Trazodone Hydrochloride (Page 3 of 4)

Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS Clinical Worsening and Suicide Risk).

Anyone considering the use of trazodone HCl in a child or adolescent must balance the potential risks with the clinical need.

Adverse Reactions to Trazodone Hydrochloride

Because the frequency of adverse drug effects is affected by diverse factors (e.g., drug dose, method of detection, physician judgment, disease under treatment, etc.) a single meaningful estimate of adverse event incidence is difficult to obtain. This problem is illustrated by the variation in adverse event incidence observed and reported from the inpatients and outpatients treated with trazodone HCl. It is impossible to determine precisely what accounts for the differences observed.

Clinical Trial Reports

Table 2 below is presented solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of trazodone HCl.

The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors often differ from those which prevailed in clinical trials. These incidence figures, also, cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials is conducted under a different set of conditions.

Table 2

Treatment Emergent

Symptom Incidence

InpatientsOutpatients

T 1 P 2 T 1 P 2

Number of Patients 142 95 157 158

% of Patients Reporting

Allergic

Skin Condition/Edema 2.8 1.1 7.0 1.3

Autonomic

Blurred Vision 6.3 4.2 14.7 3.8

Constipation 7.0 4.2 7.6 5.7

Dry Mouth 14.8 8.4 33.8 20.3

Cardiovascular

Hypertension 2.1 1.1 1.3 *3

Hypotension 7.0 1.1 3.8 0.0

Shortness of Breath *3 1.1 1.3 0.0

Syncope 2.8 2.1 4.5 1.3

Tachycardia/Palpitations 0.0 0.0 7.0 7.0

CNS

Anger/Hostility 3.5 6.3 1.3 2.5

Confusion 4.9 0.0 5.7 7.6

Decreased Concentration 2.8 2.1 1.3 0.0

Disorientation 2.1 0.0 *3 0.0

Dizziness/Lightheadedness 19.7 5.3 28.0 15.2

Drowsiness 23.9 6.3 40.8 19.6

Excitement 1.4 1.1 5.1 5.7

Fatigue 11.3 4.2 5.7 2.5

Headache 9.9 5.3 19.8 15.8

Insomnia 9.9 10.5 6.4 12.0

Impaired Memory 1.4 0.0 *3 *3

Nervousness 14.8 10.5 6.4 8.2

Gastrointestinal

Abdominal/Gastric Disorder 3.5 4.2 5.7 4.4

Bad Taste in Mouth 1.4 0.0 0.0 0.0

Diarrhea 0.0 1.1 4.5 1.9

Nausea/Vomiting 9.9 1.1 12.7 9.5

Musculoskeletal

Musculoskeletal Aches/Pains 5.6 3.2 5.1 2.5

Neurological

Incoordination 4.9 0.0 1.9 0.0

Paresthesia 1.4 0.0 0.0 *3

Tremors 2.8 1.1 5.1 3.8

Sexual Function

Decreased Libido *3 1.1 1.3 *3

Other

Decreased Appetite 3.5 5.3 0.0 *3

Eyes Red/Tired/Itching 2.8 0.0 0.0 0.0

Head Full-Heavy 2.8 0.0 0.0 0.0

Malaise 2.8 0.0 0.0 0.0

Nasal/Sinus Congestion 2.8 0.0 5.7 3.2

Nightmares/Vivid Dreams *3 1.1 5.1 5.7

Sweating/Clamminess 1.4 1.1 *3 *3

Tinnitus 1.4 0.0 0.0 *3

Weight Gain 1.4 0.0 4.5 1.9

Weight Loss *3 3.2 5.7 2.5

1
T=Trazodone HCl 2P=Placebo 3Incidence less than 1%

Occasional sinus bradycardia has occurred in long-term studies.

In addition to the relatively common (i.e., greater than 1%) untoward events enumerated above, the following adverse events have been reported to occur in association with the use of trazodone HCl in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, and retrograde ejaculation.

Post Introduction Reports: Although the following adverse reactions have been reported in trazodone HCl users, the causal association has neither been confirmed nor refuted.

