PAXIL- paroxetine hydrochloride tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Physicians Total Care, Inc.

INN (International Name):

PAROXETINE HYDROCHLORIDE

구성:

PAROXETINE HYDROCHLORIDE 20 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

PAXIL is indicated for the treatment of major depressive disorder. The efficacy of PAXIL 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 PAXIL in hospitalized depressed patients have not been adequately studied. The efficacy of PAXIL in maintaining a response in major depressive

제품 요약:

Film-coated, modified-oval as follows: 20-mg pink, scored tablets engraved on the front with PAXIL and on the back with 20. NDC 54868-2976-2 Bottles of 30 NDC 54868-2976-3 Bottles of 60 30-mg blue tablets engraved on the front with PAXIL and on the back with 30. NDC 54868-3526-0 Bottles of 30 NDC 54868-3526-1 Bottles of 60 Store tablets between 15° and 30°C (59° and 86°F). PAXIL is a registered trademark of GlaxoSmithKline. GlaxoSmithKline Research Triangle Park, NC 27709 ©2011, GlaxoSmithKline. All rights reserved. July 2011 PXL:59PI Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146

승인 상태:

New Drug Application

환자 정보 전단

PAXIL - PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
PAXIL® (PAX-il)
(paroxetine hydrochloride)
Tablets and Oral Suspension
Read the Medication Guide that comes with PAXIL 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 PAXIL?
PAXIL and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
PAXIL 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 PAXIL 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

제품 특성 요약

PAXIL - PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
PAXIL
(PAROXETINE HYDROCHLORIDE) TABLETS AND ORAL SUSPENSION
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
PAXIL 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.
PAXIL IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS: CLINICAL
WORSENING AND SUICIDE
RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS:
PEDIATRIC USE.)
DESCRIPTION
PAXIL (paroxetine hydrochloride) is an orally administered
psychotropic drug. 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 hydrochloride is:
Paroxetine hydrochloride is an odorless, off-white powder, having a
melting point range of 120° to
138°C and a solubility of 5.4 mg/mL in water.
TABLETS
Each film-coated tablet cont