ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount.In the literature, there were four well-controlled, randomized, double-blind, parallel group comparison clinical studies done with Tofranil in the elderly population. Read the information carefully and ask your doctor or pharmacist if you have any questions. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. 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 Tofranil 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.An ECG recording should be taken prior to the initiation of larger-than-usual doses of Tofranil and at appropriate intervals thereafter until steady state is achieved. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. The complete text of the Medication Guide is reprinted at the end of this document.Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking imipramine hydrochloride.Patients should be advised that taking Tofranil can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. There were no additional adverse experiences identified in the elderly.Clinical studies of Tofranil in the original application did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Children who wet the bed early in the evening may be given one dose in the mid-afternoon and another dose at bedtime. However, it does not act primarily by stimulation of the central nervous system. There is not enough information to explain how imipramine prevents bedwetting.In childhood bedwetting, imipramine is thought to work one of several ways:Imipramine also induces sedation through histamine-1 receptor blockage; hypotension through beta-adrenergic blockage; and diverse parasympatholytic effects. An acute overdose of any amount in infants or young children, especially, must be considered serious and potentially fatal.These may vary in severity depending upon factors such as the amount of drug absorbed, the age of the patient, and the interval between drug ingestion and the start of treatment. Imipramine hydrochloride may potentiate the effects of CNS depressant drugs.Patients should be warned that imipramine hydrochloride may enhance the CNS depressant effects of alcohol (Animal reproduction studies have yielded inconclusive results (There have been no well-controlled studies conducted with pregnant women to determine the effect of Tofranil on the fetus. If the child starts wetting again, then a repeat course of treatment may be restarted.Imipramine is also used occasionally to treat eating disorders and panic disorders. 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 to 24) with major depressive disorder (MDD) and other psychiatric disorders. If needed, Tofranil may be resumed in lower dosage when these episodes are relieved.Administration of a tranquilizer may be useful in controlling such episodes.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 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.Imipramine hydrochloride should be used with caution in patients with significantly impaired renal or hepatic function.Patients who develop a fever and a sore throat during therapy with imipramine hydrochloride should have leukocyte and differential blood counts performed.

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