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Patients on all REVATIO doses achieved a statistically significant reduction in mean pulmonary arterial pressure mPAP compared to those on placebo in a study with no background vasodilatorsStudy 1 in Clinical Studies 14 Data on other hemodynamic measures for the REVATIO 20 mg three times a day and placebo dosing regimens is displayed in Table 3.

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Clinical data
Pronunciation/ s ɪ l ˈ d ɛ n ə f ɪ l / sil- DEN -ə-fil
Trade namesViagra, Revatio, others
License dataEU  EMA:  by INN, US   FDA: Sildenafil
Pregnancy categoryAU: B1 US: B (No risk in non-human studies)
Routes of administrationBy mouth (tablets), IV
ATC codeG04BE03 ( WHO )
Legal status
Legal statusAU: S4 (Prescription only) CA : ℞-only UK: P (Pharmacy medicines) US: ℞-only In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability41% (mean) [1]
Protein binding~96%
MetabolismLiver: CYP3A4 (major route), CYP2C9 (minor route)
MetabolitesN -desmethylsildenafil (~50% potency for PDE 5 )
Elimination half-life3–4 hours
ExcretionFeces (~80%), urine (~13%) [2]

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For these four subjects, the placebo-subtracted mean maximum decreases from baseline in supine and standing systolic blood pressures were 14. Saurav A, Kaushik M, Mooss A, Esterbrooks D. Effect of Sildenafil on Pulmonary Hemodynamics and Right Ventricular Function in Patients of Non-Ischemic ... In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 1 hour after administration of sildenafil 50 mg and resolving after approximately 7.


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