Delamanid

Generic name
Delamanid
Brand name
ATC Code
J04AK06
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Treatment with the recommended doses of delamanid for adolescents and children with a body weight of at least 10 kg resulted in a plasma exposure similar to that of adults. [SmPC Deltyba]

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Multi-drug resistant tuberculosis
  • Oral
    • 10 up to 20 kg
      [1]
      • 50 mg/day in 2 doses.
      • Duration of treatment:

        24 weeks

    • 20 up to 30 kg
      [1]

      • 50 mg/dose in the morning and 25 mg/dose in the evening

      • Duration of treatment:

        24 weeks

    • 30 up to 50 kg
      [1]
      • 100 mg/day in 2 doses.
      • Duration of treatment:

        24 weeks

    • ≥ 50 kg
      [1]
      • 200 mg/day in 2 doses.
      • Duration of treatment:

        24 weeks

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The frequency, type and severity of adverse reactions are similar in children and adults with the exception of halluzinations which were more frequently reported in children (5.4% vs. 1%).

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

DRUGS FOR TREATMENT OF TUBERCULOSIS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antibiotics
J04AB02
Hydrazides
J04AC01
Other drugs for treatment of tuberculosis
J04AK05
J04AK02
J04AK01

Reference

  1. Otsuka Novel Products GmbH, SmPC Deltyba (EU/1/13/875), 07/2023

Changes

Therapeutic Drug Monitoring


Overdose