TRAZODONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)

Available from:

Major Pharmaceuticals

INN (International Name):

TRAZODONE HYDROCHLORIDE

Composition:

TRAZODONE HYDROCHLORIDE 50 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
MAJOR PHARMACEUTICALS
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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 silicon