CHLOROMYCETIN SUMMARY
Chloromycetin® Sodium Succinate
(sterile chloramphenicol sodium succinate, USP)
IMPORTANT CONSIDERATIONS IN PRESCRIBING INJECTABLE CHLORAMPHENICOL SODIUM SUCCINATE
CHLORAMPHENICOL SODIUM SUCCINATE IS INTENDED FOR INTRAVENOUS USE ONLY. IT HAS BEEN DEMONSTRATED TO BE INEFFECTIVE WHEN GIVEN INTRAMUSCULARLY.
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Chloramphenicol sodium succinate must be hydrolyzed to its microbiologically active form, and there is a lag in achieving adequate blood levels compared with the base given intravenously.
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Patients started on intravenous chloramphenicol sodium succinate should be changed to the oral form of another appropriate antibiotic as soon as practicable.
Chloramphenicol is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. Sensitivity testing is essential to determine its indicated use, but may be performed concurrently with therapy initiated on clinical impression that one of the indicated conditions exists (see INDICATIONS AND USAGE section).
In accord with the concepts in the Warning Box and this INDICATIONS AND USAGE section, chloramphenicol must be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. However, chloramphenicol may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present; in vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests. The decision to continue use of chloramphenicol rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, efficacy of the various drugs in the infection, and the important additional concepts contained in the Warning Box above.
1. Acute infections caused by Salmonella typhi*
It is not recommended for the routine treatment of the typhoid carrier state.
2. Serious infections caused by susceptible strains in accordance with the concepts expressed above:
a) Salmonella species
b) H. influenzae, specially meningeal infections
c) Rickettsia
d) Lymphogranuloma-psittacosis group
e) Various gram-negative bacteria causing bacteremia, meningitis, or other serious gram-negative infections
f) Other susceptible organisms which have been demonstrated to be resistant to all other appropriate antimicrobial agents.
3. Cystic fibrosis regimens
*In treatment of typhoid fever some authorities recommend that chloramphenicol be administered at therapeutic levels for 8 to 10 days after the patient has become afebrile to lessen the possibility of relapse.
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