Clofazimine (Cfz)

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    Update: August 2022

     

    Forms and strengths

    • 50 mg and 100 mg soft capsules or tablets

    Dosage

    • Child under 10 kg: doses are administered 3 times a week (Monday, Wednesday, Friday = M/W/F)

    • Child 10 to 29 kg: 2 to 5 mg/kg once daily

    • Child 30 kg and over and adult: 100 mg once daily

     

    Weight
    (kg)

    Daily dose
    (mg)

    100 mg

    capsule (a) Citation a. Capsule or tablet

    50 mg

    capsule (a) Citation a. Capsule or tablet

    5

    1 caps (M/W/F)

    6

    1 caps (M/W/F)

    7

    1 caps (M/W/F)

    8

    1 caps (M/W/F)

    9

    1 caps (M/W/F)

    10

    20-50

    1 caps

    11

    22-55

    1 caps

    12

    24-60

    1 caps

    13

    26-65

    1 caps

    14

    28-70

    1 caps

    15

    30-75

    1 caps

    16

    32-80

    1 caps

    17

    34-85

    1 caps

    18

    36-90

    1 caps

    19

    38-95

    1 caps

    20

    40-100

    1 caps

    21

    42-105

    1 caps

    22

    44-110

    1 caps

    23

    46-115

    1 caps

    24

    48-120 1 caps

    25

    50-125 1 caps

    26

    52-130 1 caps

    27

    54-135 1 caps

    28

    56-140 1 caps

    29

    58-145 1 caps

     

    30-35

    100

    1 caps

    36-45

    100 1 caps

    46-55

    100 1 caps

    56-70

    100 1 caps

    > 70

    100 1 caps

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with hypersensitivity to clofazimine.
    • Administer with caution to patients with severe hepatic impairment.
    • May cause:
      • orange-brown discolouration of skin and body fluids;
      • strong QT prolongation;
      • gastrointestinal disturbances (nausea, vomiting, abdominal pain);
      • severe abdomen pain, bowel obstruction, intestinal bleeding;
      • eye and skin dryness and irritation, hypersensitivity reactions, photosensitivity.
    • For the management of adverse effects, see Appendix 17.
    • Avoid or use with caution and under close monitoring in patients taking other QT prolonging drugs (Appendix 19).
    • Pregnancy: use only if the benefits outweigh the risks (safety not established).
    • Breast-feeding: avoid breastfeeding during treatment (safety not established). If used, may cause reversible breast milk discolouration and skin discolouration in breastfed infants.

    Monitoring

    • Symptomatic monitoring.
    • ECG.

    Patient instructions

    • Take with food to improve gastrointestinal tolerance.
    • Protect your skin from sun.
    • Harmless orange-brown discoloration of the skin and body fluids (urine, sweat, saliva, sputum, tears, breast milk, etc.). It is reversible but may take months to disappear after stopping treatment.

    Storage

     
    –  Below 25 °C 
    • (a) Capsule or tablet