traZODone

General

**REMS Drug**
Pronunciation
TRAZ-oh-done [Pronunciation]

Trade Name(s)

• Desyrel

• Oleptro

Indications

Major depression.

Unlabelled Use(s):
Insomnia, chronic pain syndromes, including diabetic neuropathy, and anxiety.

Action

Alters the effects of serotonin in the CNS.

Therapeutic Effect(s):
Antidepressant action, which may develop only over several weeks.

Pharmacokinetics

Absorption: Well absorbed after oral administration.

Distribution: Widely distributed.

Protein Binding: 89–95%.

Metabolism and Excretion: Extensively metabolized by the liver (CYP3A4 enzyme system); minimal excretion of unchanged drug by the kidneys.

Half-life: 5–9 hr (immediate-release); 10 hr (extended-release).

TIME/ACTION PROFILE (antidepressant effect)

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity;

• Recovery period after MI;

• Concurrent electroconvulsive therapy;

• Concurrent MAO inhibitor therapy (may result in serious, potentially fatal reactions).

• Cardiovascular disease;

• Suicidal behavior;

• May ↑ risk of suicide attempt/ideation especially during early treatment or dose adjustment;

• Severe hepatic or renal disease (dose ↓ recommended);

• Lactation: Discontinue drug or bottle feed;

• Pedi: Suicide risk may be greater in children and adolescents; safe use not established;

• Geri: Initial dose ↓ recommended; use extended-release tablets with caution.

Adverse Reactions/Side Effects

CNS: SUICIDAL THOUGHTS, drowsiness, confusion, dizziness, fatigue, hallucinations, headache, insomnia, nightmares, slurred speech, syncope, weakness.

EENT: blurred vision, tinnitus.

CV: hypotension, arrhythmias, chest pain, hypertension, palpitations, QT interval prolongation, tachycardia.

GI: dry mouth, altered taste, constipation, diarrhea, excess salivation, flatulence, nausea, vomiting.

GU: hematuria, erectile dysfunction, priapism, urinary frequency.

Derm: rash.

Hemat: anemia, leukopenia.

MS: myalgia.

Neuro: tremor.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• Serious, potentially fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability, with fluctuating vital signs and extreme agitation, which may proceed to delirium and coma) may occur with concurrent MAO inhibitors . MAO inhibitors should be stopped at least 14 days before trazodone therapy. Trazodone should be stopped at least 14 days before MAO inhibitor therapy.

• May ↑ digoxin or phenytoin serum levels.

• ↑ CNS depression with other CNS depressants , including alcohol , opioid analgesics , and sedative/hypnotics .

• ↑ hypotension with antihypertensives , acute ingestion of alcohol , or nitrates .

• Concurrent use with fluoxetine ↑ levels and risk of toxicity from trazodone.

• Drugs that inhibit the CYP3A4 enzyme system , including ritonavirindinavir and ketoconazole ↑ levels and the risk of toxicity.

• Drugs that induce the CYP3A4 enzyme system , including carbamazepine ↓ levels and may decrease effectiveness.

• Drugs that affect serotonergic neurotransmitter systems, including linezolid , tramadol , and triptans , ↑ risk of serotonin syndrome.

• ↑ risk of bleeding with NSAIDS , aspirin , clopidogrel , or warfarin .

• Concomitant use of kava-kava , valerian , or chamomile can ↑ CNS depression.

• ↑ risk of serotinergic side effects including serotonin syndrome with St. John's wort and SAMe .

Route/Dosage

Depression

• PO (Adults): Immediate-release—150 mg/day in 3 divided doses; ↑ by 50 mg/day q 3–4 days until desired response (not to exceed 400 mg/day in outpatients or 600 mg/day in hospitalized patients); Extended-release—150 mg once daily; ↑ by 75 mg/day q 3 days until desired response (not to exceed 375 mg/day)..

• PO (Geriatric Patients): Immediate-release—75 mg/day in divided doses initially; may be ↑ q 3–4 days..

