Clarem Film-Coated Tablet 500 mg

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

CLARITHROMYCIN

Διαθέσιμο από:

EUCOGEN SDN BHD

INN (Διεθνής Όνομα):

CLARITHROMYCIN

Μονάδες σε πακέτο:

100 Tablets; 14 Tablets

Κατασκευάζεται από:

Remedica Ltd

Αρχείο Π.Χ.Π.

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PACKAGE INSERT
1.
NAME OF THE PRODUCT
CLAREM 250 TABLET
Clarem Film-Coated Tablet 500 mg
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT
_CLAREM 250 TABLET:_
Each film-coated tablet contains 250 mg clarithromycin.
_ _
_Clarem Film-Coated Tablet 500 mg:_
Each film-coated tablet contains 500 mg
clarithromycin.
3.
DOSAGE FORM
Film-coated tablet.
_CLAREM 250 TABLET:_
Yellow, parallel, capsule shaped, film-coated tablets with
Remedica’s logo on both sides.
_ _
_Clarem Film-Coated Tablet 500 mg:_
Yellow, oval, film-coated tablets, scored on one
side and embossed with “CL500” on the other side.
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:
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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