Indicated for:

Depression:

• The relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.

Childhood Enuresis:

• Use as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.

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.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.

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.

A dose of 2.5 mg/kg/day of Imipramine Hydrochloride Tablets USP should not be exceeded in childhood.

Imipramine Hydrochloride is not approved for use in treating bipolar depression.

The concomitant use of monoamine oxidase inhibiting compounds is contraindicated. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations.

Tofranil is contraindicated during the acute recovery period after a myocardial infarction. 

Sufficient time must elapse before initiating Imipramine Hydrochloride treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Lower doses are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision.

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.

Extreme caution should be used when this drug is given to 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

Imipramine Hydrochloride should be used with caution in patients with significantly impaired renal or hepatic function.

Patients taking Imipramine Hydrochloride should avoid excessive exposure to sunlight since there have been reports of photosensitization.

Both elevation and lowering of blood sugar levels have been reported with Imipramine Hydrochloride use.

An activation of the psychosis may occasionally be observed in schizophrenic patients and may require reduction of dosage and the addition of a phenothiazine.

Concurrent administration of Tofranil with electroshock therapy may increase the hazards; such treatment should be limited to those patients for whom it is essential, since there is limited clinical experience.

Patients should be warned that Imipramine Hydrochloride may enhance the CNS depressant effects of alcohol.

Extreme caution should be used when this drug is given to patients receiving guanethidine, clonidine, or similar agents, since Imipramine Hydrochloride may block the pharmacologic effects of these drugs.

Downward dosage adjustment of Imipramine Hydrochloride may be required when given concomitantly with methylphenidate hydrochloride.

Avoid the use of preparations, such as decongestants and local anesthetics, that contain any sympathomimetic amine (e.g., epinephrine, norepinephrine), since it has been reported that tricyclic antidepressants can potentiate the effects of catecholamines.

Caution should be exercised when Imipramine Hydrochloride is used with agents that lower blood pressure.

Imipramine Hydrochloride may potentiate the effects of CNS depressant drugs. 

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug.

The plasma concentration of imipramine may increase when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decrease by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), and adjustment of the dosage of imipramine may therefore be necessary.

There have been clinical reports of congenital malformations associated with the use of the drug. Although a causal relationship between these effects and the drug could not be established, the possibility of fetal risk from the maternal ingestion of Imipramine Hydrochloride cannot be excluded.

As a general rule, a woman taking a drug should not nurse since the possibility exists that the drug may be excreted in breast milk and be harmful to the child.

GoToSource

• Use in patients for depression under the age of 18. GoToSource

• Use in patients for enuresis under the age of 6. GoToSource

• Adult dosage for out-patients greater than 200 mg per day. GoToSource

• Adult dosage for hospitalized patients greater than 300 mg per day. GoToSource

• Obsessive-compulsive disorder. GoToSource

• Cocaine and methamphetamine dependence. GoToSource

• Attention-deficit/hyperactivity disorder. GoToSource

• Panic disorder. GoToSource

• Chronic neuropathic pain. GoToSource

• Migraine prophylaxis. GoToSource

• Post-traumatic stress disorder. GoToSource 

• Alcoholism. GoToSource

• Irritable bowel syndrome. GoToSource

• Infantile autism. GoToSource

• Female stress incontinence. GoToSource 

• Stress urinary incontinence in prostate cancer. GoToSource

• Cyclic vomiting syndrome. GoToSource

• Non-cardiac chest pain. GoToSource 

• Smoking cessation. GoToSource 

• Narcolepsy. GoToSource 

• Bipolar-II depression. GoToSource 

• Generalized anxiety disorder. GoToSource 

• Tinnitus. GoToSource 

• Fibromyalgia. GoToSource

• Alopecia areata. GoToSource 

• Bulimia. GoToSource

Liver injury. GoToSource

Primary insomnia. GoToSource 

Hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar). GoToSource 

Galactorrhea (milky fluid secretion from the breast). GoToSource 

Suicidality or suicidal behavior. GoToSource 

QTc prolongation (heart rhythm disorder). GoToSource 

Drug-induced immune thrombocytopenia. GoToSource 

Hyperpigmentation. GoToSource 

Sexual dysfunction. GoToSource 

Dilated cardiomyopathy. GoToSource 

Weight gain. GoToSource 

Tremors. GoToSource 

Acrocyanosis (blueness of the hands and feet). GoToSource 

Cardiac arrhythmia and sudden death. GoToSource

Floppy iris syndrome. GoToSource 

Serotonin syndrome. GoToSource 

Acute colonic pseudo-obstruction (ogilvie’s syndrome). GoToSource

Seizures. GoToSource

Myoclonus (involuntary muscle jerk). GoToSource

Acute angle closure glaucoma. GoToSource

Ileus, constipation and urinary retention. GoToSource

Lawsuits filed for overdose.