਍伀氀攀瀀琀爀漀∀‡椀猀 椀渀搀椀挀愀琀攀搀 昀漀爀 琀栀攀 琀爀攀愀琀洀攀渀琀 漀昀 洀愀樀漀爀 搀攀瀀爀攀猀猀椀瘀攀 搀椀猀漀爀搀攀爀 ⠀䴀䐀䐀⤀ 椀渀 愀搀甀氀琀猀⸀ 吀栀攀 攀昀昀椀挀愀挀礀 漀昀 伀氀攀瀀琀爀漀 栀愀猀 戀攀攀渀 攀猀琀愀戀氀椀猀栀攀搀 椀渀 愀 琀爀椀愀氀 漀昀 漀甀琀瀀愀琀椀攀渀琀猀 眀椀琀栀 䴀䐀䐀 愀猀 眀攀氀氀 愀猀 椀渀 琀爀椀愀氀猀 眀椀琀栀 琀栀攀 椀洀洀攀搀椀愀琀攀 爀攀氀攀愀猀攀 昀漀爀洀甀氀愀琀椀漀渀 漀昀 琀爀愀稀漀搀漀渀攀⸀ഀഀ

਍㰀氀椀㸀伀氀攀瀀琀爀漀 戀椀猀攀挀琀愀戀氀攀 琀愀戀氀攀琀猀 挀漀渀琀愀椀渀椀渀最 ㄀㔀　 洀最 漀昀 琀爀愀稀漀搀漀渀攀 栀礀搀爀漀挀栀氀漀爀椀搀攀 ⠀礀攀氀氀漀眀椀猀栀ⴀ戀攀椀最攀Ⰰ 挀愀瀀猀甀氀攀ⴀ猀栀愀瀀攀搀 琀愀戀氀攀琀Ⰰ 挀漀愀琀攀搀 愀渀搀 猀挀漀爀攀搀 漀渀 戀漀琀栀 猀椀搀攀猀 眀椀琀栀 䐀䐀匀 　㠀　 瀀爀椀渀琀攀搀 漀渀 漀渀攀 猀椀搀攀⤀ഀഀ
• Oleptro bisectable tablets containing 300 mg of trazodone hydrochloride (beige-orange, capsule-shaped tablet, coated and scored on both sides with DDS 081 printed on one side)਍㰀⼀甀氀㸀ഀഀ
  ਍ഀഀ ਍㰀愀 渀愀洀攀㴀∀䌀伀一吀刀䄀䤀一䐀䤀䌀䄀吀䤀伀一匀∀㸀ഀഀ ਍㰀倀㸀ഀഀ
  ਍㰀䠀㐀㸀ഀഀ CONTRAINDICATIONS਍㰀⼀䠀㐀㸀ഀഀ

  ਍一漀渀攀⸀ഀഀ

  ਍ഀഀ ਍㰀愀 渀愀洀攀㴀∀圀䄀刀一䤀一䜀匀∀㸀ഀഀ ਍㰀倀㸀ഀഀ
  ਍㰀䠀㐀㸀ഀഀ WARNINGS AND PRECAUTIONS਍㰀⼀䠀㐀㸀ഀഀ

  ਍㰀䈀㸀䌀氀椀渀椀挀愀氀 圀漀爀猀攀渀椀渀最 愀渀搀 匀甀椀挀椀搀攀 刀椀猀欀猀㰀⼀戀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders and these disorders themselves are the strongest predictors of suicide. There has been a long standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18਍ጀ†㈀㐀⤀ 眀椀琀栀 䴀䐀䐀 愀渀搀 漀琀栀攀爀 瀀猀礀挀栀椀愀琀爀椀挀 搀椀猀漀爀搀攀爀猀⸀ 匀栀漀爀琀ⴀ琀攀爀洀 猀琀甀搀椀攀猀 搀椀搀 渀漀琀 猀栀漀眀 愀渀 椀渀挀爀攀愀猀攀 椀渀 琀栀攀 爀椀猀欀 漀昀 猀甀椀挀椀搀愀氀椀琀礀 眀椀琀栀 愀渀琀椀搀攀瀀爀攀猀猀愀渀琀猀 挀漀洀瀀愀爀攀搀 琀漀 瀀氀愀挀攀戀漀 椀渀 愀搀甀氀琀猀 戀攀礀漀渀搀 愀最攀 ㈀㐀㬀 琀栀攀爀攀 眀愀猀 愀 爀攀搀甀挀琀椀漀渀 眀椀琀栀 愀渀琀椀搀攀瀀爀攀猀猀愀渀琀猀 挀漀洀瀀愀爀攀搀 琀漀 瀀氀愀挀攀戀漀 椀渀 愀搀甀氀琀猀 愀最攀搀 㘀㔀 愀渀搀 漀氀搀攀爀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.਍㰀戀爀㸀ഀഀ
  ਍㰀椀洀最 戀漀爀搀攀爀㴀∀　∀ 猀爀挀㴀∀椀洀愀最攀猀⼀漀氀攀瀀琀爀漀㄀⸀樀瀀最∀ 愀氀琀㴀∀吀愀戀氀攀 ㄀䐀爀甀最ⴀ倀氀愀挀攀戀漀 䐀椀昀昀攀爀攀渀挀攀 椀渀 一甀洀戀攀爀 漀昀 䌀愀猀攀猀 漀昀 匀甀椀挀椀搀愀氀椀琀礀 瀀攀爀 ㄀Ⰰ　　　 倀愀琀椀攀渀琀猀 吀爀攀愀琀攀搀㨀 嘀椀爀愀氀 䌀氀攀愀爀愀渀挀攀 刀攀猀甀氀琀猀 ⠀氀漀最㄀　 爀攀搀甀挀琀椀漀渀猀⤀∀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.਍㰀戀爀㸀ഀഀ
  ਍䤀琀 椀猀 甀渀欀渀漀眀渀 眀栀攀琀栀攀爀 琀栀攀 猀甀椀挀椀搀愀氀椀琀礀 爀椀猀欀 攀砀琀攀渀搀猀 琀漀 氀漀渀最攀爀ⴀ琀攀爀洀 甀猀攀Ⰰ 椀⸀攀⸀Ⰰ 戀攀礀漀渀搀 猀攀瘀攀爀愀氀 洀漀渀琀栀猀⸀ 䠀漀眀攀瘀攀爀Ⰰ 琀栀攀爀攀 椀猀 猀甀戀猀琀愀渀琀椀愀氀 攀瘀椀搀攀渀挀攀 昀爀漀洀 瀀氀愀挀攀戀漀ⴀ挀漀渀琀爀漀氀氀攀搀 洀愀椀渀琀攀渀愀渀挀攀 琀爀椀愀氀猀 椀渀 愀搀甀氀琀猀 眀椀琀栀 搀攀瀀爀攀猀猀椀漀渀 琀栀愀琀 琀栀攀 甀猀攀 漀昀 愀渀琀椀搀攀瀀爀攀猀猀愀渀琀猀 挀愀渀 搀攀氀愀礀 琀栀攀 爀攀挀甀爀爀攀渀挀攀 漀昀 搀攀瀀爀攀猀猀椀漀渀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.਍㰀戀爀㸀ഀഀ
  ਍吀栀攀 昀漀氀氀漀眀椀渀最 猀礀洀瀀琀漀洀猀Ⰰ 愀渀砀椀攀琀礀Ⰰ 愀最椀琀愀琀椀漀渀Ⰰ 瀀愀渀椀挀 愀琀琀愀挀欀猀Ⰰ 椀渀猀漀洀渀椀愀Ⰰ 椀爀爀椀琀愀戀椀氀椀琀礀Ⰰ 栀漀猀琀椀氀椀琀礀Ⰰ 愀最最爀攀猀猀椀瘀攀渀攀猀猀Ⰰ 椀洀瀀甀氀猀椀瘀椀琀礀Ⰰ 愀欀愀琀栀椀猀椀愀 ⠀瀀猀礀挀栀漀洀漀琀漀爀 爀攀猀琀氀攀猀猀渀攀猀猀⤀Ⰰ 栀礀瀀漀洀愀渀椀愀Ⰰ 愀渀搀 洀愀渀椀愀Ⰰ 栀愀瘀攀 戀攀攀渀 爀攀瀀漀爀琀攀搀 椀渀 愀搀甀氀琀 愀渀搀 瀀攀搀椀愀琀爀椀挀 瀀愀琀椀攀渀琀猀 戀攀椀渀最 琀爀攀愀琀攀搀 眀椀琀栀 愀渀琀椀搀攀瀀爀攀猀猀愀渀琀猀 昀漀爀 洀愀樀漀爀 搀攀瀀爀攀猀猀椀瘀攀 搀椀猀漀爀搀攀爀 愀猀 眀攀氀氀 愀猀 昀漀爀 漀琀栀攀爀 椀渀搀椀挀愀琀椀漀渀猀Ⰰ 戀漀琀栀 瀀猀礀挀栀椀愀琀爀椀挀 愀渀搀 渀漀渀瀀猀礀挀栀椀愀琀爀椀挀⸀ 䄀氀琀栀漀甀最栀 愀 挀愀甀猀愀氀 氀椀渀欀 戀攀琀眀攀攀渀 琀栀攀 攀洀攀爀最攀渀挀攀 漀昀 猀甀挀栀 猀礀洀瀀琀漀洀猀 愀渀搀 攀椀琀栀攀爀 琀栀攀 眀漀爀猀攀渀椀渀最 漀昀 搀攀瀀爀攀猀猀椀漀渀 愀渀搀⼀漀爀 琀栀攀 攀洀攀爀最攀渀挀攀 漀昀 猀甀椀挀椀搀愀氀 椀洀瀀甀氀猀攀猀 栀愀猀 渀漀琀 戀攀攀渀 攀猀琀愀戀氀椀猀栀攀搀Ⰰ 琀栀攀爀攀 椀猀 挀漀渀挀攀爀渀 琀栀愀琀 猀甀挀栀 猀礀洀瀀琀漀洀猀 洀愀礀 爀攀瀀爀攀猀攀渀琀 瀀爀攀挀甀爀猀漀爀猀 琀漀 攀洀攀爀最椀渀最 猀甀椀挀椀搀愀氀椀琀礀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.਍㰀戀爀㸀ഀഀ
  ਍㰀戀㸀䘀愀洀椀氀椀攀猀 愀渀搀 挀愀爀攀最椀瘀攀爀猀 漀昀 瀀愀琀椀攀渀琀猀 戀攀椀渀最 琀爀攀愀琀攀搀 眀椀琀栀 愀渀琀椀搀攀瀀爀攀猀猀愀渀琀猀 昀漀爀 洀愀樀漀爀 搀攀瀀爀攀猀猀椀瘀攀 搀椀猀漀爀搀攀爀 漀爀 漀琀栀攀爀 椀渀搀椀挀愀琀椀漀渀猀Ⰰ 戀漀琀栀 瀀猀礀挀栀椀愀琀爀椀挀 愀渀搀 渀漀渀瀀猀礀挀栀椀愀琀爀椀挀Ⰰ 猀栀漀甀氀搀 戀攀 愀氀攀爀琀攀搀 愀戀漀甀琀 琀栀攀 渀攀攀搀 琀漀 洀漀渀椀琀漀爀 瀀愀琀椀攀渀琀猀 昀漀爀 琀栀攀 攀洀攀爀最攀渀挀攀 漀昀 愀最椀琀愀琀椀漀渀Ⰰ 椀爀爀椀琀愀戀椀氀椀琀礀Ⰰ 甀渀甀猀甀愀氀 挀栀愀渀最攀猀 椀渀 戀攀栀愀瘀椀漀爀Ⰰ 愀渀搀 琀栀攀 漀琀栀攀爀 猀礀洀瀀琀漀洀猀 搀攀猀挀爀椀戀攀搀 愀戀漀瘀攀Ⰰ 愀猀 眀攀氀氀 愀猀 琀栀攀 攀洀攀爀最攀渀挀攀 漀昀 猀甀椀挀椀搀愀氀椀琀礀Ⰰ 愀渀搀 琀漀 爀攀瀀漀爀琀 猀甀挀栀 猀礀洀瀀琀漀洀猀 椀洀洀攀搀椀愀琀攀氀礀 琀漀 栀攀愀氀琀栀 挀愀爀攀 瀀爀漀瘀椀搀攀爀猀⸀ 匀甀挀栀 洀漀渀椀琀漀爀椀渀最 猀栀漀甀氀搀 椀渀挀氀甀搀攀 搀愀椀氀礀 漀戀猀攀爀瘀愀琀椀漀渀 戀礀 昀愀洀椀氀椀攀猀 愀渀搀 挀愀爀攀最椀瘀攀爀猀⸀ 倀爀攀猀挀爀椀瀀琀椀漀渀猀 昀漀爀 伀氀攀瀀琀爀漀 猀栀漀甀氀搀 戀攀 眀爀椀琀琀攀渀 昀漀爀 琀栀攀 猀洀愀氀氀攀猀琀 焀甀愀渀琀椀琀礀 漀昀 琀愀戀氀攀琀猀 挀漀渀猀椀猀琀攀渀琀 眀椀琀栀 最漀漀搀 瀀愀琀椀攀渀琀 洀愀渀愀最攀洀攀渀琀Ⰰ 椀渀 漀爀搀攀爀 琀漀 爀攀搀甀挀攀 琀栀攀 爀椀猀欀 漀昀 漀瘀攀爀搀漀猀攀⸀㰀⼀戀㸀ഀഀ

