Ambrisentan

Generic name
Ambrisentan
Brand name
ATC Code
C02KX02
Compare …

Ambrisentan

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The pharmacokinetics of ambrisentan after oral administration in children 8 to 17 years old with PAH were broadly similar to the pharmacokinetics in adults after adjusting for body weight (source SmPC Volibris)

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
    • 8 years up to 18 years and 20 up to 35 kg
      • Initial dose: 2.5 mg/day in 1 dose
      • Maintenance dose: If indicated based on clinical response and tolerability, increase to 5 mg/day in 1 dose
    • 8 years up to 18 years and 35 up to 50 kg
      • Initial dose: 5 mg/day in 1 dose
      • Maintenance dose: If indicated based on clinical response and tolerability, increase to 7.5 mg/day in 1 dose
    • 8 years up to 18 years and ≥ 50 kg
      • Initial dose: 5 mg/day in 1 dose
      • Maintenance dose: If indicated based on clinical response and tolerability, increase to 10 mg/day in 1 dose

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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 is similar to that of adults. Headache and nasal congestion are mostly reported in children.

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
C02KX01
C02KX04
C02KX05

Reference

  1. GlaxoSmithKline (Ireland) Limited, SmPC Volibris( EU/1/08/451/001) Rev 23, 24-5-2023, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose