Imipramine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Black Box Warning
Suicidality and Antidepressant DrugsSee 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 imipramine 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. Imipramine hydrochloride is not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use).
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Overview
Imipramine is a Tricyclic antidepressant that is FDA approved for the {{{indicationType}}} of depression, nocturnal enuresis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include weight gain, bloating symptom, constipation, xerostomia, asthenia, dizziness, headache, somnolence, blurred vision,urinary retention,fatigue.
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 Imipramine 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 Imipramine in pediatric patients.
Contraindications
- Condition 1
- Condition 2
- Condition 3
- Condition 4
- Condition 5
Warnings
Suicidality and Antidepressant DrugsSee 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 imipramine 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. Imipramine hydrochloride is not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use).
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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 Imipramine in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Imipramine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Imipramine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Imipramine in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Imipramine in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Imipramine in geriatric settings.
Gender
There is no FDA guidance on the use of Imipramine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Imipramine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Imipramine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Imipramine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Imipramine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Imipramine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Imipramine Administration in the drug label.
Monitoring
There is limited information regarding Imipramine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Imipramine and IV administrations.
Overdosage
There is limited information regarding Imipramine 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 Imipramine Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Imipramine Mechanism of Action in the drug label.
Structure
There is limited information regarding Imipramine Structure in the drug label.
Pharmacodynamics
There is limited information regarding Imipramine Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Imipramine Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Imipramine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Imipramine Clinical Studies in the drug label.
How Supplied
There is limited information regarding Imipramine How Supplied in the drug label.
Storage
There is limited information regarding Imipramine 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 Imipramine Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Imipramine 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 Imipramine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Imipramine 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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