BUPROPION HYDROCHLORIDE (SR)- 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:

Wockhardt USA LLC.

INN (International Name):

BUPROPION HYDROCHLORIDE

Composition:

BUPROPION HYDROCHLORIDE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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

Product summary:

Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg of bupropion hydrochloride, are blue, round, biconvex, film coated tablets with bevelled edge, debossed with 'W' on one side and '101' on the other side in Bottles of 30 Tablets (NDC - 64679-101-01) Bottles of 60 Tablets (NDC - 64679-101-02) Bottles of 100 Tablets (NDC - 64679-101-03) Bottles of 500 Tablets (NDC - 64679-101-07) Unit dose package of 100 (NDC 64679-101-05) Bupropion hydrochloride extended-release tablets, USP (SR), 150 mg of bupropion hydrochloride, are purple, round, biconvex, film coated tablets with bevelled edge, debossed with 'W' on one side and plain on the other side in                         105 Bottles of 30 Tablets (NDC - 64679-105-01) Bottles of 60 Tablets (NDC - 64679-105-02) Bottles of 100 Tablets (NDC - 64679-105-03) Bottles of 500 Tablets (NDC - 64679-105-04) Unit dose package of 100 (NDC 64679-105-05) Bupropion hydrochloride extended-release tablets, USP (SR), 200 mg of  bupropion hydrochloride, are pink, round, biconvex, film coated tablets with bevelled edge, debossed with  'W' on one side and plain on the other side in                         107 Bottles of 30 Tablets (NDC - 64679-107-01) Bottles of 60 Tablets (NDC - 64679-107-02) Bottles of 100 Tablets (NDC - 64679-107-03) Bottles of 500 Tablets (NDC - 64679-107-04) Unit dose package of 100 (NDC 64679-107-05) Store at 20°-25°C (68°-77°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

BUPROPION HYDROCHLORIDE (SR)- BUPROPION HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
Wockhardt USA LLC.
----------
SPL MEDGUIDE
MEDICATION GUIDE
Bupropion Hydrochloride
(bue proe' pee on hye" droe klor' ide)
Extended-Release Tablets, USP (SR)
Read this Medication Guide carefully before you start taking bupropion
hydrochloride extended-release
tablets (SR) and each time you get a refill. There may be new
information. This information does not take
the place of talking with your healthcare provider about your medical
condition or your treatment. If you
have any questions about bupropion hydrochloride extended-release
tablets (SR), ask your healthcare
provider or pharmacist.
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. Talk to your healthcare provider or your
family member's healthcare provider
about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
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 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
action

Summary of Product characteristics

BUPROPION HYDROCHLORIDE (SR)- BUPROPION HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
WOCKHARDT USA 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, USP (SR), FOR ORAL
USE
INITIAL U.S. APPROVAL: 1985
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC
REACTIONS
_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)
SERIOUS NEUROPSYCHIATRIC EVENTS HAVE BEEN REPORTED IN PATIENTS TAKING
BUPROPION FOR SMOKING
CESSATION. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Angle-Closure Glaucoma (5.7) 07/2014
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 per 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 per day, given as 150 mg
twice daily at an interval of at least 8 hours.
(2.1)
Usual target dose: 300 mg per day as 150 mg twice daily. (2.1)
Maximum dose: 400 mg per day, given as 200 mg twice daily, for
patients not responding to 300 mg per 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
Sei