Active Ingredient: Tadalafil
Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity.
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Treatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 40 milligrams tadalafil, once daily.
The recommended dose is 40 mg taken once daily.
If there is a delay in the administration of ADCIRCA, but yet within the same day, the dose should be taken with no changes to the subsequent dose schedules. Patients should not take an extra dose if a dose is missed.
Patients should not take an extra dose if vomiting occurs.
For:
Regimen A, in case that patient age in years is ≥ 2 and patient weight is ≥ 40 kg
Oral, 40 milligrams tadalafil, once daily.
Regimen B, in case that patient age in years is ≥ 2 and patient weight is < 40 kg
Oral, 20 milligrams tadalafil, once daily.
The recommended once daily doses based on age and weight categories in paediatric patients are shown below.
| Paediatric patient's age and/or weight | Recommended daily dose and dosing regimen |
| Age ≥2 years old Body weight ≥40 kg Body weight <40 kg | 40 mg once daily 20 mg once daily |
* Oral suspension is available for administration to paediatric patients who require 20 mg and are not able to swallow tablets.
For patients <2 years old no PK or efficacy data are available from clinical trials. The most appropriate dose of tadalafil in children aged between 6 months to <2 years has not been established. Therefore, tadalafil is not recommended in this age subset.
If there is a delay in the administration of tadalafil, but yet within the same day, the dose should be taken with no changes to the subsequent dose schedules. Patients should not take an extra dose if a dose is missed.
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