PAROXETINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aurolife Pharma LLC

INN (International Name):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Composition:

PAROXETINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Adverse Reactions (6.1) , (6.2) ] . Risk Summary Based on data from publ

Product summary:

Paroxetine Tablets USP, 10 mg are yellow colored film-coated modified capsule shaped, biconvex tablets debossed with ‘C 55’ on one side and a deep breakline on the other side.                     Bottles of 30               NDC 13107-154-30                     Bottles of 90               NDC 13107-154-90                     Bottles of 100             NDC 13107-154-01                     Bottles of 500             NDC 13107-154-05                     Bottles of 1,000          NDC 13107-154-99 Paroxetine Tablets USP, 20 mg are pink colored film-coated modified capsule shaped, biconvex tablets debossed with ‘56’ on one side and ‘C’ with a deep breakline on the other side.                     Bottles of 30               NDC 13107-155-30                     Bottles of 90               NDC 13107-155-90                     Bottles of 100             NDC 13107-155-01                     Bottles of 500             NDC 13107-155-05                     Bottles of 1,000          NDC 13107-155-99 Paroxetine Tablets USP, 30 mg are blue colored film-coated modified capsule shaped, biconvex tablets debossed with ‘F’ on one side and ‘12’ on the other side.                     Bottles of 30               NDC 13107-156-30                     Bottles of 90               NDC 13107-156-90                     Bottles of 100             NDC 13107-156-01                     Bottles of 500             NDC 13107-156-05                     Bottles of 1,000          NDC 13107-156-99 Paroxetine Tablets USP, 40 mg are pink colored film-coated modified capsule shaped, biconvex tablets debossed with ‘A 59’ on one side and plain on the other side.                     Bottles of 30               NDC 13107-157-30                     Bottles of 90               NDC 13107-157-90                     Bottles of 100             NDC 13107-157-01                     Bottles of 500             NDC 13107-157-05                     Bottles of 1,000          NDC 13107-157-99 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aurolife Pharma LLC
----------
MEDICATION GUIDE
Paroxetine Tablets, USP
(par ox' e teen)
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 does 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 on
dangerous impulses
•
acting aggressive or violent • thoughts
about suicide or dying
•
new or worse depression
•
new or
worse anxiety or panic attacks
•
feeling agitated, restless, angry, or irritable • trouble
sleeping
•
an increase in activity and talking more than what is normal for you
• other
unusual changes in behavior or mood
What
is
paroxetine
tablets?
Paroxetine tablets are a prescription medicine used in adults to
treat:
•
A certain type of depression called Major Depressive Disorder (MDD)

Summary of Product characteristics

PAROXETINE - PAROXETINE TABLET, FILM COATED
AUROLIFE PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
IS 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 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
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 of the inactive
ingredients in paroxetine tablets. (4)
WARNINGS AND