Clofazimine (Cfz)

Therapeutic action

– Antibacterial with in vitro activity (no evidence in vivo)

Presentation

– 50 mg and 100 mg soft capsules

Dosage

– Child under 30 kg: 2 to 3 mg/kg/day
– Child over 30 kg and adult: 200 to 300 mg/day for 2 months then 100 mg/day

The daily dose is administered in 2 divided doses or once daily, depending on tolerance and available formulation.

Weight
(kg)

Daily dose
(mg)

100 mg
capsule

50 mg
capsule

5

10-15

6

12-18

7

14-21

8

16-24

9

18-27

10

20-30

11

22-33

12

24-36

13

26-39

14

28-42

15

30-45

16

32-48

1 caps

17

34-51

1 caps

18

36-54

1 caps

19

38-57

1 caps

20

40-60

1 caps

21

42-63

1 caps

22

44-66

1 caps

23

46-69

1 caps

24

48-72

1 caps

25

50-75

1 caps

26

52-78

1 caps

27

54-81

1 caps

28

56-84

1 caps

29

58-87

1 caps


30-35



First 2 months:
200 to 300 mg
then reduce to
100 mg


First 2 months:
1 caps x 2
or
2 caps (morning) + 1 caps (evening)
then
1 caps

36-45

46-55

56-70

> 70

Contra-indications, adverse effects, precautions

– Do not administer to patients with history of allergy to clofazimine.
– Administer with caution to patients with severe hepatic impairment.
– May cause:
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, diarrhoea) sometimes severe (acute abdomen presentation, intestinal bleeding);
• pink, red or brownish-black discolouration of skin, body fluids and faeces;
• eye and skin dryness and irritation, hypersensitivity reactions, photosensitivity;
• QT prolongation (newly reported).
– For the management of adverse effects, see Appendix 10.
Pregnancy: not recommended (safety is not established)
Breast-feeding: can be used; may cause breast milk discolouration and reversible skin discolouration in breastfed infants.

Monitoring

– Symptomatic monitoring

Patient instructions

– Take with food to improve gastrointestinal tolerance.
– Protect your skin from sun.
– Clofazimine may cause reversible discolouration of the skin, conjunctiva, faeces, urine, sweat, tears, saliva, sputum, breast-milk, etc. However, it may take months to years to disappear after stopping treatment.

Remarks

 Storage: below 25°C -