BUPROPION HCL tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Direct_Rx

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. Bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder.• Bupropion hydrochloride tablets 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 bupropion hydrochloride tablets [see Warnings and Precautions (5.3)]. Bupropion hydrochloride tablets 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 o

Ürün özeti:

Bupropion hydrochloride tablets, USP 75 mg are available for oral administration as orange, round, unscored, film coated tablets, imprinted "APO" on one side and "BU" over "75" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0158-3) Bottles of 90 (NDC 60505-0158-9) Bottles of 100 (NDC 60505-0158-1) Bottles of 500 (NDC 60505-0158-5) Bottles of 1,000 (NDC 60505-0158-7) Bupropion hydrochloride tablets, USP 100 mg are available for oral administration as purple, round, unscored, film coated tablets, imprinted "APO" on one side and "BUP" over "100" on the other side. They are supplied as follows: Bottles of 30 (NDC 72189-457-30) Bottles of 90 (NDC 60505-0157-9) Bottles of 100 (NDC 60505-0157-1) Bottles of 500 (NDC 60505-0157-5) Bottles of 1,000 (NDC 60505-0157-7)

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Direct_Rx
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Bupropion Hydrochloride Tablets, USP
(bue proe' pee on hye'' droe klor' ide).
Medication Guide available at
https://www.apotex.com/products/us/mg.asp
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.
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 the risk of 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 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, behaviors, thoughts, or feelings.
This is very important when an antidepressant medicine is started or
when the dose is changed.
Call your healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts, or
feelings.
Keep all follow-up visits with your healthcare provider as scheduled.
Call the healthcare provider

Ürün özellikleri

BUPROPION HCL- BUPROPION HCL TABLET, FILM COATED
DIRECT_RX
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BUPROPION HCL
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk of suicidal thoughts and behavior
in children,
adolescents, and young adults in short-term trials. These trials did
not show an
increase in the risk of suicidal thoughts and behavior with
antidepressant use in
subjects over age 24; there was a reduction in risk with
antidepressant use in
subjects aged 65 and older [see Warnings and Precautions (5.1)].
In patients of all ages who are started on antidepressant therapy,
monitor closely
for worsening, and for emergence of suicidal thoughts and behaviors.
Advise
families and caregivers of the need for close observation and
communication with
the prescriber [see Warnings and Precautions (5.1)].
Bupropion hydrochloride tablets are indicated for the treatment of
major depressive
disorder (MDD), as defined by the Diagnostic and Statistical Manual
(DSM).
The efficacy of bupropion hydrochloride tablets in the treatment of a
major depressive
episode was established in two 4-week controlled inpatient trials and
one 6-week
controlled outpatient trial of adult subjects with MDD [see Clinical
Studies (14)].
2.1 General Instructions for Use
To minimize the risk of seizure, increase the dose gradually [see
Warnings and
Precautions (5.3)]. Increases in dose should not exceed 100 mg/day in
a 3-day period.
Bupropion hydrochloride tablets should be swallowed whole and not
crushed, divided, or
chewed. Bupropion hydrochloride tablets may be taken with or without
food.
The recommended starting dose is 200 mg/day, given as 100 mg twice
daily. After 3
days of dosing, the dose may be increased to 300 mg/day, given as 100
mg 3 times
daily, with at least 6 hours between successive doses. Dosing above
300 mg/day may
be accomplished using the 75- or 100-mg tablets.
A maximum of 450 mg/day, given in divided doses of not more than 150
mg each, may
be considered for patients who show no clinical improvem