PAROXETINE- paroxetine hydrochloride tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Golden State Medical Supply, Inc.

INN (Kansainvälinen yleisnimi):

PAROXETINE HYDROCHLORIDE ANHYDROUS

Koostumus:

PAROXETINE 10 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Paroxetine tablets are indicated in adults for the treatment of: - Major depressive disorder (MDD) - Obsessive compulsive disorder (OCD) - Panic disorder (PD) - Social anxiety disorder (SAD) - Generalized anxiety disorder (GAD) - Posttraumatic stress disorder (PTSD) Paroxetine tablets are contraindicated in patients: - Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2), Drug Interactions ( 7)]. - Taking thioridazine because of risk of QT prolongation  [see Warnings and Precautions ( 5. 3) and Drug Interactions ( 7)] - Taking pimozide because of risk of QT prolongation  [see Warnings and Precautions ( 5.3), Drug Interactions ( 7)]. - With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome)  to paroxetine or any of the inactive ingredients in paroxetine tablets [see Adv

Tuoteyhteenveto:

Paroxetine tablets, USP are oval shaped film-coated tablets supplied as: Store tablets between 20°C and 25°C (68°F and 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

PAROXETINE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
Golden State Medical Supply, Inc.
----------
MEDICATION GUIDE
Paroxetine (pa rox' e teen)Tablets, USP
Medication Guide available at
https://www.apotex.com/products/us/mg.asp to each patient.
What is the most important information I should know about Paroxetine
tablets?
Paroxetine tablets can cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions.Paroxetine tablets and
other antidepressant medicines
may increase suicidal thoughts and actions in some people 24 years of
age and younger, especially
within the first few months of treatment or when the dose is changed.
Paroxetine tablets are not for
use in children.
•
Depression or other mental illnesses are the most important causes of
suicidal thoughts and
actions. How can I watch for and try to prevent suicidal thoughts and
actions?
•
Pay close attention to any changes, especially sudden changes in mood,
behavior, thoughts
or feelings or if you develop suicidal thoughts or actions. This is
very important when an
antidepressant medicine is started or when the dose is changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts or feelings or if you develop suicidal thoughts or
actions.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call your healthcare provider or get emergency medical help right away
if you have any of the following
symptoms, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting aggressive or violent
•
new or worse depression
•
feeling agitated, restless, angry, or irritable
•
an increase in activity and talking more than what is normal for you
•
acting on dangerous impulses
•
thoughts about suicide or dying
•
new or worse anxiety or panic attacks
•
trouble sleeping
•
other unusual changes in behavior or mood
What are Paro

Valmisteyhteenveto

PAROXETINE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PAROXETINE TABLETS. THESE HIGHLIGHTS DO NOT INCLUDE ALL THE
INFORMATION NEEDED TO USE
PAROXETINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
PAROXETINE TABLETS. PAROXETINE TABLETS, FOR ORAL USE INITIAL U.S.
APPROVAL: 1992
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC AND
YOUNG ADULT PATIENTS TAKING ANTIDEPRESSANTS. CLOSELY MONITOR ALL
ANTIDEPRESSANT- TREATED PATIENTS FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL
THOUGHTS AND
BEHAVIORS. PAROXETINE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS. ( 5.1,
8.4)
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.2, 5.5) 8/2023
INDICATIONS AND USAGE
Paroxetine tablets is a selective serotonin reuptake inhibitor (SSRI)
indicated in adults for the treatment of
( 1):
Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Generalized Anxiety Disorder (GAD)
Posttraumatic Stress Disorder (PTSD)
DOSAGE AND ADMINISTRATION
Recommended starting and maximum daily dosage for MDD, OCD, PD, and
PTSD: ( 2.2)
INDICATION STARTING DAILY DOSE MAXIMUM DAILY DOSE
MDD
20 mg
50 mg
OCD
20 mg
60 mg
PD
10 mg
60 mg
PTSD
20 mg
50 mg
Recommended starting dosage for SAD and GAD is 20 mg daily. ( 2.3)
Elderly patients, patients with severe renal impairment or severe
hepatic impairment: Starting dosage
is 10 mg daily. Maximum dosage is 40 mg daily. ( 2.4)
When discontinuing paroxetine tablets, reduce dosage gradually. ( 2.6,
5.7)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 10 mg, scored; 20 mg, scored; 30 mg, scored;
and 40 mg, scored tablets ( 3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within
14 days of discontinuing a
MAOI. ( 4, 5.3, 7)
Concomitant use of pimozide or thioridazine. ( 4, 5.3, 7)
Known