BUPROPION HYDROCHLORIDE- bupropion hydrochloride tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)

थमां उपलब्ध:

Preferred Pharmaceuticals,Inc.

INN (इंटरनेशनल नाम):

BUPROPION HYDROCHLORIDE

रचना:

BUPROPION HYDROCHLORIDE 100 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM) . The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)] . Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. All pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. No clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately equal to the maximum recommended human do

उत्पाद समीक्षा:

Bupropion hydrochloride tablets, USP, 100 mg of bupropion hydrochloride, are lavender, round, film-coated tablets, debossed GG 930 on one side and plain on the reverse side. Bottle of 30 – 68788-9781-3 Bottle of 60 – 68788-9781-6 Bottle of 90 – 68788-9781-9 Bottle of 100 – 68788-9781-1 Bottle of 120 – 68788-9781-8 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
Preferred Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
Bupropion Hydrochloride Tablets, USP
(byoo-PROE-pee-on)
IMPORTANT: Be sure to read the three sections of this Medication
Guide. The first section is about the risk
of suicidal thoughts and actions with antidepressant medicines; the
second section is about the risk of
changes in thinking and behavior, depression and suicidal thoughts or
actions with medicines used to quit
smoking; and the third section is entitled “What Other Important
Information Should I Know About
Bupropion Hydrochloride Tablets?”
Antidepressant Medicines, Depression and Other Serious Mental
Illnesses, and Suicidal Thoughts or Actions
This section of the Medication Guide is only about the risk of
suicidal thoughts and actions with
antidepressant medicines.
What is the most important information I should know about
antidepressant medicines, depression and other
serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase the risk of suicidal thoughts
or actions in some children, teenagers,
or young adults within the first few months of treatment.
2. Depression or other serious mental illnesses are the most important
causes of suicidal thoughts and actions.
Some people may have a particularly high risk of having suicidal
thoughts or actions. These include people
who have (or have a family history of) bipolar illness (also called
manic- depressive illness) or suicidal
thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and
actions in myself or a family member?
•
Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. 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.
•
Keep all follow-up visits with your healthcare provider as scheduled.

उत्पाद विशेषताएं

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPROPION HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUPROPION
HYDROCHLORIDE TABLETS.
BUPROPION HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1985
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Boxed Warning 05/2017
Warnings and Precautions, Neuropsychiatric Adverse 05/2017
Events and Suicide Risk in Smoking Cessation Treatment (5.2)
INDICATIONS AND USAGE
Bupropion hydrochloride is an aminoketone antidepressant, indicated
for the treatment of major depressive disorder
(MDD). (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg and 100 mg. (3)
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS. (5.1)
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS. (5.1)
Starting dose: 200 mg per day given as 100 mg twice daily (2.1)
General: Increase dose gradually to reduce seizure risk. (2.1, 5.3)
After 3 days, may increase the dose to 300 mg per day, given as 100 mg
3 times daily at an interval of at least 6 hours
between doses. (2.1)
Usual target dose: 300 mg per day as 100 mg 3 times daily. (2.1)
Maximum dose: 450 mg per day given as 150 mg 3 times daily. (2.1)
Periodically reassess the dose and need for maintenance treatment.
(2.1)
Moderate to severe hepatic impairment: 75 mg once daily. (2.2, 8.7)
Mild hepatic impairment: Consider reducing the dose and/or frequency
of dosing. (2.2, 8.7)
Renal impairment: Consider reducing the dose and/or frequency. (2.3,
8.6)
Seizure disorder. (4, 5.3)
Current or prior diagnosis of bulimia or anorexia nervosa. (4, 5.3)
Abrupt discontinua