  ਍㰀䈀㸀匀攀爀漀琀漀渀椀渀 匀礀渀搀爀漀洀攀 漀爀 一攀甀爀漀氀攀瀀琀椀挀 䴀愀氀椀最渀愀渀琀 匀礀渀搀爀漀洀攀 ⠀一䴀匀⤀ⴀ氀椀欀攀 刀攀愀挀琀椀漀渀猀㰀⼀戀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ The development of a potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions have been reported with antidepressants alone and may occur with trazodone treatment, but particularly with concomitant use of other serotoninergic drugs (including SSRIs, SNRIs and triptans) and with drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs]), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea). Serotonin syndrome, in its most severe form, can resemble neuroleptic malignant syndrome, which includes਍栀礀瀀攀爀琀栀攀爀洀椀愀Ⰰ 洀甀猀挀氀攀 爀椀最椀搀椀琀礀Ⰰ 愀甀琀漀渀漀洀椀挀 椀渀猀琀愀戀椀氀椀琀礀 眀椀琀栀 瀀漀猀猀椀戀氀攀 爀愀瀀椀搀 昀氀甀挀琀甀愀琀椀漀渀 漀昀 瘀椀琀愀氀 猀椀最渀猀Ⰰ 愀渀搀 洀攀渀琀愀氀 猀琀愀琀甀猀 挀栀愀渀最攀猀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Treatment with Oleptro and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated.਍㰀戀爀㸀ഀഀ
  ਍伀氀攀瀀琀爀漀 猀栀漀甀氀搀 渀漀琀 戀攀 甀猀攀搀 眀椀琀栀椀渀 ㄀㐀 搀愀礀猀 漀昀 愀渀 䴀䄀伀䤀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 愀渀搀 䐀爀甀最 䤀渀琀攀爀愀挀琀椀漀渀猀崀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ If concomitant treatment with Oleptro and an SSRI, SNRI or a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.਍㰀戀爀㸀ഀഀ
  ਍吀栀攀 挀漀渀挀漀洀椀琀愀渀琀 甀猀攀 漀昀 伀氀攀瀀琀爀漀 眀椀琀栀 猀攀爀漀琀漀渀椀渀 瀀爀攀挀甀爀猀漀爀猀 ⠀猀甀挀栀 愀猀 琀爀礀瀀琀漀瀀栀愀渀⤀ 椀猀 渀漀琀 爀攀挀漀洀洀攀渀搀攀搀⸀ഀഀ

  ਍㰀䈀㸀匀挀爀攀攀渀椀渀最 倀愀琀椀攀渀琀猀 昀漀爀 䈀椀瀀漀氀愀爀 䐀椀猀漀爀搀攀爀 愀渀搀 䴀漀渀椀琀漀爀椀渀最 昀漀爀 䴀愀渀椀愀⼀䠀礀瀀漀洀愀渀椀愀㰀⼀戀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described for clinical worsening and suicide risk represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Oleptro is not approved for use in treating bipolar depression.਍㰀倀㸀ഀഀ QT Prolongation and Risk of Sudden Death਍㰀戀爀㸀ഀഀ
  ਍吀爀愀稀漀搀漀渀攀 椀猀 欀渀漀眀渀 琀漀 瀀爀漀氀漀渀最 琀栀攀 儀吀⼀儀吀挀 椀渀琀攀爀瘀愀氀⸀ 匀漀洀攀 搀爀甀最猀 琀栀愀琀 瀀爀漀氀漀渀最 琀栀攀 儀吀⼀儀吀挀 椀渀琀攀爀瘀愀氀 挀愀渀 挀愀甀猀攀 吀漀爀猀愀搀攀猀 搀攀 倀漀椀渀琀攀猀 眀椀琀栀 猀甀搀搀攀渀Ⰰ 甀渀攀砀瀀氀愀椀渀攀搀 搀攀愀琀栀⸀ 吀栀攀 爀攀氀愀琀椀漀渀猀栀椀瀀 漀昀 儀吀 瀀爀漀氀漀渀最愀琀椀漀渀 椀猀 挀氀攀愀爀攀猀琀 昀漀爀 氀愀爀最攀爀 椀渀挀爀攀愀猀攀猀 ⠀㈀　 洀猀攀挀 愀渀搀 最爀攀愀琀攀爀⤀Ⰰ 戀甀琀 椀琀 椀猀 瀀漀猀猀椀戀氀攀 琀栀愀琀 猀洀愀氀氀攀爀 儀吀⼀儀吀挀 瀀爀漀氀漀渀最愀琀椀漀渀猀 洀愀礀 愀氀猀漀 椀渀挀爀攀愀猀攀 爀椀猀欀Ⰰ 攀猀瀀攀挀椀愀氀氀礀 椀渀 猀甀猀挀攀瀀琀椀戀氀攀 椀渀搀椀瘀椀搀甀愀氀猀Ⰰ 猀甀挀栀 愀猀 琀栀漀猀攀 眀椀琀栀 栀礀瀀漀欀愀氀攀洀椀愀Ⰰ 栀礀瀀漀洀愀最渀攀猀攀洀椀愀Ⰰ 漀爀 愀 最攀渀攀琀椀挀 瀀爀攀搀椀猀瀀漀猀椀琀椀漀渀 琀漀 瀀爀漀氀漀渀最攀搀 儀吀⼀儀吀挀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Although Torsades de Pointes has not been observed with the use of Oleptro at recommended doses in premarketing trials, experience is too limited to rule out an increased risk. However, there have been postmarketing reports of Torsades de Pointes with the immediate-release form of trazodone (in the presence of multiple confounding factors), even at doses of 100 mg per day or less.਍㰀倀㸀ഀഀ Use in Patients with Heart Disease਍㰀戀爀㸀ഀഀ
  ਍吀爀愀稀漀搀漀渀攀 栀礀搀爀漀挀栀氀漀爀椀搀攀 椀猀 渀漀琀 爀攀挀漀洀洀攀渀搀攀搀 昀漀爀 甀猀攀 搀甀爀椀渀最 琀栀攀 椀渀椀琀椀愀氀 爀攀挀漀瘀攀爀礀 瀀栀愀猀攀 漀昀 洀礀漀挀愀爀搀椀愀氀 椀渀昀愀爀挀琀椀漀渀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Caution should be used when administering Oleptro to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including trazodone hydrochloride) may cause cardiac arrhythmias.਍㰀戀爀㸀ഀഀ
  ਍儀吀 瀀爀漀氀漀渀最愀琀椀漀渀 栀愀猀 戀攀攀渀 爀攀瀀漀爀琀攀搀 眀椀琀栀 琀爀愀稀漀搀漀渀攀 琀栀攀爀愀瀀礀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 ⠀㔀⸀㐀⤀崀⸀ 䌀氀椀渀椀挀愀氀 猀琀甀搀椀攀猀 椀渀 瀀愀琀椀攀渀琀猀 眀椀琀栀 瀀爀攀ⴀ攀砀椀猀琀椀渀最 挀愀爀搀椀愀挀 搀椀猀攀愀猀攀 椀渀搀椀挀愀琀攀 琀栀愀琀 琀爀愀稀漀搀漀渀攀 栀礀搀爀漀挀栀氀漀爀椀搀攀 洀愀礀 戀攀 愀爀爀栀礀琀栀洀漀最攀渀椀挀 椀渀 猀漀洀攀 瀀愀琀椀攀渀琀猀 椀渀 琀栀愀琀 瀀漀瀀甀氀愀琀椀漀渀⸀ 䄀爀爀栀礀琀栀洀椀愀猀 椀搀攀渀琀椀昀椀攀搀 椀渀挀氀甀搀攀 椀猀漀氀愀琀攀搀 倀嘀䌀猀Ⰰ 瘀攀渀琀爀椀挀甀氀愀爀 挀漀甀瀀氀攀琀猀Ⰰ 琀愀挀栀礀挀愀爀搀椀愀 眀椀琀栀 猀礀渀挀漀瀀攀Ⰰ 愀渀搀 吀漀爀猀愀搀攀猀 搀攀 倀漀椀渀琀攀猀⸀ 倀漀猀琀洀愀爀欀攀琀椀渀最 攀瘀攀渀琀猀 栀愀瘀攀 戀攀攀渀 爀攀瀀漀爀琀攀搀 愀琀 搀漀猀攀猀 漀昀 ㄀　　 洀最 漀爀 氀攀猀猀 眀椀琀栀 琀栀攀 椀洀洀攀搀椀愀琀攀ⴀ爀攀氀攀愀猀攀 昀漀爀洀 漀昀 琀爀愀稀漀搀漀渀攀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Concomitant administration of drugs that prolong the QT interval or that are inhibitors of CYP3A4 may increase the risk of cardiac arrhythmia.਍㰀倀㸀ഀഀ Orthostatic Hypotension and Syncope਍㰀戀爀㸀ഀഀ
  ਍䠀礀瀀漀琀攀渀猀椀漀渀Ⰰ 椀渀挀氀甀搀椀渀最 漀爀琀栀漀猀琀愀琀椀挀 栀礀瀀漀琀攀渀猀椀漀渀 愀渀搀 猀礀渀挀漀瀀攀 栀愀猀 戀攀攀渀 爀攀瀀漀爀琀攀搀 椀渀 瀀愀琀椀攀渀琀猀 爀攀挀攀椀瘀椀渀最 琀爀愀稀漀搀漀渀攀 栀礀搀爀漀挀栀氀漀爀椀搀攀⸀ 䌀漀渀挀漀洀椀琀愀渀琀 甀猀攀 眀椀琀栀 愀渀 愀渀琀椀栀礀瀀攀爀琀攀渀猀椀瘀攀 洀愀礀 爀攀焀甀椀爀攀 愀 爀攀搀甀挀琀椀漀渀 椀渀 琀栀攀 搀漀猀攀 漀昀 琀栀攀 愀渀琀椀栀礀瀀攀爀琀攀渀猀椀瘀攀 搀爀甀最⸀ഀഀ

  ਍㰀䈀㸀䄀戀渀漀爀洀愀氀 䈀氀攀攀搀椀渀最㰀⼀戀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Postmarketing data have shown an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal (GI) bleeding. While no association between trazodone and bleeding events, in particular GI bleeding, was shown, patients should be cautioned about potential risk of bleeding associated with the concomitant use of trazodone and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding. Other bleeding events related to SSRIs and SNRIs have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.਍㰀倀㸀ഀഀ Interaction with MAOIs਍㰀戀爀㸀ഀഀ
  ਍䤀渀 瀀愀琀椀攀渀琀猀 爀攀挀攀椀瘀椀渀最 猀攀爀漀琀漀渀攀爀最椀挀 搀爀甀最猀 椀渀 挀漀洀戀椀渀愀琀椀漀渀 眀椀琀栀 愀 洀漀渀漀愀洀椀渀攀 漀砀椀搀愀猀攀 椀渀栀椀戀椀琀漀爀 ⠀䴀䄀伀䤀⤀Ⰰ 琀栀攀爀攀 栀愀瘀攀 戀攀攀渀 爀攀瀀漀爀琀猀 漀昀 猀攀爀椀漀甀猀Ⰰ 猀漀洀攀琀椀洀攀猀 昀愀琀愀氀 爀攀愀挀琀椀漀渀猀 椀渀挀氀甀搀椀渀最 栀礀瀀攀爀琀栀攀爀洀椀愀Ⰰ 爀椀最椀搀椀琀礀Ⰰ 洀礀漀挀氀漀渀甀猀Ⰰ 愀甀琀漀渀漀洀椀挀 椀渀猀琀愀戀椀氀椀琀礀 眀椀琀栀 爀愀瀀椀搀 昀氀甀挀琀甀愀琀椀漀渀 椀渀 瘀椀琀愀氀 猀椀最渀猀Ⰰ 愀渀搀 洀攀渀琀愀氀 猀琀愀琀甀猀 挀栀愀渀最攀猀 琀栀愀琀 椀渀挀氀甀搀攀 攀砀琀爀攀洀攀 愀最椀琀愀琀椀漀渀 瀀爀漀最爀攀猀猀椀渀最 琀漀 搀攀氀椀爀椀甀洀 愀渀搀 挀漀洀愀⸀ 吀栀攀猀攀 爀攀愀挀琀椀漀渀猀 栀愀瘀攀 愀氀猀漀 戀攀攀渀 爀攀瀀漀爀琀攀搀 椀渀 瀀愀琀椀攀渀琀猀 眀栀漀 栀愀瘀攀 爀攀挀攀渀琀氀礀 搀椀猀挀漀渀琀椀渀甀攀搀 愀渀琀椀搀攀瀀爀攀猀猀愀渀琀 琀爀攀愀琀洀攀渀琀 愀渀搀 栀愀瘀攀 戀攀攀渀 猀琀愀爀琀攀搀 漀渀 愀渀 䴀䄀伀䤀⸀ 匀漀洀攀 挀愀猀攀猀 瀀爀攀猀攀渀琀攀搀 眀椀琀栀 昀攀愀琀甀爀攀猀 爀攀猀攀洀戀氀椀渀最 渀攀甀爀漀氀攀瀀琀椀挀 洀愀氀椀最渀愀渀琀 猀礀渀搀爀漀洀攀⸀ 䘀甀爀琀栀攀爀洀漀爀攀Ⰰ 氀椀洀椀琀攀搀 愀渀椀洀愀氀 搀愀琀愀 漀渀 琀栀攀 攀昀昀攀挀琀猀 漀昀 挀漀洀戀椀渀攀搀 甀猀攀 漀昀 猀攀爀漀琀漀渀攀爀最椀挀 愀渀琀椀搀攀瀀爀攀猀猀愀渀琀猀 愀渀搀 䴀䄀伀䤀猀 猀甀最最攀猀琀 琀栀愀琀 琀栀攀猀攀 搀爀甀最猀 洀愀礀 愀挀琀 猀礀渀攀爀最椀猀琀椀挀愀氀氀礀 琀漀 攀氀攀瘀愀琀攀 戀氀漀漀搀 瀀爀攀猀猀甀爀攀 愀渀搀 攀瘀漀欀攀 戀攀栀愀瘀椀漀爀愀氀 攀砀挀椀琀愀琀椀漀渀⸀ 吀栀攀爀攀昀漀爀攀Ⰰ 椀琀 椀猀 爀攀挀漀洀洀攀渀搀攀搀 琀栀愀琀 伀氀攀瀀琀爀漀 猀栀漀甀氀搀 渀漀琀 戀攀 甀猀攀搀 椀渀 挀漀洀戀椀渀愀琀椀漀渀 眀椀琀栀 愀渀 䴀䄀伀䤀 漀爀 眀椀琀栀椀渀 ㄀㐀 搀愀礀猀 漀昀 搀椀猀挀漀渀琀椀渀甀椀渀最 琀爀攀愀琀洀攀渀琀 眀椀琀栀 愀渀 䴀䄀伀䤀⸀ 匀椀洀椀氀愀爀氀礀Ⰰ 愀琀 氀攀愀猀琀 ㄀㐀 搀愀礀猀 猀栀漀甀氀搀 戀攀 愀氀氀漀眀攀搀 愀昀琀攀爀 猀琀漀瀀瀀椀渀最 伀氀攀瀀琀爀漀 戀攀昀漀爀攀 猀琀愀爀琀椀渀最 愀渀 䴀䄀伀䤀⸀ഀഀ

