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 perphenazine and amitriptyline 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. Perphenazine and amitriptyline is not approved for use in pediatric patients.
|
SUMMARY
PERPHENAZINE and AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP 2 mg/10 mg, 2 mg/25 mg, 4 mg/10 mg, 4 mg/25 mg and 4 mg/50 mg
Perphenazine and amitriptyline HCl, a broad-spectrum psychotherapeutic agent for the management of outpatients and hospitalized patients with psychoses or neuroses characterized by mixtures of anxiety or agitation with symptoms of depression, is a combination of perphenazine and amitriptyline HCl. Since such mixed syndromes can occur in patients with various degrees of intensity of mental illness, perphenazine and amitriptyline HCl tablets are provided in multiple combinations to afford dosage flexibility for optimum management. Perphenazine is a phenothiazine derivative. The formula is 4-[3-(2-chloro-10 H -phenothiazin-10yl) propyl]-piperazineethanol. It is a white, odorless, bittertasting powder that is insoluble in water.
Perphenazine and amitriptyline HCl is recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. In many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate.
Schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline HCl.
|
