PAROXETINE- paroxetine hydrochloride tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Nazwa):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Skład:

PAROXETINE 20 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 studi

Podsumowanie produktu:

Paroxetine Tablets USP, 10 mg are yellow colored film-coated modified capsule shaped, biconvex tablets debossed with ‘C 55’ on one side and a deep breakline on the other side.                     Bottles of 30         NDC 52343-073-30                 Bottles of 90         NDC 52343-073-90                 Bottles of 1000     NDC 52343-073-99                  Paroxetine Tablets USP, 20 mg are pink colored film-coated modified capsule shaped, biconvex tablets debossed with ‘56’ on one side and ‘C’ with a deep breakline on the other side.                                  Bottles of 30        NDC 52343-074-30                 Bottles of 90        NDC 52343-074-90                 Bottles of 1000    NDC 52343-074-99                Paroxetine Tablets USP, 30 mg are blue colored film-coated modified capsule shaped, biconvex tablets debossed with ‘F’ on one side and ‘12’ on the other side.                 Bottles of 30        NDC 52343-075-30                 Bottles of 90        NDC 52343-075-90                 Bottles of 1000    NDC 52343-075-99                 Paroxetine Tablets USP, 40 mg are pink colored film-coated modified capsule shaped, biconvex tablets debossed with ‘A 59’ on one side and plain on the other side.                 Bottles of 30        NDC 52343-076-30                 Bottles of 90        NDC 52343-076-90                 Bottles of 1000    NDC 52343-076-99 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]. Manufactured by:  Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for:  LUCID PHARMA LLC 2 Tower Center Blvd, Suite-1101B East Brunswick, NJ 08816 USA Revised: 04/2015

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

PAROXETINE - PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Paroxetine Tablets, USP
(par ox' e teen)
Read the Medication Guide that comes with paroxetine tablets before
you start taking them 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 behav

Charakterystyka produktu

PAROXETINE - PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, 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 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 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:
19
20
3
2
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/mL in water.
Each film-coated tablet