Pulmonary arterial hypertension

Active Ingredient: Sildenafil

Indication for Sildenafil

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

For this indication, competent medicine agencies globally authorize below treatments:

30-60 mg in 3 divided doses daily

Route of admnistration

Oral

Defined daily dose

30 - 60 mg

Dosage regimen

From 10 To 20 mg 3 time(s) per day every day for 30 day(s)

Loading dose

30 mg

Detailed description

For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤20 kg is 10mg three times a day and for patients >20 kg is 20mg three times a day. Higher than recommended doses should not be used in paediatric patients with PAH. The 20mg tablet should not be used in cases where 10mg TID should be administered in younger patients. Other pharmaceutical forms are available for administration to patients ≤20 kg and other younger patients who are not able to swallow tablets.

Active ingredient

Sildenafil

Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the enzyme that is responsible for degradation of cGMP. Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.

Read more about Sildenafil

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