Country: United States
Language: English
Source: NLM (National Library of Medicine)
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)
McKesson Contract Packaging
TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET MCKESSON CONTRACT PACKAGING ---------- TRAZODONE HYDROCHLORIDE TABLETS, USP SUICIDALITY AND ANTIDEPRESSANT DRUGS 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 HCL 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 HCL IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS, CLINICAL WORSENING AND SUICIDE RISK, PRECAUTIONS, INFORMATION FOR PATIENTS, AND PRECAUTIONS, PEDIATRIC US E DESCRIPTION Trazodone Hydrochloride Tablets USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1, 2, 4-triazolo[4, 3-a]-pyridin- 3(2_H_)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows: Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal si Read the complete document