trazodone hydrochloride

Apo-Trazodone, Dom-Trazodone, Gen-Trazodone, Molipaxin, Novo-Trazodone, Nu-Trazodone, Oleptro, PHL-Trazodone, PMS-Trazodone, Ratio-Trazodone, Trazorel

Pharmacologic class: Triazolopyridine derivative

Therapeutic class: Antidepressant

Pregnancy risk category C

FDA Box Warning

Drug may increase risk of suicidal thinking and behavior in children and adolescents with major depressive disorder and other psychiatric disorders. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family and caregivers to observe patient closely and communicate with prescriber as needed.

Drug isn't approved for use in pediatric patients.

Action

Unclear. Thought to selectively inhibit serotonin and norepinephrine uptake in brain.

Availability

Tablets: 50 mg, 100 mg, 150 mg, 300 mg

Tablets (extended-release, bisectable): 150 mg, 300 mg

Indications and dosages

➣ Major depression

Adults: 150 mg/day P.O. (immediate-release) in three divided doses; may increase by 50 mg/day q 3 to 4 days until desired response occurs. Don't exceed 400 mg/day in outpatient or 600 mg/day in hospitalized patient. Or, 150 mg P.O. (extended-release) daily; may increase by 75 mg/day q 3 days. Don't exceed 375 mg/day.

Dosage adjustment

• Concurrent use of antihypertensives

Off-label uses

• Alcohol dependence

• Cocaine withdrawal

• Anxiety neurosis

• Insomnia

Contraindications

• Hypersensitivity to drug

• None (Oleptro)

Precautions

Use cautiously in:

• cardiovascular disease, severe hepatic or renal disease, suicidal behavior or ideation

• initial recovery period after myocardial infarction (not recommended)

• concurrent use of drugs that increase QT interval, antidopaminergic agents including antipsychotics, or nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation (avoid use)

• concurrent use or within 14 days of monoamine oxidase (MAO) inhibitors (avoid use)

• concurrent use of selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5-hydroxytryptamine receptor agonist such as triptan, or serotonin precursors such as tryptophan (not recommended)

• elderly patients

• pregnant or breastfeeding patients

• children (safety not established).

Administration

• Give immediate-release tablets after meals or snacks. Give extended-release tablets whole or broken in half along score line at same time every day in late evening or at bedtime, on an empty stomach.

• Know that drug is often used in conjunction with psychotherapy.

• Be aware that when discontinuing extended-release tablets, gradual dosage reduction is recommended.

See Don't administer within 14 days of MAO inhibitor use.

Adverse reactions

CNS: drowsiness, confusion, dizziness, fatigue, hallucinations, headache, insomnia, nightmares, slurred speech, syncope, weakness, tremor, activation of mania or hypomania, suicidal behavior or ideation (especially in child or adolescent), neuroleptic malignant syndrome-like reactions

CV: chest pain, orthostatic hypotension, hypotension, hypertension, palpitations, tachycardia, arrhythmias, prolonged QT interval

EENT: blurred vision, tinnitus

GI: nausea, vomiting, diarrhea, constipation, excessive salivation, flatulence, dry mouth

GU: urinary frequency, hematuria, erectile dysfunction, priapism

Hematologic: anemia, bleeding, leukopenia

Metabolic: hyponatremia

Musculoskeletal: myalgia

Skin: rash

Other: serotonin syndrome

Interactions

Drug-drug. Antihypertensives: additive hypotension

Aspirin, NSAIDs, other drugs that affect coagulation: increased risk of bleeding

CYP3A4 inducers (such as carbamazepine): increased risk of decreased trazodone plasma concentration

CYP3A4 inhibitors (such as indinavir, itraconazole, ketoconazole): increased risk of substantial increases in trazodone plasma concentration and cardiac arrhythmias

Digoxin, phenytoin: increased blood levels of these drugs

Drugs that prolong QT interval (such as amiodarone, fluconazole, fluoxetine, imipramine): increased risk of torsades de pointes, with sudden, unexplained death

MAO inhibitors: risk of fatal reactions, including hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuation in vital signs, and mental status changes

Other CNS depressants (such as opioid analgesics, sedative-hypnotics): additive CNS depression

Serotonergics (including SNRIs, SSRIs, triptans): increased risk of serotonin syndrome

Warfarin: risk of increased or decreased prothrombin time

Drug-diagnostic tests. Alkaline phosphatase, bilirubin, glucose: increased levels

Urinary catecholamines: false increases

Serum sodium, urinary 5-hydroxyindole acetic acid, vanillylmandelic acid: decreased levels

St. John's wort: increased risk of serotonergic effects (including serotonin syndrome)

Drug-behaviors. Alcohol use: additive CNS depression and hypotension

Patient monitoring

See Monitor vital signs and ECG. Be aware that drug is known to prolong QT/QTc interval; some drugs that prolong QT/QTc interval can cause torsades de pointes, with sudden, unexplained death.

See Monitor neurologic status. Report significant adverse reactions, particularly signs and symptoms of neuroleptic malignant syndrome-like reactions (hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes).

• Watch for signs and symptoms of serotonin syndrome, including mental status changes (such as agitation, hallucinations, and coma), autonomic instability (such as tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (such as hyperreflexia, incoordination), or GI symptoms (such as nausea, vomiting, and diarrhea).

See Assess patient's mood frequently. Stay alert for worsening depression and suicidal ideation.

• Watch for drug hoarding or overuse.

• When discontinuing extended-release tablets, taper dosage and watch for such symptoms as anxiety and sleep disturbance.

Patient teaching

• Tell patient to take immediate-release tablets with meals or snacks to improve drug absorption.

• Tell patient to take extended-release tablets at same time every day in late evening or at bedtime, on an empty stomach. Advise patient to swallow extended-release tablets whole or broken in half along the score line, and not to chew or crush them.

• Instruct patient to take only as prescribed. Caution him not to overuse or hoard drug.

• Advise patient (and significant other as appropriate) to monitor his mood. Explain that drug should ease depression.

See Caution patient (and parent or significant other) to immediately report suicidal thoughts or behavior, especially in child or adolescent.

• Tell patient drug may cause significant adverse reactions. Instruct him to report priapism, hallucinations, fainting spells, and other serious problems.

• Instruct patient not to take over-the-counter drugs or drink alcohol during drug therapy without consulting prescriber.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, vision, and alertness. Reassure him that dizziness and drowsiness usually subside after first few weeks.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

trazodone hydrochloride

trazodone hydrochloride