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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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|Pronunciation||/ s ɪ l ˈ d ɛ n ə f ɪ l / sil- DEN -ə-fil|
|Trade names||Viagra, Revatio, others|
|License data||EU EMA: by INN, US FDA: Sildenafil|
|Pregnancy category||AU: B1 US: B (No risk in non-human studies)|
|Routes of administration||By mouth (tablets), IV|
|ATC code||G04BE03 ( WHO )|
|Legal status||AU: S4 (Prescription only) CA : ℞-only UK: P (Pharmacy medicines) US: ℞-only In general: ℞ (Prescription only)|
|Bioavailability||41% (mean) |
|Metabolism||Liver: CYP3A4 (major route), CYP2C9 (minor route)|
|Metabolites||N -desmethylsildenafil (~50% potency for PDE 5 )|
|Elimination half-life||3–4 hours|
|Excretion||Feces (~80%), urine (~13%) |
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