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| Trazodone Hydrochloride |
| Trade Name(s): |
Trazodone Hydrochloride ·Tablets
50 mg
·Tablets
100 mg
·Tablets
150 mg
·Tablets
300 mg
Apo-Trazodone

Apo-Trazodone D

Gen-Trazodone

PMS-Trazodone

ratio-Trazodone

Indicates Canadian Trade Name.
|
|
| Class: |
Antidepressant
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Action: |
Undetermined; may affect serotonin uptake at presynaptic neuronal membrane.
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.
|
|
Excretion: 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: |
Treatment of depression.
|
Indications: |
Unlabeled use(s): Treatment of aggression, cocaine withdrawal, neurogenic pain, panic disorder.
|
Contraindications: |
Standard considerations.
|
Interactions: |
|
|
Alcohol, barbiturates, CNS depressants
CNS depressant effects may be additive.
|
|
Carbamazepine
Plasma concentrations of trazodone and its active metabolite may be decreased, producing a decrease in therapeutic effect.
|
|
CYP3A4 inhibitors (eg, indinavir, itraconazole, ketoconazole, nefazodone)
May increase trazodone levels, increasing adverse reactions.
|
|
Digoxin, hydantoins
Serum levels may be elevated by trazodone, increasing the pharmacologic and adverse reactions.
|
|
Hypotensive agents
May cause additive hypotensive effects.
|
|
MAOIs
It is unknown whether interactions may take place. Initiate trazodone therapy cautiously if patient is currently taking, or has recently stopped taking, MAOIs.
|
|
Phenothiazines, protease inhibitors
Elevated trazodone serum concentrations have occurred, increasing the pharmacologic and toxic effects.
|
|
Ritonavir
Increased C
max
, AUC, and elimination t
½
, and decreased Cl of trazodone.
|
|
SSRIs
A serotonin syndrome, including altered consciousness, increased muscle tone, irritability, myoclonus, and shivering may occur.
|
|
Warfarin
Reports of increased and decreased PT.
|
Lab Test Interferences: |
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).
|
|
gu:
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).
|
|
labtestabs:
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: |
|
| Warning: |
Antidepressants increase the risk of suicidal thinking and behavior in short-term studies in children and adolescents with major depressive disorders and other psychiatric disorders. Closely observe patients who are started on therapy for clinical worsening, suicidal, or unusual changes in behavior.
|
|
Monitoring:
WBC and differential counts are recommended in patients developing fever and sore throat during therapy.
|
|
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: |
Signs & symptoms
Death, drowsiness, ECG changes, priapism, respiratory arrest, seizures, vomiting.
|
Patient/Family Education: |
- 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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