PAROXETINE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

TYA Pharmaceuticals

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Paroxetine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of paroxetine tablets, USP in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. CLINICAL PHARMACOLOGY —Clinical Trials The effects of paroxetine tablets, USP in hospitalized depressed patients have not b

Termék összefoglaló:

NDC:64725-0197-1 in a BOTTLE of 60 TABLET, FILM COATEDS Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Manufactured by: Cadila Healthcare Ltd. India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Rev.: 08/14 Revision Date: 2014/08/05

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

PAROXETINE- PAROXETINE TABLET, FILM COATED
TYA Pharmaceuticals
----------
Medication Guide
Paroxetine
(pa-ROX-a-teen)
Tablets, USP
Read the Medication Guide that comes with paroxetine tablets before
you start taking it and each time
you get a refill. There may be new information. This Medication Guide
does not take the place of talking
to your healthcare provider about your medical condition or treatment.
Talk with your healthcare provider
if there is something you do not understand or want to learn more
about.
What is the most important information I should know about paroxetine?
Paroxetine and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
in some children, teenagers, or young adults within the . Paroxetine
and other antidepressant
medicines may increase suicidal thoughts or actionsfirst few months of
treatment or when the dose
is changed
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
• New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
• Pay particular attention to such changes when paroxetine is
started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry, or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of

Termékjellemzők

PAROXETINE- PAROXETINE TABLET, FILM COATED
TYA PHARMACEUTICALS
----------
PAROXETINE 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 PAROXETINE 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.
PAROXETINE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (SEE
WARNINGS: ,
PRECAUTIONS: , AND PRECAUTIONS: ). CLINICAL WORSENING AND SUICIDE
RISKINFORMATION FOR PATIENTSPEDIATRIC USE
DESCRIPTION
Paroxetine tablets, USP are an orally administered psychotropic drug.
It is the hydrochloride salt of a
phenylpiperidine compound identified chemically as - -(4'
fluorophenyl)- -[(3',4'-
methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate
and has the molecular 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 hydrochloride hemihydrate is: _(-)-trans4R-3S_
Paroxetine hydrochloride, USP is an odorless, white to off-white
crystalline powder, having a melting
point range of 120° to 138°C. It is freely soluble in methanol,
soluble in ethanol, sparingly soluble i