Imipramine Full Prescribing Information
Brand Name: Tofranil, Janimine
Generic Name: Imipramine
Tofranil (Imipramine, Janimine) is a tricyclic antidepressant used to treat depression, esp. endogenous depression. Uses, dosage, side effects of Tofranil.
Outside U.S., Brand Names also known as: Antidep; Apo-Imipramine; Chrytemin; Daypress; Depsol; Depsonil; Ethipramine; Fronil; Imidol; Imimine; Imine; Imipramin; Imipramine HCl; Imiprex; Imiprin; Impril; Medipramine; Melipramine; Mipralin; Novopramine; Primonil; Pryleugan; Sermonil; Sipramine; Surplix; Talpramin; Tofnil; Tofranil-PM; Venefon
Tofranil patient information (in plain English)
Imipramine (Tofranil, Janimine) is a tricyclic antidepressant used to treat depression. It may also be used to treat bedwetting (enuresis) in children (5 years & older).
The mechanism of action of imipramine HCl is not definitely known. However, it does not act primarily by stimulation of the central nervous system. The clinical effect is hypothesized as being due to potentiation of adrenergic synapses by blocking uptake of norepinephrine at nerve endings. The mode of action of the drug in controlling childhood enuresis is thought to be apart from its antidepressant effect.
Depression: Imipramine (Tofranil, Janimine) is used for 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: May be useful as temporary adjunctive therapy in reducing enuresis in children aged 5 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.
Imipramine (Janimine, Tofranil) is contraindicated in patients known to be hypersensitive to it.
Monoamine Oxidase Inhibitors: The concomitant use of monoamine oxidase inhibiting compounds (MAOIs) is contraindicated. Hyperpyretic crises or severe convulsive seizures may occur in patients receiving such combinations. The potentiation of adverse effects can be serious, or even fatal. When it is desired to substitute imipramine in patients receiving a monoamine oxidase inhibitor, as long an interval should elapse as the clinical situation will allow, with a minimum of 14 days. Initial dosage should be low and increases should be gradual and cautiously prescribed.
The drug is contraindicated during the acute recovery period after a myocardial infarction.
The possibility of cross-sensitivity to other tricyclic antidepressants/dibenzazepine compounds should be kept in mind.
Children: A dose of 2.5 mg/kg/day of imipramine HCl 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.
Imipramine should be used with caution in hyperthyroid patients or those on thyroid medication because of the possibility of cardiovascular toxicity.
Patients with a history of seizure disorder should be cautious because this drug has been shown to lower the seizure threshold.
Patients receiving guanethidine, clonidine, or similar agents, need to be watched since imipramine may block the pharmacologic effects of these drugs.
Imipramine may produce urinary retention and should be used with caution in patients with urinary pathology, particularly in the presence of prostatic hypertrophy.
Suicide/Overdose: Imipramine may enhance the CNS depressant effects of alcohol. Therefore, it should be kept in mind that the dangers inherent in a suicide attempt of accidental overdosage with the drug may be increased for the patient who uses excessive amounts of alcohol.
Sulfa Allergies: (For the Injectable form only) Contains sodium sulfite and sodium bisulfite, that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
An ECG recording should be taken prior to the initiation of larger-than-usual doses of imipramine and at appropriate intervals thereafter until steady state is achieved.
Elderly patients and patients with cardiac disease or a prior history of cardiac disease are at special risk of developing the cardiac abnormalities associated with the use of imipramine.
It should be kept in mind that the possibility of suicide in seriously depressed patients is inherent in the illness and may persist until significant remission occurs. Such patients should be carefully supervised during the early phase of treatment with imipramine, and may require hospitalization. Prescriptions should be written for the smallest amount feasible.
Hypomanic or manic episodes may occur, particularly in patients with cyclic disorders. Such reactions may necessitate discontinuation of the drug. If needed, imipramine may be resumed in lower dosage when these episodes are relieved.
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 imipramine 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.
Imipramine should be used with caution in patients with significantly impaired renal or hepatic function.
Patients taking imipramine 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 use.
Lengthy treatment with tricyclic antidepressants can lead to an increased incidence of dental caries.
Usage in Children:: The effectiveness of the drug in children for conditions other than nocturnal enuresis (bedwetting) has not been established. The safety and effectiveness of the drug as temporary adjunctive therapy for nocturnal enuresis in children less than 6 years of age has not been established. Consideration should be given to instituting a drug-free period following an adequate therapeutic trial with a favorable response.
A dose of 2.5 mg/kg/day should not be exceeded in childhood. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount.
Pregnancy and Withdrawl: There have been no well-controlled studies conducted with pregnant women to determine the effect of imipramine on the fetus. However, there have been clinical reports of congenital malformations associated with the use of the drug. Although a casual relationship between these effects and the drug could not be established, the possibility of fetal risk from the maternal ingestion of imipramine cannot be excluded. Therefore, imipramine should be used in women who are or might become pregnant only if the clinical condition clearly justifies potential risk to the fetus.
Limited data suggest that imipramine is likely to be excreted in human breast milk. 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.
Interference with Cognitive or Motor Performance: Since imipramine 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.
Patients should be warned that, while taking imipramine their responses to alcoholic beverages, other CNS depressants (e.g., barbiturates, benzodiazepines or general anesthetics) or anticholinergic agents (e.g., atropine, biperiden, levodopa) may be exaggerated. When tricyclic antidepressants are given in combinations with anticholinergics or neuroleptics with an anticholinergic action, hyperexcitation states or delirium may occur, as well as attacks of glaucoma. Tricyclic antidepressants should not be employed in combination with anti-arrhythmic agents of the quinidine type.
