PAROXETINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

New Horizon Rx Group, LLC

INN (International Name):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Composition:

PAROXETINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Paroxetine tablets are indicated for the treatment of major depressive disorder. The efficacy of paroxetine tablets 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 four of the following eight 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 in hospitalized depressed patients have not been adequately studied. The efficacy of parox

Product summary:

Paroxetine Tablets, USP are available as 20 mg tablets. The 20 mg tablet is a blue film-coated, modified capsule-shaped, scored tablet debossed with M on one side of the tablet and N to the left of the score and 2 to the right of the score on the other side. They are available as follows: NDC 58517-160-30    bottles of 30 tablets Store at 20° to 25 °C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Distributed by: New Horizon Rx Group, LLC Kenner, LA 70062 1-855-465-5545 Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Rev. 10/13

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PAROXETINE HYDROCHLORIDE - PAROXETINE HYDROCHLORIDE TABLET
New Horizon Rx Group, LLC
----------
MEDICATION GUIDE
PAROXETINE TABLETS, USP
(pa rox′ e teen hye″ droe klor′ ide)
Read the Medication Guide that comes with paroxetine tablets 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?
Paroxetine tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Paroxetine tablets 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 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 agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in

Summary of Product characteristics

PAROXETINE HYDROCHLORIDE - PAROXETINE HYDROCHLORIDE TABLET
NEW HORIZON RX GROUP, LLC
----------
PAROXETINE TABLETS, USP
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
(3_S_-_trans_)-3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-
(4-fluorophenyl)-piperidine hydrochloride hemihydrate and has the
molecular 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 (hemihydrate), USP is an odorless, white or
almost white crystalline powder,
having a melting point range of 129° to 131°C and a solubility of
5.4 mg/mL in water.
Each fil