  ਍㰀䈀㸀倀爀椀愀瀀椀猀洀㰀⼀戀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Rare cases of priapism (painful erections greater than 6 hours in duration) were reported in men receiving trazodone. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Men who have an erection lasting greater than 6 hours, whether painful or not, should immediately discontinue the drug and seek emergency medical attention [see Adverse Reactions (6.2) and Overdosage (10)].਍㰀戀爀㸀ഀഀ
  ਍吀爀愀稀漀搀漀渀攀 猀栀漀甀氀搀 戀攀 甀猀攀搀 眀椀琀栀 挀愀甀琀椀漀渀 椀渀 洀攀渀 眀栀漀 栀愀瘀攀 挀漀渀搀椀琀椀漀渀猀 琀栀愀琀 洀椀最栀琀 瀀爀攀搀椀猀瀀漀猀攀 琀栀攀洀 琀漀 瀀爀椀愀瀀椀猀洀 ⠀攀⸀最⸀Ⰰ 猀椀挀欀氀攀 挀攀氀氀 愀渀攀洀椀愀Ⰰ 洀甀氀琀椀瀀氀攀 洀礀攀氀漀洀愀Ⰰ 漀爀 氀攀甀欀攀洀椀愀⤀Ⰰ 漀爀 椀渀 洀攀渀 眀椀琀栀 愀渀愀琀漀洀椀挀愀氀 搀攀昀漀爀洀愀琀椀漀渀 漀昀 琀栀攀 瀀攀渀椀猀 ⠀攀⸀最⸀Ⰰ 愀渀最甀氀愀琀椀漀渀Ⰰ 挀愀瘀攀爀渀漀猀愀氀 昀椀戀爀漀猀椀猀Ⰰ 漀爀 倀攀礀爀漀渀椀攀✀猀 搀椀猀攀愀猀攀⤀⸀ഀഀ

  ਍㰀䈀㸀䠀礀瀀漀渀愀琀爀攀洀椀愀㰀⼀戀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Hyponatremia may occur as a result of treatment with antidepressants. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with antidepressants. Also, patients taking diuretics or who are otherwise volume-depleted can be at greater risk. Discontinuation of Oleptro should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.਍㰀戀爀㸀ഀഀ
  ਍匀椀最渀猀 愀渀搀 猀礀洀瀀琀漀洀猀 漀昀 栀礀瀀漀渀愀琀爀攀洀椀愀 椀渀挀氀甀搀攀 栀攀愀搀愀挀栀攀Ⰰ 搀椀昀昀椀挀甀氀琀礀 挀漀渀挀攀渀琀爀愀琀椀渀最Ⰰ 洀攀洀漀爀礀 椀洀瀀愀椀爀洀攀渀琀Ⰰ 挀漀渀昀甀猀椀漀渀Ⰰ 眀攀愀欀渀攀猀猀Ⰰ 愀渀搀 甀渀猀琀攀愀搀椀渀攀猀猀Ⰰ 眀栀椀挀栀 挀愀渀 氀攀愀搀 琀漀 昀愀氀氀猀⸀ 匀椀最渀猀 愀渀搀 猀礀洀瀀琀漀洀猀 愀猀猀漀挀椀愀琀攀搀 眀椀琀栀 洀漀爀攀 猀攀瘀攀爀攀 愀渀搀⼀漀爀 愀挀甀琀攀 挀愀猀攀猀 栀愀瘀攀 椀渀挀氀甀搀攀搀 栀愀氀氀甀挀椀渀愀琀椀漀渀Ⰰ 猀礀渀挀漀瀀攀Ⰰ 猀攀椀稀甀爀攀Ⰰ 挀漀洀愀Ⰰ 爀攀猀瀀椀爀愀琀漀爀礀 愀爀爀攀猀琀Ⰰ 愀渀搀 搀攀愀琀栀⸀ഀഀ

  ਍㰀䈀㸀倀漀琀攀渀琀椀愀氀 昀漀爀 䌀漀最渀椀琀椀瘀攀 愀渀搀 䴀漀琀漀爀 䤀洀瀀愀椀爀洀攀渀琀㰀⼀戀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Oleptro may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.਍㰀倀㸀ഀഀ Discontinuation Symptoms਍㰀戀爀㸀ഀഀ
  ਍圀椀琀栀搀爀愀眀愀氀 猀礀洀瀀琀漀洀猀 椀渀挀氀甀搀椀渀最 愀渀砀椀攀琀礀Ⰰ 愀最椀琀愀琀椀漀渀 愀渀搀 猀氀攀攀瀀 搀椀猀琀甀爀戀愀渀挀攀猀Ⰰ 栀愀瘀攀 戀攀攀渀 爀攀瀀漀爀琀攀搀 眀椀琀栀 琀爀愀稀漀搀漀渀攀⸀ 䌀氀椀渀椀挀愀氀 攀砀瀀攀爀椀攀渀挀攀 猀甀最最攀猀琀猀 琀栀愀琀 琀栀攀 搀漀猀攀 猀栀漀甀氀搀 戀攀 最爀愀搀甀愀氀氀礀 爀攀搀甀挀攀搀 戀攀昀漀爀攀 挀漀洀瀀氀攀琀攀 搀椀猀挀漀渀琀椀渀甀愀琀椀漀渀 漀昀 琀栀攀 琀爀攀愀琀洀攀渀琀⸀ഀഀ

  ਍㰀䈀㸀匀攀爀漀琀漀渀椀渀 匀礀渀搀爀漀洀攀 漀爀 一攀甀爀漀氀攀瀀琀椀挀 䴀愀氀椀最渀愀渀琀 匀礀渀搀爀漀洀攀 ⠀一䴀匀⤀ⴀ氀椀欀攀 刀攀愀挀琀椀漀渀猀㰀⼀戀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ

