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Update: September 2022
Forms and strengths
- 50 mg tablet
- 25 mg dispersible tablet
Dosage
- Child under 10 kg: according to weight and age
- Child 10 to 15 kg: 25 mg 2 times daily
- Child 16 to 29 kg: 50 mg morning and 25 mg evening
- Child 30 to 45 kg and under 15 years: 50 mg 2 times daily
- Child 46 kg and over and adult: 100 mg 2 times daily
Weight (kg) |
Daily dose (mg) |
50 mg tablet |
25 mg dispersible tablet |
---|---|---|---|
5-9 | 25-50 | – |
< 3 months: 1 tab ≥ 3 months: 1 tab x 2 |
10-15 | 50 | – | 1 tab x 2 |
16-29 | 75 | – | 2 tab (morning) + 1 tab (evening) |
30-45 | 100-200 |
< 15 years: 1 tab x 2 ≥ 15 years: 2 tab x 2 |
– |
- If 25 mg dispersible tablets are not available, 50 mg tablets can be crushed and suspended in 10 ml of water or fruit juice to obtain a solution of 5 mg of delamanid per ml, administered as follows:
Weight (kg) |
Daily dose (mg) |
50 mg tablet in 10 ml (5 mg/ml) |
---|---|---|
5-9 | 25-50 |
< 3 months: 5 ml ≥ 3 months: 5 ml x 2 |
10-15 | 50 | 5 ml x 2 |
16-29 | 75 | 10 ml (morning) + 5 ml (evening) |
Contra-indications, adverse effects, precautions
- Do not administer (or discontinue) to patients with QTcF > 500 ms or albumin level < 2.8 g/dl.
- Avoid or use with caution and under close monitoring in patients with:
- history of syncopal episodes or torsades de pointes, congenital QT prolongation, cardiac disease;
- electrolyte disturbances (correct first K, Ca, Mg);
- severe renal or hepatic impairment.
- Use with caution and under close monitoring in patients taking QT-prolonging drugs (Appendix 19).
- May cause:
- nausea, vomiting, dizziness, insomnia;
- mild QT prolongation, hypersensitivity reactions.
- For the management of adverse effects, see Appendix 17.
Pregnancy: use only if the benefits outweigh the risks (safety not established).
Breastfeeding: avoid breastfeeding during treatment (safety not established).
Monitoring
- Symptomatic monitoring.
- ECG.
Patient instructions
- Take with food.
- 50 mg tablets should be swallowed whole if possible.
- 25 mg tablets should be dispersed in water or fruit juice.
Storage
– Below 25 °C