CHLORAMPHENICOL

Posology Adults and elderly The normal dose is 50 mg/kg body weight daily in 4 divided doses. For severe infections (meningitis, septicaemia) this dose may be doubled initially, but it must be reduced as soon as clinically practical.

Paediatric population The safety and efficacy of Chloramphenicol 250 mg Capsules BP have not yet been established in children. Method of administration For oral administration.

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/100,000), not known (cannot be estimated from the available data).

Blood and lymphatic disorders Rare: (i) A reversible dose related bone marrow depression. (ii) An irreversible aplastic anaemia Not known: Increase in bleeding time.

Immune system disorders Not known:

Hypersensitivity reactions including allergic skin reactions.

Eye disorders Not known:

Optic neuritis leading to blindness.

Ear and labyrinth disorders Not known:

Ototoxicity.

Vascular disorders Not known:

Acidotic cardiovascular collapse.

Gastrointestinal disorders Not known:

Nausea, vomiting, glossitis, stomatitis, diarrhoea, enterocolitis. Pregnancy, puerperium and perinatal conditions Not known: “Gray” syndrome, particularly in the newborn, which appears to be related to excessively high plasma levels.

The Gray baby syndrome consists of abdominal distension, pallid cyanosis, vomiting, progressing to vasomotor collapse, irregular respiration and death within a few hours of onset of symptoms. (These symptoms are thought to be dose related and rapid clearance of chloramphenicol has been associated with recovery).

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Chloramphenicol should only be used if other treatments are ineffective and its use should always be carefully monitored. 5). Periodic blood testing should be conducted during prolonged or repeated treatment. Chloramphenicol should be discontinued if a significant detrimental effect is seen.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

1. Chloramphenicol is contra-indicated in prophylaxis or treatment of minor infections; during active immunisation; and in porphyria patients. 5). Chloramphenicol must not be used in breast-feeding mothers and during pregnancy or labour, due to a risk of foetal/ infant damage (Gray Baby syndrome).