• PO (Adults): 25–100 mg at bedtime..

Availability

• Tablets (immediate-release): 50 mg, 100 mg, 150 mg, 300 mg

» Cost:
Generic: 50 mg $10.00/90, 100 mg $10.00/90, 150 mg $10.00/90, 300 mg $386.44/90.

• Tablets (extended-release) (Oleptro): 150 mg, 300 mg

» Cost: 150 mg $299.98/90.

Assessment

• Monitor BP and pulse rate before and during initial therapy. Monitor ECGs in patients with pre-existing cardiac disease before and periodically during therapy to detect arrhythmias.

• Assess for possible sexual dysfunction.

• Assess mental status (orientation, mood, and behavior) frequently.

» Assess for suicidal tendencies, especially during early therapy. Restrict amount of drug available to patient. Risk may be increased in children, adolescents, and adults ≤24 yr. After starting therapy, children, adolescents, and young adults should be seen by health care professional at least weekly for 4 wk, every 3 wk for next 4 wk, and on advice of health care professional thereafter.

• Assess location, duration, intensity, and characteristics of pain before and periodically during therapy. Use pain scale to assess effectiveness of medicine.

• Assess CBC and renal and hepatic function before and periodically during therapy. Slight, clinically insignificant ↓ in leukocyte and neutrophil counts may occur.

Potential Nursing Diagnoses

• Ineffective coping (Indications)

• Sexual dysfunction (Side Effects)

Implementation

• Do not confuse trazodone with tramadol.

• PO: Administer with or immediately after meals to minimize side effects (nausea, dizziness) and allow maximum absorption of trazodone. A larger portion of the total daily dose may be given at bedtime to decrease daytime drowsiness and dizziness.

» Oleptro should be administered on an empty stomach at bedtime and swallowed whole or broken along scored lines; do not chew or crush.

Patient/Family Teaching

• Instruct patient to take medication as directed. If a dose is missed, take as soon as remembered. Do not take if within 4 hr of next scheduled dose; do not double doses. Oleptro should be taken at bedtime. Consult health care professional before discontinuing medication; gradual dose reduction is necessary to prevent aggravation of condition. Advise patient to read Medication Guide prior starting therapy and with each Rx refill in case of changes.

• May cause drowsiness and blurred vision. Caution patient to avoid driving and other activities requiring alertness until response to drug is known.

• Caution patient to change positions slowly to minimize orthostatic hypotension.

• Advise patient to avoid concurrent use of alcohol or other CNS depressant drugs.

• Advise patient, family, and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care professional immediately if thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, or other changes in mood or behavior occur.

• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially aspirin and NSAIDs.

• Inform patient that frequent rinses, good oral hygiene, and sugarless candy or gum may diminish dry mouth. Health care professional should be notified if this persists >2 wk. An increase in fluid intake, fiber, and exercise may prevent constipation.

• Advise patient to notify health care professional of medication regimen before treatment or surgery.

• Instruct patient to notify health care professional if priapism, irregular heartbeat, fainting, confusion, skin rash, or tremors occur or if dry mouth, nausea and vomiting, dizziness, headache, muscle aches, constipation, or diarrhea becomes pronounced.

• Instruct patient to notify health care professional if signs of serotonin syndrome (mental status changes: agitation, hallucinations, coma; autonomic instability: tachycardia, labile BP, hyperthermia; neuromuscular aberrations: hyperreflexia, incoordination; and/or gastrointestinal symptoms: nausea, vomiting, diarrhea) occur.

• Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

• Emphasize the importance of follow-up exams to evaluate progress.

Evaluation/Desired Outcomes

• Resolution of depression.

» Increased sense of well-being.

» Renewed interest in surroundings.

» Increased appetite.

» Improved energy level.

» Improved sleep.

• Decrease in severity of pain in chronic pain syndromes. Therapeutic effects are usually seen within 1 wk, although 4 wk may be required to obtain significant therapeutic results.