Cefuroxim STADA 500 mg Film Coated Caplet

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

CEFUROXIME AXETIL

Saatavilla:

DKSH MALAYSIA SDN BHD

INN (Kansainvälinen yleisnimi):

CEFUROXIME AXETIL

Kpl paketissa:

10tablet Tablets

Valmistaja:

PYMEPHARCO

Pakkausseloste

_Consumer Medication Information Leaflet (RiMUP) _
CEFUROXIM STADA FILM COATED CAPLET
Cefuroxime axetil (250mg, 500mg)
1
WHAT IS IN LEAFLET
1.
What Cefuroxim STADA is used for
2.
How Cefuroxim STADA works
3.
Before you use Cefuroxim STADA
4.
How to use Cefuroxim STADA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Cefuroxim
STADA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CEFUROXIM STADA IS USED FOR
Your doctor has chosen this medicine to
suit you and your condition. Your
doctor has prescribed this medicine
because you have an infection on:
•
Lower respiratory tract infections:
pneumonia, acute bronchitis, and
acute exacerbations of chronic
bronchitis.
•
Upper respiratory tract infections:
ear, nose and throat infections, such
as otitis media, sinusitis, tonsillitis,
pharyngitis.
•
Genito-urinary tract infections:
pyelonephritis, cystitis and
urethritis.
•
Skin and soft tissue infections:
furunculosis, pyoderma, impetigo.
•
Gonorrhoea, acute uncomplicated
gonococcal urethritis, and cervicitis.
HOW CEFUROXIM STADA WORKS
Cefuroxime axetil which is found
Cefuroxim STADA belongs to a group
of medicines called cephalosporins
which is a type of antibiotic. Antibiotics
kill bacteria or “germs” which cause
infections.
BEFORE YOU USE CEFUROXIM STADA
-
_When you must not use it _
Do not take Cefuroxim STADA if you
have ever had a severe allergenic
reaction to an antibiotic known as
cephalosporin or any of the ingredients
in Cefuroxim STADA. Ask your doctor
or pharmacist if you are not sure.
-
_Before you start to use it _
Tell your doctor about all your medical
conditions, including if you:
•
have experienced an allergic
reaction to penicillins or other beta-
lactams;
•
have kidney failure;
•
have severe gastrointestinal disease;
•
are in pregnancy
•
or you are breast feeding a baby
because cefuroxime is found in
human milk.
-
_Taking other medicines _
Please tell your doctor or pharmacist if
you taking or have recently take

Valmisteyhteenveto

CEFUROXIM STADA
® 500MG FILM COATED CAPLET
COMPOSITION
Active
Ingredient:
Each
film
coated
caplet
contains
cefuroxime axetil equivalent to 500mg of cefuroxime
Other Ingredients: Microcrystalline cellulose, maize starch,
crocarmellose
sodium,
magnesium
stearate,
talc,
hypromellose, polyethylene glycol, titanium dioxide.
PHARMACODYNAMIC PROPERTIES
The in vivo bactericidal activity of cefuroxime axetil is due to
cefuroxime’s binding to essential target proteins and the
resultant inhibition of cell-wall synthesis.
Cefuroxime has bactericidal activity against a wide range of
common
pathogens,
including
many
beta-lactamase-
producing strains. Cefuroxime is stable to many bacterial
beta-lactamases,
especially
plasmid-mediated
enzymes
that are commonly found in enterobacteriaceae.
Cefuroxime has been demonstrated to be active against
most strains of the following microorganisms both in vitro
and in clinical infections.
AEROBIC GRAM-POSITIVE MICROORGANISMS:
_Staphylococcus _
_aureus_
(including
beta-lactamase-
producing
strains),
_Streptococcus _
_pneumoniae_,
_Streptococcus pyogenes_.
AEROBIC GRAM-NEGATIVE MICROORGANISMS:
_Escherichia coli_, _ Haemophilus influenza_ (including beta-
lactamase-producing strains), _Haemophilus parainfluenzae_,
_Klebsiella _
_pneumoniae_,
_Moraxella _
_catarrhalis_
(including
beta-lactamase-producing strains), _ Neisseria gonorrhoeae_
(including beta-lactamase-producing strains)
SPIROCHETES: _Borrelia burgdorferi_
PHARMACOKINETIC PROPERTIES
ABSORPTION AND METABOLISM: After oral administration,
cefuroxime axetil is absorbed from the gastrointestinal tract
and rapidly hydrolyzed by nonspecific esterases in the
intestinal mucosa and blood to cefuroxime. Absorption of the
tablet
is
greater
when
taken
after
food
(absolute
bioavailability of cefuroxime tablets increases from 37% to
52%). Cefuroxime is not metabolized.
DISTRIBUTION:
Cefuroxime
is
subsequently
distributed
throughout the extracellular fluids. The axetil moiety is
metabolized to acetaldehyde and acetic acid. Approximately
50% of s