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

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Actavis Pharma, Inc.

INN (Tarptautinis Pavadinimas):

BUPROPION HYDROCHLORIDE

Sudėtis:

BUPROPION HYDROCHLORIDE 150 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Bupropion hydrochloride extended-release tablets (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 disorders) concomitantly with bupropion hydrochloride extended-release tablets (SR) or within 14 days of discontinuing treatment with bupropion hydrochloride extended-release tablets

Produkto santrauka:

Bupropion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg of bupropion hydrochloride, USP are white to off-white, round, unscored, film-coated tablets imprinted with "WPI" over "867" on one side and supplied in bottles of 60 tablets (NDC 0591-3543-60) and the Starter Pack containing 1 bottle of 60 tablets (NDC 0591-3543-76). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Actavis Pharma, Inc.
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MEDICATION GUIDE
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 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
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
•
frustration
•
restlessness
•
depressed mood
•
anger
•
decreased heart rate
•
trouble sleeping
•
feeling anxious
•
increased appetite
•
irritability
•
difficulty concentrating
•
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, hosti

Prekės savybės

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 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 hydrochloride extended