PAROXETINE - paroxetine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Composition:

PAROXETINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Major Depressive Disorder Paroxetine tablets, USP is indicated for the treatment of major depressive disorder. The efficacy of paroxetine tablets, USP 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 tablets, USP in hospitalized depressed patients have not been adequ

Product summary:

Paroxetine Tablets, USP, 10 mg are yellow colored, film coated, modified capsule shaped tablets debossed with ‘421’ on one side and ‘Scored’ on other side are available as follows:  Bottles of 30               NDC 57664-421-83 Bottles of 90               NDC 57664-421-99 Bottles of 100             NDC 57664-421-08 Bottles of 500             NDC 57664-421-13 Bottles of 1000           NDC 57664-421-18 Paroxetine Tablets, USP, 20 mg are white to off-white colored, film coated, modified capsule shaped tablets debossed with ‘422’ on one side and ‘Scored’ on other side are available as follows: Bottles of 30                 NDC 57664-422-83 Bottles of 90                 NDC 57664-422-99 Bottles of 100               NDC 57664-422-08 Bottles of 500               NDC 57664-422-13 Bottles of 1000             NDC 57664-422-18 Paroxetine Tablets, USP, 30 mg are blue colored, film coated, modified capsule shaped tablets debossed with ‘424’ on one side and ‘C’ on other side are available as follows: Bottles of 30                 NDC 57664-424-83 Bottles of 90                 NDC 57664-424-99 Bottles of 100               NDC 57664-424-08 Bottles of 500               NDC 57664-424-13 Bottles of 1000             NDC 57664-424-18 Paroxetine Tablets, USP, 40 mg are green colored, film coated, modified capsule shaped tablets debossed with ‘425’ on one side and ‘C’ on other side are available as follows: Bottles of 30                 NDC 57664-425-83 Bottles of 90                 NDC 57664-425-99 Bottles of 100               NDC 57664-425-08 Bottles of 500               NDC 57664-425-13 Bottles of 1000             NDC 57664-425-18 Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from Light and Moisture. SUN PHARMACEUTICAL INDUSTRIES, INC. Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvári, Kabay János u. 29., Hungary Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Revision date: 02/2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
----------
SPL MEDGUIDE
Medication Guide
Paroxetine (pa rox’ e teen) Tablets, USP
Read the Medication Guide that comes with paroxetine tablets, USP
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
tablets, USP?
Paroxetine tablets, USP and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
• Paroxetine tablets, USP 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 paroxetine tablets,
USP 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 heal

Summary of Product characteristics

PAROXETINE - PAROXETINE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
PRESCRIBING INFORMATION
PAROXETINE TABLETS, USP
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 IS 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 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.
Each film-coated tablet co