VIVACTIL- protriptyline hydrochloride tablet, film coated
Teva Women�s Health, Inc.
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)
DESCRIPTION
Protriptyline hydrochloride, USP is N -methyl-5H dibenzo[a ,d ]-cycloheptene-5-propanamine hydrochloride
C19 H21 N�HCl M.W. 299.84
Protriptyline hydrochloride, USP, a dibenzocycloheptene derivative, is a white to yellowish powder that is freely soluble in water and soluble in dilute hydrochloride. Protriptyline hydrochloride, USP 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.
CLINICAL PHARMACOLOGY
Protriptyline hydrochloride is an antidepressant agent. The mechanism of its antidepressant action in man is not known. It is not a monoamine oxidase inhibitor, and it does not act primarily by stimulation of the central nervous system.
Protriptyline has been found in some studies to have a more rapid onset of action than imipramine or amitriptyline. The initial clinical effect may occur within one week. Sedative and tranquilizing properties are lacking. The rate of excretion is slow.
INDICATIONS AND USAGE
Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.
DOSAGE AND ADMINISTRATION
Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.
Usual Adult Dosage
Fifteen to 40 mg a day divided into 3 or 4 doses. If necessary, dosage may be increased to 60 mg a day. Dosages above this amount are not recommended. Increases should be made in the morning dose.
Adolescent and Elderly Patients
In general, lower dosages are recommended for these patients. Five mg 3 times a day may be given initially, and increased gradually if necessary. In elderly patients, the cardiovascular system must be monitored closely if the daily dose exceeds 20 mg.
When satisfactory improvement has been reached, dosage should be reduced to the smallest amount that will maintain relief of symptoms.
Minor adverse reactions require reduction in dosage. Major adverse reactions or evidence of hypersensitivity require prompt discontinuation of the drug.
The safety and effectiveness of protriptyline in pediatric patients have not been established.
