Imipramine

Imipramine
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: Chetan Lokhande, M.B.B.S [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 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

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)

Depression

• (hospitalized patients) 100 mg orally per day in divided doses; may increase up to a max of 300 mg/day
• (outpatients) 75 mg orally per day; may increase up to a max of 200 mg/day; usual maintenance dose, 50 to 150 mg/day

Nocturnal enuresis

• 25 mg orally at bedtime, may increase in 25 mg increments to max dose of 150mg at bedtime

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

Binging

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

Diabetic neuropathy

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

Panic disorder

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

Urinary incontinence

• 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)

Nocturnal enuresis

• (children 6 to 12 y) initial, 25 mg orally 1 h before bedtime, may increase in 25 mg increments to max dose of 50 mg/d or 2.5 mg/kg/d

• (children over 12 y) initial, 25 mg orally 1 h before bedtime, may increase in 25 mg increments to max dose of 75 mg/d or 2.5 mg/kg/d

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

• Concomitant use of monoamine oxidase inhibiting compounds
• Acute recovery period after a myocardial infarction
• Hypersensitivity

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 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

Clinical Worsening and Suicide Risk

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table. No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for imipramine hydrochloride should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Screening Patients for Bipolar Disorder

A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that imipramine hydrochloride is not approved for use in treating bipolar depression.

Children

A dose of 2.5 mg/kg/day of imipramine hydrochloride should not be exceeded in childhood. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount. Extreme caution should be used when this drug is given to:

patients with cardiovascular disease because of the possibility of conduction defects, arrhythmias, congestive heart failure, myocardial infarction, strokes, and tachycardia. These patients require cardiac surveillance at all dosage levels of the drug;

patients with increased intraocular pressure, history of urinary retention, or history of narrow-angle glaucoma because of the drug’s anticholinergic properties;

hyperthyroid patients or those on thyroid medication because of the possibility of cardiovascular toxicity;

patients with a history of seizure disorder because this drug has been shown to lower the seizure threshold;

patients receiving guanethidine, clonidine, or similar agents, since imipramine hydrochloride may block the pharmacologic effects of these drugs;

patients receiving methylphenidate hydrochloride. Since methylphenidate hydrochloride may inhibit the metabolism of imipramine, downward dosage adjustment of imipramine hydrochloride may be required when given concomitantly with methylphenidate hydrochloride. Imipramine may enhance the CNS depressant effects of alcohol. Therefore, it should be borne in mind that the dangers inherent in a suicide attempt or accidental overdosage with the drug may be increased for the patient who uses excessive amounts of alcohol. Since imipramine hydrochloride may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as operating an automobile or machinery, the patient should be cautioned accordingly.

Adverse Reactions

Clinical Trials Experience

Central Nervous System

Numbness, tingling, paresthesias of extremities, incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus.

Cardiovascular

Orthostatic hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, ECG changes, precipitation of congestive heart failure, stroke.h4

Gastrointestinal

Nausea and vomiting, anorexia, epigastric distress, diarrhea; peculiar taste, stomatitis, abdominal cramps, black tongue.

Hypersensitive Reactions

Skin rash, petechiae, urticaria, itching, photosensitization, edema (general or of face and tongue); drug fever, cross-sensitivity with desipramine.

Miscellaneous

Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness and fatigue; headache; parotid swelling; alopecia; proneness to falling.

Postmarketing Experience

There is limited information regarding Imipramine Postmarketing Experience in the drug label.

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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