PAROXETINE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

DirectRX

INN (Kansainvälinen yleisnimi):

PAROXETINE HYDROCHLORIDE ANHYDROUS

Koostumus:

PAROXETINE 30 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

- 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 adequatel

Tuoteyhteenveto:

Paroxetine Tablets USP, 10 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of 'ZC, 15 and bisect' on one side and plain on other side, and are supplied as follows: NDC 68382-097-06 in bottles of 30 tablets NDC 68382-097-16 in bottles of 90 tablets NDC 68382-097-01 in bottles of 100 tablets NDC 68382-097-05 in bottles of 500 tablets NDC 68382-097-10 in bottles of 1000 tablets Paroxetine Tablets USP, 20 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of 'ZC, 16 and bisect' on one side and plain on other side, and are supplied as follows: NDC 68382-098-06 in bottles of 30 tablets NDC 68382-098-16 in bottles of 90 tablets NDC 68382-098-01 in bottles of 100 tablets NDC 68382-098-05 in bottles of 500 tablets NDC 68382-098-10 in bottles of 1000 tablets Paroxetine Tablets USP, 30 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of 'ZC17' on one side and plain on other side, and are supplied as follows: NDC 68382-099-06 in bottles of 30 tablets NDC 68382-099-16 in bottles of 90 tablets NDC 68382-099-01 in bottles of 100 tablets NDC 68382-099-05 in bottles of 500 tablets NDC 68382-099-10 in bottles of 1000 tablets Paroxetine Tablets USP, 40 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of 'ZC18' on one side and plain on other side, and are supplied as follows: NDC 68382-001-06 in bottles of 30 tablets NDC 68382-001-16 in bottles of 90 tablets NDC 68382-001-01 in bottles of 100 tablets NDC 68382-001-05 in bottles of 500 tablets NDC 68382-001-10 in bottles of 1000 tablets Storage Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Manufactured by: Cadila Healthcare Ltd. India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 08/17

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

PAROXETINE- PAROXETINE TABLET, FILM COATED
DirectRX
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Medication Guide
Paroxetine
(pa-ROX-a-teen)
Tablets, USP
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?
Paroxetine and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
Paroxetine 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 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 healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency.
Paroxetin

Valmisteyhteenveto

PAROXETINE- PAROXETINE TABLET, FILM COATED
PAROXETINE- PAROXETINE TABLET, FILM COATED
DIRECTRX
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PAROXETINE
BOXED WARNING SECTION
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 are not approved
for use in pediatric patients. (See WARNINGS, Clinical Worsening and
Suicide Risk,
PRECAUTIONS, Information for Patients, and PRECAUTIONS, Pediatric
Use.)
DESCRIPTION SECTION
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 anhydrous and
has the empirical formula
of C19H20FNO3•HCl. The molecular weight is 365.8 (anhydrous) (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 116° to
120°C and a solubility of 5.4 mg/mL in water.
Each film-coated