A tricyclic antidepressant - It is used to treat depression
FDA Alerts
Suicidality
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Imipramine is not approved for use in pediatric patients except patients ≥6 years of age with enuresis. (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
Appropriately monitor and closely observe all patients who are started on imipramine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)
Results of several studies of TCAs in preadolescent and adolescent patients with major depression indicate lack of overall efficacy in this age group.
Enuresis
Temporary adjunctive therapy in the treatment of nocturnal enuresis (bed-wetting) in children ≥6 years of age.
Safety and efficacy of long-term use not established.
Panic Disorder
Management of panic disorder† with or without agoraphobia†.
Attention Deficit Hyperactivity Disorder
Second-line agent in attention deficit hyperactivity disorder† (ADHD) in patients unable to tolerate or unresponsive to stimulants.
Associated with a narrower margin of safety than some other therapeutic agents; use only if clearly indicated and with careful monitoring, including baseline and subsequent determinations of ECG and other parameters.
Eating Disorders
Has been used for management of eating disorders† (e.g., bulimia†, anorexia nervosa†) with equivocal results; avoid use in underweight individuals and in those exhibiting suicidal ideation.
Bipolar Disorder
Has been used for the short-term management of acute depressive episodes in bipolar disorder†.
TCAs associated with a greater risk of precipitating hypomania or manic episodes than other classes of antidepressants; should always be used in combination with a mood stabilizer (e.g., lithium).
Schizophrenia
Has been used for the management of acute depressive episodes (in combination with an antipsychotic) in patients with schizophrenia†.
Anxiety Disorders
Has been used for the management of anxiety† (in combination with an anxiolytic, a sedative, or an antipsychotic) in patients with depression.
Postherpetic Neuralgia
Among the drugs of choice for the symptomatic treatment of postherpetic neuralgia†.
Insomnia
Less effective for insomnia† and associated with more serious adverse reactions than conventional hypnotics.
Dosage and Administration
General
Major Depressive Disorder
Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of imipramine and vice versa. Also allow at least 5 weeks to elapse when switching from fluoxetine.
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
Sustained therapy may be required; administer lowest effective dosage and monitor periodically for need for continued therapy.
Avoid abrupt discontinuance of therapy in patients receiving high dosages for prolonged periods. To avoid withdrawal reactions, taper dosage gradually.
Enuresis
Exclude organic causes of enuresis prior to initiation of therapy.
If daytime urgency and frequency occur, perform appropriate examinations (e.g., voiding cystourethrography, cystoscopy).
Tolerance (tachyphylaxis) to therapeutic effects possible with continuous administration of imipramine; consider instituting a drug-free period following an adequate therapeutic trial with favorable response.
Long-term, chronic use not recommended; gradually discontinue therapy following a period of satisfactory response. To minimize risk of relapse, avoid abrupt discontinuance of therapy.
Children who relapse when the drug is discontinued may not respond to subsequent treatment with imipramine.
Administration
Oral Administration
Administer orally in up to 4 divided doses (without regard to meals) or as a single daily dose at bedtime to avoid daytime sedation.
Reserve use of Tofranil-PM® capsules until recommended total daily imipramine hydrochloride dosage ≥75 mg. Tofranil-PM® usually administered once daily, but divided doses may be necessary in some patients. Tofranil-PM® should not be used in children of any age. (See Pediatric Warnings under Cautions.)
Dosage
Available as imipramine hydrochloride or imipramine pamoate; dosage is expressed in terms of imipramine hydrochloride.
Individualize dosage carefully according to individual requirements and response.
Pediatric Patients
Enuresis
Oral
Children ≥6 years of age: Initially, 25 mg daily, administered 1 hour prior to bedtime. If satisfactory response not obtained within 1 week, dosage may be increased to 50 mg nightly for children <12 years of age or 75 mg nightly for children ≥12 years of age. Higher dosages provide no additional therapeutic benefit but may increase risk of adverse effects. Maximum 2.5 mg/kg daily.
For children who are early-night bed-wetters, better results may be obtained by administering 25 mg in midafternoon and again at bedtime.
Adults
Major Depressive Disorder
Outpatients
Oral
Initially, 75 mg daily. May increase dosage to 150 mg daily and then if necessary to 200 mg daily.
Maintenance dosages: 50–150 mg daily.
Hospitalized Patients
Oral
Initially, 100–150 mg daily (administered in divided doses). May increase dosages to 200 mg daily and then if there is no response after 2 weeks to 250–300 mg daily.
Prescribing Limits
Pediatric Patients
Enuresis
Oral
Maximum 2.5 mg/kg daily.
Adults
Major Depressive Disorder
Outpatients
Oral
Maximum 200 mg daily.
Hospitalized Patients
Oral
Maximum 300 mg daily.
Special Populations
Geriatric Patients
Initially, 25–50 mg daily as imipramine hydrochloride (e.g., Tofranil®). Increase dosage based on response and tolerance up to a maximum of 100 mg daily.
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