vardenafil

G04BE09

Forms & Strengths

Adult Dosing

Erectile Dysfunction: 10 mg orally approximately 60 minutes prior to sexual activity
Dose adjustment range: 5 mg to 20 mg based on efficacy and tolerability
Maximum frequency: Once daily
Initial dose in hepatic impairment (moderate, Child-Pugh B): 5 mg
Initial dose with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): Max 2.5 mg to 5 mg

Pediatric Dosing

Not indicated for pediatric use (safety and efficacy not established in individuals under 18 years of age)

Indications

Mechanism of Action

Selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5)
Enhances nitric oxide (NO) mediated vasodilation in the corpus cavernosum during sexual stimulation, increasing blood flow

Contraindications

Concomitant use of organic nitrates or nitric oxide donors in any form (regular or intermittent)
Co-administration with soluble guanylate cyclase (sGC) stimulators, such as riociguat
Known hypersensitivity to vardenafil or any component of the formulation

Adverse Reactions

Common: Headache, flushing, rhinitis, dyspepsia, dizziness, nausea
Serious: Hypotension, visual disturbances (including NAION), sudden hearing loss, prolonged erection/priapism, cardiovascular events (myocardial infarction, ventricular arrhythmias)

Drug Interactions

Nitrates and NO donors: Contraindicated due to risk of severe, potentially fatal hypotension
Alpha-blockers: May cause additive blood pressure-lowering effects and symptomatic hypotension
CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin): Significantly increase vardenafil plasma concentrations
CYP3A4 inducers (rifampin): May decrease vardenafil efficacy
Drugs prolonging QT interval (Class IA and III antiarrhythmics): Potential for additive QTc prolongation

Curated Content: Needs Vetting Before Put to Clinical Use