udenafil (Pending FDA Approval)

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Dosing & Uses

AdultPediatric

Single Ventricle Heart Disease

Pending FDA approval for patients aged ≥12 years with single ventricle heart disease who have undergone the Fontan operation

Single Ventricle Heart Disease

Pending FDA approval for patients aged ≥12 years with single ventricle heart disease who have undergone the Fontan operation

<12 years: Safety and efficacy not established

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Pharmacology

Mechanism of Action

Inhibits PDE-5, increasing cyclic guanosine monophosphate cGMP to allow smooth-muscle relaxation

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.