Revatio Dosage/Direction for Use

Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered.
Adults (≥18 years): The recommended dose is 20 mg three times a day (TID). Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.
Patients using other medicinal products: In general, any dose adjustment should be administered only after a careful benefit-risk assessment. A downward dose adjustment to 20 mg twice daily 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 once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors clarithromycin, telithromycin and nefazodone. For the use of sildenafil with the most potent CYP3A4 inhibitors, see Contraindications. Dose adjustments of sildenafil may be required when co-administered with CYP3A4 inducers (see Interactions).
Special populations: Elderly (≥65 years): Dose adjustments are not required in elderly patients. Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients.
Renal impairment: Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30 ml/min). A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Hepatic impairment: Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B). A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Revatio is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see Contraindications).
Use in children: Revatio is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Discontinuation of treatment: Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension. However, to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered. Intensified monitoring is recommended during the discontinuation period.
Method of administration: Revatio is for oral use only. Tablets should be taken approximately 6 to 8 hours apart with or without food.