  ਍ഀഀ ਍㰀⼀愀㸀ഀഀ

  ਍㰀⼀倀㸀ഀഀ

  ਍䄀䐀嘀䔀刀匀䔀 刀䔀䄀䌀吀䤀伀一匀ഀഀ

  ਍㰀倀㸀ഀഀ The following serious adverse reactions are described elsewhere in the labeling:਍㰀甀氀㸀ഀഀ
• Clinical Worsening and Suicide Risk [see Boxed Warning and Warnings and Precautions (5.1)]਍㰀氀椀㸀匀攀爀漀琀漀渀椀渀 匀礀渀搀爀漀洀攀 漀爀 一䴀匀ⴀ氀椀欀攀 刀攀愀挀琀椀漀渀猀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 ⠀㔀⸀㈀⤀崀ഀഀ
• QT Prolongation and Risk of Sudden Death [see Warnings and Precautions (5.4)]਍㰀氀椀㸀伀爀琀栀漀猀琀愀琀椀挀 䠀礀瀀漀琀攀渀猀椀漀渀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 ⠀㔀⸀㘀⤀崀ഀഀ
• Abnormal bleeding events [see Warnings and Precautions (5.7)]਍㰀氀椀㸀倀爀椀愀瀀椀猀洀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 ⠀㔀⸀㤀⤀崀ഀഀ
• Hyponatremia [see Warnings and Precautions (5.10)]਍㰀氀椀㸀䌀漀最渀椀琀椀瘀攀 愀渀搀 䴀漀琀漀爀 䤀洀瀀愀椀爀洀攀渀琀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 ⠀㔀⸀㄀㄀⤀崀ഀഀ
• Discontinuation symptoms [see Warnings and Precautions (5.12)]਍㰀⼀甀氀㸀ഀഀ The most common adverse reactions (reported in ≥5% and at twice the rate of placebo) are: somnolence/sedation, dizziness, constipation, vision blurred਍㰀戀爀㸀ഀഀ
  ਍吀愀戀氀攀 ㈀ 瀀爀攀猀攀渀琀猀 琀栀攀 猀甀洀洀愀爀礀 漀昀 愀搀瘀攀爀猀攀 攀瘀攀渀琀猀 ⠀䄀䔀猀⤀ 氀攀愀搀椀渀最 琀漀 搀椀猀挀漀渀琀椀渀甀愀琀椀漀渀 漀昀 伀氀攀瀀琀爀漀 琀爀攀愀琀洀攀渀琀 眀椀琀栀 愀渀 椀渀挀椀搀攀渀挀攀 漀昀 愀琀 氀攀愀猀琀 ㄀─ 愀渀搀 愀琀 氀攀愀猀琀 琀眀椀挀攀 琀栀愀琀 昀漀爀 瀀氀愀挀攀戀漀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ ਍㰀戀爀㸀ഀഀ
  ਍㰀戀㸀䌀氀椀渀椀挀愀氀 匀琀甀搀椀攀猀 䔀砀瀀攀爀椀攀渀挀攀㰀⼀戀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ The data described below reflects exposure in a clinical trial of 406 patients, including 204 exposed to placebo and 202 exposed to Oleptro. Patients were between 18-80 years of age and 69.3% and 67.5% of patients had at least one previous episode of depression in the last 24 months in the placebo and active-treated group, respectively. In individual patients, doses were flexible and ranged from 150 to 375 mg per day. The mean daily dose during the 6-week treatment period was 310 mg. The tablets were administered orally and were given once a day for a total duration of 8 weeks, including the titration period.਍㰀戀爀㸀ഀഀ
  ਍䈀攀挀愀甀猀攀 挀氀椀渀椀挀愀氀 琀爀椀愀氀猀 愀爀攀 挀漀渀搀甀挀琀攀搀 甀渀搀攀爀 眀椀搀攀氀礀 瘀愀爀礀椀渀最 挀漀渀搀椀琀椀漀渀猀Ⰰ 愀搀瘀攀爀猀攀 爀攀愀挀琀椀漀渀 爀愀琀攀猀 漀戀猀攀爀瘀攀搀 椀渀 琀栀攀 挀氀椀渀椀挀愀氀 琀爀椀愀氀猀 漀昀 愀 搀爀甀最 挀愀渀渀漀琀 戀攀 搀椀爀攀挀琀氀礀 挀漀洀瀀愀爀攀搀 琀漀 爀愀琀攀猀 椀渀 琀栀攀 挀氀椀渀椀挀愀氀 琀爀椀愀氀猀 漀昀 愀渀漀琀栀攀爀 搀爀甀最 愀渀搀 洀愀礀 渀漀琀 爀攀昀氀攀挀琀 琀栀攀 爀愀琀攀猀 漀戀猀攀爀瘀攀搀 椀渀 瀀爀愀挀琀椀挀攀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Table 3 presents the summary of all treatment emergent AEs that occurred at an incidence of ≥ 5% in the Oleptro group, whether considered by the clinical investigator to be related to the study drug or not.਍㰀戀爀㸀ഀഀ
  ਍㰀椀洀最 戀漀爀搀攀爀㴀∀　∀ 猀爀挀㴀∀椀洀愀最攀猀⼀漀氀攀瀀琀爀漀㌀⸀樀瀀最∀ 愀氀琀㴀∀吀愀戀氀攀 ㌀⸀ 䴀漀猀琀 䌀漀洀洀漀渀 吀爀攀愀琀洀攀渀琀 䔀洀攀爀最攀渀琀 䄀搀瘀攀爀猀攀 䔀瘀攀渀琀猀 ⠀攀•㔀─ 漀昀 倀愀琀椀攀渀琀猀 漀渀 䄀挀琀椀瘀攀 吀爀攀愀琀洀攀渀琀⤀∀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Sexual Dysfunction਍㰀戀爀㸀ഀഀ
  ਍䄀搀瘀攀爀猀攀 攀瘀攀渀琀猀 爀攀氀愀琀攀搀 琀漀 猀攀砀甀愀氀 搀礀猀昀甀渀挀琀椀漀渀 ⠀爀攀最愀爀搀氀攀猀猀 漀昀 挀愀甀猀愀氀椀琀礀⤀ 眀攀爀攀 爀攀瀀漀爀琀攀搀 戀礀 㐀⸀㤀─ 愀渀搀 ㄀⸀㔀─ 漀昀 瀀愀琀椀攀渀琀猀 琀爀攀愀琀攀搀 眀椀琀栀 伀氀攀瀀琀爀漀 愀渀搀 瀀氀愀挀攀戀漀Ⰰ 爀攀猀瀀攀挀琀椀瘀攀氀礀⸀ 䤀渀 琀栀攀 伀氀攀瀀琀爀漀 最爀漀甀瀀Ⰰ 攀樀愀挀甀氀愀琀椀漀渀 搀椀猀漀爀搀攀爀猀ഀഀ occurred in 1.5% of patients, decreased libido occurred in 1.5% of patients, and erectile dysfunction and਍愀戀渀漀爀洀愀氀 漀爀最愀猀洀 㰀 ㄀─ 漀昀 瀀愀琀椀攀渀琀猀⸀㰀⼀倀㸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Vital Signs and Weight਍㰀戀爀㸀ഀഀ
  ਍吀栀攀爀攀 眀攀爀攀 渀漀 渀漀琀愀戀氀攀 挀栀愀渀最攀猀 椀渀 瘀椀琀愀氀 猀椀最渀猀 ⠀戀氀漀漀搀 瀀爀攀猀猀甀爀攀Ⰰ 爀攀猀瀀椀爀愀琀漀爀礀 爀愀琀攀Ⰰ 瀀甀氀猀攀⤀ 漀爀 眀攀椀最栀琀 椀渀 攀椀琀栀攀爀ഀഀ treatment group.਍㰀戀爀㸀ഀഀ
  ਍䘀漀氀氀漀眀椀渀最 椀猀 愀 氀椀猀琀 漀昀 琀爀攀愀琀洀攀渀琀ⴀ攀洀攀爀最攀渀琀 愀搀瘀攀爀猀攀 爀攀愀挀琀椀漀渀猀 眀椀琀栀 愀渀 椀渀挀椀搀攀渀挀攀 漀昀 攀•㄀─ 琀漀 㰀 㔀─ ⠀椀⸀攀⸀Ⰰ 氀攀猀猀ഀഀ common) in patients treated with Oleptro. This listing is not intended to include reactions (i) already਍氀椀猀琀攀搀 椀渀 瀀爀攀瘀椀漀甀猀 琀愀戀氀攀猀 漀爀 攀氀猀攀眀栀攀爀攀 椀渀 琀栀攀 氀愀戀攀氀椀渀最 ⠀椀椀⤀ 昀漀爀 眀栀椀挀栀 琀栀攀 愀猀猀漀挀椀愀琀椀漀渀 眀椀琀栀 琀爀攀愀琀洀攀渀琀 椀猀ഀഀ remote, (iii) which were so general as to be uninformative, and (iv) which were not considered to have਍猀椀最渀椀昀椀挀愀渀琀 挀氀椀渀椀挀愀氀 椀洀瀀氀椀挀愀琀椀漀渀猀⸀ 刀攀愀挀琀椀漀渀猀 愀爀攀 挀氀愀猀猀椀昀椀攀搀 戀礀 戀漀搀礀ⴀ猀礀猀琀攀洀 甀猀椀渀最 琀栀攀 昀漀氀氀漀眀椀渀最 搀攀昀椀渀椀琀椀漀渀猀㨀ഀഀ frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are਍琀栀漀猀攀 漀挀挀甀爀爀椀渀最 椀渀 氀攀猀猀 琀栀愀渀 ㄀⼀㄀　　 瀀愀琀椀攀渀琀猀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Ear and Labyrinth Disorders— Infrequent: hypoacusis, tinnitus, vertigo਍㰀戀爀㸀ഀഀ
  ਍䔀礀攀 䐀椀猀漀爀搀攀爀猀᐀†䘀爀攀焀甀攀渀琀㨀 瘀椀猀甀愀氀 搀椀猀琀甀爀戀愀渀挀攀㬀 䤀渀昀爀攀焀甀攀渀琀㨀 搀爀礀 攀礀攀Ⰰ 攀礀攀 瀀愀椀渀Ⰰ 瀀栀漀琀漀瀀栀漀戀椀愀ഀഀ
  ਍㰀戀爀㸀ഀഀ Gastrointestinal Disorders— Frequent: abdominal pain, vomiting; Infrequent: reflux esophagitis਍㰀戀爀㸀ഀഀ
  ਍䜀攀渀攀爀愀氀 䐀椀猀漀爀搀攀爀猀 愀渀搀 䄀搀洀椀渀椀猀琀爀愀琀椀漀渀 匀椀琀攀 䌀漀渀搀椀琀椀漀渀猀᐀†䘀爀攀焀甀攀渀琀㨀 攀搀攀洀愀㬀 䤀渀昀爀攀焀甀攀渀琀㨀 最愀椀琀ഀഀ disturbance Immune System Disorders— Infrequent: hypersensitivity
  ਍㰀戀爀㸀ഀഀ Musculoskeletal and Connective Tissue Disorders— Frequent: musculoskeletal complaints, myalgia;਍䤀渀昀爀攀焀甀攀渀琀㨀 洀甀猀挀氀攀 琀眀椀琀挀栀椀渀最ഀഀ Nervous System Disorders— Frequent: coordination abnormal, dysgeusia, memory impairment, migraine, paraesthesia, tremor; Infrequent: amnesia, aphasia, hypoesthesia, speech disorder਍㰀戀爀㸀ഀഀ
  ਍倀猀礀挀栀椀愀琀爀椀挀 䐀椀猀漀爀搀攀爀猀᐀†䘀爀攀焀甀攀渀琀㨀 愀最椀琀愀琀椀漀渀Ⰰ 挀漀渀昀甀猀椀漀渀愀氀 猀琀愀琀攀Ⰰ 搀椀猀漀爀椀攀渀琀愀琀椀漀渀ഀഀ
  ਍㰀戀爀㸀ഀഀ Renal and Urinary Disorders— Frequent: micturition urgency; Infrequent: bladder pain, urinary਍椀渀挀漀渀琀椀渀攀渀挀攀ഀഀ
  ਍㰀戀爀㸀ഀഀ Respiratory, Thoracic and Mediastinal Disorders— Frequent: dyspnea਍㰀戀爀㸀ഀഀ
  ਍匀欀椀渀 愀渀搀 匀甀戀挀甀琀愀渀攀漀甀猀 吀椀猀猀甀攀 䐀椀猀漀爀搀攀爀猀᐀†䘀爀攀焀甀攀渀琀㨀 渀椀最栀琀 猀眀攀愀琀猀㬀 䤀渀昀爀攀焀甀攀渀琀㨀 愀挀渀攀Ⰰ 栀礀瀀攀爀栀椀搀爀漀猀椀猀Ⰰഀഀ photosensitivity reaction਍㰀戀爀㸀ഀഀ
  ਍嘀愀猀挀甀氀愀爀 䐀椀猀漀爀搀攀爀猀᐀†䤀渀昀爀攀焀甀攀渀琀㨀 昀氀甀猀栀椀渀最 倀漀猀琀洀愀爀欀攀琀椀渀最 䔀砀瀀攀爀椀攀渀挀攀ഀഀ
  ਍㰀戀爀㸀ഀഀ Spontaneous reports regarding trazodone hydrochloride received from postmarketing experience include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestasis, clitorism, congestive heart਍昀愀椀氀甀爀攀Ⰰ 搀椀瀀氀漀瀀椀愀Ⰰ 攀搀攀洀愀Ⰰ 攀砀琀爀愀瀀礀爀愀洀椀搀愀氀 猀礀洀瀀琀漀洀猀Ⰰ 最爀愀渀搀 洀愀氀 猀攀椀稀甀爀攀猀Ⰰ 栀愀氀氀甀挀椀渀愀琀椀漀渀猀Ⰰ 栀攀洀漀氀礀琀椀挀 愀渀攀洀椀愀Ⰰ 栀椀爀猀甀琀椀猀洀Ⰰ 栀礀瀀攀爀戀椀氀椀爀甀戀椀渀攀洀椀愀Ⰰ 椀渀挀爀攀愀猀攀搀 愀洀礀氀愀猀攀Ⰰ 椀渀挀爀攀愀猀攀搀 猀愀氀椀瘀愀琀椀漀渀Ⰰ 椀渀猀漀洀渀椀愀Ⰰ 氀攀甀欀漀挀礀琀漀猀椀猀Ⰰ 氀攀甀欀漀渀礀挀栀椀愀Ⰰ 樀愀甀渀搀椀挀攀Ⰰ 氀愀挀琀愀琀椀漀渀Ⰰ 氀椀瘀攀爀 攀渀稀礀洀攀 愀氀琀攀爀愀琀椀漀渀猀Ⰰ 洀攀琀栀攀洀漀最氀漀戀椀渀攀洀椀愀Ⰰ 渀愀甀猀攀愀⼀瘀漀洀椀琀椀渀最 ⠀洀漀猀琀 昀爀攀焀甀攀渀琀氀礀⤀Ⰰ 瀀愀爀攀猀琀栀攀猀椀愀Ⰰ 瀀愀爀愀渀漀椀搀 爀攀愀挀琀椀漀渀Ⰰ 瀀爀椀愀瀀椀猀洀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 ⠀㔀⸀㤀⤀ 愀渀搀 倀愀琀椀攀渀琀 䌀漀甀渀猀攀氀椀渀最 䤀渀昀漀爀洀愀琀椀漀渀 ⠀㄀㜀⸀㄀⤀崀Ⰰ 瀀爀甀爀椀琀甀猀Ⰰ 瀀猀漀爀椀愀猀椀猀Ⰰ 瀀猀礀挀栀漀猀椀猀Ⰰ 爀愀猀栀Ⰰ 猀琀甀瀀漀爀Ⰰ 椀渀愀瀀瀀爀漀瀀爀椀愀琀攀 䄀䐀䠀 猀礀渀搀爀漀洀攀Ⰰ 琀愀爀搀椀瘀攀 搀礀猀欀椀渀攀猀椀愀Ⰰ 甀渀攀砀瀀氀愀椀渀攀搀 搀攀愀琀栀Ⰰ 甀爀椀渀愀爀礀 椀渀挀漀渀琀椀渀攀渀挀攀Ⰰ 甀爀椀渀愀爀礀 爀攀琀攀渀琀椀漀渀Ⰰ 甀爀琀椀挀愀爀椀愀Ⰰ 瘀愀猀漀搀椀氀愀琀椀漀渀Ⰰ 瘀攀爀琀椀最漀Ⰰ 愀渀搀 眀攀愀欀渀攀猀猀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Cardiovascular system effects which have been reported include the following: conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. In postmarketing surveillance, prolonged QT interval, Torsades de Pointes, and ventricular tachycardia have been reported with the immediate-release form of trazodone at doses of 100 mg per day or less [see Warnings and Precautions].਍㰀⼀倀㸀ഀഀ ਍ഀഀ ਍㰀愀 渀愀洀攀㴀∀䐀刀唀䜀䤀一吀䔀刀䄀䌀吀䤀伀一匀∀㸀ഀഀ ਍㰀倀㸀ഀഀ
  ਍㰀䠀㐀㸀ഀഀ DRUG INTERACTIONS਍㰀⼀䠀㐀㸀ഀഀ

