HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LEVITRA safely and effectively. See full prescribing information for LEVITRA
LEVITRA (vardenafil hydrochloride) tablets, for oral use
Initial U.S. Approval: 2003
RECENT MAJOR CHANGES
• Warnings and Precautions, Effects on the Eye ( 5.4) 8/2017
INDICATIONS AND USAGE
• LEVITRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1)
DOSAGE AND ADMINISTRATION
• LEVITRA is taken as needed: For most patients, the starting dose is 10 mg, up to once daily. Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability. ( 2.1) • A starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years of age. ( 2.3) • LEVITRA is taken orally, approximately 60 minutes before sexual activity. ( 2.1) • The maximum recommended dosing frequency is one tablet per day. ( 2.1) • LEVITRA may be taken with or without food. ( 2.2) • If taking potent or moderate inhibitors of CYP3A4, the dose of LEVITRA should be adjusted as follows ( 2.4, 5.2, 7.2): • Ritonavir: No more than 2.5 mg in a 72-hour period • Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour period • Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period. • In patients on stable alpha-blocker therapy the recommended starting dose of LEVITRA is 5 mg ( 2.4, 5.6) • The recommended starting dose of LEVITRA is 5 mg in patients with moderate hepatic impairment (Child-Pugh B). The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. ( 2.3, 8.6)
DOSAGE FORMS AND STRENGTHS
• LEVITRA tablets 2.5 mg, 5 mg, 10 mg, 20 mg ( 3)
CONTRAINDICATIONS
• Administration with nitrates and nitric oxide donors ( 2.4, 4.1) • Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 2.4, 4.2)
WARNINGS AND PRECAUTIONS
• Cardiovascular Effects: Patients should not use LEVITRA if sex is inadvisable due to cardiovascular status. ( 5.1) • Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. ( 5.3) • Effects on the Eye: Patients should stop use of LEVITRA, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). LEVITRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION. ( 5.4, 6.2) • Sudden Hearing Loss: Patients should stop LEVITRA and seek medical attention in the event of sudden decrease or loss in hearing. ( 5.5, 6.2) • Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, faint
