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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Buy It Now

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bupropion hydrochloride extended-release tablets (SR) is 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 hydrochloride extended-release tablets (SR) 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 i

Product summary:

Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg of bupropion hydrochloride, are blue, blackberry flavored, round, biconvex, film coated tablets, debossed with ‘SG, 174’ on one side and plain on other side in Bottles of 60 (NDC 77771-174-60) Tablets Bottles of 500 (NDC 77771-174-05) Tablets Bupropion hydrochloride extended-release tablets, USP (SR), 150 mg of bupropion hydrochloride, are purple, blackberry flavored, round, biconvex, film coated tablets, debossed with ‘SG, 175’ on one side and plain on other side in Bottles of 60 (NDC 77771-175-60) Tablets Bottles of 500 (NDC 77771-175-05) Tablets Bupropion hydrochloride extended-release tablets, USP (SR), 200 mg of bupropion hydrochloride, are pink, blackberry flavored, round, biconvex, film coated tablets, debossed with ‘SG, 176’ on one side and plain on other side in Bottles of 60 (NDC 77771-176-60) Tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure (as required). Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

                                BUPROPION HYDROCHLORIDE SR- bupropion hydrochloride tablet, film
coated, extended
release
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
(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 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,
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                BUPROPION HYDROCHLORIDE SR- BUPROPION HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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
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 Inhibi
                                
                                Read the complete document
                                
                            

Search alerts related to this product