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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 in adults.

    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) Up to 400mg/day in divided doses. (Inpatient) 600mg/day in divided doses. Once adequate response is achieved, may 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 maintenance treatment. May administer major portion of daily dose at hs or reduce dose if drowsiness occurs.

    HOW SUPPLIED

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

    WARNINGS/PRECAUTIONS

    Monitor for withdrawal symptoms when discontinuing treatment; gradually reduce dose whenever possible. Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions reported; d/c immediately if symptoms occur and initiate supportive symptomatic treatment. May precipitate a mixed/manic episode in patients at risk for bipolar disorder. Not approved for treatment of bipolar depression. May cause QT/QTc interval prolongation and torsades de pointes. Not recommended 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. Priapism reported; caution in men with conditions that may predispose to priapism (eg, sickle cell anemia, multiple myeloma, leukemia) or with penile anatomical deformation (eg, angulation, cavernosal fibrosis, Peyronie's disease); d/c with erection lasting >6 hrs (painful or not). Hyponatremia may occur; caution in elderly and volume-depleted patients. Consider discontinuation in patients with symptomatic hyponatremia and institute appropriate medical intervention. May cause somnolence or sedation and may impair mental/physical abilities. Pupillary dilation that occurs following use may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Caution with hepatic/renal impairment and in elderly.

    ADVERSE REACTIONS

    Somnolence/sedation, dizziness, constipation, blurred vision, dry mouth, headache, nervousness, N/V, fatigue, abdominal/gastric disorder, nasal/sinus congestion, musculoskeletal aches/pains.

    DRUG INTERACTIONS

    Increased risk of serotonin syndrome or NMS-like reactions when used concomitantly with other serotonergic drugs (eg, SSRIs, SNRIs, triptans), and with drugs that impair metabolism of serotonin, antipsychotics, or other dopamine antagonists; d/c trazodone and any concomitant serotonergic agent immediately and initiate supportive symptomatic treatment. Caution with other drugs that may affect the neurotransmitter systems. Not recommended with serotonin precursors (eg, tryptophan). CYP3A4 inhibitors (eg, ritonavir, ketoconazole, indinavir) may increase levels with the potential for adverse effects. Potent CYP3A4 inhibitors may increase risk of cardiac arrhythmia; consider lower dose of trazodone. CYP3A4 inducers (eg, carbamazepine) may decrease levels; monitor to determine if a trazodone dose increase is required. Increased serum digoxin or phenytoin levels reported; monitor serum levels and adjust dosages as needed. Should not be used with an MAOI or within 14 days of discontinuing an MAOI; allow at least 14 days after stopping trazodone before starting 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 for potential risk of bleeding and use caution with NSAIDs, aspirin, and other drugs that affect coagulation or bleeding. May increase risk of hyponatremia with diuretics. Increased risk of cardiac arrhythmia with drugs that prolong QT interval.

    PREGNANCY

    Category C, caution in nursing.

    MECHANISM OF ACTION

    Triazolopyridine derivative; 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 activity as an antagonist at 5-HT-2A/2C serotonin receptors.

    PHARMACOKINETICS

    Absorption: Well-absorbed; Tmax=1 hr (fasted), 2 hrs (fed). Distribution: Plasma protein binding (89%-95%); found in breast milk. 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), cardiac disease (eg, recent MI), conditions that may predispose to priapism, penile anatomical deformation, susceptibility to angle closure glaucoma, volume depletion, hepatic/renal impairment, pregnancy/nursing status, and possible drug interactions.

    MONITORING

    Monitor for signs/symptoms of clinical worsening, suicidality, unusual changes in behavior, serotonin syndrome, NMS-like reactions, angle closure glaucoma, QT/QTc interval prolongation, cardiac arrhythmias, hypotension, syncope, bleeding events, priapism, hyponatremia, withdrawal symptoms, and other adverse reactions. Periodically reassess to determine the continued need for maintenance treatment.

    PATIENT COUNSELING

    Advise patients, families, and caregivers about the benefits and risks of treatment and instruct on appropriate use. Inform that drug may cause mild pupillary dilation, which in susceptible individuals, may lead to an episode of angle closure glaucoma; advise patients to have themselves be examined to determine whether they are susceptible, and have a prophylactic procedure (eg, iridectomy), if susceptible. Instruct to notify physician if signs of clinical worsening, changes in behavior, or suicidality occur. Inform that withdrawal symptoms (eg, anxiety, agitation, sleep disturbances) may occur. Caution about the risk of serotonin syndrome. Caution against performing potentially hazardous tasks (eg, operating machinery, driving) until accustomed to effects of medication. Instruct to notify physician if pregnant, intending to become pregnant, or breastfeeding. Instruct men to immediately d/c therapy and seek emergency medical attention if erection lasts >6 hrs, whether painful or not.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Take shortly after a meal or light snack. Swallow tabs whole or administer as a half tab by breaking the tab along the score line. Storage: 20-25°C (68-77°F); excursions permitted from 15-30°C (59-86°F).