule, for oral administration, contains nortriptyline hydrochloride equivalent to 10 mg, 25 mg, 50 mg or 75 mg of nortriptyline. In addition, each capsule contains the following inactive ingredients: black iron oxide, colloidal silicon dioxide, D&C Yellow #10 (aluminum lake), D&C Yellow #10, FD&C Blue #1 (aluminum lake), FD&C Blue #2 (aluminum lake), FD&C Green #3 (10, 50 and 75 mg only), FD&C Red #40 (aluminum lake), gelatin, I.M.S. 74 OP, magnesium stearate, pregelatinized corn starch, shellac, sodium lauryl sulfate and titanium dioxide.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Nortriptyline 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 Nortriptyline Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Nortriptyline 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.