BUPROPION HYDROCHLORIDE tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

PD-Rx Pharmaceuticals, Inc.

INN (Միջազգային անվանումը):

BUPROPION HYDROCHLORIDE

Կազմը:

BUPROPION HYDROCHLORIDE 100 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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)] . - Bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. - Bupropion hydrochloride tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride tablets [see Warnings and Precautions (5.3)] . - Bupropion hydrochloride tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and an

Ապրանքի ամփոփագիր:

Bupropion Hydrochloride Tablets, USP are available containing 100 mg of bupropion hydrochloride, USP. The 100 mg tablets are light blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and 435 on the other side. They are available as follows: NDC 55289-733-30 bottles of 30 tablets NDC 55289-733-60 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

PD-Rx Pharmaceuticals, Inc.
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MEDICATION GUIDE
Bupropion Hydrochloride Tablets, USP
(bue proe' pee on hye'' droe klor' ide)
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?
1.
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.
2.
Call your healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
3.
Keep all follow-up visits with your healthcare provider as scheduled.
Call the healthcare
provider between visits as needed

Ապրանքի հատկությունները

BUPROPION HYDROCHLORIDE- BUPROPION HYDROCHLORIDE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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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._
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)
INDICATIONS AND USAGE
Bupropion hydrochloride tablets are an aminoketone antidepressant,
indicated for the treatment of major depressive
disorder (MDD). ( 1)
DOSAGE AND ADMINISTRATION
Starting dose: 200 mg/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/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/day as 100 mg 3 times daily. ( 2.1)
Maximum dose: 450 mg/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)
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg and 100 mg. ( 3)
CONTRAINDICATIONS
Seizure disorder. ( 4, 5.3)
Current or prior diagnosis of bulimia or anorexia nervosa. ( 4, 5.3)
Abrupt discontinuation of alcohol, benzodiazepines, barbiturates,
antiepileptic drugs. ( 4, 5.3)
Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to
treat psychiatric disorders with bupropion
hydrochloride tablets or within 14 days of stopping treatment