APLENZIN ER- bupropion hydrobromide tablet, extended release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

BUPROPION HYDROBROMIDE (UNII: E70G3G5863) (BUPROPION - UNII:01ZG3TPX31)

थमां उपलब्ध:

STAT RX USA LLC

INN (इंटरनेशनल नाम):

BUPROPION HYDROBROMIDE

रचना:

BUPROPION HYDROBROMIDE 348 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Aplenzin™ (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) [see CLINICAL STUDIES (14) ] . A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide atte

उत्पाद समीक्षा:

Aplenzin Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off white, round tablets printed with "BR" over "174" in bottles of 30 tablets (NDC xxxxx-xxx-xx) and 90 tablets (NDC xxxxx-xxx-xx). Aplenzin Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off white, round tablets printed with "BR" over "348" in bottles of 30 tablets (NDC xxxxx-xxx-xx) and 90 tablets (NDC xxxxx-xxx-xx). Aplenzin Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off white, round tablets printed with "BR" over "522" in bottles of 30 tablets (NDC xxxxx-xxx-xx) and 90 tablets (NDC xxxxx-xxx-xx). Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

APLENZIN ER- BUPROPION HYDROBROMIDE TABLET, EXTENDED RELEASE
STAT RX USA LLC
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MEDICATION GUIDE
Aplenzin (a-plen-zin)
(bupropion hydrobromide extended-release tablets)
Read this Medication Guide carefully before you start using Aplenzin
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 Aplenzin, ask your doctor or
pharmacist.
IMPORTANT: Be sure to read both sections of this Medication Guide. The
first section is about the risk
of suicidal thoughts and actions with antidepressant medicines; the
second section is entitled "What other
important information should I know about Aplenzin?"
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 suicidal thoughts or actions.
3.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
•
Pay close attention to any changes, especially sudden changes in mood,

उत्पाद विशेषताएं

APLENZIN ER- BUPROPION HYDROBROMIDE TABLET, EXTENDED RELEASE
STAT RX USA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APLENZIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR APLENZIN.
APLENZIN (BUPROPION HYDROBROMIDE) TABLET, FILM COATED, EXTENDED
RELEASE FOR ORAL USE
INITIAL U.S. APPROVAL: 1985
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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 (5.1) (8.4)
ANYONE CONSIDERING THE USE OF APLENZIN OR ANY OTHER ANTIDEPRESSANT IN
A CHILD, ADOLESCENT, OR YOUNG
ADULT MUST BALANCE THIS RISK WITH THE CLINICAL NEED. (8.4)
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. (5.1)
DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES
ASSOCIATED WITH INCREASES IN THE RISK
OF SUICIDE. (5.1)
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. (5.1)
FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR CLOSE
OBSERVATION AND COMMUNICATION WITH
THE PRESCRIBER. (17)
APLENZIN IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. [SEE WARNINGS
AND PRECAUTIONS: CLINICAL
WORSENING AND SUICIDE RISK (5.1) AND USE IN SPECIFIC POPULATIONS:
PEDIATRIC USE (8.4)]
INDICATIONS AND USAGE
Aplenzin is an aminoketone antidepressant indicated for the treatment
of: Major depressive disorder (1)
Periodically reevaluate long-term usefulness for the individual
patient. (1)
DOSAGE AND ADMINISTRATION
General: Increase dose gradually to reduce seizure risk an