PAROXETINE HYDROCHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Composition:

PAROXETINE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Paroxetine Hydrochloride Controlled-Release Tablets are indicated for the treatment of major depressive disorder. The efficacy of Paroxetine Hydrochloride Controlled-Release Tablets in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: Depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or

Product summary:

Paroxetine Hydrochloride Controlled-Release Tablets are supplied as enteric film-coated, controlled-release, round tablets, as follows: 12.5-mg yellow tablets, engraved with GSK on one side and 12.5 on the other. NDC 60505-3673-3 Bottles of 30 25-mg pink tablets, engraved with GSK on one side and 25 on the other. NDC 60505-3674-3 Bottles of 30 37.5 mg blue tablets, engraved with GSK on one side and 37.5 on the other NDC 60505-3675-3 Bottles of 30 Store at or below 25o C (77o F) [see USP]. GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. Manufactured by: GlaxoSmithKline Research Triangle Park, NC 27709 Manufactured for: Apotex Corp. Weston, FL 33326 December 2012 PCA-AP:5PI

Authorization status:

New Drug Application

Patient Information leaflet

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Paroxetine Hydrochloride (PA-rox-eh-tine HY-dro-chlo-ride)
Controlled-Release Tablets
Read the Medication Guide that comes with Paroxetine Hydrochloride
Controlled-Release Tablets before
you start taking them 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
Hydrochloride Controlled-
Release Tablets?
Paroxetine Hydrochloride and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Paroxetine Hydrochloride and other antidepressant medicines may
increase suicidal thoughts or
actions in some children, teenagers, and 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 and
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
Hydrochloride Controlled-Release
Tablets are 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

Summary of Product characteristics

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
BRYANT RANCH PREPACK
----------
PAROXETINE HYDROCHLORIDE
CONTROLLED-RELEASE 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
PAROXETINE HYDROCHLORIDE CONTROLLED-RELEASE 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 HYDROCHLORIDE
CONTROLLED-RELEASE TABLETS
ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS:
CLINICAL WORSENING AND
SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS:
PEDIATRIC
US E.)
DESCRIPTION
Paroxetine hydrochloride is an orally administered psychotropic drug
with a chemical structure
unrelated to other selective serotonin reuptake inhibitors or to
tricyclic, tetracyclic, or other available
antidepressant or antipanic agents. 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 we