ZYBAN SUSTAINED-RELEASE TABLETS 150 mg

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

BUPROPION HCl

Boleh didapati daripada:

GLAXOSMITHKLINE PTE LTD

Kod ATC:

N06AX12

Dos:

150 mg

Borang farmaseutikal:

TABLET, FILM COATED

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

GlaxoSmithKline LLC

Tarikh kebenaran:

1999-06-16

Risalah maklumat

ZYBAN
 
BUPROPION HYDROCHLORIDE 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 150mg of bupropion hydrochloride. 
PHARMACEUTICAL FORM 
Sustained release film-coated tablet. 
CLINICAL PARTICULARS 
INDICATIONS 
_ZYBAN_ tablets are indicated for the treatment of nicotine
dependence as an aid to 
smoking cessation. 
DOSAGE AND ADMINISTRATION 
_ZYBAN_ tablets should be swallowed whole and not crushed or
chewed. 
USE IN ADULTS 
It is recommended that treatment is started while the patient is
still smoking and a "target 
stop date" set within the first two weeks
of treatment with _ZYBAN_, preferably in the 
second week. 
The initial dose is 150mg taken daily for
three days increasing to 150mg twice daily. 
There should be an interval of at least 8 hours
between successive doses. The maximum 
single dose should not exceed 150mg and the total daily dose should
not exceed 300mg. 
Insomnia is a very common adverse event which is often transient.
Insomnia may be 
reduced by avoiding dosing at bedtime (provided there is at least
8 hours between doses) 
or, if clinically indicated, dose reduction. 
Treatment should be continued for at least 7 weeks. The recommended
treatment period 
is 7 to 12 weeks. 
Discontinuation should be considered if the patient has not made
significant progress 
towards abstinence by the seventh week of therapy, since
it is unlikely that they will stop 
smoking during that attempt.  
As many patients attempting to stop smoking experience multiple
relapses, whether 
treatment with _ZYBAN_ should be continued for longer periods
should be determined on 
an individual basis. 
The recommended posology does not require
modification if _ZYBAN_ is used in 
combination with Nicotine Transdermal Systems
for nicotine dependence _(see Warnings _
_and Precautions)_. 
USE IN CHILDREN AND ADOLESCENTS 
The safety and efficacy of _ZYBAN_ tablets in patients under
18 years of ag