PAROXETINE- paroxetine hydrochloride tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

PAROXETINE HYDROCHLORIDE (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H)

Disponible desde:

Contract Pharmacy Services-PA

Designación común internacional (DCI):

PAROXETINE HYDROCHLORIDE

Composición:

PAROXETINE HYDROCHLORIDE 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Paroxetine is 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. The efficacy of paroxetine in maintaining a respons

Resumen del producto:

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. 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. Paroxetine Tablets USP, 30 mg are white to off-white, round-shapped, biconvex, film-coated tablets debossed with the logo of "ZC17" on one side and plain on other side. Paroxetine Tablets USP, 40 mg are white to off-white, round-shapped, biconvex, film-coated tablets debossed with the logo of "ZC18" on one side and plain on other sid. Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). MANUFACTURED BY: Cadila Healthcare Ltd. Ahmedabad, India Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--08/2010--NJW Rev: 02/09

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

PAROXETINE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
Contract Pharmacy Services-PA
----------
MEDICATION GUIDE
PAROXETINE TABLETS USP
Rx only
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Read the Medication Guide that comes with you or your family
member’s antidepressant medicine.
This Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant
medicines. Talk to your, or your family member’s, healthcare
provider about:
• all risks and benefits of treatment with antidepressant medicines
• all treatment choices for depression or other serious mental
illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions
in some children, teenagers, and
young adults when the medicine is first started.
2. Depression and other serious mental illnesses are the most
important causes of suicidal thoughts and
actions. Some people may have a particularly high risk of having
suicidal thoughts or actions. These
iclude people who have (or have a family history of) bipolar illness
(also called manic-depressive illness)
or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and
actions in myself or a family member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
first started or when the dose
is changed.
•
Call the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especi

Ficha técnica

PAROXETINE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
----------
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 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 and has the
molecular formula of
C
H FNO HCl. The molecular weight is 365.8 (329.4 as free base). The
structural formula is:
STRUCTURAL FORMULA
Paroxetine hydrochloride is an odorless, white to off-white powder,
slightly soluble in water and
soluble in methanol and in alcohol.
Each film-coated tablet contains paroxetine hydrochloride equivalent
to paroxetine as follows: 10 mg-