Tofranil (Imipramine Hydrochloride) - Indications and Dosage

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.

Childhood Enuresis - May be useful 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.

DOSAGE AND ADMINISTRATION

Depression

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.

Usual Adult Dose

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 to 300 mg/day.

Outpatients - Initially, 75 mg/day increased to 150 mg/day. Dosages over 200 mg/day are not recommended. Maintenance, 50 to 150 mg/day.

Adolescent and Geriatric Patients - Initially, 30 to 40 mg/day; it is generally not necessary to exceed 100 mg/day.

Childhood Enuresis

Initially, an oral dose of 25 mg/day should be tried in children aged 6 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 Tofranil as temporary adjunctive therapy for nocturnal enuresis in children less than 6 years of age has not been established.

HOW SUPPLIED

The three strengths of Tofranil^® (imipramine hydrochloride USP) are available as follows:

Tablets 10 mg – triangular, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with

      Bottles of 30 ……………… NDC 0406-9920-03

      Bottles of 100 ……………… NDC 0406-9920-01

Tablets 25 mg – round, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with

      Bottles of 30 ……………… NDC 0406-9921-03

      Bottles of 100 ……………… NDC 0406-9921-01

Tablets 50 mg – round, biconvex, coral-reddish brown, sugar-coated tablet, imprinted with

      Bottles of 30 ……………… NDC 0406-9922-03

      Bottles of 100 ……………… NDC 0406-9922-01

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight container (USP) with a child-resistant closure.