LEVITRA significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (47% on 10 mg and 48% on 20 mg LEVITRA compared to 22% on placebo; p <0.0001).

 

LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (37% on 10 mg, 34% on 20 mg LEVITRA compared to 10% on placebo; p<0.0001).

16 HOW SUPPLIED/STORAGE AND HANDLING

 

LEVITRA (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “2.5”, “5”, “10”, and “20” on the other side equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. 

 

Package

 

Strength

 

NDC Code

 

 

Bottles of 30

 

2.5 mg

 

0173-0828-13

 

5 mg

 

0173-0829-13

 

 

10 mg

 

0173-0830-13

 

20 mg

 

0173-0831-13

 

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

 

“See FDA-approved patient labeling (Patient Information)”

 

Nitrates 

 

Inform patients that LEVITRA is contraindicated with regular and/or intermittent use of organic nitrates. Patients should be counseled 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.

 

Guanylate Cyclase (GC) Stimulators 

 

Inform patients that Levitra is contraindicated in patients who use guanylate cyclase stimulators, such as riociguat.

 

Cardiovascular 

 

Discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors.

 

Concomitant Use with Drugs which Lower Blood Pressure 

 

Inform patients that in some patients concomitant use of PDE5 inhibitors, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Patients prescribed LEVITRA who are taking alpha-blockers should be started on the lowest recommended starting dose of LEVITRA [see Dosage and Administration (2.4) and Drug Interactions (7)]. Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with LEVITRA are prescribed by another healthcare provider.

 

Recommended Administration