BUPROPION HYDROCHLORIDE- bupropion hydrochloride tablet, extended release
国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
资料单张 有效成分:
BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)
可用日期:
Sandoz Inc
INN（国际名称）:
BUPROPION HYDROCHLORIDE
组成:
BUPROPION HYDROCHLORIDE 150 mg
给药途径:
ORAL
处方类型:
PRESCRIPTION DRUG
疗效迹象:
Bupropion hydrochloride extended-release tablets (SR) are indicated as an aid to smoking cessation treatment. Pregnancy Category C 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 2 times the maximum recommended human dose (MRHD) and greater and decreased fetal weights were seen at doses three times the MRHD and greater. Bupropion hydrochloride extended-release tablets (SR) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clinical Consideratio
產品總結:
Bupropion hydrochloride extended-release tablets, USP (SR), 150 mg of bupropion hydrochloride are light yellow, round, biconvex, film-coated tablets debossed with an “A” over “117” on one side and plain on the other side, in bottles of 60 tablets. NDC 0781-5169-60 Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect from light and moisture.
授权状态:
Abbreviated New Drug Application
资料单张
BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Sandoz Inc
----------
MEDICATION GUIDE
BuPROPion Hydrochloride Extended-Release Tablets (SR)
(byoo-PROE-pee-on)
IMPORTANT: Be sure to read the three sections of this Medication
Guide. The first section is
about the risk of changes in thinking and behavior, depression and
suicidal thoughts or actions with
medicines used to quit smoking; the second section is about the risk
of suicidal thoughts and actions
with antidepressant medicines; and the third section is entitled
“What Other Important Information
Should I Know About Bupropion Hydrochloride Extended-release Tablets
(SR)?”
Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and
Behavior,
Depression, and Suicidal Thoughts or Actions
This section of the Medication Guide is only about the risk of changes
in thinking and behavior,
depression and suicidal thoughts or actions with drugs used to quit
smoking. Talk to your healthcare
provider or your family member’s healthcare provider about:
•
all risks and benefits of quit-smoking medicines.
•
all treatment choices for quitting smoking.
When you try to quit smoking, with or without bupropion hydrochloride
extended-release tablets (SR),
you may have symptoms that may be due to nicotine withdrawal,
including:
•
urge to smoke
•
depressed mood
•
trouble sleeping
•
irritability
•
frustration
•
anger
•
feeling anxious
•
difficulty concentrating
•
restlessness
•
decreased heart rate
•
increased appetite
•
weight gain
Some people have even experienced suicidal thoughts when trying to
quit smoking without medication.
Sometimes quitting smoking can lead to worsening of mental health
problems that you already have, such
as depression.
Some people have had serious side effects while taking bupropion
hydrochloride extended-release tablets
(SR) to help them quit smoking, including:
New or worse mental health problems, such as changes in behavior or
thinking, aggression, hostility,
agitation, depression, suicidal
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产品特点
BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
SANDOZ INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUPROPION HYDROCHLORIDE
EXTENDED-RELEASE TABLETS(SR) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BUPROPION
HYDROCHLORIDE EXTENDED-RELEASE TABLETS(SR).
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR), 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 – Removed Neuropsychiatric Reactions in
Warnings and Precautions, Neuropsychiatric Adverse Events
INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (SR) are an
aminoketone agent indicated as an aid to smoking cessation
treatment. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
•
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)
Patients taking Bupropion for Smoking Cessation 05/2017
And Suicide Risk in Smoking Cessation Treatment (5.2) 05/2017
Starting dose: 150 mg per day for first 3 days. (2.1)
General: Increase dose gradually to reduce seizure risk. (2.1, 5.3)
Begin dosing one week before quit day. (2.1)
After 3 days, increase the dose to 300 mg per day, given as 150 mg
twice daily at an interval of at least 8 hours. (2.1)
May be used with a nicotine transdermal system. (2.5)
Moderate to severe hepatic impairment: 150 mg every other day. (2.6,
8.7)
Mild hepatic impairment: Consider reducing the dose and/or frequency
of dosing. (2.6, 8.7)
Renal Impairment: Consider reducing the dose and/or frequency. (2.7,
8.6)
Tablets:150 mg. (3)
Seizure disorder. (4, 5.3)
Current or prior diagnosis of bulimia or anorexia nervosa. (4, 5.3)
Abrupt discontinuation of alcohol, benz
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