Clarithromycin STELLA 500mg Film-Coated Tablet

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

CLARITHROMYCIN

から入手可能:

STADPHARM SDN. BHD.

INN（国際名）:

CLARITHROMYCIN

パッケージ内のユニット:

28 Tablet Tablets

製:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

情報リーフレット

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CLARITHROMYCIN STELLA 500MG FILM-
COATED TABLET
Clarithromycin 500mg
1
WHAT IS IN THIS LEAFLET
1.
What Clarithromycin STELLA 500mg
is used for
2.
How Clarithromycin STELLA 500mg
works
3.
Before you use Clarithromycin
STELLA 500mg
4.
How to use Clarithromycin STELLA
500mg
5.
Side effects
6.
Storage and Disposal of
Clarithromycin STELLA 500mg
7.
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT CLARITHROMYCIN STELLA 500MG
IS USED FOR
Clarithromycin STELLA 500mg is used
to treat following infections:
•
Treatment of infections caused by
pathogens sensitive to clarithromycin.
•
Infections of nose-pharynx tract
(tonsillitis, pharyngitis) and of
paranasal sinuses.
•
Infections of lower respiratory tract:
bronchitis, bacterial pneumonia and
atypical pneumonia.
•
Skin infections: impetigo, erysipelas,
folliculitis, furunculosis and septic
wounds.
HOW CLARITHROMYCIN STELLA 500MG
WORKS
Clarithromycin exerts its antibacterial
action by binding to the 50S ribosomal
subunit of susceptible microorganisms
resulting in inhibition of protein
synthesis.
BEFORE YOU USE CLARITHROMYCIN
STELLA 500MG
Do not take Clarithromycin STELLA
500mg if you are taking any of the
following medicines:
Domperidone (used for nausea &
vomiting).
_When you must not use it _
•
If you are allergic to clarithromycin,
other macrolide antibiotics or any of
the other ingredients of this medicine.
•
The following drugs must not be
concomitant used with clarithromycin:
•
terfenadine, astemizole, cisapride
and pimozide.
•
ergot alkaloids (ergotamine,
dihydroergotamine)
_._
Talk to your doctor if you are taking
or have recently taken these above
drugs.
_Before you start use it _
Talk to your doctor or pharmacist before
taking clarithromycin:
•
if you are in presence of severe
renal impairment with or without
coexisting hepatic impairment.
•
if you are using ranitidine bismuth
citrate.
•
if you have history of
acuteporphyria.
•
if you are pregnant

製品の特徴

DESCRIPTION
Active ingredient: One tablet contains 500 mg of Clarithromycin.
PHARMACODYNAMICS
Clarithromycin exerts its antibacterial action by binding to the 50S
ribosomal subunit of susceptible microorganisms
resulting in inhibition of protein synthesis.
Additionally, the 14-hydroxyclarithromycin metabolite also has
clinically significant antimicrobial activity. The
14-hydroxyclarithromycin is twice as active against Haemophilus
influenzae microorganisms as the parent compound.
However, for Mycobacterium avium complex (MAC) isolates the
14-hydroxymetabolite is 4 to 7 times less active than
clarithromycin. The clinical significance of this activity against
Mycobacterium avium complex is unknown.
Clarithromycin is rapidly absorbed from the gastrointestinal tract,
and undergoes first-pass metabolism; the
bioavailability of the parent drug is about 55%. The extent of
absorption is relatively unaffected by the presence of
food. Peak concentrations of clarithromycin and its principal active
metabolite, 14-hydroxyclarithromycin, are
reported to be about 900 and 600 ng/ml, respectively after a single
250 mg dose by mouth; at steady state the same
dose given every 12 hours as tablets produces peak concentrations of
clarithromycin of about 1 mg/ml.
The pharmacokinetics of clarithromycin are non-linear and dose
dependent; high doses may produce
disproportionate increases in peak concentrations of the parent drug,
due to saturation of the metabolic pathways.
Clarithromycin and its principal metabolite are widely distributed,
and tissue concentrations exceed those in serum,
in part because of intracellular uptake. Clarithromycin has been
detected in breast milk. It is extensively metabolised
in the liver, and excreted in faeces via the bile. At steady state
about 20% and 30% of a 250 mg or 500 mg dose as
tablets, respectively, is excreted in the urine as unchanged drug.
14-hydroxyclarithromycin as well as other
metabolites are also excreted in the urine accounting for 10 to 15% of
the dose. The terminal half-life of
clarith