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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 |
Daily dose |
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