Patients taking Class 1A (for example. quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using LEVITRA.

 

5.8 Hepatic Impairment

 

Dosage adjustment is necessary in patients with moderate hepatic impairment (Child-Pugh B). Do not use LEVITRA in patients with severe (Child-Pugh C) hepatic impairment. [See Dosage and Administration (2.3) Clinical Pharmacology (12.3)] and Use in Specific Populations (8.6).] 

 

5.9 Renal Impairment

 

Do not use LEVITRA in patients on renal dialysis, as vardenafil has not been eva luated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)]. 

 

5.10 Combination with Other Erectile Dysfunction Therapies

 

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.

5.11 Effects on Bleeding

 

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. LEVITRA 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.

 

5.12 Sexually Transmitted Disease

 

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 Immunodeficiency Virus (HIV), should be considered.

6 ADVERSE REACTIONS

 

The following serious adverse reactions with the use of LEVITRA (vardenafil) are discussed elsewhere in the labeling:

1. Cardiovascular Effects  [see Contraindications (4.1) and Warnings and Precautions (5.1)] 2. Priapism [see Warnings and Precautions (5.3)] 3. Effects on Eye [see Warnings and Precautions (5.4)] 4. Sudden Hearing Loss [see Warnings and Precautions (5.5)] 5. QT Prolongation [see Warnings and Precautions (5.7)] 

  

 

6.1 Clinical Studies Experience

 

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 

 

LEVITRA was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year.