Macitentan

Generic name
Macitentan
Brand name
ATC Code
C02KX04

Macitentan

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information is present at this moment.

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

Pulmonary arterial hypertension
  • Oral
    • ≥ 2 years and 10 up to 20 kg
      • 5 mg/day in 1 dose
    • ≥ 2 years and 20 up to 40 kg
      • 7.5 mg/day in 1 dose
    • ≥ 2 years and ≥ 40 kg
      • 10 mg/day in 1 dose

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 safety profile in children aged 2-18 years corresponds to that in adults.

The following adverse reactions occurred with a different frequency than in adults: upper respiratory tract infection (31.9%), rhinitis (8.3%) and gastroenteritis (11.1%).

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

OTHER ANTIHYPERTENSIVES

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

Serotonin antagonists
C02KD01
Antihypertensives for pulmonary arterial hypertension
C02KX02
C02KX01
C02KX05

Reference

  1. Janssen-Cilag International NV, SmPC Opsumit (EU/1/13/893/004) 26-11-2024 Rev 24, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose