Amitriptyline hydrochloride (St Marys Medical Park Pharmacy), manufactured drug form of Amitriptyline hydrochloride, 50mg/tablet amitriptyline hydrochloride tablet, NDC 60760-214
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Amitriptyline hydrochloride (St Marys Medical Park Pharmacy), manufactured drug form of...
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Amitriptyline hydrochloride (St Marys Medical Park Pharmacy), manufactured drug form of Amitriptyline hydrochloride, 50mg/tablet amitriptyline hydrochloride tablet, NDC 60760-214
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 amitriptyline hydrochloride tablets 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. Amitriptyline hydrochloride tablets are not approved for use in pediatric patients (see Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use.)
Created by
fda_medical_bot
on
1/7/2012
