Suicidality and Antidepressant Drugs
id: 3352D63C-4EEB-BDCE-848A-EC7DF8103A97
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of trazodone hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Trazodone hydrochloride is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)
DESCRIPTION
id: E13D74C6-3565-E120-B4B9-6F6E10298BE3
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Trazodone hydrochloride is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(m-Chlorophenyl)-1-piperazinyl]propyl]s-triazolo[4,3-a]-pyridin-3(2H )-one monohydrochloride. It is a white orderless crystalline powder which is freely soluble in water. The structural formula is represented below:
C19H22ClN5O•HCl M.W. 408.32
Trazodone hydrochloride is supplied for oral administration in 50 mg or 100 mg tablets.Trazodone Hydrochloride Tablets USP 50 mg and 100 mg contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide.
CLINICAL PHARMACOLOGY
id: 91735D76-6496-7DB8-02B6-EAC5C692E01F
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
The mechanism of trazodone’s antidepressant action in man is not fully understood. In animals, trazodone selectively inhibits serotonin uptake by brain synaptosomes and potentiates the behavioral changes induced by the serotonin precursor, 5-hydroxytryptophan. Cardiac conduction effects of trazodone in the anesthetized dog are qualitatively dissimilar and quantitatively less pronounced than those seen with tricyclic antidepressants. Trazodone is not a monoamine oxidase inhibitor and, unlike amphetamine-type drugs, does not stimulate the central nervous system.
INDICATIONS AND USAGE
id: 9FA48F2E-ECBA-5FEB-94D8-01A3584DE695
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Trazodone hydrochloride is indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and out-patient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, III.aMajor Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.
CONTRAINDICATIONS
id: 41DA6C91-5ADB-34BC-6840-FBE5A9E17C47
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
This product is contraindicated in patients hypersensitive to trazodone.
ADVERSE REACTIONS
id: 10910DB2-11A6-56A0-09C4-49BBCA7AB624
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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 hydrochloride. It is impossible to determine precisely what accounts for the differences observed.
DOSAGE AND ADMINISTRATION
id: 8BCA2E14-ADFF-F21A-0BC0-995357102280
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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 hydrochloride 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 2 weeks. Twenty-five percent of those who respond to trazodone require more than 2 weeks (up to 4 weeks) of drug administration.
HOW SUPPLIED
id: D63C9110-819F-0E05-43E1-F9CEB5BCA1E7
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Trazodone Hydrochloride Tablets USP, 50 mg are scored, round, white, film-coated tablets imprinted DAN DAN and 5600 supplied in bottles of 100 and 1000.Trazodone Hydrochloride Tablets USP, 100 mg are scored, round, white, film-coated tablets imprinted DAN DAN and 5599 supplied in bottles of 100 and 1000.Dispense in a tight, light-resistant container with child-resistant closure.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]
REFERENCES
id: D7966723-1E41-1285-AAB8-40CD97BC5BE6
displayName: REFERENCES SECTION
FDA Article Code: 34093-5
- Williams JBW, Ed: Diagnostic and Statistical Manual of Mental Disorders-III, American Psychiatric Association May, 1980.
- 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.
- 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.
- Yealy DM, Hogya PT: Priapism. Emerg Med Clin North Am. 1988; 6:509-520.
- Banos JE, Bosch F, Farre M, Drug-induced priapism. Its aetiology, incidence and treatment. Med Toxicol Adverse Drug Exp. 1989; 4:46-58.
- O’Brien WM, O’Connor KP, Lynch JH. Priapism: current concepts. Ann Emerg Med. 1989: 980-983.
- Bardin ED, Krieger JN. Pharmacological priapism: comparison of trazodone- and papaverine-associated cases. Int Urol Nephrol. 1990; 22:147-152.
Watson Laboratories, Inc.
Corona, CA 92880 USARevised: August 2007
0807B
