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Nortriptyline Hydrochloride Oral Solution

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Nortriptyline Hydrochloride Oral Solution

Nortriptyline Hydrochloride Oral Solution, USP

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Nortriptyline Hydrochloride Oral Solution or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nortriptyline hydrochloride is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: INFORMATION FOR PATIENTS, and PRECAUTIONS: Pediatric Use)

DRUG DESCRIPTION

Nortriptyline Hydrochloride, USP is 1-propanamine, 3-(10, 11-dihydro-5H-dibenzo [a,d] cyclohepten-5-ylidene)-N-methyl, hydrochloride. Its molecular weight is 299.8, and its molecular formula is C19H21N•HCl.

The oral solution contains nortriptyline hydrochloride equivalent to 10 mg/5 mL (38.0 Ámol) of the base and 4% alcohol. It also contains benzoic acid, flavors, sorbitol, and water. The structural formula is as follows:

NORTRIPTYLINE HYDROCHLORIDE ORAL Structural Formula Illustration

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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