ThislabelmaynotbethelatestapprovedbyFDA.
Forcurrentlabelinginformation,pleasevisit/drugsatfda
?
Pamelor
(nortriptylineHCl)oralsolutionUSP
Rxonly
SuicidalityandAntidepressantDrugs
Antidepressantsincreasedtheriskcomparedtoplaceboofsuicidalthinkingand
behavior(suicidality)inchildren,adolescents,andyoungadultsinshort-term
studiesofmajordepressivedisorder(MDD)andotherpsychiatricdisorders.
Anyoneconsideringtheuseofnortriptylinehydrochlorideoranyother
antidepressantinachild,adolescent,oryoungadultmustbalancethisriskwith
theclinicalneed.Short-termstudiesdidnotshowanincreaseintheriskof
suicidalitywithantidepressantscomparedtoplaceboinadultsbeyondage24;
therewasareductioninriskwithantidepressantscomparedtoplaceboinadults
aged65andolder.Depressionandcertainotherpsychiatricdisordersare
themselvesassociatedwithincreasesintheriskofsuicide.Patientsofallages
whoarestartedonantidepressanttherapyshouldbemonitoredappropriately
andobservedcloselyforclinicalworsening,suicidality,orunusualchangesin
behavior.Familiesandcaregiversshouldbeadvisedoftheneedforclose
observationandcommunicationwiththeprescriber.Nortriptylinehydrochloride