Vardenafil Hydrochloride
(var den’ ah fill)
Levitra, Staxyn
PREGNANCY CATEGORY B
Drug Classes
ED drug
Phosphodiesterase type 5 inhibitor
Therapeutic Actions
Selectively inhibits cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5. The mechanism of penile erection involves the release of nitric oxide into the corpus cavernosum of the penis during sexual stimulation. Nitrous oxide activates cGMP, which causes smooth muscle relaxation allowing the flow of blood into the corpus cavernosum. Vardenafil prevents the breakdown of cGMP by phosphodiesterase, leading to increased cGMP levels and prolonged smooth muscle relaxation promoting the flow of blood into the corpus cavernosum.
Indications
Treatment of ED occurring in the presence of sexual stimulation
Unlabeled use: Raynaud phenomenon
Contraindications and Cautions
Contraindicated with allergy to components of the tablet; concurrent use of nitrates or alpha blockers; women and children.
Use cautiously with hepatic or renal impairment; with anatomic deformation of the penis, with known cardiac disease (effects of sexual activity need to be evaluated), congenital prolonged QT interval, unstable angina; hypotension (systolic pressure less than 90 mm Hg); uncontrolled hypertension (greater than 170/110 mm Hg), severe hepatic impairment; end-stage renal disease with dialysis; hereditary degenerative retinal disorders.
Available Forms
Tablets—2.5, 5, 10, 20 mg; orally disintegrating tablets—10 mg
Dosages
Adults
10–20 mg PO taken 1 hr before anticipated sexual activity; range 5–20 mg PO. Limit use to once per day.
Pediatric patients
Not intended for use in children.
Geriatric patients and those with moderate hepatic impairment
Starting dose of 5 mg PO is suggested; orally disintegrating tablet is not recommended.
Pharmacokinetics
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