BUPROPION HYDROCHLORIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Contract Pharmacy Services-PA

INN (Algemene Internationale Benaming):

BUPROPION HYDROCHLORIDE

Samenstelling:

BUPROPION HYDROCHLORIDE 75 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. A physician considering bupropion hydrochloride tablets for the management of a patient’s first episode of depression should be aware that the drug may cause generalized seizures in a dose-dependent manner with an approximate incidence of 0.4% (4/1,000). This incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted (see WARNINGS ). The efficacy of bupropion hydrochloride tablets has been established in 3 placebo-controlled trials, including 2 of approximately 3 weeks’ duration in depressed inpatients and one of approximately 6 weeks’ duration in depressed outpatients. The depressive disorder of the patients studied corresponds most closely to the Major Depression category of the APA Diagnostic and Statistical Manual III. Major Depression implies a prominent and relatively p

Product samenvatting:

Bupropion hydrochloride tablets, USP are supplied as: 75 mg: Lavender, round, film-coated tablets, debossed GG 929 on one side and plain on the reverse side. NDC 67046-044-30 in blisters of 30 tablets 100 mg: Lavender, round, film-coated tablets, debossed GG 930 on one side and plain on the reverse side. NDC 67046-045-30 in blisters of 30 tablets Store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature). Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED
Contract Pharmacy Services-PA
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MEDICATION GUIDE
BuPROPion Hydrochloride Tablets, USP
Read this Medication Guide carefully before you start using bupropion
hydrochloride tablets and each
time you get a refill. There may be new information. This information
does not take the place of talking
with your doctor about your medical condition or your treatment. If
you have any questions about
bupropion hydrochloride tablets, ask your doctor 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 Tablets?”
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, 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,
and young adults within the first few months of treatment.
2.
Depression and 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-
depr

Productkenmerken

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
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BUPROPION
SUICIDALITY AND ANTIDEPRESSANT DRUGS
_USE IN TREATING PSYCHIATRIC DISORDERS:_ Antidepressants increased the
risk compared to placebo of
suicidal thinking and behavior (suicidality) in children, adolescents,
and young adults in short-term
studies of major depressive disorder (MDD) and other psychiatric
disorders. Anyone considering
the use of bupropion hydrochloride tablets or any other antidepressant
in a child, adolescent, or
young adult must balance this risk with the clinical need. Short-term
studies did not show an
increase in the risk of suicidality with antidepressants compared to
placebo in adults beyond age
24; there was a reduction in risk with antidepressants compared to
placebo in adults aged 65 and
older. Depression and certain other psychiatric disorders are
themselves associated with
increases in the risk of suicide. Patients of all ages who are started
on antidepressant therapy
should be monitored appropriately and observed closely for clinical
worsening, suicidality, or
unusual changes in behavior. Families and caregivers should be advised
of the need for close
observation and communication with the prescriber. Bupropion
hydrochloride tablets is not
approved for use in pediatric patients. (See WARNINGS: CLINICAL
WORSENING AND SUICIDE RISK
IN TREATING PSYCHIATRIC DISORDERS, PRECAUTIONS: INFORMATION FOR
PATIENTS, and
PRECAUTIONS: PEDIATRIC USE.)
_USE IN SMOKING CESSATION TREATMENT:_ Bupropion hydrochloride,
bupropion hydrochloride, the
sustained-release formulation, and bupropion hydrochloride, the
extended-release formulation,
are not approved for smoking cessation treatment, but bupropion under
the name ZYBAN®
(bupropion hydrochloride) Sustained-Release Tablets is approved for
this use. Serious
neuropsychiatric events, including but not limited to depression,
suicidal ideation, suicide attempt,
and completed suicide have been reported in patients taking bupropion
for smoking ce