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trazodone hydrochloride

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tra·zo·done hydrochloride (trz-dn)
n.
A triazolopyridine antidepressant drug.

trazodone hydrochloride

Molipaxin (UK), Trazorel (CA)

Pharmacologic class: Triazolopyridine derivative

Therapeutic class: Antidepressant

Pregnancy risk category C

FDA Boxed 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

Indications and dosages

Major depression

Adults: 150 mg/day P.O. 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.

Dosage adjustment

• Elderly patients

Off-label uses

• Alcohol dependence
• Cocaine withdrawal
• Anxiety neurosis
• Insomnia

Contraindications

• Hypersensitivity to drug
• Recovery period after myocardial infarction

Precautions

Use cautiously in:
• cardiovascular disease, severe hepatic or renal disease, suicidal behavior or ideation
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Give after meals or snacks.
• Know that drug is often used in conjunction with psychotherapy.

RouteOnsetPeakDuration
P.O.1-2 wk2-4 wkWks

Adverse reactions

CNS: drowsiness, confusion, dizziness, fatigue, hallucinations, headache, insomnia, nightmares, slurred speech, syncope, weakness, tremor, suicidal behavior or ideation (especially in child or adolescent)

CV: chest pain, hypotension, hypertension, palpitations, tachycardia, arrhythmias

EENT: blurred vision, tinnitus

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

GU: urinary frequency, hematuria, erectile dysfunction, priapism

Hematologic: anemia, leukopenia

Musculoskeletal: myalgia

Skin: rash

Interactions

Drug-drug. Antihypertensives, nitrates: additive hypotension

Digoxin, phenytoin: increased blood levels of these drugs

Fluoxetine: increased trazodone blood level, greater risk of toxicity

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

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

Urinary catecholamines: false increases

Urinary 5-hydroxyindole acetic acid, vanillylmandelic acid: decreased levels

Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression

S-adenosylmethionine (SAM-e), St. John's wort, increased risk of serotonergic effects (including serotonin syndrome)

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

Patient monitoring

• Monitor vital signs and ECG.
• Monitor neurologic status. Report significant adverse reactions.
• Assess patient's mood frequently. Stay alert for worsening depression and suicidal ideation.
• Watch for drug hoarding or overuse.

Patient teaching

• Tell patient to take with meals or snacks to improve drug absorption.
• 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.
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 drink alcohol during drug therapy.
• Tell patient that many common herbs worsen drug's adverse reactions. Tell him to consult prescriber before taking these products.
• 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.



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Labopharm notes that the API manufacturer, Angelini, has said that the observations raised by the FDA are “not critical and that it has not been questioned about the continued supply of trazodone hydrochloride to the U.
Baxter and his colleagues treated obsessive-compulsiveswith another serotonin-squelching antidepressant, trazodone hydrochloride.
 
 
 
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