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

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Preferred Pharmaceuticals Inc.

INN (Διεθνής Όνομα):

BUPROPION HYDROCHLORIDE

Σύνθεση:

BUPROPION HYDROCHLORIDE 300 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Bupropion hydrochloride extended-release tablets, (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1)]. Bupropion hydrochloride extended-release tablets, (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets, (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled tr

Περίληψη προϊόντος:

Bupropion hydrochloride extended-release tablets, USP (XL), 300 mg are white to off white capsule shaped, biconvex coated tablets de-bossed with ‘I 71’ on one side and plain on the other side and are available in bottles of 30 tablets

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

BUPROPION HYDROCHLORIDE (XL)- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Bupropion Hydrochloride Extended-Release tablets, USP (XL)
(bue proe' pee on hye'' droe klor' ide)
Read this Medication Guide carefully before you start using bupropion
hydrochloride extended-release
tablets (XL) 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
(XL), 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 (XL)?”
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 or actions.
Some p

Αρχείο Π.Χ.Π.

BUPROPION HYDROCHLORIDE (XL)- BUPROPION HYDROCHLORIDE TABLET, EXTENDED
RELEASE
PREFERRED PHARMACEUTICALS 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 (XL) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BUPROPION
HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL).
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, (XL), FOR ORAL USE
INITIAL U.S. APPROVAL: 1985 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS
_ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablet, USP (XL) is an
aminoketone antidepressant, indicated for the treatment
of major depressive disorder (MDD) and prevention of seasonal
affective disorder (SAD). Periodically reevaluate long-
term usefulness for the individual patient. (1)
DOSAGE AND ADMINISTRATION
Ge ne ral:
• Increase dose gradually to reduce seizure risk. (2.1, 5.3)
• Periodically reassess the dose and need for maintenance treatment.
(2.2)
Major Depressive Disorder
• Starting dose: 150 mg/day once daily. Usual target dose: 300 mg
once daily (2.2)
• After 4 days, may increase the dose to 300 mg once daily. (2.2)
Seasonal Affective Disorder
• Initiative treatment in the autumn prior to onset of seasonal
depressive symptoms. (2.3)
• Starting dose: 150 mg once daily. Usual target dose: 300 mg once
daily. (2.3)
• After one week, may increase the dose to 300 mg once daily. (2.3)
• Continue treatment through the winter season. (2.3)
Hepatic Impairment
• Moderate to severe hepatic impairment: 150 mg every other day (2.6
)
• 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 of dosing. (2.7, 8.6)
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most co