vardenafil hydrochloride trihydrate: clinical use

Prescribing considerations

• Confirm erectile dysfunction and assess potentially reversible or underlying causes before prescribing.
• Assess cardiovascular fitness for sexual activity and account for vardenafil's vasodilator effect.
• Review hepatic and renal function, age, concurrent medicines and previous response or adverse effects.
• Use caution with left-ventricular outflow obstruction, penile anatomical abnormalities, priapism risk, bleeding disorders or active peptic ulceration.
• Avoid combining vardenafil formulations or using it with other erectile-dysfunction treatments.

Contraindications and cautions

• Hypersensitivity to vardenafil or an excipient.
• Concurrent nitrates, nitric-oxide donors or riociguat.
• Previous loss of vision from non-arteritic anterior ischaemic optic neuropathy.
• Severe cardiovascular disease where sexual activity is inadvisable, including unstable angina or severe cardiac failure.
• Severe hepatic impairment, dialysis-dependent end-stage renal disease or clinically significant hypotension.
• Recent myocardial infarction or stroke.
• Known hereditary retinal degenerative disorder.
• Concurrent ritonavir or indinavir; additional product-specific restrictions apply to potent CYP3A4 inhibitors.

Monitoring

• No routine laboratory monitoring is specified; assess efficacy, tolerability and adherence to administration instructions.
• Review blood pressure and symptoms where cardiovascular disease, antihypertensives or alpha-blockers are relevant.
• Advise immediate discontinuation and assessment for sudden visual disturbance or signs of severe cutaneous reaction.
• Review persistent dizziness, abnormal vision, hearing change, chest symptoms or prolonged erection.

Clinical pharmacology

Selective PDE5 inhibition preserves cyclic GMP generated by nitric oxide during sexual stimulation, increasing cavernosal smooth-muscle relaxation and penile blood flow. Vardenafil is metabolised predominantly by CYP3A4, with contributions from CYP3A5 and CYP2C pathways; it is highly protein-bound and eliminated mainly as faecal metabolites.

Formulation and product differences

• The selected product is a film-coated tablet for oral use.
• Its decorative score line assists swallowing and is not intended to produce equal portions.
• A high-fat meal can slow absorption of the film-coated tablet.
• Orodispersible and film-coated presentations studied were not bioequivalent and should not be treated as directly interchangeable.

Tablet

Route: Oral

Strengths: 5 mg, 10 mg, 20 mg