PAROXETINE HYDROCHLORIDE tablet, film coated, extended release

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Apotex Corp

SNN (starptautisko nepatentēto nosaukumu):

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Kompozīcija:

PAROXETINE 12.5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Paroxetine HCL CR is indicated in adults for the treatment of: - Major depressive disorder (MDD) - Panic disorder (PD) - Social anxiety disorder (SAD) - Premenstrual dysphoric disorder (PMDD) Paroxetine HCL CR 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)]. - Paroxetine HCL CR should not be used in patients receiving medications that can prolong QT interval and are also metabolized by CYP450 2D6,such as thioridazine or pimozide [see Drug Interactions (7),Warnings and Precautions (5.3)]. - With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in Paroxetine HCL CR [see Adverse Reactions (6.1, 6.2)]. Pregnancy Exposure Registry   There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidep

Produktu pārskats:

Paroxetine HCL CR extended‑release tablets, USP are available as: 12.5 mg yellow, round tablets, one face is plain and the other face is engraved with “12.5”. Bottles of 30 NDC 60505-1316-3   25 mg pink, round tablets, one face is plain and the other face is engraved with “25”. Bottles of 30 NDC 60505-1317-3   37.5 mg blue, round tablets, one face is plain and the other face is engraved with “37.5”. Bottles of 30 NDC 60505-1318-3   Store at or below 25°C (77°F); [see USP].

Autorizācija statuss:

New Drug Application

Lietošanas instrukcija

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
Apotex Corp
----------
MEDICATION GUIDE
Paroxetine HCL CR
(PA-rox-eh-tine HY-dro-chlo-ride)
extended-release tablets,USP
What is the most important information I should know about Paroxetine
HCL CR?
Paroxetine HCL CR 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 HCL CR 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?
•
Depression or other serious mental illnesses are the most important
causes of 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
•
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

Produkta apraksts

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
APOTEX CORP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PAROXETINE HCL CR SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PAROXETINE HCL
CR.
PAROXETINE HCL CR (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
HCL CR IS
NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (5.1, 8.4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2 ,5.4, 5.5) 08/2023
INDICATIONS AND USAGE
Paroxetine HCL CR 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 HCL CR, reduce dose gradually. (2.7)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets:12.5