Chloromycetin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Chloramphenicol sodium succinate 1.4 g equivalent to 1 g chloramphenicol

Available from:

Link Pharmaceuticals Ltd

INN (International Name):

Chloramphenicol sodium succinate 1.4 g (equivalent to 1 g chloramphenicol)

Dosage:

1 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Chloramphenicol sodium succinate 1.4 g equivalent to 1 g chloramphenicol

Units in package:

Vial, glass, single dose, 10 x 1g, 10 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Quimica Sintetica SA

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, 10 x 1g - 10 g - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

1969-12-31

Summary of Product characteristics

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Data Sheet
CHLOROMYCETIN
®
 SUCCINATE
Chloromycetin sodium succinate powder for injection.
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
Inter-individual variation exists in determining the pharmacokinetics for a given patient with impaired
and/or immature hepatic or renal function (see DOSAGE AND ADMINISTRATION).
Intramuscular chloramphenicol sodium succinate may produce lower blood concentrations than identical
intravenous doses. Intramuscul