Trazodone Hydrochloride

Trade Names:
Trazodone Hydrochloride
- Tablets 50 mg
- Tablets 100 mg
- Tablets 150 mg
- Tablets 300 mg

Pharmacology

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Undetermined; may affect serotonin uptake at presynaptic neuronal membrane.

Pharmacokinetics

Absorption

Well absorbed after administration. T _max is 1 h on an empty stomach and 2 h with food.

Metabolism

Metabolized to an active metabolite, m-chlorophenyl-piperazine, by CYP3A4.

Elimination

Undergoes biphasic elimination with an initial phase (t _½ , 3 to 6 h) followed by a slower phase (t _½ , 5 to 9 h).

Indications and Usage

Treatment of depression.

Unlabeled Uses

Treatment of aggression, cocaine withdrawal, neurogenic pain, panic disorder.

Contraindications

Standard considerations.

Dosage and Administration

PO 150 mg/day in divided doses initially; increase in 50 mg increments up to max of 400 mg/day (outpatients) or 600 mg/day (inpatients).

Storage/Stability

Store in tight, light-resistant container at room temperature (56° to 86°F). Protect from temperatures above 104°F.

Drug Interactions

CNS depressant effects may be additive.

Plasma concentrations of trazodone and its active metabolite may be decreased, producing a decrease in therapeutic effect.

May increase trazodone levels, increasing adverse reactions.

Serum levels may be elevated by trazodone, increasing the pharmacologic and adverse reactions.

May cause additive hypotensive effects.

It is unknown whether interactions may take place. Initiate trazodone therapy cautiously if patient is currently taking, or has recently stopped taking, MAOIs.

Elevated trazodone serum concentrations have occurred, increasing the pharmacologic and toxic effects.

Increased C _max , AUC, and elimination t _½ , and decreased Cl of trazodone.

A serotonin syndrome, including altered consciousness, increased muscle tone, irritability, myoclonus, and shivering may occur.

Reports of increased and decreased PT.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension, hypotension, syncope, tachycardia/palpitation (at least 1%); arrhythmia, atrial fibrillation, bradycardia, cardiac arrest, cardiospasm, cerebrovascular accident, CHF, conduction block, MI, orthostatic hypotension, vasodilation, ventricular ectopic activity including ventricular arrhythmia (postmarketing).

CNS

Abnormal dreams, anger/hostility, confusion, decreased appetite, decreased concentration, disorientation, dizziness/lightheadedness, drowsiness, excitement, fatigue, headache, insomnia, incoordination, impaired memory, malaise, nervousness, nightmares/vivid dreams, paresthesia, tremors (at least 1%); agitation, anxiety, aphasia, ataxia, extrapyramidal symptoms, generalized tonic-clonic seizures, hallucination, paranoid reaction, psychosis, stupor, tardive dyskinesia, weakness, vertigo (postmarketing).

Dermatologic

Edema, sweating/clamminess (at least 1%); alopecia, hirsutism, pruritus, psoriasis, rash, urticaria (postmarketing).

EENT

Blurred vision, nasal/sinus congestion, red/itching/tired eyes, tinnitus (at least 1%); diplopia.

GI

Abdominal/gastric disorder, bad taste in mouth, constipation, diarrhea, dry mouth, nausea/vomiting (at least 1%); increased salivation (postmarketing).

Genitourinary

Decreased libido (at least 1%); breast enlargement or engorgement, lactation, priapism, urinary incontinence, urinary retention (postmarketing).

Hepatic

Cholestasis (postmarketing).

Hematologic-Lymphatic

Hemolytic anemia, leukocytosis, leukonychia, methemoglobinemia (postmarketing).

Lab Tests

Hyperbilirubinemia, increased amylase, liver enzyme alterations (postmarketing).

Metabolic-Nutritional

Weight gain and loss (at least 1%); inappropriate ADH syndrome (postmarketing).

Musculoskeletal

Aches/pain (at least 1%).

Respiratory

Apnea, shortness of breath (at least 1%).

Miscellaneous

Full/heavy head (at least 1%); chills, edema, unexplained death (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Cardiac disease

Not recommended for patients in acute recovery from MI. Trazodone also may cause arrhythmias; closely monitor patients with preexisting cardiac disease.

Priapism

Priapism (prolonged, painful inappropriate penile erection) has been reported. Condition may require surgical intervention. Any patient experiencing inappropriate or prolonged erection should stop taking trazodone immediately and notify health care provider.

Suicide

Closely monitor patients at risk. Prescribe the smallest quantity consistent with good patient management to reduce the risk of overdose.

Overdosage

Symptoms

Death, drowsiness, ECG changes, priapism, respiratory arrest, seizures, vomiting.

Patient Information

• Advise patient, family, and caregiver to be alert to changes in behavior, worsening of depression, and suicidal thinking, all of which indicate a need for very close monitoring and possible change in medication.
• Tell patient that max effect may not be evident for up to 4 wk.
• Instruct family to monitor mood during therapy. Observe for suicidal tendencies.
• Advise patient to check weight weekly because appetite may increase with drug.
• Tell patient taking antihypertensives or nitrates about potential for additive hypotensive effect.
• Instruct patient to report the following symptoms to health care provider: chest pain, confusion, convulsions, impotence, prolonged or inappropriate penile erections, shortness of breath.
• Advise patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum to prevent dry mouth or unpleasant tastes.
• Instruct patient to avoid intake of alcoholic beverages, sedatives/hypnotics, or other CNS depressants.
• Advise patient to use caution while driving or performing other tasks requiring mental alertness until effect is determined.

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