Voluntary reports received since market introduction include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestatis, clitorism, congestive heart failure, diplopia, edema, extrapyramidal symptoms, grand mal seizures, hallucinations, hemolytic anemia, hirsutism, hyperbilirubinemia, increased amylase, increased salivation, insomnia, leukocytosis, leukonychia, jaundice, lactation, liver enzyme alterations, methemoglobinemia, nausea/vomiting (most frequently), paresthesia, paranoid reaction, priapism (see WARNINGS and PRECAUTIONS, Information for Patients; some patients have required surgical intervention), pruritus, psoriasis, psychosis, rash, stupor, inappropriate ADH syndrome, tardive dyskinesia, unexplained death, urinary incontinence, urinary retention, urticaria, vasodilation, vertigo, and weakness.

Cardiovascular system effects which have been reported include the following: conduction block orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, and ventricular ectopic activity, including ventricular tachycardia (see WARNINGS).

OVERDOSAGE

Animal Oral LD50: The oral LD50 of the drug is 610 mg/kg in mice, 486 mg/kg in rats, and 560 mg/kg in rabbits.

Signs and Symptoms: Death from overdose has occurred in patients ingesting trazodone HCl and other drugs concurrently (namely, alcohol; alcohol + chloral hydrate + diazepam; amobarbital; chlordiazepoxide; or meprobamate).

The most severe reactions reported to have occurred with overdose of trazodone HCl alone have been priapism, respiratory arrest, seizures, and EKG changes. The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions (see ADVERSE REACTIONS).

Treatment

There is no specific antidote for trazodone HCl. Treatment should be symptomatic and supportive in the case of hypotension or excessive sedation. Any patient suspected of having taken an overdose should have the stomach emptied by gastric lavage. Forced diuresis may be useful in facilitating elimination of the drug.

DOSAGE AND ADMINISTRATION

The dosage should be initiated at a low level and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. Trazodone HCl should be taken shortly after a meal or light snack. Symptomatic relief may be seen during the first week with optimal antidepressant effects typically evident within two weeks. Twenty-five percent of those who respond to trazodone HCl require more than two weeks (up to four weeks) of drug administration.

Usual Adult Dosage: An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every three to four days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.

Maintenance: Dosage during prolonged maintenance therapy should be kept at the lowest effective level. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Although there has been no systematic evaluation of the efficacy of trazodone beyond 6 weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.

HOW SUPPLIED

Trazodone Hydrochloride Tablets, USP:

50 mg — White, round, scored tablets in bottles of 30, 90, 100, 500, and 1000.

Debossed: PLIVA 433

100 mg — White, round, scored tablets in bottles of 30, 90, 100, 500 and 1000.

Debossed: PLIVA 434

150 mg — White, trapezoidal-shaped tablets, bisected one side to yield two 75 mg units (Debossed PLIVA 441); trisected the other side to yield three 50 mg units (Debossed 50 in each triangular segment); in bottles of 30, 90,100, 500, and 1000.

Dispense in a tight, light-resistant container.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

REFERENCES

a) Williams JBW, Ed: Diagnostic and Statistical Manual of Mental Disorders lll, American Psychiatric Association, May, 1980. (b) Lue TF, Physiology of erection and pathophysiology of impotence. In: Wash PC, Retik AB, Stamey TA, Vaughan ED, eds. Campbell’s Urology. Sixth edition. Philadelphia: W.B. Saunders: 1992: 722-725. (c) Goldstein I, Krane RJ, Diagnosis and therapy of erectile dysfunction. In: Wash PC. Retik AB, Stamey TA, Vaughan ED, eds. Campbell’s Urology. Sixth edition. Philadelphia: W.B. Saunders: 1992: 3071-3072. (d) Yealy DM, Hogya PT: Priapism. Emerg Med Clin North Am, 1988: 6:509-520. (e) Banos JE, Bosch F, Farre M. Drug-induced priapism, its aetiology, incidence and treatment. Med Toxicol Adverse Drug Exp. 1989: 4:46-58. (f) O’Brien WM, O’Connor KP, Lynch JH. Priapism: current concepts. Ann Emerg Med. 1989: 980-983. (g) Bardin ED, Krieger JN. Pharmacological priapism: comparison of trazodone- and papaverine-associated cases. Int Urol Nephrol. 1990: 22:147-152.

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