OMEGAPHARM CEFEPIME FOR INJECTION

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefepime

Available from:

Omegapharm

INN (International Name):

Cefepime

Authorization status:

Registered

Patient Information leaflet

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 of age caused
by bacteria in the lungs (pneumonia),
in the kidney and bladder (urinary
tract infections), or in the skin; or in
the blood; or if the child has a lack of
white blood cells with fever.
There may be other reasons why your
doctor has prescribed Omegapharm
Cefepime for Injection. Ask your
doctor why Omegapharm Cefepime
for Injection has

Summary of Product characteristics

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
500 mg
8.2
12.5
12.0
6.9
1.9
0.7
1 g
14.8
25.9
26.3
16.0
4.5
1.4
2 g
36.1
49.9
51.3
31.5
8.7
2.3
Concentrations of cefepime achieved in specific tissues and body
fluids are listed in Table 2.
TABLE 2
MEAN CONCENTRATIONS OF CEFEPIME IN VARIOUS BODY FLUIDS (MICROGRAM/ML)
AND TISSUES
(MICROGRAM/G)
TISSUE OR FLUID
INTRAVENOUS
DOSE (G)
AVERAGE TIME OF
SAMPLE AFTER