PAROXETINE - paroxetine hydrochloride hemihydrate tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

Paroxetine Hydrochloride Hemihydrate (UNII: X2ELS050D8) (Paroxetine - UNII:41VRH5220H)

Διαθέσιμο από:

Jubilant Cadista Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

Paroxetine Hydrochloride Hemihydrate

Σύνθεση:

Paroxetine 10 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Major Depressive Disorder: Paroxetine tablets, USP 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.

Περίληψη προϊόντος:

Paroxetin tablets, USP 10 mg are white, modified capsule shaped, film coated tablets, debossed with 'C' on the scored side and debossed with '457' on the other side. Bottle of 30’s (Child Resistant)          NDC 59746-457-30 Bottle of 90’s (Child Resistant)          NDC 59746-457-90 Bottle of 100’s (Child Resistant)        NDC 59746-457-01 Bottle of 1000’s (Ribbed Stock)         NDC 59746-457-10   Paroxetin tablets, USP 20 mg are white, modified capsule shaped, film coated tablets, debossed with 'C' on the scored side and debossed with '458' on the other side. Bottle of 30’s (Child Resistant)          NDC 59746-458-30 Bottle of 90’s (Child Resistant)          NDC 59746-458-90 Bottle of 100’s (Child Resistant)        NDC 59746-458-01 Bottle of 1000’s (Ribbed Stock)         NDC 59746-458-10   Paroxetin tablets, USP 30 mg are bue colored, modified capsule shaped, film coated tablets, debossed with 'C' on one side and '459' on the other side. Bottle of 30’s (Child Resistant)          NDC 59746-459-30 Bottle of 90’s (Child Resistant)          NDC 59746-459-90 Bottle of 100’s (Child Resistant)        NDC 59746-459-01 Bottle of 1000’s (Ribbed Stock)        NDC 59746-459-10   Paroxetin tablets, USP 40 mg are white modified capsule shaped, film coated tablets, debossed with 'C' on one side and '460' on  the other side. Bottle of 30’s (Child Resistant)          NDC 59746-460-30 Bottle of 100’s (Child Resistant)        NDC 59746-460-01 Bottle of 90’s (Child Resistant)          NDC 59746-460-90 Bottle of 1000’s (Ribbed Stock)         NDC 59746-460-10   Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Manufactured by:                             Jubilant Generics Limited Roorkee - 247661, India   Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA   Revised: 05/2018

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

PAROXETINE - PAROXETINE HYDROCHLORIDE HEMIHYDRATE TABLET, FILM COATED
Jubilant Cadista Pharmaceuticals Inc.
----------
MEDICATION GUIDE
PAROXETINE TABLETS, USP
(PA ROX’ E TEEN)
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

Αρχείο Π.Χ.Π.

PAROXETINE - PAROXETINE HYDROCHLORIDE HEMIHYDRATE TABLET, FILM COATED
JUBILANT CADISTA PHARMACEUTICALS INC.
----------
PRESCRIBING INFORMATION
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
US E.)
DESCRIPTION
Paroxetine hydrochloride, USP is an orally administered psychotropic
drug. It is the hydrochloride salt
of a phenylpiperidine compound identified chemically as
(3S-trans)-3-[(1,3-Benzodioxol-5-
yloxy)methyl]-4-(4-fluorophenyl)-piperidine hydrochloride hemihydrate
and has the molecular formula
of C
H FNO •HCl•
H O. The molecular weight is 374.8 (329.4 as free base). The
structural
formula of paroxetine hydrochloride is:
Paroxetine hydrochloride, USP is a white or almost white, crystalline
powder slightly soluble in water,
soluble in methanol and alcohol.
Each film-coat