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.

The following recommended dosages for Tofranil-PM® (imipramine pamoate capsules) should be modified as necessary by the clinical response and any evidence of intolerance.

Initial Adult Dosage

Outpatients - Therapy should be initiated at 75 mg/day. Dosage may be increased to 150 mg/day which is the dose level at which optimum response is usually obtained. If necessary, dosage may be increased to 200 mg/day.

Dosage higher than 75 mg/day may also be administered on a once-a-day basis after the optimum dosage and tolerance have been determined. The daily dosage may be given at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients.

Hospitalized Patients - Therapy should be initiated at 100 to 150 mg/day and may be increased to 200 mg/day. If there is no response after two weeks, dosage should be increased to 250 to 300 mg/day.

Dosage higher than 150 mg/day may also be administered on a once-a-day basis after the optimum dosage and tolerance have been determined. The daily dosage may be given at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients.

Adult Maintenance Dosage - Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission after which the dosage should gradually be decreased.

The usual maintenance dosage is 75 to 150 mg/day. The total daily dosage can be administered on a once-a-day basis, preferably at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

In cases of relapse due to premature withdrawal of the drug, the effective dosage of imipramine should be reinstituted.

Adolescent and Geriatric Patients - Therapy in these age groups should be initiated with Tofranil®, brand of imipramine hydrochloride, tablets at a total daily dosage of 25 to 50 mg, since Tofranil-PM® capsules are not available in these strengths. Dosage may be increased according to response and tolerance, but it is generally unnecessary to exceed 100 mg/day in these patients. Tofranil-PM® capsules may be used when total daily dosage is established at 75 mg or higher.

The total daily dosage can be administered on a once-a-day basis, preferably at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients.

Adolescent and geriatric patients can usually be maintained at lower dosage. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission after which the dosage should gradually be decreased.

The total daily maintenance dosage can be administered on a once-a-day basis, preferably at bedtime. In some patients it may be necessary to employ a divided-dose schedule.

In cases of relapse due to premature withdrawal of the drug, the effective dosage of imipramine should be reinstituted.

Tofranil-PM® (imipramine pamoate capsules)

Capsules 75 mg - coral body imprinted in black “M” and coral cap imprinted in black “Tofranil-PM 75 mg”.

Bottles of 30.......... NDC 0406-9923-03

Capsules 100 mg - maize body imprinted in black “M” and coral cap imprinted in black “Tofranil-PM 100 mg”.

Bottles of 30.......... NDC 0406-9924-03

Capsules 125 mg - ivory body imprinted in black “M” and coral cap imprinted in black “Tofranil-PM 125 mg”.

Bottles of 30........... NDC 0406-9925-03

Capsules 150 mg - coral body imprinted in black “M” and coral cap imprinted in black “Tofranil-PM 150 mg”.

Bottles of 30........... NDC 0406-9926-03

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.

Tofranil and Tofranil-PM are registered trademarks of Mallinckrodt Inc. M is a registered trademark of Mallinckrodt Inc. Manufactured by Patheon Inc. Whitby, Ontario, Canada L1N 5Z5. Manufactured for Mallinckrodt Inc. Hazelwood, MO 63042 U.S.A.
FDA Rev date: 7/13/2007

Bookmark this page: