BUPROPION HYDROCHLORIDE (SR)- bupropion hydrochloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr. Reddy's Laboratories Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bupropion hydrochloride extended-release tablets, USP (SR) are indicated as an aid to smoking cessation treatment. - 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 Precautions (5.3)]. - Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3), Drug Interactions (7.3)]. - The use of MAOIs (intended to treat psychiatric d

Product summary:

Bupropion hydrochloride extended-release tablets, USP (SR) 150 mg of bupropion hydrochloride, are purple, blackberry flavored, round, biconvex, film coated tablets debossed with ‘SG, 338’ on one side and plain on other side and supplied in bottles of 30 tablets (NDC 43598-863-30), 60 tablets (NDC 43598-863-60) and 1,000 tablets (NDC 43598-863-10). Store at room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

BUPROPION HYDROCHLORIDE (SR)- bupropion hydrochloride tablet, extended
release
Dr. Reddy's Laboratories Inc
----------
MEDICATION GUIDE
Bupropion (bue-PROE-pee-on) Hydrochloride
Extended-Release Tablets, USP (SR)
IMPORTANT: Be sure to read the three sections of this Medication
Guide. The first section is about the risk
of changes in thinking and behavior, depression and suicidal thoughts
or actions with medicines used to quit
smoking; the second section is about the risk of suicidal thoughts and
actions with antidepressant medicines;
and the third section is entitled “What Other Important Information
Should I Know About Bupropion
hydrochloride extended-release tablets, (SR)?”
Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and
Behavior, Depression, and Suicidal
Thoughts or Actions
This section of the Medication Guide is only about the risk of changes
in thinking and behavior, depression
and suicidal thoughts or actions with drugs used to quit smoking. Talk
to your healthcare provider or your
family member’s healthcare provider about:
•
all risks and benefits of quit-smoking medicines.
•
all treatment choices for quitting smoking.
When you try to quit smoking, with or without bupropion hydrochloride
extended-release tablets, (SR), you
may have symptoms that may be due to nicotine withdrawal, including:
•
urge to
smoke
•
depressed
mood
•
trouble
sleeping
•
irritability
•
frustration
•
anger
•
feeling
anxious
•
difficulty
concentrating
•
restlessness
•
decreased heart rate
•
increased appetite
•
weight gain
Some people have even experienced suicidal thoughts when trying to
quit smoking without medication.
Sometimes quitting smoking can lead to worsening of mental health
problems that you already have, such as
depression.
Some people have had serious side effects while taking bupropion
hydrochloride extended-release tablets,
(SR), to help them quit smoking, including:
New or worse mental health problems, such as changes in behavior or
thinking, aggression, hostility,

Summary of Product characteristics

BUPROPION HYDROCHLORIDE (SR)- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
DR. REDDY'S LABORATORIES INC
----------
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, USP (SR) are an
aminoketone agent indicated as an
aid to smoking cessation treatment. ( 1)
DOSAGE AND ADMINISTRATION
Starting dose: 150 mg per day for first 3 days. ( 2.1)
General: Increase dose gradually to reduce seizure risk. ( 2.1, 5.3)
Begin dosing one week before quit day. ( 2.1)
After 3 days, increase the dose to 300 mg per day, given as 150 mg
twice daily at an interval of at least
8 hours. ( 2.1)
May be used with a nicotine transdermal system. ( 2.5)
Moderate to severe hepatic impairment: 150 mg every other day. ( 2.6,
8.7)
Mild hepatic impairment: Consider reducing the dose and/or frequency
of dosing. ( 2.6, 8.7)
Renal impairment: Consider reducing the dose and/or frequency. ( 2.7,
8.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 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 extended-release tablets (SR) or within 14
days of stopping treatment with
bupropion hydroc