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Pamelor

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Pamelor

Pamelor

INDICATIONS

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 is not recommended for children.

Pamelor 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.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Pamelor. Conversely, at least 14 days should be allowed after stopping Pamelor before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use of Pamelor With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start Pamelor in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving Pamelor therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Pamelor should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Pamelor may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Pamelor is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

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 PAMELOR 10 mg“ in black and white opaque body printed “M“ in black.

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

25 mg: Light orange opaque cap printed PAMELOR 25 mg“ in black and white opaque body printed “M“ in black.

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

50 mg: White opaque cap printed PAMELOR 50 mg“ in black and white opaque body printed “M“ in black.

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

75 mg: Light orange opaque cap printed PAMELOR 75 mg“ in black and light orange opaque body printed “M“ in black.

Bottles of 30 ............ NDC 0406-9913-03

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.

Capsules manufactured by: Patheon Inc. Whitby, Ontario, Canada L1N 5Z5, Oral Solution manufactured by: Novartis Consumer Health, Inc. Lincoln, Nebraska 68517. Manufactured for: Mallinckrodt Inc. Hazelwood, MO 63042 USA. Rev 10/2012

Last reviewed on RxList: 11/6/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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