Phil Pharmawealth
Full Prescribing Info
Chloramphenicol sodium succinate.
Each vial contains Chloramphenicol sodium succinate equivalent to chloramphenicol 1 gram.
Pharmacology: Chloramphenicol binds specifically to the 50S subunit of 70S ribosomes, preventing its movement along messenger RNA, which occurs in the early stages of protein synthesis. It inhibits peptide bond formation presumably due to direct inhibition of peptide transferase or prevention of attachment of AA-TRNA to the 50S subunit. Inhibition of mitochondrial respiratory chain. Its antimicrobial and toxic effects may be explained by all of these mechanisms.
Typhoid and parathyphoid fever; shigella infections; bacterial meningitis; H. influenzae infections; pertusis; gram-negative bacterial infections; bacterial eye infections; cerebral abscesses; other infections caused by susceptible organisms.
Dosage/Direction for Use
Adults: Should receive 50 mg/kg/day in divided doses at 6 hourly intervals, in exceptional cases, patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve blood levels required to inhibit the pathogens, but these high doses should be decreased as soon as possible. Dosage should be adjusted in patients with liver and renal impairment.
Children: Dosage of 50 mg/kg/day divided into 4 doses at 6 hourly intervals yields blood level in the range effective against most susceptible organisms. Severe infections eg, bacteremia or meningitis, especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. The injection is preferably given intravenous route. If intravenous injection is not possible, it could also be administered by intramuscular injection.
Chloramphenicol may cause serious and sometimes fatal adverse effects and it should be discontinued immediately on the appearance of toxic symptoms.
A toxic manifestation 'gray syndrome' which is characterized by abdominal hypothermia, progressive pallid cyanosis, irregular respiration and circulatory collapse followed by death has occurred in premature and other newborn infants receiving large doses of chloramphenicol.
Charcoal haemoperfusion was found to be far superior to exchange transfusion in the removal of chloramphenicol from the blood.
Chloramphenicol is contraindicated in patients with a history of hypersensitivity or toxic reaction to the drug. It should never be given for minor infections or for prophylaxis. Repeated courses and prolonged treatment should be avoided because of the risk of 'gray syndrome', newborn infants should never be given chloramphenicol. Chloramphenicol is also indicated in pregnancy and lactation.
Adverse Reactions
The most serious effect of chloramphenicol is its depression of the marrow which can take two different forms. The first reversible is characterized by morphological changes in the bone marrow, decreased iron utilization, reticulocytopenia, anaemia, leucopenia and thrombocytopenia. All these abnormalities return to normal 2-3 weeks after cessation of therapy.
The second is severe irreversible aplastic anaemia which is fairly rare with an incidence estimated to be 1 case per 4000 courses of therapy. Mortality is approximately 50%. Those who survive may have a higher incidence of leukemia. Haemolytic anaemia has occurred in some persons with a genetic deficiency of glucose-6-phosphate dehydrogenase activity.
In neonates, especially prematures and in young infants, overdose of chloramphenicol may lead to Gray baby syndrome. The syndrome occurs because of defective ability to conjugate the drug in neonates. Three to four days after initiation of therapy, abdominal distension, vomiting, respiratory difficulty, pale cyanotic skin, hypotension and metabolic acidosis followed by cardiovascular collapse occurs.
Peripheral as well as optic neuritis has been reported in patients receiving chloramphenicol usually over prolonged periods.
Drug Interactions
Chloramphenicol is inactivated in the liver and may therefore interact with drugs which are metabolized by hepatic microsomal enzymes. Chloramphenicol enhances the effects of coumarin anticoagulants, some hypoglycemic agents and antiepileptics. The half life of chloramphenicol may be affected by paracetamol, phenobarbitone, phenytoin or rifampicin.
Chloramphenicol can give disulfiram-like reaction with alcohol.
Store at temperature not exceeding 30°C.
MIMS Class
ATC Classification
J01BA01 - chloramphenicol ; Belongs to the class of amphenicols. Used in the systemic treatment of infections.
Powd for inj (vial) 1 g x 10's.
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