PAROXETINE- paroxetine hydrochloride tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S) (PAROXETINE - UNII:41VRH5220H)

থেকে পাওয়া:

Major Pharmaceuticals

INN (আন্তর্জাতিক নাম):

PAROXETINE HYDROCHLORIDE ANHYDROUS

রচনা:

PAROXETINE 10 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Paroxetine tablets are indicated in adults for the treatment of: Paroxetine tablets are contraindicated in patients: Pregnancy Category D [see Warnings and Precautions ( 5.4)] Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations. If paroxetine is used during pregnancy, or if the patient becomes pregnant while taking paroxetine, advise the patient of the potential hazard to the fetus. Clinical Considerations Unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant [see Warnings and Precautions (5.7)]. For Other studies have found varying results as to whether there was an increased risk of overall, cardiovascular, or specific congenital malformations. A meta-analysis of epidemiological data over a 16-year period (1992 to 2008) on fir

পণ্য সারাংশ:

Paroxetine tablets, USP are supplied as white to off-white, oval, film-coated tablets as follows: 10 mg scored tablets imprinted “APO” with a partial bisect on one side and “097” on the other side; Cartons of 100 tablets (10 each blister pack x 10), NDC 0904-5676-61 20 mg scored tablets imprinted “APO” with a partial bisect score on one side and “083” on the other side. Cartons of 100 tablets (10 each blister pack x 10), NDC 0904-5677-61 30 mg unscored tablets imprinted “APO” on one side and “084” on the other side. Cartons of 100 tablets (10 each blister pack x 10), NDC 0904-5678-61 40 mg unscored tablets imprinted “APO” on one side and “101” on the other side. NDC 0904-5679-61 Cartons of 100 tablets (10 each blister pack x 10), NDC 0904-5679-61 Dispense in a tight, light-resistant container [see USP]. Store tablets between 20°C and 25°C (68°F and 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

PAROXETINE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
Major Pharmaceuticals
----------
MEDICATION GUIDE
Paroxetine Tablets, USP
(pa rox' e teen)
Medication Guide available at www1.apotex.com/products/us
What is the most important information I should know about Paroxetine
tablets?
Paroxetine tablets can cause serious side effects, including:
1.
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.
1.
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?
2.
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.
3.
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.
4.
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:
What are Paroxetine tablets?
Paroxetine tablets are the prescription medicine used in adults to
treat:
1.
A certain type of depression called Major Depressive Disorder (MDD)
2.
Obsessive Compulsive Disorder (OCD)
3.
Panic Disorder (PD)
4.
Social Anxiety Disorder (SAD)
5.
Generalized Anxiety Disorder (GAD)
6.
Posttraumatic Stress Disorder (PTSD)
Do not take Paroxetine tablets if you:
1.
take a monoamine oxidase inhibitor (MAOI)
2.
have stopped taking

পণ্য বৈশিষ্ট্য

PAROXETINE- PAROXETINE HYDROCHLORIDE TABLET, FILM COATED
MAJOR PHARMACEUTICALS
----------
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
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 TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS. (5.1, 8.4)
RECENT MAJOR CHANGES
Warnings and Precautions, Sexual Dysfunction (5.13) 9/2021
INDICATIONS AND USAGE
Paroxetine tablets is a selective serotonin reuptake inhibitor (SSRI)
indicated in adults for the treatment of
(1):
7.
8.
9.
10.
11.
12.
DOSAGE AND ADMINISTRATION
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
4.
5.
6.
DOSAGE FORMS AND STRENGTHS
2.
CONTRAINDICATIONS
4.
5.
6.
WARNINGS AND PRECAUTIONS
8.
9.
10.
11.
12.
13.
14.
ADVERSE REACTIONS
Most common adverse reactions (≥5% and at least twice placebo) are
abnormal ejaculation, asthenia,
constipation, decreased appetite, diarrhea, dizziness, dry mouth,
female genital disorder, impotence,
infection, insomnia, libido decreased, male genital disorder, nausea,
nervousness,
somnolence, sweating, tremor, yawn. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APOTEX CORP. AT
1-800-706-5575 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
4.
5.
6.
USE IN SPECIFIC POPULATIONS
3.
4.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 8/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder