CHLOROMYCETIN SUCCINATE INJECTION

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

chloramphenicol sodium succinate (Equivalent: chloramphenicol, Qty 1 g)

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

Chloramphenicol sodium succinate

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous, Intramuscular

Units in package:

1g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Chloromycetin Succinate is specifically indicated for bacterial meningitis, typhoid fever, rickettsial infections, intra ocular infections, other serious infections where bacteriological evidence or clinical judgement indicates that chloramphenicol is appropriate antibiotic.

Product summary:

Visual Identification: White to yellowish white cake; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1997-02-04

Patient Information leaflet

Version 3.0
1
CHLOROMYCETIN
 SUCCINATE INJECTION
Chloramphenicol
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Chloromycetin
Succinate injection. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
treating you with Chloromycetin
Succinate against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CHLOROMYCETIN
SUCCINATE IS USED FOR
Chloromycetin Succinate injection is
used to treat serious infections
including bacterial meningitis,
typhoid fever, rickettsial infections
and eye infections.
Chloromycetin Succinate belongs to
a group of medicines called
antibiotics.
It works by stopping the growth of
bacteria causing your infection.
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.
Chloromycetin Succinate is not
addictive.
It is available only with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
CHLOROMYCETIN SUCCINATE
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN
CHLOROMYCETIN SUCCINATE IF YOU
HAVE AN ALLERGY TO:
•
chloramphenicol
•
any of the ingredients listed at
the end of this leaflet
•
any other similar medicines
Symptoms of an allergic reaction may
include shortness of breath, wheezing
or difficulty breathing; swelling of
the face, lips, tongue or other parts of
the body; rash, itching or hives on the
skin.
CHLOROMYCETIN SUCCINATE MUST NOT
BE GIVEN AFTER THE EXPIRY DATE
PRINTED ON THE PACK OR IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
If you are not sure whether you
should be given this medicine, talk to
your doctor.
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR D

Summary of Product characteristics

PRODUCT INFORMATION
CHLOROMYCETIN
® SUCCINATE
(1 g chloramphenicol per vial, as chloramphenicol sodium succinate)
Chloromycetin Succinate contains the active component chloramphenicol
sodium succinate.
CHEMICAL NAME:
Chloramphenicol sodium succinate is a mixture of variable proportions
of
sodium
(2R,
3R)-2-(2,2-dichloroacetamido)-3-hydroxy-3-(4-nitrophenyl)-propyl
succinate
(‘3-isomer’)
and
sodium
(1R,
2R)-2-(2,2-dichloroacetamido)-3-hydroxy-1-(4-nitrophenyl)
propyl succinate (‘1-isomer’).
DESCRIPTION
Chloramphenicol sodium succinate is a white or yellowish-white
hygroscopic powder.
_ _
It is
soluble 1 in less than 1 part
_ _
of water, 1 in 1 part
_ _
of alcohol; practically insoluble in
chloroform and ether. A 25% solution in water has a pH of 6.4 to 7.0.
Each vial of
Chloromycetin Succinate contains chloramphenicol sodium succinate
equivalent to 1 g of
chloramphenicol.
EMPIRICAL FORMULA:
C
15
H
15
Cl
2
N
2
NaO
8
MW:
445.2
PHARMACOLOGY
Chloramphenicol
sodium
succinate
is
a
prodrug.
After
parenteral
administration
it
is
hydrolysed in the liver to produce free active chloramphenicol. The
rate of hydrolysis is
variable in different individuals.
Chloramphenicol is effective in a wide variety of bacterial and
rickettsial infections. It
possesses high antimicrobial activity, crosses tissue barriers
readily, and diffuses widely and
rapidly through nearly all body tissues and fluids.
PHARMACOKINETICS
Interindividual variation exists in determining the pharmacokinetics
for a given patient with impaired
and/or immature hepatic or renal function (see DOSAGE AND
ADMINISTRATION).
Page 1 of 7
Intramuscular chloramphenicol sodium succinate may produce lower blood
concentrations
than identical intravenous doses. Intramuscular absorption is slow and
produces peak blood
levels in approximately 2 to 4 hours.
_DISTRIBUTION _
Chloramphenicol has high lipid solubility and diffuses rapidly
throughout tissues and body
fluids,
with
highest
concentrations
in
the
liver
and
kidneys.
Chloramphenicol
enters
cerebrospinal fluid even