PAROXETINE- paroxetine hydrochloride hemihydrate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Composition:

PAROXETINE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Major Depressive Disorder: 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 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 in hospitalized depressed patients have not been adequately studied.

Product summary:

Tablets: Film-coated, capsule-shaped as follows: Paroxetine Tablets USP, 10-mg beige to light brown, scored tablets, debossed with ‘710’ on one side and ‘HH’ on the other side with the score line in between. NDC 43547-347-03 Bottles of 30 NDC 43547-347-09 Bottles of 90 NDC 43547-347-50 Bottles of 500 NDC 43547-347-11 Bottles of 1000 Paroxetine Tablets USP, 20-mg beige to light brown, scored tablets, debossed with ‘711’ on one side and ‘HH’ on the other side with the score line in between. NDC 43547-348-03 Bottles of 30 NDC 43547-348-09 Bottles of 90 NDC 43547-348-50 Bottles of 500 NDC 43547-348-11 Bottles of 1000 The above 10 mg and 20 mg strength tablets are functionally scored, each can be split into two halves. Paroxetine Tablets USP, 30-mg beige to light brown tablets, debossed with ‘712’ on one side and ‘HH’ on the other side. NDC 43547-349-03 Bottles of 30 NDC 43547-349-09 Bottles of 90 NDC 43547-349-50 Bottles of 500 NDC 43547-349-11 Bottles of 1000 Paroxetine Tablets USP, 40-mg beige to light brown tablets, debossed with ‘713’ on one side and ‘HH’ on the other side. NDC 43547-350-03 Bottles of 30 NDC 43547-350-09 Bottles of 90 NDC 43547-350-50 Bottles of 500 NDC 43547-350-11 Bottles of 1000 Store tablets at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC. Cranbury, NJ 08512, USA Issue Date: 10/2014 07490-01

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PAROXETINE- PAROXETINE HYDROCHLORIDE HEMIHYDRATE TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Paroxetine Tablets USP
(PA-rox-eh-tine)
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 c

Summary of Product characteristics

PAROXETINE- PAROXETINE HYDROCHLORIDE HEMIHYDRATE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
PAROXETINE TABLETS USP, FILM COATED FOR ORAL USE
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_-_4R_-
(4'_-_fluorophenyl)-_3S_-[(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, USP is an odorless, off-white powder, having
a melting point
range of 120° to 138°C and a solubility of 5.4 mg