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes carbamazepine, cimetidine, dicumarol, clonidine, mibefradil, paroxetine, tramadol, other medicines for depression or emotional disorders, and medicines for seizures. Inform your doctor of any other medical conditions including heart conditions, allergies, pregnancy, or breast-feeding.
Caution should be exercised when imipramine is used with agents that lower blood pressure.
In occasional susceptible patients or in those receiving anticholinergic drugs (including antiparkinsonism agents) in addition, the atropine-like effects may become more pronounced (e.g., paralytic ileus). Close supervision and careful adjustment of dosage is required when imipramine is administered concomitantly with anticholinergic drugs.
Avoid the use of preparations, such as decongestants and local anesthetics, which contain any sympathomimetic amine (e.g., epinephrine, norepinephrine), since it has been reported that tricyclic antidepressants can potentiate the effects of catecholamines.
Imipramine should be discontinued prior to elective surgery for as long as clinically feasible, since little is known about the interaction between imipramine and general anesthetics.
If administered concomitantly with estrogens, the dose of imipramine should be reduced since steroid hormones inhibit the metabolism of imipramine.
Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when imipramine is administered.
Cardiovascular: Orthostatic hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, ECG changes, precipitation of congestive heart failure, stroke. king, feeling, and acting with excitement and activity you cannot control.
Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis.
Neurological: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus.
Anticholinergic: Dry mouth, and rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary track.
Allergic: Skin rash, petechiae, urticaria, itching, photosensitization, edema (general or of face and tongue); drug fever; cross-sensitivity with desipramine.
Hematologic: Bone marrow depression including agranulocytosis; eosinophilia; purpura; thrombocytopenia.
Gastrointestinal: Nausea and vomiting, anorexia, epigastric distress, diarrhea; peculiar taste, stomatitis, abdominal cramps, black tongue.
Endocrine: Gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; inappropriate antidiuretic hormone (ADH) secretion syndrome.
Other: 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.
Drug Abuse and Dependence
Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, malaise, and anxiety.
In enuretic children treated with imipramine the most common adverse reactions have been nervousness, sleep disorders, tiredness, and mild gastrointestinal disturbances. These usually disappear during continued drug administration or when dosage is decreased. Other reactions which have been reported include constipation, convulsions, anxiety, emotional instability, syncope, and collapse. All of the adverse effects reported with adult use should be considered.
Signs and Symptoms
Children have been reported to be more sensitive than adults to an acute overdosage of imipramine hydrochloride. An acute overdose of any amount in infants or young children, especially, must be considered serious and potentially fatal.
Symptoms of an overdose 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.
CNS abnormalities may include drowsiness, stupor, coma (loss of consciousness), ataxia, restlessness, agitation, hyperactive reflexes, muscle rigidity, athetoid and choreiform movements, and convulsions.
Cardiac abnormalities may include arrhythmia, tachycardia (fast or irregular heartbeat), ECG evidence of impaired conduction, and signs of congestive failure. Respiratory depression, cyanosis, hypotension, shock, vomiting, hyperpyrexia, mydriasis, and diaphoresis may also be present.
Other symptoms of overdose may include flushing, dry mouth, drowsiness, confusion, agitation, enlarged pupils, seizures.
If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.
Because CNS involvement, respiratory depression and cardiac arrhythmia can occur suddenly, hospitalization and close observation may be necessary, particularly with children, even when the amount ingested is thought to be small or the initial degree of intoxication appears slight or moderate.
All patients with ECG abnormalities should have continuous cardiac monitoring and be closely observed until well after cardiac status has returned to normal; relapses may occur after apparent recovery.
Maintain adequate airway, empty stomach contents, and treat symptomatically.
After you start using this medicine, several weeks may pass before you feel the full benefit. If your symptoms do not improve after taking this medicine for 4 weeks, inform your doctor.
- Follow the directions for using this medicine provided by your doctor.
- Store this medicine at room temperature, away from heat and light.
- Take this medicine everyday at evenly spaced intervals.
- If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you take 1 dose daily at bedtime, do not take missed dose the next morning.
Additional Information:Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.
Discontinuation: The effects of this medicine may last for 3 to 7 days after you stop taking it. Continue to follow the warnings during this time.
IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
Lower dosages 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. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance, medication may be required for a longer period of time, at the lowest dose that will maintain remission.
Hospitalized patients: Initially, 100 mg/day in divided doses gradually increased to 200 mg/day as required. If no response after two weeks, increase to 250-300 mg/day.
Outpatients: Initially 75 mg/day increased to 150 mg/day. Dosages over 200 mg/day are not recommended. Maintenance, 50-150 mg/day.
Adolescent and geriatric patients: Initially, 30-40 mg/day; it is generally not necessary to exceed 100 mg/day.
Initially, an oral dose of 25 mg/day should be tried in children aged 5 and older. Medication should be given one hour before bedtime. If a satisfactory response does not occur within one week, increase the dose to 50 mg nightly in children under 12 years; children over 12 may receive up to 75 mg nightly. A daily dose greater than 75 mg does not enhance efficacy and tends to increase side effects. Evidence suggests that in early night bedwetters, the drug is more effective given earlier and in divided amounts, i.e., 25 mg in midafternoon, repeated at bedtime. Consideration should be given to instituting a drug-free period following an adequate therapeutic trial with a favorable response. Dosage should be tapered off gradually rather than abruptly discontinued; this may reduce the tendency to relapse. Children who relapse when the drug is discontinued do not always respond to a subsequent course of treatment.
A dose of 2.5 mg/kg/day should not be exceeded. ECG changes of unknown significance have been reported in pediatric patients with doses twice this amount.
The safety and effectiveness of imipramine as temporary adjunctive therapy for nocturnal enuresis in children less than 5 years of age has not been established.
Tablets: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg.
Tofranil Patient Information Sheet (in plain English)
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.
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