PAROXETINE HYDROCHLORIDE tablet film coated extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

PAROXETINE HYDROCHLORIDE HEMIHYDRATE (UNII: X2ELS050D8) (PAROXETINE - UNII:41VRH5220H)

थमां उपलब्ध:

AvKARE, Inc.

INN (इंटरनेशनल नाम):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

रचना:

PAROXETINE 12.5 mg

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
AVKARE, INC.
----------
PAROXETINE EXTENDED-RELEASE TABLETS, USP
RX ONLY
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
PAROXETINE 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.
PAROXETINE IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL
WORSENING AND SUICIDE
RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS:
PEDIATRIC USE.)
DESCRIPTION
Paroxetine Extended-Release Tablets, USP is an orally administered
psychotropic drug with a chemical
structure unrelated to other selective serotonin reuptake inhibitors
or to tricyclic, tetracyclic, or other
available antidepressant or antipanic agents. It is the hydrochloride
salt of a phenylpiperidine compound
identified chemically as (-)- _trans_-4 _R-_(4'-fluorophenyl)-3
_S_-[(3',4'-methylenedioxyphenoxy) methyl]
piperidine hydrochloride hemihydrate and has the empirical formula of
C
H
FNO
•HCl•1/2H
O.
The molecular weight is 374.8 (329.4 as free base). The structural
formula of paroxetine
hyd