Levitra Tablets (Luh-VEE-Trah) (vardenafil HCl)
Warnings and Precautions
Cardiovascular effects
Effect of Co-administration of Strong CYP3A4 inhibitors
Other Effects
Patient Subgroups Not Studied in Clinical Trials
Warnings
Cardiovascular effects
General: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, any treatment for erectile dysfunction, including Levitra, generally should not be used.
Left Ventricular Outflow Obstruction: Patients with left ventricular outflow obstruction, e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.
Blood Pressure Effects: Levitra has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8mmHg diastolic) (see CLINICAL PHARMACOLOGY, Pharmacodynamics). While this normally would be expected to be of little consequence in most [patients, prior to proscribing Levitra, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such vasodilatory effects.
Effect of Co-administration of Strong CYP3A4 inhibitors
Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors. Concomitant administration with ritonavir or indinavir substantially increases plasma concentrations of vardenafil. To decrease the chance of adverse events in patients concomitantly taking ritonavir or indinavir, which are strong inhibitors of CYP3A4 metabolism, a maximum single dose of 2.5 mg Levitra should not be exceeded. Because ritonavir prolongs elimination half-life (5-6 fold), no more than a single 2.5 mg dose of Levitra should be taken in a 72-hour period by patients also taking ritonavir. Patients taking indinavir, ketoconazole 400 mg daily, or itraconazole 400 mg daily should not exceed Levitra 2.5 mg once daily. For patients taking ketoconazole or itraconazole 200 mg daily, a single dose of 5 mg Levitra should not be exceeded in a 24 hour period (see PRECAUTIONS, Drug Interactions and DOSAGE AND ADMINISTRATION).
Other Effects
There have been rare reports of prolonged erections greater then 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil. In the event that a erection persists longer than 4 hours, the patient should seek immediate medical assistance. If the priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Patient Subgroups Not Studied in Clinical Trials
There is no controlled clinical data on the safety or efficacy of Levitra in the following patient; and therefore its use is not recommended until further information is available.
- Unstable angina; hypotension (resting systolic blood pressure of <90 mm Hg); uncontrolled hypertension (>170/110mm Hg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within the last 6 months); severe cardiac failure
- Sever hepatic impairment (Child-Pugh C)
- End stage renal disease requiring dialysis
- Known hereditary degenerative retinal disorders, including retinitis pigmentosa
Precautions
The evaluation of erectile dysfunction should include a determination of potential underlying causes, a medical assessment, and the identification of appropriate treatment.
Before prescribing Levitra, it is important to note the following:
Hepatic Insufficiency: In volunteers with moderate impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. Consequently, a starting dose of 5 mg is recommended for patients with moderate hepatic impairment and the maximum dose should not exceed 10 mg (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations, and DOSAGE AND ADMINISTRATION). Vardenafil has not been evaluated in patients with severe hepatic impairment (Child-Pugh C).
Congenital or acquired QT Prolongation: In a study of the effect of Levitra on QT interval in 59 healthy males (see CLINICAL PHARMACOLOGY, Electrophysiology), therapeutic (10 mg) and supratherapeutic (80 mg) doses of Levitra and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. This observation should be considered in clinical decisions when prescribing Levitra. Patients with congenital QT prolongation and those taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic mediactions should avoid using Levitra.
Renal Insufficiency: In patients with moderate (CLcr =30-50ml/min) to severe (CLcr <30ml/min) renal impairment, the AUC of vardenafil was 20-30% higher compared to that observed in a control group with normal renal function (CLcr >80ml/min) (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis.
General
In humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. Vardenafil has not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore Levitra should be administered to these patients after careful benefit-risk assessment.
Treatment for erectile dysfunction should generally be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
The safety and efficacy of Levitra used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
Information for Patients
Physicians should discuss with patients the contraindications ov Levitra with regular and/or intermittent use of organic nitrates. Patients should be counselled that concomitant use of Levitra with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope or even heart attack or stroke.
Physicians should inform their patients that concomitant use of Levitra with alpha-blockers is contraindicated because co-administration can produce hypotension.
Physicians should discuss with patients the appropriate use of Levitra and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking Levitra. Levitra should be taken approximately 60 minutes before sexual activity. Patients should be counselled regarding the dosing of Levitra. Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with Levitra or incase of an unwanted effect. Patients should be advised to contact the prescribing physician if new medications that may interact with Levitra are prescribed by another healthcare provider.
Physicians should discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors.
The use of Levitra offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodefiency Virus (HIV), should be considered.
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