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:

Blenheim Pharmacal, Inc.

INN (International Name):

PAROXETINE HYDROCHLORIDE ANHYDROUS

Composition:

PAROXETINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Paroxetine is 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 response

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. Bottles of 30 (NDC 10544-433-30) 40 mg unscored tablets imprinted “APO” on one side and “101” on the other side. Bottles of 30 (NDC 10544-809-30) 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]. Blenheim Pharmacal, Inc. PAROXETINE TABLETS, USP 10 mg, 20 mg, 30 mg and 40 mg Manufactured by: Manufactured for: Marketed/ Packaged by: Apotex Inc. Apotex Corp. Blenheim Pharmacal, Inc. Toronto, Ontario Weston, North Blenheim, Canada      Florida New York, M9L 1T9 33326 12131, (USA) Revised: February 2013 Rev. 10

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PAROXETINE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
Blenheim Pharmacal, Inc.
----------
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
BLENHEIM PHARMACAL, INC.
----------
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, 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
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° to
120°C and a solubility of 5.4 mg/mL in water.
Each