  ਍㰀甀㸀䴀䄀伀䤀猀㰀⼀甀㸀ഀഀ
  ਍䴀䄀伀䤀猀 猀栀漀甀氀搀 渀漀琀 戀攀 甀猀攀搀 眀椀琀栀椀渀 ㄀㐀 搀愀礀猀 漀昀 伀氀攀瀀琀爀漀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 ⠀㔀⸀㠀⤀崀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Central Nervous System (CNS) Depressants਍㰀戀爀㸀ഀഀ Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.਍㰀戀爀㸀ഀഀ
  ਍㰀甀㸀䌀礀琀漀挀栀爀漀洀攀 倀㐀㔀　 ㌀䄀㐀 䤀渀栀椀戀椀琀漀爀猀㰀⼀甀㸀ഀഀ
  ਍䤀渀 瘀椀琀爀漀 搀爀甀最 洀攀琀愀戀漀氀椀猀洀 猀琀甀搀椀攀猀 猀甀最最攀猀琀 琀栀愀琀 琀栀攀爀攀 椀猀 愀 瀀漀琀攀渀琀椀愀氀 昀漀爀 搀爀甀最 椀渀琀攀爀愀挀琀椀漀渀猀 眀栀攀渀 琀爀愀稀漀搀漀渀攀 椀猀 最椀瘀攀渀 眀椀琀栀 挀礀琀漀挀栀爀漀洀攀 倀㐀㔀　 ㌀䄀㐀 ⠀䌀夀倀㌀䄀㐀⤀ 椀渀栀椀戀椀琀漀爀猀⸀ 吀栀攀 攀昀昀攀挀琀 漀昀 猀栀漀爀琀ⴀ琀攀爀洀 愀搀洀椀渀椀猀琀爀愀琀椀漀渀 漀昀 爀椀琀漀渀愀瘀椀爀 ⠀㈀　　 洀最 琀眀椀挀攀 搀愀椀氀礀Ⰰ 㐀 搀漀猀攀猀⤀ 漀渀 琀栀攀 瀀栀愀爀洀愀挀漀欀椀渀攀琀椀挀猀 漀昀 愀 猀椀渀最氀攀 搀漀猀攀 漀昀 琀爀愀稀漀搀漀渀攀 ⠀㔀　 洀最⤀ 栀愀猀 戀攀攀渀 猀琀甀搀椀攀搀 椀渀 ㄀　 栀攀愀氀琀栀礀 猀甀戀樀攀挀琀猀⸀ 吀栀攀 䌀洀愀砀 漀昀 琀爀愀稀漀搀漀渀攀 椀渀挀爀攀愀猀攀搀 戀礀 ㌀㐀─Ⰰ 琀栀攀 䄀唀䌀 椀渀挀爀攀愀猀攀搀 ㈀⸀㐀ⴀ昀漀氀搀Ⰰ 琀栀攀 栀愀氀昀ⴀ氀椀昀攀 椀渀挀爀攀愀猀攀搀 戀礀 ㈀⸀㈀ⴀ昀漀氀搀Ⰰ 愀渀搀 琀栀攀 挀氀攀愀爀愀渀挀攀 搀攀挀爀攀愀猀攀搀 戀礀 㔀㈀─⸀ 䄀搀瘀攀爀猀攀 攀昀昀攀挀琀猀 椀渀挀氀甀搀椀渀最 渀愀甀猀攀愀Ⰰ 栀礀瀀漀琀攀渀猀椀漀渀Ⰰ 愀渀搀 猀礀渀挀漀瀀攀 眀攀爀攀 漀戀猀攀爀瘀攀搀 眀栀攀渀 爀椀琀漀渀愀瘀椀爀 愀渀搀 琀爀愀稀漀搀漀渀攀 眀攀爀攀 挀漀ⴀ愀搀洀椀渀椀猀琀攀爀攀搀⸀ 䤀琀 椀猀 氀椀欀攀氀礀 琀栀愀琀 欀攀琀漀挀漀渀愀稀漀氀攀Ⰰ 椀渀搀椀渀愀瘀椀爀Ⰰ 愀渀搀 漀琀栀攀爀 䌀夀倀㌀䄀㐀 椀渀栀椀戀椀琀漀爀猀 猀甀挀栀 愀猀 椀琀爀愀挀漀渀愀稀漀氀攀 洀愀礀 氀攀愀搀 琀漀 猀甀戀猀琀愀渀琀椀愀氀 椀渀挀爀攀愀猀攀猀 椀渀 琀爀愀稀漀搀漀渀攀 瀀氀愀猀洀愀 挀漀渀挀攀渀琀爀愀琀椀漀渀猀 眀椀琀栀 琀栀攀 瀀漀琀攀渀琀椀愀氀 昀漀爀 愀搀瘀攀爀猀攀 攀昀昀攀挀琀猀⸀ 䤀昀 琀爀愀稀漀搀漀渀攀 椀猀 甀猀攀搀 眀椀琀栀 愀 瀀漀琀攀渀琀 䌀夀倀㌀䄀㐀 椀渀栀椀戀椀琀漀爀Ⰰ 琀栀攀 爀椀猀欀 漀昀 挀愀爀搀椀愀挀 愀爀爀栀礀琀栀洀椀愀 洀愀礀 戀攀 椀渀挀爀攀愀猀攀搀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 ⠀㔀⸀㐀⤀崀 愀渀搀 愀 氀漀眀攀爀 搀漀猀攀 漀昀 琀爀愀稀漀搀漀渀攀 猀栀漀甀氀搀 戀攀 挀漀渀猀椀搀攀爀攀搀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Cytochrome P450 Inducers (e.g., carbamazepine)਍㰀戀爀㸀ഀഀ Carbamazepine induces CYP3A4. Following co-administration of carbamazepine 400 mg per day with trazodone 100 mg to 300 mg daily, carbamazepine reduced plasma concentrations of trazodone and mchlorophenlypiperazine਍⠀愀渀 愀挀琀椀瘀攀 洀攀琀愀戀漀氀椀琀攀⤀ 戀礀 㜀㘀─ 愀渀搀 㘀　─ 爀攀猀瀀攀挀琀椀瘀攀氀礀Ⰰ 挀漀洀瀀愀爀攀搀 琀漀 瀀爀攀挀愀爀戀愀洀愀稀攀瀀椀渀攀ഀഀ values. Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking both drugs.਍㰀戀爀㸀ഀഀ
  ਍㰀甀㸀䐀椀最漀砀椀渀 愀渀搀 倀栀攀渀礀琀漀椀渀㰀⼀甀㸀ഀഀ
  ਍䤀渀挀爀攀愀猀攀搀 猀攀爀甀洀 搀椀最漀砀椀渀 漀爀 瀀栀攀渀礀琀漀椀渀 氀攀瘀攀氀猀 栀愀瘀攀 戀攀攀渀 爀攀瀀漀爀琀攀搀 椀渀 瀀愀琀椀攀渀琀猀 爀攀挀攀椀瘀椀渀最 琀爀愀稀漀搀漀渀攀 挀漀渀挀甀爀爀攀渀琀氀礀 眀椀琀栀 攀椀琀栀攀爀 漀昀 琀栀攀猀攀 搀爀甀最猀⸀ 䴀漀渀椀琀漀爀 猀攀爀甀洀 氀攀瘀攀氀猀 愀渀搀 愀搀樀甀猀琀 搀漀猀愀最攀猀 愀猀 渀攀攀搀攀搀⸀ഀഀ
  ਍㰀戀爀㸀ഀഀ Serotonergic Drugs਍㰀戀爀㸀ഀഀ Based on the mechanism of action of Oleptro and the potential for serotonin syndrome, caution is advised when Oleptro is co-administered with other drugs that may affect the neurotransmitter systems [see Warnings and Precautions (5.2)].਍㰀戀爀㸀ഀഀ
  ਍㰀甀㸀一匀䄀䤀䐀猀Ⰰ 䄀猀瀀椀爀椀渀Ⰰ 漀爀 伀琀栀攀爀 䐀爀甀最猀 䄀昀昀攀挀琀椀渀最 䌀漀愀最甀氀愀琀椀漀渀 漀爀 䈀氀攀攀搀椀渀最㰀⼀甀㸀ഀഀ
  ਍䐀甀攀 琀漀 愀 瀀漀猀猀椀戀氀攀 愀猀猀漀挀椀愀琀椀漀渀 戀攀琀眀攀攀渀 猀攀爀漀琀漀渀椀渀 洀漀搀甀氀愀琀椀渀最 搀爀甀最猀 愀渀搀 最愀猀琀爀漀椀渀琀攀猀琀椀渀愀氀 戀氀攀攀搀椀渀最Ⰰ 瀀愀琀椀攀渀琀猀 猀栀漀甀氀搀 戀攀 洀漀渀椀琀漀爀攀搀 昀漀爀 愀渀搀 挀愀甀琀椀漀渀攀搀 愀戀漀甀琀 琀栀攀 瀀漀琀攀渀琀椀愀氀 爀椀猀欀 漀昀 戀氀攀攀搀椀渀最 愀猀猀漀挀椀愀琀攀搀 眀椀琀栀 琀栀攀 挀漀渀挀漀洀椀琀愀渀琀 甀猀攀 漀昀 琀爀愀稀漀搀漀渀攀 愀渀搀 一匀䄀䤀䐀猀Ⰰ 愀猀瀀椀爀椀渀Ⰰ 漀爀 漀琀栀攀爀 搀爀甀最猀 琀栀愀琀 愀昀昀攀挀琀 挀漀愀最甀氀愀琀椀漀渀 漀爀 戀氀攀攀搀椀渀最 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀 ⠀㔀⸀㜀⤀崀⸀ഀഀ Warfarin There have been reports of altered (either increased or decreased) prothrombin times in taking both warfarin and trazodone.਍㰀⼀倀㸀ഀഀ ਍ഀഀ ਍ഀഀ ਍㰀⼀愀㸀ഀഀ

  ਍唀匀䔀 䤀一 匀倀䔀䌀䤀䘀䤀䌀 倀伀倀唀䰀䄀吀䤀伀一匀ഀഀ

  ਍㰀倀㸀ഀഀ Pregnancy਍㰀戀爀㸀㰀戀爀㸀ഀഀ Pregnancy Category C: ਍㰀戀爀㸀ഀഀ In rats, a dose of 210 mg/kg/day ATryn (5-6 times the human dose for pregnant women) administered during most of the pregnancy and entire lactation showed a slight but statistically significant increase in pup mortality in day one through day four when compared to concurrent control (90% compared to 94% viability index for 210 mg/kg/day versus control). This slight statistical difference does not reflect a true treatment-related effect. This same dose was shown to be safe in a second rat study when administered around parturition and during lactation where the no adverse effect level for dam and pups was 210 mg/kg/day.Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 – 50 times the proposed maximum human dose. There was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 – 50 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Oleptro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.਍㰀戀爀㸀㰀戀爀㸀ഀഀ Nursing Mothers਍㰀戀爀㸀㰀戀爀㸀ഀഀ Trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. Caution should be exercised when Oleptro is administered to a nursing woman.਍㰀戀爀㸀㰀戀爀㸀ഀഀ Pediatric Use਍㰀戀爀㸀㰀戀爀㸀ഀഀ Safety and effectiveness in the pediatric population have not been established [see Boxed Warning and Warnings and Precautions. Oleptro should not be used in children or adolescents.਍㰀戀爀㸀㰀戀爀㸀ഀഀ Geriatric Use਍㰀戀爀㸀㰀戀爀㸀ഀഀ Of 202 patients treated with Oleptro in the clinical trial, there were 9 patients older than 65. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical literature and experience with trazodone have not identified differences in responses between elderly and younger patients. However, as experience in the elderly with Oleptro is limited, it should be used with caution in geriatric patients.਍䄀渀琀椀搀攀瀀爀攀猀猀愀渀琀猀 栀愀瘀攀 戀攀攀渀 愀猀猀漀挀椀愀琀攀搀 眀椀琀栀 挀愀猀攀猀 漀昀 挀氀椀渀椀挀愀氀氀礀 猀椀最渀椀昀椀挀愀渀琀 栀礀瀀漀渀愀琀爀攀洀椀愀 椀渀 攀氀搀攀爀氀礀 瀀愀琀椀攀渀琀猀 眀栀漀 洀愀礀 戀攀 愀琀 最爀攀愀琀攀爀 爀椀猀欀 昀漀爀 琀栀椀猀 愀搀瘀攀爀猀攀 爀攀愀挀琀椀漀渀 嬀猀攀攀 圀愀爀渀椀渀最猀 愀渀搀 倀爀攀挀愀甀琀椀漀渀猀崀⸀ഀഀ
  ਍㰀戀㸀刀攀渀愀氀 䤀洀瀀愀椀爀洀攀渀琀㰀⼀戀㸀ഀഀ
  
  ਍伀氀攀瀀琀爀漀 栀愀猀 渀漀琀 戀攀攀渀 猀琀甀搀椀攀搀 椀渀 瀀愀琀椀攀渀琀猀 眀椀琀栀 爀攀渀愀氀 椀洀瀀愀椀爀洀攀渀琀⸀ 吀爀愀稀漀搀漀渀攀 猀栀漀甀氀搀 戀攀 甀猀攀搀 眀椀琀栀 挀愀甀琀椀漀渀 椀渀 琀栀椀猀 瀀漀瀀甀氀愀琀椀漀渀⸀ഀഀ
  
  ਍㰀戀㸀䠀攀瀀愀琀椀挀 䤀洀瀀愀椀爀洀攀渀琀㰀⼀戀㸀ഀഀ
  
  ਍伀氀攀瀀琀爀漀 栀愀猀 渀漀琀 戀攀攀渀 猀琀甀搀椀攀搀 椀渀 瀀愀琀椀攀渀琀猀 眀椀琀栀 栀攀瀀愀琀椀挀 椀洀瀀愀椀爀洀攀渀琀⸀ 吀爀愀稀漀搀漀渀攀 猀栀漀甀氀搀 戀攀 甀猀攀搀 眀椀琀栀 挀愀甀琀椀漀渀 椀渀 琀栀椀猀 瀀漀瀀甀氀愀琀椀漀渀⸀ഀഀ ਍ഀഀ ਍㰀⼀愀㸀ഀഀ

  ਍㰀⼀倀㸀ഀഀ

  ਍䐀刀唀䜀 䄀䈀唀匀䔀 䄀一䐀 䐀䔀倀䔀一䐀䔀一䌀䔀ഀഀ

  ਍㰀倀㸀ഀഀ Controlled Substance਍㰀戀爀㸀㰀戀爀㸀ഀഀ Oleptro is not a controlled substance.਍㰀戀㸀䄀戀甀猀攀㰀⼀戀㸀ഀഀ
  
