PAROXETINE- paroxetine hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 107, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Paroxetine tablets 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 of paroxetine in maintaining a

Product summary:

Paroxetine tablets, USP are supplied as white to off-white, oval, film-coated tablets as follows: 20 mg scored tablets imprinted “APO” with a partial bisect score on one side and “083” on the other side. Overbagged with 10 tablets per bag, NDC 55154-7999-0 Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F 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, Florida Canada M9L 1T9 33326 Distributed By: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 Refer to package label for Distributor's NDC Number Distributed By: Cardinal Health Dublin, OH 43017 L55118110422 Revised: January 2017 Rev. 12

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PAROXETINE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
Cardinal Health 107, LLC
----------
MEDICATION GUIDE
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:
1.
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.
2.
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
3.
Watch for these changes and call your healthcare provider right away
if you notice:
1.
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
2.
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:
1.
attempts to commit suicide
2.
acting on dangerous impulses
3.
acting aggressive or violent
4.
thoughts about suicide or dying
5.
new or worse depression
6.
new or worse anxiety or panic attacks
7.
feeling agitated, restless, angry, or irritable
8.
trouble sleeping
9.
an increase in activity or talking more than what is normal for you
10.
other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of

Summary of Product characteristics

PAROXETINE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
----------
PAROXETINE TABLETS, USP
10 MG, 20 MG, 30 MG AND 40 MG
RX ONLY
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 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 ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS (SEE WARNINGS, CLINICAL WORSENING AND SUICIDE RISK,
PRECAUTIONS, INFORMATION FOR PATIENTS, AND PRECAUTIONS, PEDIATRIC
USE).
DESCRIPTION
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 anhydrous and has the empirical formula of C
H
FNO •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°C to 120°C and a solubility of 5.4 mg/mL in water.
Each film-coat