Delamanid (Dlm)

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المحتويات

    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 
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