NEFAZODONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEFAZODONE HYDROCHLORIDE (UNII: 27X63J94GR) (NEFAZODONE - UNII:59H4FCV1TF)

Available from:

AvKARE, Inc.

INN (International Name):

NEFAZODONE HYDROCHLORIDE

Composition:

NEFAZODONE HYDROCHLORIDE 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEFAZODONE HYDROCHLORIDE- NEFAZODONE HYDROCHLORIDE TABLET
AVKARE, INC.
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NEFAZODONE HYDROCHLORIDE TABLET, USP
RX ONLY
(PATIENT INFORMATION INCLUDED)
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
NEFAZODONE HYDROCHLORIDE TABLETS 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.
NEFAZODONE HYDROCHLORIDE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS (SEE
WARNINGS, CLINICAL WORSENING AND SUICIDE RISK; PRECAUTIONS,
INFORMATION FOR
PATIENTS; AND PRECAUTIONS, PEDIATRIC USE).
Before prescribing nefazodone hydrochloride tablets, the physician
should be thoroughly familiar with
the details of this prescribing information.
Warning
CASES OF LIFE-THREATENING HEPATIC FAILURE HAVE BEEN REPORTED IN
PATIENTS TREATED WITH
NEFAZODONE HYDROCHLORIDE TABLETS. THE REPORTED RATE IN THE UNITED
STATES IS ABOUT 1 CASE OF
LIVER FAILURE RESULTING IN DEATH OR TRANSPLANT PER 250,000 TO 300,000
PATIENT-YEARS OF
NEFAZODONE HYDROCHLORIDE TREATMENT. THE TOTAL PATIENT-YEARS IS A
SUMMATION OF EACH
PATIENT’S DURATION OF EXPOSURE EXPRESSED IN YEARS. FOR EXAMPLE, 1
PATIENT-YE