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OMEGAPHARM CEFEPIME FOR INJECTION 1 G AND 2 G
CONSUMER MEDICINE INFORMATION
OMEGAPHARM CEFEPIME FOR INJECTION 1 G AND 2 G
CEFEPIME (AS CEFEPIME HYDROCHLORIDE)
CONSUMER MEDICINE INFORMATION
_ _
OMEGAPHARM CEFEPIME FOR INJECTION 1 g and 2 g
Page 1 of 3
WHAT IS IN THIS LEAFLET?
The medicine which your doctor has
prescribed for you is called
Omegapharm Cefepime for Injection.
The information in this leaflet
answers some questions you may
have about Omegapharm Cefepime
for Injection.
This leaflet does not contain all the
information about Omegapharm
Cefepime for Injection. Your doctor
or pharmacist has been provided with
full information, and can answer any
questions you may have. Follow your
doctor's advice, even if it differs from
what is in this leaflet.
You should read this leaflet carefully
before Omegapharm Cefepime for
Injection is given to you. Keep this
leaflet in a safe place, you may need
to read it again.
WHAT OMEGAPHARM
CEFEPIME FOR INJECTION IS
USED FOR:
Omegapharm Cefepime for Injection
contains cefepime which belongs to a
group of antibiotics called
cephalosporins. These antibiotics
work by killing the bacteria that are
causing the infection.
Omegapharm Cefepime for Injection
is an injectable antibiotic used for
serious infections in adults caused by
bacteria in the lungs (pneumonia and
bronchitis), in the kidney and bladder
(urinary tract infections), in the skin,
inside the abdomen (peritonitis and
biliary tract infections), in the womb
or vagina, or in the blood
(septicaemia). It may be
given before
surgery or if you have a lack of white
blood cells with fever.
Omegapharm Cefepime for Injection
is also used for serious infections in
children over 2 months o
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Product Information:
Omegapharm Cefepime for Injection 1 g and 2 g
Page 1 of 15
PRODUCT INFORMATION
OMEGAPHARM CEFEPIME FOR INJECTION 1 G AND 2 G
NAME OF THE MEDICINE
Cefepime as Cefepime hydrochloride
DESCRIPTION
Cefepime hydrochloride is a semi-synthetic broad-spectrum cephalosporin
antibiotic for parenteral
administration. The chemical name is Pyrrolidinium,
1-[[7-[[(2-amino-4-
thiazolyl)(methoxyimino)acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]
methyl]-1-methyl-,chloride, monohydrochloride, monohydrate,
[6R-[6α,7β(Z)]], which corresponds
to the following structural formula:
Cefepime hydrochloride is a white to pale yellow powder, which
is highly soluble in water.
MOLECULAR FORMULA: C
19
H
25
ClN
6
O
5
S
2
•HCl•H
2
O
MOLECULAR WEIGHT: 571.50
CAS REGISTRY NUMBER: 123171-59-5
Omegapharm Cefepime for Injection contains Arginine as an
excipient.
PHARMACOLOGY
_ _
_PHARMACOKINETICS (IN ADULTS)_
_ _
Average plasma concentrations of cefepime observed in
normal adult males at various times
following single 30-minute infusions of 500 mg, 1 g and 2 g
are summarised in Table 1. Following
intramuscular administration, cefepime is completely absorbed.
The average plasma concentrations
of cefepime at various times following a single IM injection
are summarised in Table 1.
Product Information:
Omegapharm Cefepime for Injection 1 g and 2 g
Page 2 of 15
TABLE 1
MEAN PLASMA CONCENTRATIONS OF CEFEPIME (MICROGRAM/ML)
IN MALE SUBJECTS WITH NORMAL RENAL
FUNCTION
TIME AFTER DOSE (HOURS)
DOSE
0.5
1
2
4
8
12
INTRAVENOUS INFUSION
500 mg
33.6
18.9
11.3
4.6
1.0
0.6
1 g
66.9
41.8
25.3
11.0
2.8
0.8
2 g
127.6
81.7
45.4
20.1
4.6
1.2
INTRAMUSCULAR INJECTION
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