Chemmart Cefaclor CD

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Cefaclor monohydrate

Disponível em:

Apotex Pty Ltd

Classe:

Medicine Registered

Folheto informativo - Bula

CHEMMART CEFACLOR CD
TABLETS

_Contains the active ingredient, cefaclor (as cefaclor monohydrate)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
THIS LEAFLET ANSWERS SOME COMMON
QUESTIONS ABOUT CEFACLOR. IT DOES
NOT CONTAIN ALL THE AVAILABLE
INFORMATION.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Cefaclor CD. It contains
the active ingredient, cefaclor (as
cefaclor monohydrate).
It is used to treat infections caused by
bacteria in different parts of the body
such as:
•
chest and lungs (lower respiratory
tract)
•
nose, throat, sinuses and tonsils
(upper respiratory tract)
•
bladder (lower urinary tract)
•
skin
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed it for
another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Cefaclor is an antibiotic which
belongs to a group called
cephalosporins. These are closely
related to penicillins.
It works by killing the bacteria
causing your infection or by stopping
its growth.
It will not work against infections
caused by viruses such as colds or
the flu.
There is no evidence that this
medicine is addictive.
This medicine is not expected to
affect

Características técnicas

Product Information – Australia 
Chemmart Cefaclor CD 375 mg Tablets

Page 1 
CHEMMART CEFACLOR CD TABLETS 

NAME OF THE MEDICINE 
Cefaclor monohydrate.   

Chemical Name:  
3-chloro-7-D- (2-phenylglycinamido) -3-cephem-4-carboxylic acid
monohydrate 

Structural Formula: 

H
2
N H
O
N
H
N
S
O
Cl
HO
O
H
2
O
.
H
H

Molecular Formula: 
C
15
H
14
CIN
3
O
4
S.H
2
O 

Molecular Weight: 
385.83 

CAS Registry Number:  70356-03-5 

DESCRIPTION 
Cefaclor (monohydrate) is a white to off-white
crystalline powder, slightly soluble
in water, but is insoluble 
in alcohol and chloroform. 

PHARMACOLOGY 
PHARMACOKINETICS   
Cefaclor CD is well absorbed
after oral administration, with peak plasma levels being reached
in about 2 
hours.  Following a single dose of cefaclor CD 375 mg C
max
 is approximately 3.8 
mg/mL and AUC is 11.5 
mg.h/mL.  When taken with food the time to reach maximum plasma
levels is increased to about 3 hours 
and Cmax increases by 20%.  The effects of food on C
max
  and T
max
  are also seen with other modified 
release preparations of cefaclor. 

Other studies with sustained release preparations of cefaclor have shown that although it can be taken 
with or without food, total absorption is enhanced with food. When it was given within one hour after a 
meal, the bioavailability of sustained release
cefaclor was greater than 90%, using cefaclor taken fasting 
as a reference. When taken in the fasting state, the
bioavailability of sustained release cefaclor was 77% 
that of cefaclor. Compared to cefaclor (fasted state), mean
peak plasma concentrations of sustained 
release cefaclor (both fed and fasted states) were delayed 40 to 90
minutes and were lower. Concomitant 
administration of cimetidine does not affect the rate
or extent of absorption.  Administratio