The licence for Revatio (sildenafil) has been extended to include children over 1 year.
The phosphodiesterase type-5 inhibitor is approved for the treatment of pulmonary arterial hypertension (WHO class II and III) to improve exercise capacity.
Efficacy in paediatric patients has been shown in terms of improvement of exercise capacity or pulmonary haemodynamics, in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease
Before supplying Revatio for children under 20kg or patients unable to swallow tablets an oral suspension should be made using proprietary diluents (see SPC for full details).
However, Revatio IV remains unlicensed for use in patients under 18 years.
Further Information: Pfizer