Multi-drug resistant tuberculosis (MDR-TB)

Active Ingredient: Delamanid

Indication for Delamanid

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old) , adolescents (12 years - 18 years old)
Therapeutic intent: Curative procedure

Delamanid is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

For this indication, competent medicine agencies globally authorize below treatments:

50-200 mg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

50 - 200 mg per kg of body weight

Dosage regimen

From 25 To 100 mg per kg of body weight 2 time(s) per day every day for 168 day(s)

Detailed description

Paediatric patients with a body weight of

  • ≥10 to <20 kg: the recommended dose is 25 mg twice daily for 24 weeks
  • ≥20 to <30 kg: the recommended dose is 50 mg every morning and 25 mg every evening for 24 weeks
  • ≥30 to <50 kg: the recommended dose is 50 mg twice daily for 24 weeks
  • ≥50 kg: the recommended dose is 100 mg twice daily for 24 weeks

The safety and efficacy of delamanid in children with a body weight below 10 kg have not yet been established.

Dosage considerations

Delamanid should be taken with food.

Active ingredient

Delamanid

The pharmacological mode of action of delamanid involves inhibition of the synthesis of the mycobacterial cell wall components, methoxy-mycolic and keto-mycolic acid. The identified metabolites of delamanid do not show anti-mycobacterial activity.

Read more about Delamanid

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