PAROXETINE HYDROCHLORIDE tablet, film coated, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Lannett Company, Inc.

INN (इंटरनेशनल नाम):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

रचना:

PAROXETINE 12.5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Paroxetine is indicated in adults for the treatment of: - Major depressive disorder (MDD) Major depressive disorder (MDD) - Panic disorder (PD) Panic disorder (PD) - Social anxiety disorder (SAD) Social anxiety disorder (SAD) - Premenstrual dysphoric disorder (PMDD) Premenstrual dysphoric disorder (PMDD) Paroxetine is 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, 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 ), Drug Interactions ( 7 )] . Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions ( 5

उत्पाद समीक्षा:

Paroxetine Extended-Release Tablets, USP are supplied as film-coated, extended-release, round convex tablets, as follows: 12.5 mg white tablets (debossed with “KU” on one side and “470” on the other) NDC 62175-470-32    Bottles of 30 NDC 62175-470-41    Bottles of 500 25 mg pink tablets (debossed with “KU” on one side and “471” on the other) NDC 62175-471-32    Bottles of 30 NDC 62175-471-41    Bottles of 500 37.5 mg blue tablets (debossed with “KU” on one side and “472” on the other) NDC 62175-472-32    Bottles of 30 NDC 62175-472-41    Bottles of 500 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Lannett Company, Inc.
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Dispense with Medication Guide available at:
www.lannett.com/med-guide/paroxetine
MEDICATION GUIDE
Paroxetine (pa rox` e tine)
Extended-Release Tablets, USP
What is the most important information I should know about Paroxetine?
Paroxetine can cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions. Antidepressant
medicines may increase suicidal
thoughts and actions in some children and young adults within the
first few months of treatment
or when the dose is changed. Paroxetine is not for use in people
younger than 18 years of age.
How can I watch for and try to prevent suicidal thoughts and actions?
•
Depression or other serious mental illnesses are the most important
causes of 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 is Paroxetine?
Paroxetine is a prescription medicine used in adults to treat:
•
A certain type of depre

उत्पाद विशेषताएं

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
LANNETT COMPANY, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PAROXETINE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PAROXETINE
EXTENDED-RELEASE TABLETS. PAROXETINE EXTENDED-RELEASE TABLETS, USP,
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
IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (5.1, 8.4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.4, 5.5) 8/2023
INDICATIONS AND USAGE
Paroxetine is a selective serotonin reuptake inhibitor (SSRI)
indicated in adults for the treatment of (1):
Major Depressive Disorder (MDD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Premenstrual Dysphoric Disorder (PMDD)
DOSAGE AND ADMINISTRATION
Swallow tablet whole; do not chew or crush. (2.1)
Recommended starting and maximum daily dosage: (2.2, 2.3)
INDICATION
STARTING
DOSE
MAXIMUM
DOSE
MDD
25 mg/day
62.5 mg/day
PD
12.5 mg/day75 mg/day
SAD
12.5 mg/day37.5 mg/day
PMDD
12.5 mg/day25 mg/day
For PMDD, dose continuously or intermittently (luteal phase only).
(2.3)
If inadequate response to starting dosage, titrate in 12.5 mg per day
increments once weekly. (2.2, 2.3)
Elderly patients, patients with severe renal impairment or severe
hepatic impairment: Starting dose is
12.5 mg per day. Do not exceed 50 mg per day for treatment of MDD and
PD and 37.5 mg per day for
treatment of SAD. (2.5)
When discontinuing Paroxetine, reduce dose gradually. (2.7)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 12.5 mg, 25 mg, and 37.5 mg tablets. (3)
CONTRAINDICATIONS
Concomitant use of monoami