KLACID XL TABLET

Երկիր: Հարավաֆրիկյան Հանրապետություն

Լեզու: անգլերեն

Աղբյուրը: South African Health Products Regulatory Authority (SAHPRA)

Հասանելի է:

Abbott Laboratories S.A. (Pty) Ltd

Դոզան:

See ingredients

Դեղագործական ձեւ:

TABLET

Կազմը:

EACH TABLET CONTAINS CLARITHROMYCIN 500,0 mg

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2000-01-05

Տեղեկատվական թերթիկ

1
PROPOSED PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you take these tablets. It
gives a summary of
the information available on this medicine.

Keep this leaflet. You may need to read it again.

If you have further questions or are not sure about anything, please
ask your
doctor or pharmacist.

This medicine has been prescribed for you personally and you should
not share
the medicine with other people. It may harm them, even if their
symptoms are
the same as yours.
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
KLACID XL Tablets
Clarithromycin
WHAT KLACID XL CONTAINS:
KLACID XL tablets are modified release tablets, which means that the
active ingredient
is released slowly from the tablet, so that you have to take them only
once a day.
Each KLACID XL tablet contains 500 mg clarithromycin (6-o-methyl
erythromycin A) as
the active ingredient.
2
Other ingredients include: Citric acid, sodium alginate, sodium
calcium alginate,
lactose,
povidone,
talc,
stearic
acid,
magnesium
stearate,
methyl
hydroxypropyl
cellulose, polyethylene glycol, titanium dioxide (E171), sorbic acid
and quinoline
yellow dye (E104).
WHAT KLACID XL IS USED FOR:
KLACID XL is an antibiotic belonging to a group called macrolides.
Antibiotics stop the
growth of bacteria (bugs) which cause infections. Its use is described
below.
KLACID XL is used to treat infections such as:
1.
Chest infections, such as bronchitis and pneumonia
2.
Throat and sinus infections
3.
Skin and tissue infections such as cellulitis, folliculitis or
erysipelas
BEFORE TAKING KLACID XL TABLETS:
DO NOT TAKE KLACID XL TABLETS:

if you know that you are allergic to clarithromycin, other macrolide
antibiotics such as erythromycin or azithromycin, or any of the other
ingredients in the tablets.

Do not take ergotamine or dihydroergotamine tablets or use ergotamine
inhalers for migraine
while
taking
KLACID
XL.
Consult
your
doctor,
pharmacist or other health care professional for advice for advice on
alternative medicines.
3

Do not

Ապրանքի հատկությունները

Page 1 of 9
c
APPROVED PACKAGE INSERT (APPROVED 01.12.2006)
SCHEDULING STATUS 84
PROPRIETARY NAME (AND DOSAGE FORM)
KLACID XL MODIFIED RELEASE TABLETS
COMPOSITION
KLACID XL MODIFIED RELEASE TABLETS:
Each tablet contains 500 mg clarithromycin (6-0-methyl erythromycin A)
in a homogenous
matrix, which provides sustained release during its transit through
the gastrointestinal tract.
Other
inactive
ingredients
in the
tablet
include:
citric
acid
anhydrous,
sodium
alginate,
sodium
calcium alginate,
lactose,
povidone
K30,
talc,
stearic
acid,
magnesium
stearate,
methylhydroxy propyl cellulose, polyethylene glycol, titanium dioxide
and yellow dye
E104
Aluminium Lake. Preservative: Sorbic acid 0.01% m/m.
PHARMACOLOGICAL CLASSIFICATION
A 20 .1.1 - Medium and broad spectrum antibiotics
PHARMACOLOGICAL ACTION
Clarithromycin is a macrolide antibiotic which exerts its
antibacterial action by binding to the
c
SOS ribosomal sub-units of susceptible bacteria and suppresses protein
synthesis .
The _in-vitro _antibacterial spectrum of pathogens usually sensitive
to clarithromycin is as
follows _ (in-vitro _sensitivity does not necessarily imply _in vivo
_efficacy) :
_Streptococcus agalactiae _
_Streptococcus pyogenes _
_Streptococcus pneumoniae_
_ _
_Legionella pneumophila _
_Mycoplasma pneumoniae _
_Chlamydia trachomatis _
_Branhamella catarrhalis_
Certain strains of _Staphylococcus aureus _
_Haemophilus influenzae_
_Helicobacter (Campylobacter) pylori_
Page 2 of 9
_c_
_Mycobacterium avium _
_Mycobacterium kansasii _
_Mycobacterium chelonae_
_ _
_Mycobacterium intracel/ulare_
Clarithromycin is bactericidal to _ Helicobacter pylori, _ this
activity being greater at neutral pH
than at acid pH.
The principal metabolite of clarithromycin
in man
and other
primates is
the 14-hydroxy-
clarithromycin metabolite, which also has antibacterial activity. This
metabolite is as active or
1-to-2
fold
less
active
than
the
parent
compound
for
most
organisms,
except
for
_H._
_ _
_influenzae _
against
which
it
is
twice
as
active.
The
parent
compound
a