Chloromycetin (Chloramphenicol) - Summary

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.

1. 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.

2. 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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NEWS HIGHLIGHTS

Published Studies Related to Chloromycetin (Chloramphenicol)

Gatifloxacin versus chloramphenicol for uncomplicated enteric fever: an open-label, randomised, controlled trial. [2011.06]
BACKGROUND: We aimed to investigate whether gatifloxacin, a new generation and affordable fluoroquinolone, is better than chloramphenicol for the treatment of uncomplicated enteric fever in children and adults... INTERPRETATION: Although no more efficacious than chloramphenicol, gatifloxacin should be the preferred treatment for enteric fever in developing countries because of its shorter treatment duration and fewer adverse events. FUNDING: Wellcome Trust. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Does single application of topical chloramphenicol to high risk sutured wounds reduce incidence of wound infection after minor surgery? Prospective randomised placebo controlled double blind trial. [2009.01.15]
OBJECTIVE: To determine the effectiveness of a single application of topical chloramphenicol ointment in preventing wound infection after minor dermatological surgery... CONCLUSION: Application of a single dose of topical chloramphenicol to high risk sutured wounds after minor surgery produces a moderate absolute reduction in infection rate that is statistically but not clinically significant. Trial registration Current Controlled Trials ISRCTN73223053.

Chloramphenicol versus ampicillin plus gentamicin for community acquired very severe pneumonia among children aged 2-59 months in low resource settings: multicentre randomised controlled trial (SPEAR study). [2008.01.12]
OBJECTIVE: To evaluate whether five days' treatment with injectable ampicillin plus gentamicin compared with chloramphenicol reduces treatment failure in children aged 2-59 months with community acquired very severe pneumonia in low resource settings... CONCLUSION: Injectable ampicillin plus gentamicin is superior to injectable chloramphenicol for the treatment of community acquired very severe pneumonia in children aged 2-59 months in low resource settings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN39543942.

Randomised equivalency trial comparing 2.5% povidone-iodine eye drops and ophthalmic chloramphenicol for preventing neonatal conjunctivitis in a trachoma endemic area in southern Mexico. [2007.11]
AIM: To evaluate the effectiveness of 2.5% povidone-iodine eye drops (PIED) compared with ophthalmic chloramphenicol (OC) for preventing neonatal conjunctivitis... CONCLUSIONS: PIED seems to increase the risk of acquiring chlamydial conjunctivitis in neonates. Additional measures are required to prevent mother to fetus transmission of chlamydial infection during pregnancy, delivery, and after birth.

Open-label randomized trial of oral trimethoprim-sulfamethoxazole, doxycycline, and chloramphenicol compared with trimethoprim-sulfamethoxazole and doxycycline for maintenance therapy of melioidosis. [2005.10]
Melioidosis (infection caused by Burkholderia pseudomallei) requires a prolonged course of oral antibiotics following initial intravenous therapy to reduce the risk of relapse after cessation of treatment. The current recommendation is a four-drug regimen (trimethoprim [TMP], sulfamethoxazole [SMX], doxycycline, and chloramphenicol) and a total treatment time of 12 to 20 weeks...

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Clinical Trials Related to Chloromycetin (Chloramphenicol)

Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children [Completed]
Acute lower respiratory tract infections are a leading cause of morbidity and mortality in sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous chloramphenicol for the treatment of severe pneumonia in children aged less than five years. However, up to 20% of children fail treatment due to the emergence of resistance by bacteria. Several centers now use ceftriaxone, a third generation cephalosporin, which is reported to be efficacious in the treatment of severe pneumonia. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. The purpose of this study is to compare chloramphenicol and ceftriaxone in the treatment of severe pneumonia in children under five. We hypothesize that 92. 7% of children who receive once daily intravenous ceftriaxone (75 mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80. 2 % of those who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).

Patients Response to Early Switch To Oral:Osteomyelitis Study [Not yet recruiting]
Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.

The Role of Umbilical Cord Serum Therapy on Improvement of Corneal Epithelial Defect Following Diabetic Vitrectomy [Active, not recruiting]
80 diabetic patients underwent vitrectomy and had no history of Eye herpes infection, Refractive surgery, Autoimmune disease, Immune deficiency will be randomized into two groups (double blind)to evaluate the role of umbilical cord serum therapy on improvement of corneal epithelial defect following diabetic vitrectomy. Both groups will take the conventional medication including Chloramphenicol, Betamethasone, Cycloplegic eye drops besides the case group will take umbilical cord serum eye drop in the eye operated. After surgery the corneal epithelial defect will be measured by slit lamp.

Antimicrobial Pulpotomy of Primary Molars [Completed]
There is a lack of evidence of the long-term successful outcomes of antimicrobial endodontic treatment for primary teeth. This study intended to evaluate (by survival analysis) the effectiveness of an antimicrobial pulpotomy (chloramphenicol, tetracycline, zinc oxide/eugenol) in primary molars compared to calcium hydroxide pulpectomy, testing the hypothesis that antimicrobial pulpotomy could be an alternative pulp therapy for primary teeth with pulp inflammation or necrosis.

Village Integrated Eye Workers Trial [Recruiting]
VIEW is a community-randomized trial designed to determine whether it is possible to prevent corneal ulcers on a large scale. The study compares the incidence of corneal ulceration between villages in which volunteers are trained to diagnose and treat corneal abrasions and villages which receive no intervention.

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