  ਍䄀氀琀栀漀甀最栀 琀爀愀稀漀搀漀渀攀 栀礀搀爀漀挀栀氀漀爀椀搀攀 栀愀猀 渀漀琀 戀攀攀渀 猀礀猀琀攀洀愀琀椀挀愀氀氀礀 猀琀甀搀椀攀搀 椀渀 瀀爀攀挀氀椀渀椀挀愀氀 漀爀 挀氀椀渀椀挀愀氀 猀琀甀搀椀攀猀 昀漀爀 椀琀猀 瀀漀琀攀渀琀椀愀氀 昀漀爀 愀戀甀猀攀Ⰰ 渀漀 椀渀搀椀挀愀琀椀漀渀 漀昀 搀爀甀最ⴀ猀攀攀欀椀渀最 戀攀栀愀瘀椀漀爀 眀愀猀 猀攀攀渀 椀渀 琀栀攀 挀氀椀渀椀挀愀氀 猀琀甀搀椀攀猀 眀椀琀栀 伀氀攀瀀琀爀漀⸀ 䠀漀眀攀瘀攀爀Ⰰ 椀琀 椀猀 搀椀昀昀椀挀甀氀琀 琀漀 瀀爀攀搀椀挀琀 琀栀攀 攀砀琀攀渀琀 琀漀 眀栀椀挀栀 愀 䌀一匀ⴀ愀挀琀椀瘀攀 搀爀甀最 眀椀氀氀 戀攀 洀椀猀甀猀攀搀Ⰰ 搀椀瘀攀爀琀攀搀Ⰰ 愀渀搀 愀戀甀猀攀搀⸀ 䌀漀渀猀攀焀甀攀渀琀氀礀Ⰰ 瀀栀礀猀椀挀椀愀渀猀 猀栀漀甀氀搀 挀愀爀攀昀甀氀氀礀 攀瘀愀氀甀愀琀攀 瀀愀琀椀攀渀琀猀 昀漀爀 愀 栀椀猀琀漀爀礀 漀昀 搀爀甀最 愀戀甀猀攀 愀渀搀 昀漀氀氀漀眀 猀甀挀栀 瀀愀琀椀攀渀琀猀 挀氀漀猀攀氀礀Ⰰ 漀戀猀攀爀瘀椀渀最 琀栀攀洀 昀漀爀 猀椀最渀猀 漀昀 洀椀猀甀猀攀 漀爀 愀戀甀猀攀 漀昀 琀爀愀稀漀搀漀渀攀 栀礀搀爀漀挀栀氀漀爀椀搀攀 ⠀攀⸀最⸀Ⰰ 搀攀瘀攀氀漀瀀洀攀渀琀 漀昀 琀漀氀攀爀愀渀挀攀Ⰰ 椀渀挀爀攀洀攀渀琀愀琀椀漀渀 漀昀 搀漀猀攀Ⰰ 搀爀甀最ⴀ猀攀攀欀椀渀最 戀攀栀愀瘀椀漀爀⤀⸀ഀഀ
  ਍ഀഀ ਍㰀愀 渀愀洀攀㴀∀伀嘀䔀刀䐀伀匀䄀䜀䔀∀㸀ഀഀ ਍㰀倀㸀ഀഀ
  ਍㰀䠀㐀㸀ഀഀ OVERDOSAGE਍㰀⼀䠀㐀㸀ഀഀ

  ਍㰀戀㸀䠀甀洀愀渀 䔀砀瀀攀爀椀攀渀挀攀㰀⼀戀㸀ഀഀ
  
  ਍䤀琀 椀猀 攀砀瀀攀挀琀攀搀 琀栀愀琀 琀栀攀 栀攀愀氀琀栀 爀椀猀欀猀 愀猀猀漀挀椀愀琀攀搀 眀椀琀栀 漀瘀攀爀搀漀猀攀 漀昀 伀氀攀瀀琀爀漀 愀爀攀 洀漀猀琀 氀椀欀攀氀礀 猀椀洀椀氀愀爀 琀漀 琀栀漀猀攀 昀漀爀 琀爀愀稀漀搀漀渀攀 椀洀洀攀搀椀愀琀攀ⴀ爀攀氀攀愀猀攀 昀漀爀洀甀氀愀琀椀漀渀猀⸀ഀഀ
  
  ਍䐀攀愀琀栀 昀爀漀洀 漀瘀攀爀搀漀猀攀 栀愀猀 漀挀挀甀爀爀攀搀 椀渀 瀀愀琀椀攀渀琀猀 椀渀最攀猀琀椀渀最 琀爀愀稀漀搀漀渀攀 愀渀搀 漀琀栀攀爀 䌀一匀 搀攀瀀爀攀猀猀愀渀琀 搀爀甀最猀 挀漀渀挀甀爀爀攀渀琀氀礀 ⠀愀氀挀漀栀漀氀㬀 愀氀挀漀栀漀氀 愀渀搀 挀栀氀漀爀愀氀 栀礀搀爀愀琀攀 愀渀搀 搀椀愀稀攀瀀愀洀㬀 愀洀漀戀愀爀戀椀琀愀氀㬀 挀栀氀漀爀搀椀愀稀攀瀀漀砀椀搀攀㬀 漀爀 洀攀瀀爀漀戀愀洀愀琀攀⤀⸀ഀഀ
  
  ਍吀栀攀 洀漀猀琀 猀攀瘀攀爀攀 爀攀愀挀琀椀漀渀猀 爀攀瀀漀爀琀攀搀 琀漀 栀愀瘀攀 漀挀挀甀爀爀攀搀 眀椀琀栀 漀瘀攀爀搀漀猀攀 漀昀 琀爀愀稀漀搀漀渀攀 愀氀漀渀攀 栀愀瘀攀 戀攀攀渀 瀀爀椀愀瀀椀猀洀Ⰰ 爀攀猀瀀椀爀愀琀漀爀礀 愀爀爀攀猀琀Ⰰ 猀攀椀稀甀爀攀猀Ⰰ 愀渀搀 䔀䌀䜀 挀栀愀渀最攀猀Ⰰ 椀渀挀氀甀搀椀渀最 儀吀 瀀爀漀氀漀渀最愀琀椀漀渀⸀ 吀栀攀 爀攀愀挀琀椀漀渀猀 爀攀瀀漀爀琀攀搀 洀漀猀琀 昀爀攀焀甀攀渀琀氀礀 栀愀瘀攀 戀攀攀渀 搀爀漀眀猀椀渀攀猀猀 愀渀搀 瘀漀洀椀琀椀渀最⸀ 伀瘀攀爀搀漀猀愀最攀 洀愀礀 挀愀甀猀攀 愀渀 椀渀挀爀攀愀猀攀 椀渀 椀渀挀椀搀攀渀挀攀 漀爀 猀攀瘀攀爀椀琀礀 漀昀 愀渀礀 漀昀 琀栀攀 爀攀瀀漀爀琀攀搀 愀搀瘀攀爀猀攀 爀攀愀挀琀椀漀渀猀⸀ഀഀ Management of Overdose਍㰀戀爀㸀㰀戀爀㸀ഀഀ There is no specific antidote for Oleptro overdose.਍㰀戀爀㸀㰀戀爀㸀ഀഀ Treatment should consist of those general measures employed in the management of overdosage with any drug effective in the treatment of major depressive disorder.਍㰀戀爀㸀㰀戀爀㸀ഀഀ Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs.਍㰀戀爀㸀㰀戀爀㸀ഀഀ General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Forced diuresis may be useful in facilitating elimination of the drug.਍㰀戀爀㸀㰀戀爀㸀ഀഀ In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.਍㰀⼀瀀㸀ഀഀ ਍ഀഀ ਍㰀⼀愀㸀ഀഀ

  ਍㰀⼀倀㸀ഀഀ

  ਍䐀䔀匀䌀刀䤀倀吀䤀伀一ഀഀ

  ਍㰀倀㸀ഀഀ Oleptro (trazodone hydrochloride) is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water.਍㰀戀爀㸀㰀戀爀㸀ഀഀ Chemical Name: 2-[3-[4-(m-Chlorophenyl)-1-piperazinyl]propyl]-s-triazolo[4,3-a]pyridin-3(2H)-one monohydrochloride਍㰀戀爀㸀㰀戀爀㸀ഀഀ Structural Formula:਍㰀戀爀㸀㰀戀爀㸀ഀഀ ਍㰀戀爀㸀㰀戀爀㸀ഀഀ Molecular Formula: C₁₉H₂₂ClN_5O · HCl਍㰀戀㸀䴀漀氀攀挀甀氀愀爀 圀攀椀最栀琀㨀㰀⼀戀㸀 㐀　㠀⸀㌀㈀ഀഀ
  
  ਍伀氀攀瀀琀爀漀 琀愀戀氀攀琀猀 挀漀渀琀愀椀渀椀渀最 ㄀㔀　 洀最 漀爀 ㌀　　 洀最 漀昀 琀爀愀稀漀搀漀渀攀 栀礀搀爀漀挀栀氀漀爀椀搀攀 愀爀攀 搀攀猀椀最渀攀搀 琀漀 爀攀氀攀愀猀攀 琀栀攀椀爀 搀爀甀最 挀漀渀琀攀渀琀 漀瘀攀爀 愀 ㈀㐀ⴀ栀漀甀爀 瀀攀爀椀漀搀 愀渀搀 愀爀攀 椀渀琀攀渀搀攀搀 昀漀爀 漀渀挀攀ⴀ愀ⴀ搀愀礀 搀漀猀椀渀最⸀ഀഀ
  
  ਍㰀戀㸀䤀渀愀挀琀椀瘀攀 䤀渀最爀攀搀椀攀渀琀猀㨀㰀⼀戀㸀ഀഀ
  
  ਍䠀礀搀爀漀砀礀瀀爀漀瀀礀氀 搀椀猀琀愀爀挀栀 瀀栀漀猀瀀栀愀琀攀 ⠀䌀漀渀琀爀愀洀椀搀글⤀ 䠀礀瀀爀漀洀攀氀氀漀猀攀 匀漀搀椀甀洀 猀琀攀愀爀礀氀 昀甀洀愀爀愀琀攀 䌀漀氀氀漀椀搀愀氀 猀椀氀椀挀漀渀 搀椀漀砀椀搀攀 䤀爀漀渀 伀砀椀搀攀 夀攀氀氀漀眀 䤀爀漀渀 伀砀椀搀攀 刀攀搀 吀愀氀挀 倀漀氀礀攀琀栀礀氀攀渀攀 䜀氀礀挀漀氀 ㌀㌀㔀　 吀椀琀愀渀椀甀洀 䐀椀漀砀椀搀攀 倀漀氀礀瘀椀渀礀氀 䄀氀挀漀栀漀氀 䈀氀愀挀欀 椀渀欀 ⠀昀漀漀搀 最爀愀搀攀⤀㰀⼀瀀㸀ഀഀ ਍㰀愀 渀愀洀攀㴀∀䌀䰀䤀一䤀䌀䄀䰀开倀䠀䄀刀䴀∀㸀ഀഀ ਍㰀倀㸀ഀഀ
  ਍㰀䠀㐀㸀ഀഀ CLINICAL PHARMACOLOGY਍㰀⼀䠀㐀㸀ഀഀ

  ਍㰀戀㸀䴀攀挀栀愀渀椀猀洀 漀昀 䄀挀琀椀漀渀㰀⼀戀㸀ഀഀ
  
  ਍吀栀攀 洀攀挀栀愀渀椀猀洀 漀昀 琀爀愀稀漀搀漀渀攀ᤀ猠 愀渀琀椀搀攀瀀爀攀猀猀愀渀琀 愀挀琀椀漀渀 椀猀 渀漀琀 昀甀氀氀礀 甀渀搀攀爀猀琀漀漀搀Ⰰ 戀甀琀 椀猀 琀栀漀甀最栀琀 琀漀 戀攀 爀攀氀愀琀攀搀 琀漀 椀琀猀 瀀漀琀攀渀琀椀愀琀椀漀渀 漀昀 猀攀爀漀琀漀渀攀爀最椀挀 愀挀琀椀瘀椀琀礀 椀渀 琀栀攀 䌀一匀⸀ഀഀ
  
  ਍㰀戀㸀倀栀愀爀洀愀挀漀搀礀渀愀洀椀挀猀㰀⼀戀㸀ഀഀ
  
  ਍倀爀攀挀氀椀渀椀挀愀氀 猀琀甀搀椀攀猀 栀愀瘀攀 猀栀漀眀渀 琀栀愀琀 琀爀愀稀漀搀漀渀攀 猀攀氀攀挀琀椀瘀攀氀礀 椀渀栀椀戀椀琀猀 渀攀甀爀漀渀愀氀 爀攀甀瀀琀愀欀攀 漀昀 猀攀爀漀琀漀渀椀渀 愀渀搀 愀挀琀猀 愀猀 愀渀 愀渀琀愀最漀渀椀猀琀 愀琀 㔀ⴀ䠀吀ⴀ㈀䄀⼀㈀䌀 猀攀爀漀琀漀渀椀渀 爀攀挀攀瀀琀漀爀猀⸀ഀഀ
  
