Tofranil

Description

Imipramine hydrochloride is a member of the dibenzazepine group of compounds. It is designated 5-[3-(Dimethylamino) propyl]-10, 11-dihydro-5H-dibenz [b,f]-azepine Monohydrochloride. Imipraine hydrochloride is a white to off-white, odorless, or practically odorless crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. It melts at 170-174C. Each tablet, for oral administration, contains 10 mg, 25 mg or 50 mg imipramine hydrochloride. Inactive ingredients for 10 mg include: corn starch, D&C Yellow #10 Aluminum Lake, FD&C Red #30 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrous), magnesium strearate, polyethylene glycol, povidone and titanium dioxide; for 25 mg: corn starch, D&C Yellow #10 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, hydroxyporpyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrous), magnesium stearate, polyethylene glycol, povidone and titanium dioxide; for 50 mg: corn starch, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Red #40 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrous), magnesium stearate, polyethylene glycol, povidone and titanium dioxide.

Warnings

Children: A dose of 2.5 mg/kg/day of imipramine hydrochloride should not be exceeded in childhood. ECG cahnges 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 defets, congestive heart failure, arrhythmias, 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 retnetion, 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; 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, downward dosage adjustment of imipramine may be required when given concomitantly with methylphenidate hydrochloride. Imipramine 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 or potentially hazardous tasks, such as operating an automobile or machinery, the patient should be cautioned accordingly.

Manufactured By Geneva Pharmaceuticals, Inc. Broomfield, CO 80020