Vardenafil is used to treat erectile dysfunction (ED).

Drugs for Erectile Dysfunction

Does not directly cause penile erections, but affects the response to sexual stimulation. The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation and inflow of blood to the corpus cavernosum. Vardenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE-5), which is responsible for degradation of cGMP in the corpus cavernosum; when sexual stimulation causes local release of NO, inhibition of PDE-5 by vardenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum; at recommended doses, it has no effect in the absence of sexual stimulation.

Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability.

Maximum dose: 20 mg once a day

Usual Geriatric Dose for Erectile Dysfunction (65 years or older): 5 mg orally once a day, as needed, approximately 60 minutes before sexual activity

Patients on stable alpha blocker therapy: 5 mg orally once a day

Increased risk of hypotension with α-blockers. Increased risk of priapism with alprostadil. Increased serum levels of vardenafil when used with erythromycin.

Known prolongation of QT interval (congenital or acquired); men for whom sexual intercourse is inadvisable due to CV risk factors; hypotension (systolic 170 mm Hg or diastolic >110 mm Hg); recent stroke or MI (within last 6 mth); unstable angina; severe heart failure; end-stage renal disease requiring dialysis; severe hepatic impairment; known degenerative retinal disorders e.g. retinitis pigmentosa. Women, child.

Dyspepsia, vomiting, headache, flushing, dizziness, visual disturbances, colour vision changes, raised intra-ocular pressure, nasal congestion, hypersensitivity reactions, nausea, photosensitivity reactions, hypotension, hypertension, priapism, palpitations, myalgia, increased creatinine kinase, sudden decrease or loss of hearing, tinnitus.

Pregnancy Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Safety and efficacy have not been established in patients younger than 18 years. This drug is not indicated for use in pediatric patients.

Patients stabilised on α-blocker therapy: max daily dose 5 mg and not to be taken within 6 hr of the α-blocker (except tamsulosin).

Patients on erythromycin: Max: 5 mg daily.

Renal Impairment: Haemodialysis: Avoid.

Hepatic Impairment:

• Child Pugh A-B (mild to moderate) impairment: Initiate with 5 mg.
• Max dose in moderate impairment: 10 mg.
• Child-Pugh C (severe impairment): No studies done.

Store between 15-30° C.