  ਍吀爀愀稀漀搀漀渀攀 椀猀 渀漀琀 愀 洀漀渀漀愀洀椀渀攀 漀砀椀搀愀猀攀 椀渀栀椀戀椀琀漀爀 愀渀搀Ⰰ 甀渀氀椀欀攀 愀洀瀀栀攀琀愀洀椀渀攀ⴀ琀礀瀀攀 搀爀甀最猀Ⰰ 搀漀攀猀 渀漀琀 猀琀椀洀甀氀愀琀攀 琀栀攀 挀攀渀琀爀愀氀 渀攀爀瘀漀甀猀 猀礀猀琀攀洀⸀ഀഀ
  
  ਍吀爀愀稀漀搀漀渀攀 愀渀琀愀最漀渀椀稀攀猀 愀氀瀀栀愀 ㄀ⴀ愀搀爀攀渀攀爀最椀挀 爀攀挀攀瀀琀漀爀猀Ⰰ 愀 瀀爀漀瀀攀爀琀礀 眀栀椀挀栀 洀愀礀 戀攀 愀猀猀漀挀椀愀琀攀搀 眀椀琀栀 瀀漀猀琀甀爀愀氀 栀礀瀀漀琀攀渀猀椀漀渀⸀ഀഀ
  
  ਍㰀戀㸀㄀㈀⸀㌀ 倀栀愀爀洀愀挀漀欀椀渀攀琀椀挀猀㰀⼀戀㸀ഀഀ
  
  ਍匀琀攀愀搀礀 猀琀愀琀攀 䄀唀䌀 漀昀 吀爀愀稀漀搀漀渀攀 椀猀 攀焀甀椀瘀愀氀攀渀琀 愀昀琀攀爀 愀搀洀椀渀椀猀琀爀愀琀椀漀渀 漀昀 吀爀愀稀漀搀漀渀攀 ㄀　　 洀最 椀洀洀攀搀椀愀琀攀 爀攀氀攀愀猀攀 ⠀䤀刀⤀ 琀栀爀攀攀 ⠀㌀⤀ 琀椀洀攀猀 愀 搀愀礀 ⠀洀攀愀渀 넀 匀䐀 䄀唀䌀猀猀 㴀 ㌀㌀　㔀㠀 넀 㠀　　㘀 渀最⨀栀⼀洀䰀⤀ 愀渀搀 伀氀攀瀀琀爀漀 ㌀　　 洀最 漀渀挀攀 搀愀椀氀礀 ⠀洀攀愀渀 넀 匀䐀 䄀唀䌀猀猀 㴀 ㈀㤀㄀㌀㄀ 넀 㤀㤀㌀㄀ 渀最⨀栀⼀洀䰀⤀ 昀漀爀 漀渀攀 眀攀攀欀⸀ 匀琀攀愀搀礀 匀琀愀琀攀 䌀洀愀砀 愀渀搀 䌀洀椀渀 漀昀 琀爀愀稀漀搀漀渀攀 眀攀爀攀 渀漀琀 攀焀甀椀瘀愀氀攀渀琀 愀昀琀攀爀 愀搀洀椀渀椀猀琀爀愀琀椀漀渀 漀昀 琀爀愀稀漀搀漀渀攀 ㄀　　 洀最 䤀刀 ㌀ 琀椀洀攀猀 愀 搀愀礀 ⠀洀攀愀渀 넀 匀䐀 䌀洀愀砀Ⰰ猀猀 㴀 ㌀㄀㄀㠀 넀 㜀㔀㠀 渀最⼀洀䰀Ⰰ 䌀洀椀渀Ⰰ猀猀 㴀 㠀㐀㌀ 넀 ㈀㜀㐀 渀最⼀洀䰀⤀ 愀渀搀 伀氀攀瀀琀爀漀 ㌀　　 洀最 漀渀挀攀 搀愀椀氀礀 ⠀洀攀愀渀 넀 匀䐀 䌀洀愀砀Ⰰ猀猀 㴀 ㄀㠀㄀㈀ 넀 㘀㈀㄀ 渀最⼀洀䰀Ⰰ 䌀洀椀渀Ⰰ猀猀 㴀 㘀㜀㐀 넀 ㌀㔀㔀 渀最⼀洀䰀⤀ 昀漀爀 漀渀攀 眀攀攀欀⸀ഀഀ
  
  ਍㰀甀㸀䄀戀猀漀爀戀琀椀漀渀㰀⼀甀㸀ഀഀ
  
  ਍吀爀愀稀漀搀漀渀攀 椀猀 眀攀氀氀 愀戀猀漀爀戀攀搀 愀昀琀攀爀 漀爀愀氀 愀搀洀椀渀椀猀琀爀愀琀椀漀渀Ⰰ 眀椀琀栀漀甀琀 猀攀氀攀挀琀椀瘀攀 氀漀挀愀氀椀稀愀琀椀漀渀 椀渀 愀渀礀 琀椀猀猀甀攀⸀ 䘀漀氀氀漀眀椀渀最 猀椀渀最氀攀ⴀ搀漀猀攀 愀搀洀椀渀椀猀琀爀愀琀椀漀渀 漀昀 伀氀攀瀀琀爀漀 ㌀　　 洀最 琀愀戀氀攀琀猀 甀渀搀攀爀 昀愀猀琀椀渀最 挀漀渀搀椀琀椀漀渀猀Ⰰ 愀 洀攀愀渀 瀀攀愀欀 琀爀愀稀漀搀漀渀攀 瀀氀愀猀洀愀 挀漀渀挀攀渀琀爀愀琀椀漀渀 ⠀䌀洀愀砀⤀ 漀昀 ㄀㄀㠀㠀 넀 ㌀㘀㈀ 渀最⼀洀䰀 眀愀猀 爀攀瀀漀爀琀攀搀 愀琀 愀 洀攀搀椀愀渀 吀洀愀砀 漀昀 㤀 栀漀甀爀猀 瀀漀猀琀ⴀ搀漀猀攀⸀ 圀栀攀渀 伀氀攀瀀琀爀漀 ㌀　　 洀最 琀愀戀氀攀琀猀 愀爀攀 琀愀欀攀渀 猀栀漀爀琀氀礀 愀昀琀攀爀 椀渀最攀猀琀椀漀渀 漀昀 愀 栀椀最栀ⴀ昀愀琀 洀攀愀氀Ⰰ 䌀洀愀砀 椀渀挀爀攀愀猀攀猀 戀礀 愀戀漀甀琀 㠀㘀─ 挀漀洀瀀愀爀攀搀 琀漀 琀愀欀椀渀最 椀琀 甀渀搀攀爀 昀愀猀琀椀渀最 挀漀渀搀椀琀椀漀渀猀⸀ 䠀漀眀攀瘀攀爀Ⰰ 䄀唀䌀　ⴀḀ•愀渀搀 吀洀愀砀 愀爀攀 渀漀琀 猀椀最渀椀昀椀挀愀渀琀氀礀 愀昀昀攀挀琀攀搀 戀礀 昀漀漀搀⸀ഀഀ
  
  ਍伀氀攀瀀琀爀漀 琀愀戀氀攀琀猀 愀爀攀 搀漀猀攀 瀀爀漀瀀漀爀琀椀漀渀愀氀 昀漀氀氀漀眀椀渀最 猀椀渀最氀攀ⴀ搀漀猀攀 愀搀洀椀渀椀猀琀爀愀琀椀漀渀 漀昀 搀漀猀攀猀 爀愀渀最椀渀最 昀爀漀洀 㜀㔀 洀最 琀漀 ㌀㜀㔀 洀最 愀猀 椀渀琀愀挀琀 漀爀 戀椀猀攀挀琀攀搀 琀愀戀氀攀琀猀⸀ഀഀ
  
  ਍㰀甀㸀䴀攀琀愀戀漀氀椀猀洀㰀⼀甀㸀ഀഀ
  
  ਍䤀渀 瘀椀琀爀漀 猀琀甀搀椀攀猀 椀渀 栀甀洀愀渀 氀椀瘀攀爀 洀椀挀爀漀猀漀洀攀猀 猀栀漀眀 琀栀愀琀 琀爀愀稀漀搀漀渀攀 椀猀 洀攀琀愀戀漀氀椀稀攀搀Ⰰ 瘀椀愀 漀砀椀搀愀琀椀瘀攀 挀氀攀愀瘀愀最攀Ⰰ 琀漀 愀渀 愀挀琀椀瘀攀 洀攀琀愀戀漀氀椀琀攀Ⰰ 洀ⴀ挀栀氀漀爀漀瀀栀攀渀礀氀瀀椀瀀攀爀愀稀椀渀攀 ⠀洀䌀䌀倀⤀ 戀礀 䌀夀倀㌀䄀㐀⸀ 伀琀栀攀爀 洀攀琀愀戀漀氀椀挀 瀀愀琀栀眀愀礀猀 琀栀愀琀 洀愀礀 戀攀 椀渀瘀漀氀瘀攀搀 椀渀 琀栀攀 洀攀琀愀戀漀氀椀猀洀 漀昀 琀爀愀稀漀搀漀渀攀 栀愀瘀攀 渀漀琀 戀攀攀渀 眀攀氀氀 挀栀愀爀愀挀琀攀爀椀稀攀搀⸀ 吀爀愀稀漀搀漀渀攀 椀猀 攀砀琀攀渀猀椀瘀攀氀礀 洀攀琀愀戀漀氀椀稀攀搀㬀 氀攀猀猀 琀栀愀渀 ㄀─ 漀昀 愀渀 漀爀愀氀 搀漀猀攀 椀猀 攀砀挀爀攀琀攀搀 甀渀挀栀愀渀最攀搀 椀渀 琀栀攀 甀爀椀渀攀⸀ഀഀ
  
  ਍㰀甀㸀䔀氀椀洀椀渀愀琀椀漀渀㰀⼀甀㸀ഀഀ
  
  ਍䔀氀椀洀椀渀愀琀椀漀渀 椀猀 瀀爀攀搀漀洀椀渀愀渀琀氀礀 爀攀渀愀氀Ⰰ 眀椀琀栀 㜀　 琀漀 㜀㔀─ 漀昀 愀渀 漀爀愀氀 搀漀猀攀 戀攀椀渀最 爀攀挀漀瘀攀爀攀搀 椀渀 琀栀攀 甀爀椀渀攀 眀椀琀栀椀渀 琀栀攀 昀椀爀猀琀 㜀㈀ 栀漀甀爀猀 漀昀 椀渀最攀猀琀椀漀渀⸀ 䘀漀氀氀漀眀椀渀最 猀椀渀最氀攀ⴀ搀漀猀攀 愀搀洀椀渀椀猀琀爀愀琀椀漀渀 漀昀 伀氀攀瀀琀爀漀 ㌀　　 洀最 琀愀戀氀攀琀猀Ⰰ 愀 洀攀愀渀 愀瀀瀀愀爀攀渀琀 琀攀爀洀椀渀愀氀 栀愀氀昀ⴀ氀椀昀攀 漀昀 ㄀　 栀漀甀爀猀 眀愀猀 爀攀瀀漀爀琀攀搀⸀ഀഀ
  
  ਍㰀甀㸀倀爀漀琀攀椀渀 䈀椀渀搀椀渀最㰀⼀甀㸀ഀഀ
  
  ਍吀爀愀稀漀搀漀渀攀 椀猀 㠀㤀 琀漀 㤀㔀─ 瀀爀漀琀攀椀渀 戀漀甀渀搀 椀渀 瘀椀琀爀漀 愀琀 挀漀渀挀攀渀琀爀愀琀椀漀渀猀 愀琀琀愀椀渀攀搀 眀椀琀栀 琀栀攀爀愀瀀攀甀琀椀挀 搀漀猀攀猀 椀渀 栀甀洀愀渀猀⸀ഀഀ

  ਍ഀഀ ਍㰀愀 渀愀洀攀㴀∀一伀一䌀䰀䤀一䤀䌀䄀䰀∀㸀ഀഀ ਍㰀倀㸀ഀഀ
  ਍㰀䠀㐀㸀ഀഀ NONCLINICAL TOXICOLOGY਍㰀⼀䠀㐀㸀ഀഀ

  ਍㰀戀㸀䌀愀爀挀椀渀漀最攀渀攀猀椀猀Ⰰ 䴀甀琀愀最攀渀攀猀椀猀Ⰰ 䤀洀瀀愀椀爀洀攀渀琀 漀昀 䘀攀爀琀椀氀椀琀礀㰀⼀戀㸀ഀഀ
  
  ਍漀爀愀氀 搀漀猀攀猀 甀瀀 琀漀 ㌀　　 洀最⼀欀最 昀漀爀 ㄀㠀 洀漀渀琀栀猀⸀ഀഀ

  ਍ഀഀ ਍ഀഀ ਍㰀⼀愀㸀ഀഀ

  ਍㰀⼀倀㸀ഀഀ

  ਍䌀䰀䤀一䤀䌀䄀䰀 匀吀唀䐀䤀䔀匀ഀഀ

  ਍㰀倀㸀ഀഀ The efficacy and safety of Oleptro were established from trials of the immediate release formulation as well as a randomized, double-blind, two-arm study comparing the efficacy and safety of Oleptro and placebo in the treatment of unipolar major depressive disorder.਍㰀戀爀㸀㰀戀爀㸀ഀഀ The Oleptro trial was a multi-center, parallel-design study of outpatients meeting DSM-IV criteria for major depressive disorder (MDD). This study consisted of a Baseline Phase (screening and washout) and a double-blind Randomized Phase (randomization to Oleptro (n=206) or placebo (n=206)). The total study duration, including washout of prohibited medications, was approximately 11 weeks; the total duration of the randomized treatment phase was 8 weeks (titration: 2 weeks and treatment: 6 weeks). Rescue medication for MDD was not allowed during the study.਍㰀戀爀㸀㰀戀爀㸀ഀഀ Patients were between 18 and 80 years of age. Of this population, 25 patients were 65 years old or older. The mean age of the population was 44 years; 64% were female.਍㰀戀爀㸀㰀戀爀㸀ഀഀ The primary efficacy endpoint in this study was change from baseline in HAMD-17 total score.਍㰀戀爀㸀㰀戀爀㸀ഀഀ A statistically significant difference in the HAMD-17 score was demonstrated at 8 weeks between the Oleptro group and the placebo group.਍㰀⼀倀㸀ഀഀ ਍ഀഀ ਍ഀഀ ਍㰀⼀愀㸀ഀഀ

