PAROXETINE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

McKesson Corporation dba SKY Packaging

INN (Nama Antarabangsa):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Komposisi:

PAROXETINE 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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),

Ringkasan produk:

Paroxetine Tablets USP, 10 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of 'ZC, 15 and bisect' on one side and plain on other side, and are supplied as follows: Boxes of 10x10 UD 100 NDC 63739-888-10 Paroxetine Tablets USP, 20 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of 'ZC, 16 and bisect' on one side and plain on other side, and are supplied as follows: Boxes of 10x10 UD 100 NDC 63739-963-10 Storage Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

PAROXETINE- PAROXETINE TABLET, FILM COATED
McKesson Corporation dba SKY Packaging
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Medication Guide
Paroxetine (pa rox’ e teen) Tablets, USP
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 ° other unusual changes
in behavior or mood
than what is normal for you
What are paroxetine tablets?
Paroxetine tablets are prescription medicine used in adults to treat:
• A certain type of

Ciri produk

PAROXETINE- PAROXETINE TABLET, FILM COATED
MCKESSON CORPORATION DBA SKY PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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) (1)
DOSAGE AND ADMINISTRATION
• Recommended starting and maximum daily dosage for MDD, OCD, PD,
and PTSD: (2.2) (2)
INDICATION
STARTING DAILY DOSE
MAXIMUM DAILY DOSE
MDD
20 mg
50 mg
0CD
20 mg
50 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) (2)
DOSAGE FORMS AND STRENGTHS
• Tablets: 10 mg, scored; 20 mg, scored; tablets. (3) (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) (4)
WARNINGS AND PRECAUTIONS
_• SEROTONIN SYNDROME:_ Increased risk when co-administered with
other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when
taken alone. If occurs,
discontinue paroxetine and initiate supportive measures. (5.2)
_• EMBRYOFETAL AND NEONATAL TOXICITY:_