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Basic Drug Info
Drug Name:Tofranil
Manufacturer:Geigy Pharmaceuticals
Other Info:

The recommended treatment for overdosage with tricyclic antidepressants may change periodically.

Therefore, it is recommended that the physician contact a poison control center for current information on treatment.

Because CNS involvement, respiratory depression and cardiac arrhythmia can occur suddenly, hospitalization and close observation may be necessary, 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.In the alert patient, empty the stomach promptly by lavage.

In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis).

Instillation of activated charcoal slurry may help reduce absorption of imipramine.

Minimize external stimulation to reduce the tendency to convulsions.

If anticonvulsants are necessary, diazepam and phenytoin may be useful.Maintain adequate respiratory exchange.

Do not use respiratory stimulants.Shock should be treated with supportive measures, such as appropriate position, intravenous fluids, and, if necessary, a vasopressor agent.

The use of corticosteroids in shock is controversial and may be contraindicated in cases of overdosage with tricyclic antidepressants.

Digitalis may increase conduction abnormalities and further irritate an already sensitized myocardium.

If congestive heart failure necessitates rapid digitalization, particular care must be exercised.Hyperpyrexia should be controlled by whatever external means are available, including ice packs and cooling sponge baths, if necessary.Hemodialysis, peritoneal dialysis, exchange transfusions and forced diuresis have been generally reported as ineffective because of the rapid fixation of imipramine in tissues.

Blood and urine levels of imipramine may not correlate with the degree of intoxication, and are unreliable indicators in the clinical management of the patient.The slow intravenous administration of physostigmine salicylate has been used as a last resort to reverse severe CNS anticholinergic manifestations of overdosage with tricyclic anti- depressants; however, it should not be used routinely, since it may induce seizures and cholinergic crises.



Clinical Trials:


Indications and Usage

Depression: 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.
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Contraindications

The concomitant use of monoamine oxidase inhibiting compounds 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 Tofranil 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.

Patients with a known hypersensitivity to this compound should not be given the drug.

The possibility of cross-sensitivity to other dibenzazepine compounds should be kept in mind.
Convulsive Seizures --

Adverse effects -- Problems that occur when treatment affects tissues or organs other than the ones meant to be affected by the treatment. Common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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 anti-cholinergic 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 hydrochloride, downward dosage adjustment of imipramine hydrochloride may be required when given concomitantly with methylphenidate hydrochloride.Tofranil 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.

(See PRECAUTIONS.)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.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.

The overall prevalence of sulfite sensitivity in the general population is unknown and probably 1ow.

Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.