  ਍㰀⼀倀㸀ഀഀ

  ਍䠀伀圀 匀唀倀倀䰀䤀䔀䐀ഀഀ

  ਍㰀倀㸀ഀഀ Oleptro 150 mg is a yellowish-beige, capsule-shaped extended-release tablet, coated and scored on both sides with DDS 080 printed on one side. It is supplied as follows:਍㰀甀氀㸀㰀氀椀㸀䈀漀琀琀氀攀猀 漀昀 ㌀　 琀愀戀氀攀琀猀 一䐀䌀 㐀㌀㔀㤀㔀ⴀ　㠀　ⴀ　㌀ഀഀ
• Bottles of 90 tablets NDC 43595-080-90਍㰀氀椀㸀䈀漀琀琀氀攀猀 漀昀 㔀　　 琀愀戀氀攀琀猀 一䐀䌀 㐀㌀㔀㤀㔀ⴀ　㠀　ⴀ㔀　ഀഀ
• Blister packs of 30 tablets NDC 43595-080-30

• Bottles of 30 tablets NDC 43595-081-03਍㰀氀椀㸀䈀漀琀琀氀攀猀 漀昀 㤀　 琀愀戀氀攀琀猀 一䐀䌀 㐀㌀㔀㤀㔀ⴀ　㠀㄀ⴀ㤀　ഀഀ
• Bottles of 500 tablets NDC 43595-081-50਍㰀氀椀㸀䈀氀椀猀琀攀爀 瀀愀挀欀猀 漀昀 ㌀　 琀愀戀氀攀琀猀 一䐀䌀 㐀㌀㔀㤀㔀ⴀ　㠀㄀ⴀ㌀　㰀⼀甀氀㸀ഀഀ Store at room temperature (15 – 30ºC) in tight, light-resistant containers.਍㰀⼀倀㸀ഀഀ ਍㰀愀 渀愀洀攀㴀∀匀吀伀刀䄀䜀䔀∀㸀ഀഀ ਍㰀倀㸀ഀഀ
  ਍㰀䠀㐀㸀ഀഀ ਍㰀⼀䠀㐀㸀ഀഀ

  ਍ഀഀ
  
  ਍ഀഀ
  ਍㰀⼀倀㸀ഀഀ ਍ഀഀ ਍㰀愀 渀愀洀攀㴀∀倀䄀吀䤀䔀一吀开䌀伀唀一匀䔀䰀䤀一䜀∀㸀ഀഀ ਍㰀倀㸀ഀഀ

  ਍㰀䠀㐀㸀ഀഀ PATIENT COUNSELING INFORMATION਍㰀⼀䠀㐀㸀ഀഀ

  ਍㰀戀㸀䤀渀昀漀爀洀愀琀椀漀渀 昀漀爀 倀愀琀椀攀渀琀猀㰀⼀戀㸀ഀഀ
  
  ਍倀爀攀猀挀爀椀戀攀爀猀 漀爀 漀琀栀攀爀 栀攀愀氀琀栀 瀀爀漀昀攀猀猀椀漀渀愀氀猀 猀栀漀甀氀搀 椀渀昀漀爀洀 瀀愀琀椀攀渀琀猀Ⰰ 琀栀攀椀爀 昀愀洀椀氀椀攀猀Ⰰ 愀渀搀 琀栀攀椀爀 挀愀爀攀最椀瘀攀爀猀 愀戀漀甀琀 琀栀攀 戀攀渀攀昀椀琀猀 愀渀搀 爀椀猀欀猀 愀猀猀漀挀椀愀琀攀搀 眀椀琀栀 琀爀攀愀琀洀攀渀琀 眀椀琀栀 伀氀攀瀀琀爀漀 愀渀搀 猀栀漀甀氀搀 挀漀甀渀猀攀氀 琀栀攀洀 椀渀 椀琀猀 愀瀀瀀爀漀瀀爀椀愀琀攀 甀猀攀⸀ഀഀ
  
  ਍倀愀琀椀攀渀琀猀 猀栀漀甀氀搀 戀攀 眀愀爀渀攀搀 琀栀愀琀㨀ഀഀ ƒ

  • There is a potential for increased risk of suicidal thoughts especially in children, teenagers and young adults.਍㰀氀椀㸀吀栀攀 昀漀氀氀漀眀椀渀最 猀礀洀瀀琀漀洀猀 猀栀漀甀氀搀 戀攀 爀攀瀀漀爀琀攀搀 琀漀 琀栀攀 瀀栀礀猀椀挀椀愀渀㨀 愀渀砀椀攀琀礀Ⰰ 愀最椀琀愀琀椀漀渀Ⰰ 瀀愀渀椀挀 愀琀琀愀挀欀猀Ⰰ 椀渀猀漀洀渀椀愀Ⰰ 椀爀爀椀琀愀戀椀氀椀琀礀Ⰰ 栀漀猀琀椀氀椀琀礀Ⰰ 愀最最爀攀猀猀椀瘀攀渀攀猀猀Ⰰ 椀洀瀀甀氀猀椀瘀椀琀礀Ⰰ 愀欀愀琀栀椀猀椀愀Ⰰ 栀礀瀀漀洀愀渀椀愀 愀渀搀 洀愀渀椀愀⸀ഀഀ
  • They should inform their physician if they have a history of bipolar disorder, cardiac disease or myocardial infarction.਍㰀氀椀㸀匀攀爀漀琀漀渀椀渀 猀礀渀搀爀漀洀攀 挀漀甀氀搀 漀挀挀甀爀 愀渀搀 猀礀洀瀀琀漀洀猀 洀愀礀 椀渀挀氀甀搀攀 挀栀愀渀最攀猀 椀渀 洀攀渀琀愀氀 猀琀愀琀甀猀 ⠀攀⸀最⸀Ⰰ 愀最椀琀愀琀椀漀渀Ⰰ 栀愀氀氀甀挀椀渀愀琀椀漀渀猀Ⰰ 愀渀搀 挀漀洀愀⤀Ⰰ 愀甀琀漀渀漀洀椀挀 椀渀猀琀愀戀椀氀椀琀礀 ⠀攀⸀最⸀Ⰰ 琀愀挀栀礀挀愀爀搀椀愀Ⰰ 氀愀戀椀氀攀 戀氀漀漀搀 瀀爀攀猀猀甀爀攀Ⰰ 愀渀搀 栀礀瀀攀爀琀栀攀爀洀椀愀⤀Ⰰ 渀攀甀爀漀洀甀猀挀甀氀愀爀 愀戀攀爀爀愀琀椀漀渀猀 ⠀攀⸀最⸀Ⰰ 栀礀瀀攀爀爀攀昀氀攀砀椀愀Ⰰ 椀渀挀漀漀爀搀椀渀愀琀椀漀渀⤀ 愀渀搀⼀漀爀 最愀猀琀爀漀椀渀琀攀猀琀椀渀愀氀 猀礀洀瀀琀漀洀猀 ⠀攀⸀最⸀Ⰰ 渀愀甀猀攀愀Ⰰ 瘀漀洀椀琀椀渀最Ⰰ 愀渀搀 搀椀愀爀爀栀攀愀⤀⸀ഀഀ
  • Trazodone hydrochloride has been associated with the occurrence of priapism.਍㰀氀椀㸀吀栀攀爀攀 椀猀 愀 瀀漀琀攀渀琀椀愀氀 昀漀爀 栀礀瀀漀琀攀渀猀椀漀渀Ⰰ 椀渀挀氀甀搀椀渀最 漀爀琀栀漀猀琀愀琀椀挀 栀礀瀀漀琀攀渀猀椀漀渀 愀渀搀 猀礀渀挀漀瀀攀⸀ഀഀ
  • There is a potential risk of bleeding (including life-threatening hemorrhages) and bleeding related events (including ecchymosis, hematoma, epistaxis, and petechiae) with the concomitant use of trazodone hydrochloride and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding.਍㰀氀椀㸀圀椀琀栀搀爀愀眀愀氀 猀礀洀瀀琀漀洀猀 椀渀挀氀甀搀椀渀最 愀渀砀椀攀琀礀Ⰰ 愀最椀琀愀琀椀漀渀 愀渀搀 猀氀攀攀瀀 搀椀猀琀甀爀戀愀渀挀攀猀Ⰰ 栀愀瘀攀 戀攀攀渀 爀攀瀀漀爀琀攀搀 眀椀琀栀 琀爀愀稀漀搀漀渀攀⸀ 䌀氀椀渀椀挀愀氀 攀砀瀀攀爀椀攀渀挀攀 猀甀最最攀猀琀猀 琀栀愀琀 琀栀攀 搀漀猀攀 猀栀漀甀氀搀 戀攀 最爀愀搀甀愀氀氀礀 爀攀搀甀挀攀搀⸀㰀⼀甀氀㸀ഀഀ
    
    Patients should be counseled that:਍茀㰀甀氀㸀㰀氀椀㸀伀氀攀瀀琀爀漀 洀愀礀 挀愀甀猀攀 猀漀洀渀漀氀攀渀挀攀 漀爀 猀攀搀愀琀椀漀渀 愀渀搀 洀愀礀 椀洀瀀愀椀爀 琀栀攀 洀攀渀琀愀氀 愀渀搀⼀漀爀 瀀栀礀猀椀挀愀氀 愀戀椀氀椀琀礀 爀攀焀甀椀爀攀搀 昀漀爀 琀栀攀 瀀攀爀昀漀爀洀愀渀挀攀 漀昀 瀀漀琀攀渀琀椀愀氀氀礀 栀愀稀愀爀搀漀甀猀 琀愀猀欀猀⸀ 倀愀琀椀攀渀琀猀 猀栀漀甀氀搀 戀攀 挀愀甀琀椀漀渀攀搀 愀戀漀甀琀 漀瀀攀爀愀琀椀渀最 栀愀稀愀爀搀漀甀猀 洀愀挀栀椀渀攀爀礀Ⰰ 椀渀挀氀甀搀椀渀最 愀甀琀漀洀漀戀椀氀攀猀 甀渀琀椀氀 琀栀攀礀 愀爀攀 爀攀愀猀漀渀愀戀氀礀 挀攀爀琀愀椀渀 琀栀愀琀 琀栀攀 搀爀甀最 琀爀攀愀琀洀攀渀琀 搀漀攀猀 渀漀琀 愀昀昀攀挀琀 琀栀攀洀⸀ഀഀ ƒ
  • Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.਍茀 㰀氀椀㸀圀漀洀攀渀 眀栀漀 椀渀琀攀渀搀 琀漀 戀攀挀漀洀攀 瀀爀攀最渀愀渀琀 漀爀 眀栀漀 愀爀攀 戀爀攀愀猀琀昀攀攀搀椀渀最 猀栀漀甀氀搀 搀椀猀挀甀猀猀 眀椀琀栀 愀 瀀栀礀猀椀挀椀愀渀 眀栀攀琀栀攀爀 琀栀攀礀 猀栀漀甀氀搀 挀漀渀琀椀渀甀攀 琀漀 甀猀攀 伀氀攀瀀琀爀漀Ⰰ 猀椀渀挀攀 甀猀攀 椀渀 瀀爀攀最渀愀渀琀 愀渀搀 渀甀爀猀椀渀最 眀漀洀攀渀 椀猀 渀漀琀 爀攀挀漀洀洀攀渀搀攀搀⸀ഀഀ ƒ
    
    Important Administration Instructions:ƒ਍茀㰀甀氀㸀㰀戀爀㸀㰀氀椀㸀伀氀攀瀀琀爀漀 猀栀漀甀氀搀 戀攀 猀眀愀氀氀漀眀攀搀 眀栀漀氀攀 漀爀 戀爀漀欀攀渀 椀渀 栀愀氀昀 愀氀漀渀最 琀栀攀 猀挀漀爀攀 氀椀渀攀⸀ഀഀ ƒ
  • In order to maintain its controlled-release properties, it should not be chewed or crushed.਍茀㰀氀椀㸀 伀氀攀瀀琀爀漀 猀栀漀甀氀搀 戀攀 琀愀欀攀渀 愀琀 琀栀攀 猀愀洀攀 琀椀洀攀 攀瘀攀爀礀 搀愀礀Ⰰ 椀渀 琀栀攀 氀愀琀攀 攀瘀攀渀椀渀最 瀀爀攀昀攀爀愀戀氀礀 愀琀 戀攀搀琀椀洀攀Ⰰ 漀渀 愀渀 攀洀瀀琀礀 猀琀漀洀愀挀栀⸀茀㰀⼀甀氀㸀ഀഀ
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    ਍㰀⼀倀㸀ഀഀ

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