BUPROPION HYDROCHLORIDE tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

H.J. Harkins Company, Inc.

INN (Isem Internazzjonali):

BUPROPION HYDROCHLORIDE

Kompożizzjoni:

BUPROPION HYDROCHLORIDE 100 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. A physician considering bupropion 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 has been established in three placebo-controlled trials, including two 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 persistent depressed or dysphoric mood t

Sommarju tal-prodott:

Bupropion Hydrochloride Tablets, USP are available containing 75 mg or 100 mg of bupropion hydrochloride, USP. The 75 mg tablets are peach film-coated, round, unscored tablets debossed with M on one side of the tablet and 433 on the other side. They are available as follows: NDC 0378-0433-01 bottles of 100 tablets NDC 0378-0433-05 bottles of 500 tablets The 100 mg tablets are light blue film-coated, round, unscored tablets debossed with M on one side of the tablet and 435 on the other side. They are available as follows: NDC 0378-0435-01 bottles of 100 tablets NDC 0378-0435-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. *The following are registered trademarks of their respective manufacturers: ZYBAN® /GlaxoSmithKline, WELLBUTRIN SR® /GlaxoSmithKline and WELLBUTRIN XL® /GlaxoSmithKline. U.S. Pat. No. 5,968,553 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED JANUARY 2010 BUPR:R22mpbmt

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED
H.J. Harkins Company, Inc.
----------
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, 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-
depressive illness) or suici

Karatteristiċi tal-prodott

BUPROPION HYDROCHLORIDE - BUPROPION HYDROCHLORIDE TABLET, FILM COATED
H.J. HARKINS COMPANY, INC.
----------
WARNING
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 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 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 tablets,
WELLBUTRIN SR
and
WELLBUTRIN XL
are not approved for smoking cessation treatment, but bupropion under
the
name ZYBAN
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 cessation. Some
cases may have been
complicated by the symptoms of nicotine withdrawal in patients who
stopped smoking. Depressed
mood may be a symptom of nicotine withdrawal. Depression, ra