CHLORAMPHENICOL injectable

Prescription under medical supervision

The use of chloramphenicol should be restricted to severe infections when other less toxic antibacterials are not effective or contra-indicated.


Therapeutic action

– Phenicol antibacterial

Indications

– First-line treatment of plague meningitis
– Alternative to first-line treatments of septicaemic plague
– Severe typhoid fever if the strain is susceptible (recent drug susceptibility test)

Forms and strengths, route of administration

– 1 g powder for injection, to be dissolved in 10 ml of water for injection, for IV injection over 1 to 2 minutes

Dosage

– Child from 1 year to < 13 years: 25 mg/kg every 8 hours
– Child ≥ 13 years and adult: 1 g every 8 hours

Age

Weight

1 g vial
(to be dissolved in 10 ml)

1 to < 2 years

10 to < 13 kg

3 ml x 3

2 to < 3 years

13 to < 15 kg

3.5 ml x 3

3 to < 6 years

15 to < 20 kg

5 ml x 3

6 to < 8 years

20 to < 25 kg

6 ml x 3

8 to < 9 years

25 to < 30 kg

7 ml x 3

9 to < 11 years

30 to < 35 kg

8 ml x 3

11 to < 13 years

35 to < 45 kg

9 ml x 3

≥ 13 years and adult

≥ 45 kg

10 ml x 3

Duration

– Plague: 10 days; typhoid fever: 14 days. Change to oral route as soon as possible.

Contra-indications, adverse effects, precautions

– Do not administer to children under 1 year.
– Do not administer to patients with:
• history of allergic reaction or bone marrow depression during a previous treatment with chloramphenicol;
• G6PD deficiency.
– May cause:
• dose-related haematological toxicity (bone marrow depression, anaemia, leucopenia, thrombocytopenia), allergic reactions. In these events, stop treatment immediately;
• gastrointestinal disturbances, peripheral and optic neuropathies.
– Reduce dosage in patients with hepatic or renal impairment.
– Avoid or monitor combination with potentially haematotoxic drugs (carbamazepine, co-trimoxazole, flucytocine, pyrimethamine, zidovudine, etc.).
– PregnancyCONTRA-INDICATED, except if vital, if there is no therapeutic alternative. If used during the 3rd trimester, risk of grey syndrome in the neonate (vomiting, hypothermia, blue-grey skin colour and cardiovascular depression).
– Breast-feedingCONTRA-INDICATED

Remarks

– Oral treatment is more effective than parenteral treatment: blood and tissue concentrations are higher when chloramphenicol is given orally.
– Storage: below 25 °C -