BUPROPION HYDROCHLORIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bupropion hydrochloride extended-release tablets, USP (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 hydrochloride extended-release tablets, USP (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)] . - Bupropionhydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. - Bupropion hydrochloride extended-release tablets (SR) arecontraindicated 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-r

Product summary:

Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg of bupropion hydrochloride, are white to off white colored, round shaped, bevel edged biconvex film-coated tablets debossed with “736” on one side and plain on the other side. Bottles of 60 with child-resistant cap . . . . . . . . . . . . . . . . . . . . . . ..... NDC 47335-736-86 Bottles of 100 with child-resistant cap . . . . . . . . . . . . . . . . . . . . . . ... NDC 47335-736-88 Bottles of 100. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . NDC 47335-736-08 Bottles of 500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-736-13 Bupropion hydrochloride extended-release tablets, USP (SR), 150 mg of bupropion hydrochloride, are white to off white colored, round shaped, bevel edged biconvex film-coated tablets debossed with “737” on one side and plain on the other side. Bottles of 60 with child-resistant cap. . . . . . . . . . . . . . . . . . . . . . ..... NDC 47335-737-86 Bottles of 100 with child-resistant cap . . . . . . . . . . . . . . . . . . .  . . ... NDC 47335-737-88 Bottles of 100 . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . NDC 47335-737-08 Bottles of 500 . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . NDC 47335-737-13 Bupropion hydrochloride extended-release tablets, USP (SR), 200 mg of bupropion hydrochloride, are white to off white colored, round shaped, bevel edged biconvex film-coated tablets debossed with “738” on one side and plain on the other side. Bottles of 60 with child-resistant cap. . . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-738-86 Bottles of 100 with child-resistant cap. . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-738-88 Bottles of 100. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NDC 47335-738-08 Bottles of 500. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . .. . . . . . . NDC 47335-738-13 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
MEDICATION GUIDE
Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
(byoo-PRO-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,

Summary of Product characteristics

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, 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 is 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 Inhibitors (MAOIs): Do not use MAOIs intended to
treat psych