PAXIL- paroxetine hydrochloride suspension PAXIL- paroxetine hydrochloride tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Apotex Corp

INN (Alþjóðlegt nafn):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Samsetning:

PAROXETINE 10 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

PAXIL 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)   PAXIL 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) and Drug Interactions (7)] - With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in PAXIL [see Adverse Reactions (6.1), (6.2)]. Pregnancy Category D [see Warnings and Precautions (5.4)] Epidemiological studies have

Vörulýsing:

PAXIL (paroxetine) tablets are oval shaped tablets supplied as: Store tablets between 15° and 30°C (59° and 86°F). PAXIL (paroxetine) oral suspension is supplied as: Store suspension at or below 25°C (77°F)

Leyfisstaða:

New Drug Application

Upplýsingar fylgiseðill

PAXIL- PAROXETINE HYDROCHLORIDE SUSPENSION
PAXIL- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
Apotex Corp
----------
MEDICATION GUIDE
PAXIL® (PAX-il)
(paroxetine hydrochloride)
Tablets
oral suspension
What is the most important information I should know about PAXIL?
PAXIL can cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions. PAXIL and other
antidepressant medicines may
increase suicidalthoughts 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.
PAXIL 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 youdevelop suicidal thoughts or actions. This is
very important when an
antidepressant medicine is started or when thedoes is changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts or feelings or ifyou develop suicidal thoughts or
actions.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits asneeded, especially if you have concerns
about symptoms.
Call your healthcare provider or get emergency medical help right away
if you have any of the
followingsymptoms, 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 PAXIL?
PAXIL is a prescription medicine used in adults to treat:
•
A certain type of depression called Maj

Vara einkenni

PAXIL- PAROXETINE HYDROCHLORIDE SUSPENSION
PAXIL- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
APOTEX CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PAXILSAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PAXIL. PAXIL
(PAROXETINE) TABLETS, FOR ORAL
USEPAXIL (PAROXETINE) ORAL SUSPENSIONINITIAL U.S. APPROVAL: 1992
_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. PAXIL IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (5.1, 8.4)
RECENT MAJOR CHANGES
Warnings and Precautions, Sexual Dysfunction (5.13) 7/2021
INDICATIONS AND USAGE
PAXIL 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
Shake oral suspension well before administration (2.1)
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 PAXIL, reduce dosage gradually. (2.6, 5.7)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 10 mg, scored; 20 mg, scored; 30 mg; and 40
mg tablets. (3)
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)