Note: These highlights do not include all the information needed to use LEVITRA safely and effectively.
DOSAGE FORMS AND STRENGTHS:
Levitra is made in 2.5 mg, 5 mg, 10 mg, and 20 mg.
DOSES AND ADMINISTRATION:
When Taken As Needed:
The starting dose is usually 10 mg as needed approximately 1 hour prior to sexual activity but it depends on the individual.
Based on effectiveness and tolerability, your physician may recommend an increase to 20 mg or a decrease to 5 mg. A starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years of age.
Levitra should not to be taken more than once per day.
If taking potent or moderate inhibitors of CYP3A4, the dose of LEVITRA should be adjusted as follows:
- 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.
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.
Levitra has been shown to take effect in as little as 30 minutes. The median time is 1 hour.
Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. Maximum observed plasma concentration after a single 20 mg dose in healthy volunteers are is usually reached between 30 minutes and 2 hours (median 60 minutes) after oral dosing in the fasted state.
Two food-effect studies were conducted that showed that high-fat meals caused a reduction in Cmax by 18%-50%. *This differs based on patient population (e.g., Geriatrics).
For more information, please read the FDA Prescribing Information here.
The use of Levitra in any patient using nitrates in any form is contraindicated.
Most Common (≥2%):
Include: headache, flushing, nasal congestion, dyspepsia (i.e., pain or an uncomfortable feeling in the upper middle part of your stomach), sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.
For a complete list of less common side effects, please read the FDA information here.
To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals at 1-888-84BAYER or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
WARNINGS AND PRECAUTIONS
- Cardiovascular Effects: Patients should not use LEVITRA if sex is inadvisable due to cardiovascular status.
- Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.
- 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.
- Sudden Hearing Loss: Patients should stop LEVITRA and seek medical attention in the event of sudden decrease or loss in hearing.
- Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. In some patients, concomitant use of these two drug classes can significantly lower blood pressure leading to symptomatic hypotension (for example, fainting).
- QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using LEVITRA.
- LEVITRA can potentiate the hypotensive effects of nitrates, alpha blockers, and antihypertensives.
USE IN SPECIFIC POPULATIONS
- LEVITRA is not indicated for use in pediatric patients.
- Do not use LEVITRA in patients with severe hepatic impairment (ChildPugh C).
- Do not use LEVITRA in patients on renal dialysis.