Vardenafil was well tolerated with few treatment-emergent adverse events (AEs).
Rarely, vardenafil may cause changes in vision, including loss of vision in one or both eyes. If this occurs, call your healthcare provider right away. It could be a sign of a serious problem such as a crowded optic disc.
Efficacy
After a 4-week run-in period, patients were randomly assigned to placebo or to one of two doses of vardenafil (10 or 20 mg/day) for 10 weeks. At week 4, the investigator and patient discussed and evaluated the efficacy and tolerability of the initial dose, and a clinical decision was made whether to maintain the dose at 10 mg/day or to increase it to 20 mg/day for weeks 6-10.
At week 10 (LOCF), vardenafil-treated patients had statistically significant and clinically meaningful greater least squares mean International Index of Erectile Function-Erectile Function domain scores than placebo-treated patients (t=7.43, df=214, p=0.0001). In addition, the proportion of vardenafil-treated patients with a decrease in IIEF-EF of at least 3.5 points was significantly greater than placebo-treated patients (94 of 130, 72% vs 11%; p0.001).
Other measures of sexual function and satisfaction showed statistically significant and clinically meaningful improvements as well. Moreover, vardenafil was safe and well-tolerated in this flexible-dose study of older men with ED.
Side effects
Vardenafil is very well tolerated and safe when used as prescribed. A pooled analysis of REALISE data showed high rates of efficacy, effectiveness and satisfaction for vardenafil in men with underlying conditions such as diabetes, hypertension and lipid metabolism disorder (van Ahlen et al in preparation).
A few men experience headache as a side effect when taking this medication but it is generally not serious. Other less common side effects include a decrease in vision or hearing, ringing in the ears and dizziness. Taking this medication with alcohol may increase the chance of these side effects occurring.
This medication should not be taken by women and men who have a history of heart disease or liver problems. It also should not be taken with nitrates such as those found in recreational drugs like amyl or butyl nitrate because this increases the risk of dangerously low blood pressure, chest pain or heart attack. It is important to tell your doctor about all of the medications you take, including over-the-counter medicines, vitamins and herbal products.
Interactions
Vardenafil interacts with some medications, including antidepressants and several types of nitrates used to treat angina (chest pain). It can cause the blood pressure to drop too low. This can lead to dizziness, fainting, heart attack or stroke. It is important to tell your doctor about all of the medications you take, including prescription and over-the-counter drugs, vitamins, supplements and herbal products.
This medication works by inhibiting phosphodiesterase type 5 (PDE-5). PDE-5 degrades cyclic guanosine monophosphate (cGMP), which leads to smooth muscle relaxation and increased blood flow in the penis' corpus cavernosum, leading to an erection. For more details please visit here
It is recommended to avoid drinking alcohol or taking street drugs while taking vardenafil because they can interfere with its effectiveness. It is also important to let your doctor know if you have problems with vision or eye conditions, as this medication can increase the risk of these side effects. This is especially true for older men and people with certain medical conditions.
Storage
Vardenafil is soluble in water and partially soluble in alcohol. It is expected to exist in the soil primarily in the cation form (Koc = 1X10+6), where it would adsorb more strongly to organic carbon than to clay minerals.
The oral dose of 20 mg vardenafil hydrochloride tablets in healthy male volunteers was rapidly absorbed, with peak plasma concentrations occurring about 2 hours after dosing. The time to reach maximum plasma concentrations was reduced by 50% in two food-effect studies when a high fat meal was consumed prior to dosing.
Vardenafil has not been shown to be carcinogenic in a 24-month rat carcinogenicity study or mutagenic in an in vitro bacterial Ames assay and forward mutation assay in Chinese hamster V 79 cells. The maximum recommended human dose (20 mg) of vardenafil did not result in fertility impairment in rats attenuating spermatogenesis or impairing paternal transmission, and the drug was not teratogenic in mice at a dose of 100 mg/kg/day.