Clarimycin Film Coated Tablet 500mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLARITHROMYCIN

Boleh didapati daripada:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (Nama Antarabangsa):

CLARITHROMYCIN

Unit dalam pakej:

100 Tablets

Dikeluarkan oleh:

Y.S.P. INDUSTRIES (M) SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
CLARIMYCIN FILM COATED TABLET
Clarithromycin (250mg, 500mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What
CLARIMYCIN
FILM
COATED TABLET is used for
2.
How
CLARIMYCIN
FILM
COATED TABLET works
3.
Before
you
use
CLARIMYCIN
FILM COATED TABLET
4.
How
to
use
CLARIMYCIN
FILM COATED TABLET
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
CLARIMYCIN FILM COATED
TABLET
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT CLARIMYCIN FILM
COATED TABLET IS USED FOR
CLARIMYCIN
FILM
COATED
TABLET
is
used
to
treat
certain
bacterial
infections,
including
the
following:
-
Infection
of
nosepharyns
tract
(tonsillitis,
pharyngitis),
and
of
paranasal sinuses.
-
Infection of lower respiratory tract
such
as
bronchitis,
bacterial
pneumonia and atypical pneumonia.
-
Treatment of skin infections such as
impetigo,
erysipelas,
folliculitis,
furunculosis and septic wounds.
HOW CLARIMYCIN FILM
COATED TABLET WORKS
CLARIMYCIN
FILM
COATED
TABLET is an antibiotic that belongs
to
the
group
of
medicines
called
macrolides. These medicines work by
killing
or
stopping
the
growth
of
bacteria which cause infections.
BEFORE YOU USE CLARIMYCIN
FILM COATED TABLET
-
_When you must not use it _
Do not take CLARIMYCIN FILM
COATED TABLET if:
•
You have ever had an allergic
reaction to medicines containing
clarithromycin
and
other
antibiotics
from
the
macrolide
family. Some symptoms of an
allergic
reaction
include
skin
rash, itching, shortness of breath
or swelling of the face, lips or
tongue,
which
may
cause
difficulty
in
swallowing
or
breathing.
•
You
have
heart
diseases
or
irregular heartbeat
•
You
have
electrolyte
disturbances
•
You are taking medicine such as
terfenadine, which is commonly
used to treat allergy reaction.
-
_Before you start to use it _
Tell your doctor if you are allergic
to any other medicines, foods, dyes
or preservatives.
Tell your doctor if you have or have
had kidney or liver disease.
_Pregnancy and lactation _
Please

Ciri produk

CLARIMYCIN
FILM COATED TABLET
INGREDIENT(S):
Clarimycin Film Coated Tablet 250mg:
Each tablet contains:
Clarithromycin
………………….……….………………..……………….…………
250mg
Clarimycin Film Coated Tablet 500mg:
Each tablet contains:
Clarithromycin
………………….……….………………..……………….…………
500mg
PHARMACODYNAMICS:
1.
Clarithromycin exerts its antibacterial activity by inhibiting the
synthesis of
proteins, by means of a link with the 50S sub-unit of the cellular
ribosome.
Clarithromycin has demonstrated excellent _in vitro_ activity against
both standard
strains of bacteria and clinical isolates. It is highly potent against
a wide variety
of aerobic and anaerobic gram-positive and gram-negative organisms.
PHARMACOKINETICS:
1.
ABSORPTION
Well absorbed from the gastrointestinal tract; stable in gastric acid;
food delays
the rate, but not the extent, of absorption; bioavailability is
approximately 55% in
healthy volunteers.
2.
DISTRIBUTION
Widely distributed into tissues and fluids; high concentrations found
in nasal
mucosa, tonsils, and lungs; concentrations in tissues are higher than
those in
serum because of high intracellular concentrations; readily enters
leucocytes
and macrophages.
Volume of distribution: 243-266 liters.
3.
PROTEIN BINDING
High (65-75%).
4.
BIOTRANSFORMATION
Hepatically metabolized via three main pathways, demethylation,
hydroxylation,
and hydrolysis, to eight metabolites. One metabolite,
14-hydroxyclarithromycin,
has _in vitro _antimicrobial activity comparable to that of
clarithromycin and may
act
synergistically
with
clarithromycin
against
_Haemophilus _
_influenzae_.
Saturation
of
metabolism
involves
the
demethylation
and
hydroxylation
pathways, and accounts for an increase in serum half-life.
5.
HALF-LIFE
Clarithromycin:
250mg every 12 hours – 3 to 4 hours.
500mg every 12 hours – 5 to 7 hours.
14-hydroxyclarithromycin:
250mg every 12 hours – 5 to 6 hours.
500mg every 12 hours – approximately 7 hours.
Norma