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  • Trazodone
    (Trazodone HCl) - Various

    BOXED WARNING

    Antidepressants increased the risk 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. Monitor and observe closely for clinical worsening, suicidality, or unusual changes in behavior. Not approved for use in pediatric patients.

    THERAPEUTIC CLASS

    Triazolopyridine derivative

    DEA CLASS

    RX

    INDICATIONS

    Treatment of MDD.

    ADULT DOSAGE

    Adults: Initial: 150mg/day in divided doses after a meal or light snack. Titrate: May increase by 50mg/day every 3-4 days. Max: (Outpatient) 400mg/day in divided doses. (Inpatient) 600mg/day in divided doses. Once adequate response is achieved, reduce dose gradually, with subsequent adjustment, depending on therapeutic response. Maint: Generally recommended to continue treatment for several months after an initial response. Maintain on the lowest effective dose and periodically reassess to determine the continued need for maint treatment. Administer major portion of daily dose at hs or reduce dose if drowsiness occurs.

    HOW SUPPLIED

    Tab: 50mg*, 100mg*, 150mg*, 300mg* *scored

    WARNINGS/PRECAUTIONS

    May precipitate mixed/manic episodes in patients at risk for bipolar disorder. Not approved for treatment of bipolar depression. Monitor withdrawal symptoms while d/c treatment; gradually reduce dose whenever possible. Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions reported; d/c immediately and initiate supportive symptomatic treatment. May cause QT/QTc interval prolongation and torsades de pointes. Not for use during initial recovery phase of myocardial infarction (MI). Caution with cardiac disease; may cause cardiac arrhythmias. Hypotension, including orthostatic hypotension and syncope, reported. May increase risk of bleeding events. Rare cases of priapism reported; caution in men with conditions that may predispose to priapism (eg, sickle cell anemia, multiple myeloma, or leukemia) or with penile anatomical deformation (eg, angulation, cavernosal fibrosis, or Peyronie's disease); d/c with erection lasting >6 hrs (painful or not). Hyponatremia may occur; d/c and institute appropriate medical intervention. May cause somnolence or sedation and may impair physical/mental abilities. Withdrawal symptoms, including anxiety, agitation, and sleep disturbances, reported. Caution with hepatic/renal impairment and elderly.

    ADVERSE REACTIONS

    Drowsiness, dry mouth, headache, nervousness, N/V, blurred vision, abdominal/gastric disorder, nasal/sinus congestion, musculoskeletal aches/pains, tremors.

    DRUG INTERACTIONS

    May cause serotonin syndrome or NMS-like reactions with serotonergic drugs (eg, SSRIs, SNRIs, triptans), drugs which impair serotonin metabolism, antipsychotics, or other dopamine antagonists; d/c immediately and initiate therapy if these occur. Not recommended with serotonin precursors (eg, tryptophan). CYP3A4 inhibitors (eg, ritonavir, ketoconazole, indinavir, itraconazole) may increase levels with the potential for adverse effects. Potent CYP3A4 inhibitors may increase risk of cardiac arrhythmia; consider lower dose of trazodone. Carbamazepine decreases levels; monitor to determine if a dose increase is required. Increased serum digoxin or phenytoin levels reported; monitor serum levels and adjust dose PRN. Do not use with MAOIs or within 14 days of d/c an MAOI. May enhance response to alcohol, barbiturates, and other CNS depressants. May alter PT in patients on warfarin. Concomitant use with an antihypertensive may require a dose reduction of the antihypertensive drug. Monitor and use caution with NSAIDs, aspirin, and other drugs that affect coagulation or bleeding. Increased risk of hyponatremia with diuretics. May increase risk of cardiac arrhythmia with drugs that prolong QT interval.

    PREGNANCY

    Category C, caution in nursing.

    MECHANISM OF ACTION

    Triazolopyridine derivative; mechanism not established. Suspected to be related to its potentiation of serotonergic activity in the CNS. Preclinical studies show selective inhibition of neuronal reuptake of serotonin and antagonism at 5-HT-2A/2C serotonin receptors.

    PHARMACOKINETICS

    Absorption: Well-absorbed; Tmax=1 hr (fasting), 2 hrs (fed). Distribution: Plasma protein binding (89%-95%). Metabolism: Liver (extensive); CYP3A4 via oxidative cleavage; m-chlorophenylpiperazine (active metabolite). Elimination: Urine (<1% unchanged).

    ASSESSMENT

    Assess for psychiatric history, including family history of suicide, bipolar disorder, and depression, for cardiac disease (eg, recent MI), conditions that may predispose to priapism, penile anatomical deformation, arrhythmias, renal/hepatic impairment, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for signs/symptoms of clinical worsening, suicidality, unusual changes in behavior, serotonin syndrome, QT/QTc interval prolongation, priapism, cardiac arrhythmias, orthostatic hypotension, syncope, bleeding events, hyponatremia, hepatic/renal function, withdrawal symptoms and for other adverse reactions.

    PATIENT COUNSELING

    Inform about the benefits and risks of therapy. Instruct patients and caregivers to notify physician if signs of clinical worsening, changes in behavior, or suicidality occur. Instruct men to immediately d/c use and contact physician if erection lasts >6 hrs, whether painful or not. Inform that withdrawal symptoms (eg, anxiety, agitation, and sleep disturbances) may occur. Caution against performing potentially hazardous tasks (eg, operating machinery/driving). Inform that therapy may enhance response to alcohol, barbiturates, and other CNS depressants. Instruct to notify physician if pregnant, intending to become pregnant, or nursing.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Take shortly after a meal or light snack. Swallow whole or half the tab along the score line. Storage: 20-25°C (68-77°F).