E-DRUG: Chloramphenicol oil injection

E-drug: Chloramphenicol oil injection
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Some time ago we had an exchange of information concerning chlroamphenicol
in oil for im injection. People were concerned that it was not available. I
myself questioned the use of it as chlroamphenicol is generally not
recommended for im use because of erratic absorption.

The Lancet of 5 September had a letter on the subject from which I quote parts:

Long-acting oily chloramphenicol for meningococcal meningitis
(Lewis FL et al. Lancet 1998;352:822-3)

Sir--The story of oily chloramphenicol is a fascinating tale of a drug
developed well before the era of randomised controlled trials that, through
applied field research, has found a new application in meningitis. Now, in
the world of orphan drugs for tropical diseases, this drug is in danger of
abandonment by the pharmaceutical industry and the medical profession. To
document the history and efficacy of oily chloramphenicol, we reviewed the
literature and interviewed key investigators.*

Chloramphenicol in oil suspension, marketed by Roussel in 1954 as Tifomycine
for
typhoid fever, was proposed as a single intramuscular injection for
meningococcal meningitis in 1975, at a time when increasing bacterial
resistance to sulfa drugs in Africa made standard therapy useless. Oily
chloramphenicol now costs US $13 per adult treatment on average, compared
with $30 for 10 days of ampicillin or $100 for 5 days of ceftriaxone
(excluding hospitalisation costs, injection material, and intravenous access).

Oily chloramphenicol is difficult to manufacture and, unfortunately,
availability of a high-quality product is no longer a sure thing. Production
by Roussel was stopped in 1995 and taken up by companies in Germany and
India. These new products have not been tested in clinical studies and no
bioequivalence data have been published. Oily chloramphenicol distributed by
M�decins Sans Fronti�res in Cameroon in April, 1998, had to be recalled when
the product was found to be defective. In 1997, Roussel transferred the
original oily chloramphenicol technology and equipment to the International
Dispensary Association which launched production in Malta in 1998. Let us
hope this is a step in the right direction. The availability and quality of
oily chloramphenicol must be ensured before this useful drug becomes a true
orphan. The effectiveness, safety, and pharmacokinetics of current
formulations should be documented.

*Rosamund F Lewis, Fabienne Dorlencourt, Jacques Pinel

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*Epicentre, 8 rue Saint Sabin, 75011 Paris, France; and M�decins Sans
Fronti�res, Paris

1 Rey M, Ouedraogo L, Saliou P, Perino L. Traitement minute de la m�ningite
c�r�brospinale �pid�mique par injection intramusculaire unique de
chloramph�nicol (suspension huileuse). M�decine et Maladies Infectieuses 1976;
6: 120-24.

2 Puddicombe JB, Wali SS, Greenwood BM. A field trial of a single intramuscular
injection of long-acting chloramphenicol in the treatment of meningococcal
meningitis. Trans R Soc Trop Med Hyg 1984; 78: 399-403.

3 Wali SS, MacFarlane JT, Weir WRC, et al. Single injection treatment of
meningococcal meningitis. Long acting chloramphenicol. Trans R Soc Trop Med
Hyg 1979; 73: 698-701.

4 P�coul B, Varaine F, Keita M, et al. Long-acting choramphenicol versus
intravenous ampicillin for treatment of bacterial meningitis. Lancet 1991;
338: 862-66.

5 Varaine F, Keita M, Kaninda A-V, et al. Long-acting chloramphenicol versus
ceftriaxone for treatment of bacterial meningitis in children aged 2-35
months. 8th
International Congress on Infectious Diseases. Boston, USA. May 15-18, 1998
(abstr).

*A full reference list is available from the authors or The Lancet, on request.

Kirsten Myhr
Bygsoy alle 58B
0265 Oslo
myhr@online.no

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