PAROXETINE tablet, film coated, extended release

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Lupin Pharmaceuticals, Inc.

INN (Միջազգային անվանումը):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Կազմը:

PAROXETINE 12.5 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Paroxetine extended-release tablets USP are indicated in adults for the treatment of: - Major depressive disorder (MDD) - Panic disorder (PD) - Social anxiety disorder (SAD) - Premenstrual dysphoric disorder (PMDD) Paroxetine extended-release 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), 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 to any of the inactive ingredients in paroxetine extended-release tablets [see

Ապրանքի ամփոփագիր:

Paroxetine extended-release tablets USP, 12.5 mg are supplied as yellow colored, round shaped, biconvex, film coated tablets imprinted with "L067" on one side and plain on other side. They are available as follows: Bottle of 30 tablets (NDC 68180-647-06) Bottle of 100 tablets (NDC 68180-647-01) Bottle of 500 tablets (NDC 68180-647-02) Bottle of 1000 tablets (NDC 68180-647-03) Paroxetine extended-release tablets USP, 25 mg are supplied as pink colored, round shaped, biconvex, film coated tablets imprinted with "L068" on one side and plain on other side. They are available as follows: Bottle of 30 tablets (NDC 68180-646-06) Bottle of 100 tablets (NDC 68180-646-01) Bottle of 500 tablets (NDC 68180-646-02) Bottle of 1000 tablets (NDC 68180-646-03) Paroxetine extended-release tablets USP, 37.5 mg are supplied as blue colored, round shaped, biconvex tablets imprinted with "L069" on one side and plain on other side. They are available as follows: Bottle of 30 tablets (NDC 68180-645-06) Bottle of 100 tablets (NDC 68180-645-01) Bottle of 500 tablets (NDC 68180-645-02) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

Lupin Pharmaceuticals, Inc.
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Medication Guide
PAROXETINE (pa rox' e teen) EXTENDED-RELEASE TABLETS, USP
Paroxetine extended-release tablets, 12.5 mg contain FD&C Yellow No. 5
(tartrazine) which may
cause allergic-type reactions (including bronchial asthma) in certain
susceptible persons. Although
the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in
the general population is
low, it is frequently seen in patients who also have aspirin
hypersensitivity.
What is the most important information I should know about paroxetine
extended-release tablets?
Paroxetine extended-release tablets can cause serious side effects,
including:
• Increased risk of suicidal thoughts or actions. Antidepressant
medicines may increase suicidal
thoughts and actions in some children and young adults within the
first few months of treatment or
when the dose is changed. Paroxetine extended-release tablets is not
for use in people younger
than 18 years of age.
How can I watch for and try to prevent suicidal thoughts and actions?
ο Depression or other serious mental illnesses are the most important
causes of suicidal thoughts
and actions.
ο 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.
ο 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.
ο 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:
ο attempts to commit suicide
ο acting aggressive or violent
ο new or worse depression
ο feeling agitated, restless, angry, or irritable

Ապրանքի հատկությունները

PAROXETINE- PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PAROXETINE EXTENDED
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PAROXETINE
EXTENDED RELEASE TABLETS.
PAROXETINE EXTENDED-RELEASE 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
EXTENDED-
RELEASE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (5.1,
8.4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2,5.4,5.5) 8/2023
INDICATIONS AND USAGE
Paroxetine extended-release tablet USP is a selective serotonin
reuptake inhibitor (SSRI) indicated in
adults for the treatment of (1):
Major Depressive Disorder (MDD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Premenstrual Dysphoric Disorder (PMDD)
DOSAGE AND ADMINISTRATION
Swallow tablet whole; do not chew or crush. (2.1)
Recommended starting and maximum daily dosage: (2.2,2.3)
INDICATION
STARTING DOSE
MAXIMUM DOSE
MDD
25 mg/day
62.5 mg/day
PD
12.5 mg/day
75 mg/day
SAD
12.5 mg/day
37.5 mg/day
PMDD
12.5 mg/day
25 mg/day
For PMDD, dose continuously or intermittently (luteal phase only).
(2.3)
If inadequate response to starting dosage, titrate in 12.5 mg per day
increments once weekly. (2.2, 2.3)
Elderly patients, patients with severe renal impairment or severe
hepatic impairment: Starting dose is
12.5 mg per day. Do not exceed 50 mg per day for treatment of MDD and
PD and 37.5 mg per day for
treatment of SAD. (2.5)
When discontinuing paroxetine extended-release tablets, reduce dose
gradually. (2.7)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 12.5 mg, 25 mg, and 37.5 mg ta