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Posology: Pediatric population (1 year to 17 years): For pediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤20 kg is 10 mg (1 mL of compounded suspension) three times a day and for patients >20 kg is 20 mg (2 mL of compounded suspension) three times a day. Higher than recommended doses should not be used in pediatric patients with PAH (see also Interactions and Pharmacology: Pharmacodynamics under Actions).
Patients using other medicinal products: Co-administration of most potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) with sildenafil is not recommended (see Interactions).
A downward dose adjustment to 20 mg (10 mg if by intravenous injection) twice a day should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. A downward dose adjustment to 20 mg (10 mg if by intravenous injection) once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone.
Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers (see Interactions). However, there are no data to support increasing the dose of sildenafil in combination with bosentan (see Precautions, Interactions and Pharmacology: Pharmacodynamics under Actions).
Renal impairment: Dose adjustments are not required in patients with renal impairment.
Hepatic impairment: Dose adjustments are not required in patients with mild to moderate hepatic impairment (Child-Pugh class A and B). Revatio has not been studied in patients with severe hepatic impairment (Child-Pugh class C).
Pediatric population: The safety and efficacy of Revatio in pediatric PAH have been evaluated in patients aged 1 to 17 years.
The most frequent adverse reactions were consistent with those described in adults. The benefit-risk has not been established in pediatric patients <1 year of age.
Method of administration: Revatio powder for oral suspension is for oral use only. The reconstituted oral suspension (a white, grape flavored suspension) should be taken approximately 6 to 8 hours apart with or without food.
Before withdrawing the required dose, shake the bottle vigorously for a minimum of 10 seconds.
For instructions on reconstitution of the medicinal product before administration (see Special precautions for disposal and other handling under Cautions for Usage).
