PAXIL- paroxetine hydrochloride tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

REMEDYREPACK INC.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Film‑coated, modified‑oval shaped as follows: 10-mg yellow, scored tablets engraved on the front with "PAXIL" and on the back with "10". NDC 60505-4517-3 Bottles of 30 20-mg pink, scored tablets engraved on the front with "PAXIL" and on the back with "20". NDC 60505-4518-3 Bottles of 30 30-mg blue tablets engraved on the front with "PAXIL" and on the back with "30". NDC 60505-4519-3 Bottles of 30 40-mg green tablets engraved on the front with "PAXIL" and on the back with "40". NDC 60505-4520-3 Bottles of 30 Store tablets between 15° and 30°C (59° and 86°F). PAXIL ® and PAXIL CR ® are registered trademarks of the GlaxoSmithKline group of companies. All other registered trademarks are the property of their respective owners. Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida USA 33326 August 2017 Revision: 2

Stato dell'autorizzazione:

New Drug Application

Foglio illustrativo

PAXIL- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
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MEDICATION GUIDE
PAXIL ® (PAX-il)
(paroxetine hydrochloride)
Tablets
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 you have any of the
follo

Scheda tecnica

PAXIL- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
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PAXIL
(PAROXETINE HYDROCHLORIDE)
TABLETS
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.
T ABLETS :
Each film coated tablet contains paroxetine hydrochlo