Publication date: 2018-04-20 14:33
In volunteers with mild hepatic impairment (Child-Pugh A), the C max and AUC following a 65 mg vardenafil dose were increased by 77% and 67%, respectively, compared to healthy control subjects. No dosage adjustment is necessary in patients with mild hepatic impairment.
The mean terminal half-life of vardenafil in patients receiving vardenafil 65 mg orodispersible tablets ranged between 9 6 hours. The elimination half-life of the metabolite M6 is between 8 to 5 hours, similar to parent drug.
Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Levitra with a nitrate medicine can cause a sudden and serious decrease in blood pressure.
Vardenafil is rapidly absorbed after administration of vardenafil 65 mg orodispersible tablets without water. The median time to reach C max varied between 95 to 95 minutes and was similar or slightly delayed (by 8 to 95 min) compared to the film-coated tablets. Mean vardenafil AUC was increased by 76 to 79% (middle aged and elderly ED patients) or 99% healthy subjects) with 65 mg orodispersible tablets compared to film-coated tablets as a result of local oral absorption of a small amount of drug in the oral cavity. There was no consistent difference in mean C max between orodispersible tablets and film-coated tablets.
Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications ( )].
Advise patients to contact the prescribing physician if new medications that may interact with Levitra are prescribed by another healthcare provider.
In volunteers with mild to moderate renal impairment (creatinine clearance 85 85 ml/min), the pharmacokinetics of vardenafil were similar to that of a normal renal function control group. In volunteers with severe renal impairment (creatinine clearance 85 ml/min) the mean AUC was increased by 76% and the mean C max decreased by 78%, compared to volunteers with no renal impairment. No statistically significant correlation was observed between creatinine clearance and vardenafil exposure (AUC and C max ) (see section ). Vardenafil pharmacokinetics has not been studied in patients requiring dialysis (see section ).
Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension
Otologic: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient&rsquo s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Patient Counseling Information ( 67 )].
The most common side effects with Levitra are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain. These side effects usually go away after a few hours. Call your doctor if you get a side effect that bothers you or one that will not go away.