PAROXETINE HYDROCHLORIDE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

Paroxetine Hydrochloride (UNII: X2ELS050D8) (Paroxetine - UNII:41VRH5220H)

Διαθέσιμο από:

Oxford Pharmaceuticals, LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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)]

Περίληψη προϊόντος:

Paroxetine tablets, USP are modified capsule shape, film-coated tablets supplied as: 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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

Oxford Pharmaceuticals, LLC
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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 t

Αρχείο Π.Χ.Π.

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
OXFORD PHARMACEUTICALS, LLC
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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 t