Pamelor (Nortriptyline Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Pamelor^® (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

DOSAGE AND ADMINISTRATION

Pamelor^® (nortriptyline HCl) is not recommended for children.

Pamelor^® (nortriptyline HCl) is administered orally in the form of capsules or liquid. 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

Pamelor ^® (nortriptyline HCl) Capsules USP

Pamelor^® (nortriptyline HCl) Capsules USP, equivalent to 10 mg, 25 mg, 50 mg, and 75 mg base, are available as follows:

10 mg: Light orange opaque cap printed “

Bottles of 30..................NDC 0406-9910-03

25 mg: Light orange opaque cap printed “

Bottles of 30..................NDC 0406-9911-03

50 mg: White opaque cap printed “

Bottles of 30..................NDC 0406-9912-03

75 mg: Light orange opaque cap printed “

Bottles of 100..................NDC 0406-9913-01

Store and Dispense

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.

Pamelor^® (nortriptyline HCl) Oral Solution USP

Pamelor^® (nortriptyline HCl) oral solution USP, equivalent to 10 mg base per 5 mL, is supplied in 16-fluid-ounce bottles (NDC 0406-9918-16). Alcohol content 4%.

Store and Dispense

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

Dispense in tight, light-resistant container.

Pamelor® and

10 mg, 25 mg, and 50 mg Capsules manufactured by:
Patheon Inc.
Whitby, Ontario, Canada
L1N 5Z5

75 mg Capsules manufactured by:
Novartis Pharmaceuticals Corp.
East Hanover, New Jersey 07936

Oral Solution manufactured by:
Novartis Consumer Health, Inc.
Lincoln, Nebraska 68517

Manufactured for:
Mallinckrodt Inc.
Hazelwood, MO 63042 U.S.A.