CLAREM 250 TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLARITHROMYCIN

Boleh didapati daripada:

EUCOGEN SDN BHD

INN (Nama Antarabangsa):

CLARITHROMYCIN

Unit dalam pakej:

14Tablet Tablets

Dikeluarkan oleh:

REMEDICA LTD

Ciri produk

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PACKAGE INSERT
1.
NAME OF THE PRODUCT
Clarem 250 mg film-coated tablets
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each film-coated tablet contains 250 mg clarithromycin.
3.
PRODUCT DESCRIPTION
Film-coated tablet.
Yellow, parallel, capsule shaped, film-coated tablets with
Remedica’s logo on both
sides.
The tablet can be divided into equal doses.
4.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Pharmacotherapeutic
group:
Antibacterials
for
systemic
use;
Macrolides,
lincosamides and streptogramins, ATC code: J01FA09
Mode of action
Clarithromycin is an antibiotic belonging to the macrolide antibiotic
group. It exerts
its antibacterial action by binding to the 50s ribosomal sub-unit of
susceptible
bacteria preventing translocation of activate amino acids.
It inhibits the intracellular protein synthesis of susceptible
bacteria.
The 14-hydroxy metabolite of clarithromycin, a product of parent drug
metabolism
also
has
antimicrobial
activity.
The
metabolite
is
less
active
than
the
parent
compound
for
most
organisms,
including
mycobacterium
spp.
An
exception
is
Haemophilus influenza where the 14-hydroxy metabolite is two-fold more
active than
the parent compound.
Clarithromycin is usually active against the following organisms in
vitro:
Gram-positive
Bacteria:
_Staphylococcus _
_aureus_
(methicillin
susceptible);
_Streptococcus _
_pyogenes_
(Group
A
beta-hemolytic
streptococci)
alpha-hemolytic
streptococci
(viridans
group);
_Streptococcus_
_(Diplococcus) _
_pneumoniae; _
_Streptococcus agalactiae; Listeria monocytogenes_
.
Gram-negative
Bacteria:
_Haemophilus _
_influenzae, _
_Haemophilus _
_parainfluenzae, _
_Moraxella _
_(Branhamella) _
_catarrhalis, _
_Neisseria _
_gonorrhoeae; _
_Legionella _
_pneumophila, Bordetella pertussis, Helicobacter pylori; Campylobacter
jejuni._
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Mycoplasma:
_Mycoplasma pneumoniae; Ureaplasma urealyticum._
Other Organisms:
_Chlamydia trachomatis; Mycobacterium avium; Mycobacterium _
_leprae; _
_Mycobacterum _