BUPROPION HYDROCHLORIDE SR- bupropion hydrochloride tablet, film coated, extended release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Actavis Pharma, Inc.

INN (Jina la Kimataifa):

BUPROPION HYDROCHLORIDE

Tungo:

BUPROPION HYDROCHLORIDE 100 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM) . The efficacy of bupropion 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)] . The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)] . - Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. - Bupropion hydrochloride extended-release tablets (SR) 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 the immediate-release formulation of bupropion [see Warnings and Pr

Bidhaa muhtasari:

Bupropion hydrochloride extended-release tablets USP (SR), 100 mg of bupropion hydrochloride, USP are white to off-white, round, unscored, bi-convex, film-coated tablets debossed with "WPI" over "858" on one side in bottles of 60 tablets (NDC 0591-3540-60) and 500 tablets (NDC 0591-3540-05). Bupropion hydrochloride extended-release tablets USP (SR), 150 mg of bupropion hydrochloride, USP are white to off-white, round, unscored, bi-convex, film-coated tablets debossed with "WPI" over "839" on one side in bottles of 60 tablets (NDC 0591-3541-60), 250 tablets (NDC 0591-3541-25) and 500 tablets (NDC 0591-3541-05). Bupropion hydrochloride extended-release tablets USP (SR), 200 mg of bupropion hydrochloride, USP are white to off-white, round, unscored, bi-convex, film-coated tablets debossed with "WPI" over "3385" on one side in bottles of 60 tablets (NDC 0591-3542-60). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

Actavis Pharma, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Bupropion Hydrochloride (bue proe′ pee on hye′′ droe klor′
ide)
Extended-release Tablets (SR)
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
Extended-release Tablets (SR)?”
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

Tabia za bidhaa

BUPROPION HYDROCHLORIDE SR- BUPROPION HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
ACTAVIS PHARMA, INC.
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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._
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 extended-release tablets (SR) are an
aminoketone antidepressant, indicated
for the treatment of major depressive disorder (MDD). (1)
DOSAGE AND ADMINISTRATION
Starting dose: 150 mg/day. (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 150 mg
twice daily at an interval of at
least 8 hours. (2.1)
Usual target dose: 300 mg/day as 150 mg twice daily. (2.1)
Maximum dose: 400 mg/day, given as 200 mg twice daily, for patients
not responding to 300 mg/day.
(2.1)
Periodically reassess the dose and need for maintenance treatment.
(2.1)
Moderate to severe hepatic impairment: 100 mg daily or 150 mg every
other day. (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
Extended-Release Tablets: 100 mg, 150 mg, 200 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