Active Ingredients: Vardenafil
What happens if I overdose? What should I avoid while taking vardenafil? Avoid the use of grapefruit products. Drinking alcohol can increase certain side effects of vardenafil.
Do not use any other drug to treat impotence unless your doctor tells you to.
What are the possible side effects of vardenafil? Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using vardenafil and call your doctor at once if you have: ringing in your ears, or sudden hearing loss; irregular heartbeat; swelling in your hands, ankles, or feet; shortness of breath; a light-headed feeling, like you might pass out; penis erection that is painful or lasts 4 hours or longer; or seizure convulsions.
Call your doctor for medical advice about side effects. What other drugs will affect vardenafil?
Do not take vardenafil with similar medications such as avanafil Stendra, sildenafil Viagra, or tadalafil Cialis. Tell your doctor about all other medications you use for erectile dysfunction.
This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information? Your pharmacist can provide more information about vardenafil.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc.
A diary was provided for patients to record all attempts made at sexual intercourse. Medication was to be taken without regard to meals. Patients were instructed to take each dose of medication without regard to meals, on an as-needed basis 1 hour before attempting sexual intercourse, with only 1 dose permitted per day.
During the 12-week treatment period, patients were scheduled for study visits at weeks 4, 8 and 12 for assessment of efficacy, safety, tolerability and compliance. Patient population and demographics This study included male patients with a diagnosis of ED lasting more than 6 months, defined according to the National Institutes of Health Consensus Statement the inability to attain or maintain penile erection sufficient for satisfactory sexual performance.
For randomization into the treatment phase of the trial, patients had to have been unsuccessful in at least 2 of the 4 attempts at intercourse during the 4-week treatment-free period. The primary efficacy end point was reliability of insertion as assessed by a positive SEP 2 response after each dose of study medication.
Safety and tolerability were evaluated throughout the study by assessing adverse events AEs from the start of the challenge phase to the end of week 12.