PAROXETINE HYDROCHLORIDE ANHYDROUS tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

DIRECT RX

INN (Internationale Bezeichnung):

PAROXETINE HYDROCHLORIDE ANHYDROUS

Zusammensetzung:

PAROXETINE 20 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Major Depressive Disorder Paroxetine tablets, USP are 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. The efficacy

Produktbesonderheiten:

Paroxetine tablets, USP are supplied as white to off-white, oval, film-coated tablets as follows: 10 mg scored tablets imprinted “APO” with a partial bisect on one side and “097” on the other side. NDC 60505-0097-1 Bottles of 30; NDC 60505-0097-9 Bottles of 90; NDC 60505-0097-2 Bottles of 100; NDC 60505-0097-4 Bottles of 1000; NDC 60505-0097-7 Bottles of 18,000; NDC 60505-0097-5 Unit dose blisters, package of 100 (10x10). 20 mg scored tablets imprinted “APO” with a partial bisect score on one side and “083” on the other side. NDC 60505-0083-1 Bottles of 30; NDC 60505-0083-9 Bottles of 90; NDC 60505-0083-2 Bottles of 100; NDC 60505-0083-4 Bottles of 1000; NDC 60505-0083-0 Bottles of 12,500; NDC 60505-0083-5 Unit dose blisters, package of 100 (10x10). 30 mg unscored tablets imprinted “APO” on one side and “084” on the other side. NDC 60505-0084-1 Bottles of 30; NDC 60505-0084-9 Bottles of 90; NDC 60505-0084-2 Bottles of 100; NDC 60505-0084-4 Bottles of 1000; NDC 60505-0084-5 Unit dose blisters, package of 100 (10x10). 40 mg unscored tablets imprinted “APO” on one side and “101” on the other side. NDC 60505-0101-1 Bottles of 30; NDC 60505-0101-9 Bottles of 90; NDC 60505-0101-2 Bottles of 100; NDC 60505-0101-4 Bottles of 1000; NDC 60505-0101-5 Unit dose blisters, package of 100 (10x10). 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]. APOTEX INC. PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Manufactured by                Manufactured for Apotex Inc.                          Apotex Corp. Toronto, Ontario                   Weston,  Canada                               Florida M9L 1T9                              33326 Revised: August 2014 Rev. 11

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

PAROXETINE HYDROCHLORIDE ANHYDROUS- PAROXETINE HYDROCHLORIDE ANHYDROUS
TABLET,
FILM COATED
DIRECT RX
----------
SPL MEDGUIDE SECTION
Paroxetine Tablets, USP
(pa rox’ e teen)
Read the Medication Guide that comes with paroxetine 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 pr

Fachinformation

PAROXETINE HYDROCHLORIDE ANHYDROUS- PAROXETINE HYDROCHLORIDE
ANHYDROUS TABLET, FILM COATED
DIRECT RX
----------
PAROXETINE HYDROCHLORIDE ANHYDROUS
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