Kemicetine Succinate Injection Ref.[2643] Active ingredients: Chloramphenicol

Kemicetine is to be administered only under the direction of a medical practitioner.

Chloramphenicol may cause severe bone marrow depression which may lead to agranulocytosis, thrombocytopenic purpura or aplastic anaemia. These effects of the haemopoietic system are usually associated with a high dose, prolonged administration, or repeated courses, but they may occur at relatively low doses.

Chloramphenicol should not be used in the treatment of any infection for which a less toxic antibiotic is available. It is also advisable to perform blood tests in the case of prolonged or repeated administration. Evidence of any detrimental effect on blood elements is an indication to discontinue therapy immediately.

The dosage of chloramphenicol should be reduced in patients with impairment of hepatic or renal function.

Because of its toxic nature it is important to monitor serum levels of this antibiotic particularly in new-born and premature infants, in the elderly, in patients with renal or hepatic disease and in those receiving other drugs with which chloramphenicol may interact.

Chloramphenicol has been shown to interact with, and enhance the effects of coumarin anticoagulants, some hypoglycaemic agents (e.g. tolbutamide) and phenytoin. When given concurrently, a dose reduction of these agents may be necessary.

Plasma concentrations of chloramphenicol may be reduced with concomitant usage of phenobarbital and rifampicin.

The use of chloramphenicol is contra-indicated in pregnancy and whilst breastfeeding.

None stated.

The following may become apparent after chloramphenicol treatment: dryness of the mouth, nausea and vomiting, diarrhoea, urticaria, optic neuritis with blurring or temporary loss of vision, peripheral neuritis, headache and depression.

Superinfection by fungi e.g. C. albicans in the gastro-intestinal tract or vagina, may also occur due to the disturbance of normal bacterial flora.

Chloramphenicol may also impede the development of immunity and should therefore not be given during active immunisation.

The “Grey syndrome” may occur after administration in patients with immature hepatic metabolic capacity, i.e. infants and neonates, usually in those treated with doses substantially in excess of those recommended.

None stated.