PAROXETINE HYDROCHLORIDE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Bryant Ranch Prepack

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Paroxetine is 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 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 thioridazine because of risk of QT prolongation [see Warnings and Precautions (5.3) and Drug Interactions (7)]. - T aking 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, USP[see Adverse Reactions (6.1), (6.2)] . Pregnancy Category D [see Warnings and Precautions (5.4)]

Ringkasan produk:

Paroxetine 30 mg tablets, USP are modified capsule shape, film-coated tablets. and white to off-white Debossed with "673" on one side and "O" on the other. NDC: 71335-9650-1: 30 Tablets in a BOTTLE NDC: 71335-9650-2: 60 Tablets in a BOTTLE NDC: 71335-9650-3: 90 Tablets in a BOTTLE NDC: 71335-9650-4: 180 Tablets in a BOTTLE Store at: 20-25°C (68-77°F). [See USP Controlled Room Temperature]. Dispense with Medication Guide available at: https://www.oxford-rx.com/med-guides Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Bryant Ranch Prepack
----------
MEDICATION GUIDE
MEDICATION GUIDE
Paroxetine tablets, USP
(par ox' e teen)
Dispense with Medication Guide available at:
https://www.oxford-rx.com/med-guides
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. Paroxetine 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 is not for use in
children.
º 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 is paroxetine?
Paroxetine is a prescription medicine used in adults to treat:
•
A certain type of

Karakteristik produk

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PAROXETINE TABLETS, USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PAROXETINE TABLETS, USP.
PAROXETINE 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
TABLETS, USP IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (5.1, 8.4)
RECENT MAJOR CHANGES
Warnings and Precautions, Sexual Dysfunction (5.13) 9/2021
INDICATIONS AND USAGE
Paroxetine 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, reduce dosage gradually. (2.6, 5.7)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, scored; 20 mg, scored; 30 mg; and 40 mg 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 hypersensitivity to paroxetine or to any o