PAROXETINE tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H)

Доступно од:

DIRECT RX

INN (Међународно име):

PAROXETINE HYDROCHLORIDE ANHYDROUS

Састав:

PAROXETINE 10 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Major Depressive Disorder Paroxetine is indicated for the treatment of major depressive disorder. The efficacy of paroxetine 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 CLINICAL PHARMACOLOGY: Clinical Trials). 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. The effects of paroxetine in hospitalized depressed patients have not been adequately studied. T

Резиме производа:

Paroxetine tablets, USP are supplied as white to off-white, oval, film-coated tablets 20 mg scored tablets imprinted “APO” with a partial bisect score on one side and “083” on the other side. 30 mg unscored tablets imprinted “APO” on one side and “084” on the other side. 40 mg unscored tablets imprinted �APO” on one side and “101” on the other side. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

PAROXETINE- PAROXETINE TABLET, FILM COATED
DIRECT RX
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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:
Paroxetine and other antidepressant medicines may increase suicidal
thoughts or actions in some children,
teenagers, or young adults within the first 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 the
following symptoms, or call 911 if an
emergency.
Paroxeti

Карактеристике производа

PAROXETINE- PAROXETINE TABLET, FILM COATED
PAROXETINE- PAROXETINE TABLET, FILM COATED
DIRECT RX
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PAROXETINE
BOXED WARNING SECTION
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, USP 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, USP are not approved for use
in pediatric
patients. (See WARNINGS: Clinical Worsening and Suicide Risk,
PRECAUTIONS:
Information for Patients, and PRECAUTIONS: Pediatric Use.)
DESCRIPTION SECTION
Paroxetine hydrochloride is an orally administered psychotropic drug.
It is the
hydrochloride salt of a phenylpiperidine compound identified
chemically as (-)-trans-4R-
(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine
hydrochloride anhydrous and has the empirical formula of
C19H20FNO3•HCl. The
molecular weight is 365.8 (anhydrous) (329.4 as free base). The
structural formula of
paroxetine hydrochloride is:
Paroxetine hydrochloride is an odorless, off-white powder, having a
melting point range
of 116° to 120°C and a solubility of 5.4 mg/mL in water.
Each film-coate