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Vivactil

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Anxiety is both a normal and useful response to potentially stressful or dangerous situations. It helps by increasing our awareness of what's going on around us and in other ways. For most people, the anxiety is short lived and normally goes away once the situation has passed. But that is not the case for an estimated 40 million adults in the United States who have some type of anxiety disorder and experience ongoing and unwarranted psychological distress. That distress may also manifest itself in physical symptoms such as muscle tension, headaches, or chest pain.

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Vivactil

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VIVACTIL
(protriptyline hydrochloride) Tablet, Film Coated

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 protriptyline hydrochloride 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. Protriptyline 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

Protriptyline HCl is N-methyl-5H dibenzo[a,d]-cycloheptene-5-propanamine hydrochloride. Its molecular formula is C19H21N•HCl and its structural formula is:

VIVACTIL (protriptyline hydrochloride) Structural Formula Illustration

Protriptyline HCl, a dibenzocycloheptene derivative, has a molecular weight of 299.84. It is a white to yellowish powder that is freely soluble in water and soluble in dilute HCl. Protriptyline HCl is supplied as 5 mg or 10 mg film-coated tablets. Inactive ingredients are anhydrous lactose, carnauba wax, corn starch, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, sodium starch glycolate, titanium dioxide, and the 5 mg tablets contain FD&C Yellow #6 and FD&C Red #40; the 10 mg tablets contain D&C Yellow #10 and D&C Red #30.

Last reviewed on RxList: 8/20/2009
This monograph has been modified to include the generic and brand name in many instances.

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