PAROXETINE HYDROCHLORIDE tablet, film coated, extended release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

REMEDYREPACK INC.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Paroxetine 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 CR is contraindicated in patients with a hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or to any of the inactive ingredients in paroxetine CR.   - 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 (

Resumen del producto:

Paroxetine hydrochloride controlled-release tablets are supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5 mg yellow tablets NDC 60505-1316-3 Bottles of 30 (one face is plain and the other is engraved with 12.5) 25 mg pink tablets NDC 60505-1317-3 Bottles of 30 (one face is plain and the other is engraved with 25) 37.5 mg blue tablets NDC 60505-1318-3 Bottles of 30 (one face is plain and the other is engraved with 37.5) 12.5-mg yellow tablets NDC 60505-3673-3 Bottles of 30 (engraved with GSK and 12.5) 25-mg pink tablets NDC 60505-3674-3 Bottles of 30 (engraved with GSK and 25) 37.5 mg blue tablets NDC 60505-3675-3 Bottles of 30 (engraved with GSK and 37.5) Store at or below 25° C (77° F) [see USP].

Estado de Autorización:

New Drug Application

Información para el usuario

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
REMEDYREPACK INC.
----------
MEDICATION GUIDE
Paroxetine Hydrochloride (PA-rox-eh-tine HY-dro-chlo-ride)
Controlled-Release Tablets
What is the most important information I should know about Paroxetine
Hydrochloride Controlled-Release
Tablets?
Paroxetine 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 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 in behavior or mood
What is Paroxetine Hydrochloride

Ficha técnica

PAROXETINE HYDROCHLORIDE- PAROXETINE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PAROXETINE CR SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR PAROXETINE CR.
PAROXETINE HYDROCHLORIDE 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 CR IS NOT
APPROVED FOR USE IN PEDIATRIC
PATIENTS. ( 5.1, 8.4)
INDICATIONS AND USAGE
Paroxetine hydrochloride extended-release tablets are a selective
serotonin reuptake inhibitor (SSRI) indicated for use 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 CR, reduce dose gradually. ( 2.7)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets:12.5 mg, 25 mg, and 37.5 mg tablets. ( 3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within
1