Nortriptyline (Nortriptyline Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

DOSAGE AND ADMINISTRATION

Nortriptyline hydrochloride is not recommended for children.

Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it 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.

If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.

Usual Adult Dose

25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.

Elderly and Adolescent Patients

30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day.

HOW SUPPLIED

Nortriptyline hydrochloride capsules USP, equivalent to 10 mg, 25 mg, 50 mg or 75 mg base, are available as follows:

Nortriptyline hydrochloride capsules USP, 10 mg: #3 capsules with a white body and an orange cap, imprinted "10 mg" on the cap and "93"-"810" on the body, in bottles of 100 and 500.

Nortriptyline hydrochloride capsules USP, 25 mg: #4 capsules with a white body and an orange cap, imprinted "25 mg" on the cap and "93"-"811" on the body, in bottles of 100 and 500.

Nortriptyline hydrochloride capsules USP, 50 mg: #1 capsules with a white body and a white cap, imprinted "50 mg" on the cap and "93"-"812" on the body, in bottles of 100 and 500.

Nortriptyline hydrochloride capsules USP, 75 mg: #1 capsules with an orange body and an orange cap, imprinted "75 mg" on the cap and "93"-"813" on the body, in bottles of 100 and 500.

Store at 20^o to 25^oC (68^o to 77^oF) [See USP Controlled Room Temperature].

Dispense contents in a tight container as defined in the USP, with a child‑resistant closure (as required).