PAROXETINE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] - 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 oral suspension [see Adverse Reactions (6.1), (6.2)] . Risk Summary Based on data from published observational stu

Product summary:

Paroxetine Oral Suspension is supplied as: 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

ANI Pharmaceuticals, Inc.
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
Paroxetine (pa rox’ e teen)
Oral Suspension
What is the most important information I should know about paroxetine
oral suspension?
Paroxetine oral suspension can cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions. Paroxetine oral
suspension 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 oral suspension is 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
•
onew 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
•
onew or worse anxiety or panic attacks
•
trouble sleeping
•
other unusual changes in behavior or mood
What is paroxetine oral suspension?
Paroxetine oral suspension is a prescription medicine used in adults
t

Summary of Product characteristics

PAROXETINE - PAROXETINE SUSPENSION
ANI PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PAROXETINE ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PAROXETINE ORAL
SUSPENSION.
PAROXETINE ORAL SUSPENSION
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): (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
Shake oral suspension well before administration (2.1)
Recommended starting and maximum daily dosage for MDD, OCD, PD, and
PTSD: (2.2)
INDICATION
STARTING DOSE
MAXIMUM 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 oral suspension, reduce dosage
gradually. (2.6, 5.7)
DOSAGE FORMS AND STRENGTHS
Oral suspension: 10 mg/5 mL. (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