A phosphodiesterase inhibitor - It is used to treat erection problems in men
FDA Alerts
Special Alerts:
[Posted 10/18/2007] FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors sildenafil (Viagra), tadalafil (Levitra), vardenafil (Cialis) for the treatment of erectile dysfunction, and sildenafil (Revatio) for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for sildenafil (Viagra), tadalafil, and vardenafil were revised. FDA is working with the manufacturer to revise the labeling for sildenafil (Revatio). For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#PDE5, http://www.fda.gov/cder/consumerinfo/viagra/default.htm, http://www.fda.gov/cder/foi/label/2007/020895s027lbl.pdf, http://www.fda.gov/cder/drug/infopage/cialis/default.htm, http://www.fda.gov/cder/foi/label/2007/021368s012lbl.pdf, http://www.fda.gov/cder/drug/infopage/vardenafil/default.htm and http://www.fda.gov/cder/foi/label/2007/021400s010lbl.pdf.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Erectile Dysfunction
To facilitate attainment of a sexually functional erection in males with erectile dysfunction (ED, impotence).
Dosage and Administration
General
Dosage must be individualized carefully according to the patient’s tolerance and erectile response.
Sexual stimulation is required for response to therapy.
Administration
Oral Administration
Administer orally, no more than once daily, without regard to meals.
Administer approximately 1 hour before anticipated sexual activity.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Available as vardenafil hydrochloride; dosage expressed in terms of vardenafil.
Adults
Erectile Dysfunction
Oral
Initially, 10 mg. Depending on effectiveness and tolerance, increase dosage to a maximum of 20 mg or decrease to 5 mg. Administer no more frequently than once daily.
Prescribing Limits
Adults
Erectile Dysfunction
Oral
Maximum 20 mg daily.
Special Populations
Hepatic Impairment
In patients with moderate hepatic impairment (Child-Pugh class B), decrease initial dosage to 5 mg; maximum dosage is 10 mg once daily. Not studied in patients with severe hepatic impairment (Child-Pugh class C).
Renal Impairment
Dosage adjustments not required in patients with patients with mild (Clcr of 50–80 mL/minute) to severe (Clcr <30 mL/minute) renal impairment. Not studied in patients requiring renal dialysis.
Geriatric Patients
Reduce initial dose to 5 mg given no more frequently than once daily in men ≥65 years of age.
Cautions
Contraindications
Known hypersensitivity to vardenafil or any ingredient in the formulation.
Concomitant use of nitrates, nitrites, or nitric oxide donors, either regularly or intermittently, or α-adrenergic blocking agents.
Should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
Warnings/Precautions
Warnings
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Use not recommended in patients with a recent (within 6 months) MI, stroke, or life-threatening arrhythmia; resting hypotension (<90 mm Hg resting SBP) or hypertension (170/110 mm Hg SBP/DBP); or severe heart failure or unstable angina.
Possible hypotension; consider whether patients with underlying cardiovascular disease could be affected adversely by vardenafil’s vasodilatory activity. Risk of an undesired hypotensive or vasodilatory response is of particular concern in patients with left-ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis).
Potentiation of hypotensive effect with organic nitrates may result in life-threatening hypotension and/or hemodynamic compromise. Possible significant hypotension when given concurrently with α-adrenergic blocking agents. Manufacturers state that concomitant use of nitrates or α-adrenergic blocking agents with vardenafil is contraindicated. (See Specific Drugs under Interactions.)
Safety not established with long-term use of vardenafil concomitantly with potent CYP3A4 inhibitors (e.g., ritonavir, indinavir, ketoconazole, itraconazole). Increased plasma vardenafil concentrations with concomitant use; dosage reduction of vardenafil recommended. (See Specific Drugs under Interactions.)
Priapism
Possible prolonged erections (>4 hours in duration) and priapism (painful erection >6 hours).
May result in penile tissue damage and permanent loss of potency if priapism is not treated immediately. Use with caution in patients with conditions that may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
Ocular Effects
Possible visual disturbances (e.g., abnormal, dim, or blurred vision; changes in color vision [e.g., chromatopsia]).
Not studied in patients with hereditary degenerative retinal disorders, including those with retinitis pigmentosa. Use not recommended until further information is available.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Patient Assessment
Thorough medical history and physical examination recommended to diagnose erectile dysfunction, determine potential underlying causes, and identify appropriate treatment.
Review of the patient’s current drug regimens recommended to detect possible drug-induced erectile dysfunction.
Hematologic Effects
No prolongation of bleeding time with vardenafil dosages ≤20 mg.
However, not studied in patients with bleeding disorders or active peptic ulcers; therefore, careful risk/benefit assessment is necessary before use in such patients.
GU Effects
Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease).
Specific Populations
Pregnancy
Category B. Not indicated for use in women.
Lactation
Not indicated for use in women.
Pediatric Use
Not indicated for use in neonates or children.
Geriatric Use
Safety and efficacy in males ≥65 years of age similar to that in younger males. Increased plasma vardenafil concentrations in men ≥65 years of age compared to that in younger males; therefore consider lower initial dosage. (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Decreased clearance in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. (See Hepatic Impairment under Dosage and Administration.) Not studied in patients with severe hepatic impairment (Child-Pugh class C), and use of the drug in such patients is not recommended.
Renal Impairment
Clearance decreased in patients with moderate (Clcr 30–50 mL/minute) to severe (Clcr <30 mL/minute) renal impairment. (See Renal Impairment under Dosage and Administration.) Not studied in patients with end-stage renal disease requiring dialysis.
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