Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2009 Publisher: Pharmacia Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
Kemicetine (chloramphenicol) is a broad-spectrum antibiotic and is active against many gram-negative organisms, Spirillae and Rickettsia. Kemicetine should not be used for trivial infections due to the possibility of severe blood dyscrasias, which may prove fatal.
Kemicetine succinate is indicated for typhoid, meningitis caused by H. influenzae and other serious infections caused by bacteria susceptible to chloramphenicol. It is also indicated wherever chloramphenicol is deemed the antibiotic of choice and oral administration is not possible, or where higher than usual blood concentrations are required.
To be given by i.v. or i.m. injection.
In order to ensure rapid attainment of high blood levels, Kemicetine succinate is best administered by i.v. injection. Where this is not possible, however, intramuscular administration may be used, although it should be borne in mind that absorption may be slow and unpredictable.
The injection should be reconstituted with Water for Injections, Sodium ChlorideInjection, or Dextrose Injection 5 %. The following dilution table may be useful for the administration of a proportion of the contents of a vial:
| Concentration | Solution strength | Volume of diluent to be added | Total volume after dilution |
|---|---|---|---|
| 40% | 400 mg/ml | 1.7 ml | 2.5 ml |
| 25% | 250 mg/ml | 3.2 ml | 4.0 ml |
| 20% | 200 mg/ml | 4.2 ml | 5.0 ml |
The dose administered and the concentration used is dependent on the severity of the infection. The recommended standard dosage is as follows:
Adults: The equivalent of 1 g of chloramphenicol every 6-8 hours.
Elderly: The usual adult dosage should be given subject to normal hepatic and renal function.
Children: The equivalent of 50 mg/kg chloramphenicol according to body weight, daily in divided doses every 6 hours (this dose should not be exceeded). The patient should be carefully observed for signs of toxicity.
Neonates and Premature Infants: 25 mg/kg in divided doses.
Only 10% or lower concentrations to be used. The 10% solution can be prepared by extracting 5ml of the 20% solution and adding 5ml of diluent (Water for Injections, Sodium Chloride Injection or Dextrose Injection 5%) under aseptic conditions.
The 10 % solution should be given by intravenous injection over a period of about a minute, or in a larger volume of fluid, by slow intravenous infusion. The concurrent administration of i.v. Kemicetine succinate with topical treatment has been found to be very effective in the treatment of osteomyelitic foci, abscesses, empyema and skin and urinary infections.
In exceptional cases, such as patients with septicaemia or meningitis, dosage schedule up to 100 mg/kg/day may be prescribed. However, these high doses should be decreased as soon as clinically indicated. To prevent relapses treatment should be continued after the temperature has returned to normal for 4 days in rickettsial diseases and for 8 – 10 days in typhoid fever.
48 months.
Keep container in the outer carton.
Type III colourless glass vials with grey chlorobutyl rubber bung and aluminium seal.
Pack size: 1, 20 or 25 vials.
To be reconstituted with Water for Injection, Sodium Chloride Injection or Dextrose Injection 5%.
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