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Nortriptyline Hydrochloride Oral Solution

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Nortriptyline Hydrochloride Oral Solution

INDICATIONS

Nortriptyline hydrochloride 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

Nortriptyline hydrochloride is not recommended for pediatric patients. Nortriptyline hydrochloride is administered orally in the form of an oral solution. Lower than usual dosages are recommended for elderly patients. The use of lower dosages for outpatients is more important than for hospitalized patients who will be treated under close supervision. The physician should initiate dosage at a low level and increase it gradually, checking the clinical response carefully and noting 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 3 or 4 times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dose 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 per day are not recommended.

Elderly Patients--30 to 50 mg/day in divided doses.

Plasma Levels--Optimal responses to nortriptyline have been associated with plasma concentrations of 50 to 150 ng/mL. Higher concentrations may be associated with more adverse experiences. Plasma concentrations are difficult to measure, and physicians should consult with the laboratory professional staff.

Larger plasma concentrations of the active nortriptyline metabolite 10-hydroxynortriptyline have been reported in older patients. In one case, such a condition was associated with apparent cardiotoxicity despite the fact that nortriptyline concentrations were within the “therapeutic range.” Clinical findings should predominate over plasma concentrations as primary determinants of dosage changes.

HOW SUPPLIED

Liquid, Oral Solution:

10 mg*/5 mL -- (16 fl oz) NDC 63304-202-01

*Equivalent to base.

Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature).

Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257. USA by: Ohm Laboratories Inc. Gloversville, NY 12078. USA, June 2007. FDA rev date: 8/22/2001

Last reviewed on RxList: 4/18/2008
This monograph has been modified to include the generic and brand name in many instances.

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