Although the cardiovascular effects of sildenafil reported in available randomized, controlled clinical trials were relatively minor, heart disease patients represented only a small fraction of studied patients, and patients with heart failure, patients with myocardial infarction or stroke within 6 months, or patients with uncontrolled hypertension were not included in these studies.

It is a prevalent condition affecting more than 1.5 million men in Poland.

Thus, for patients who experience an acute cardiac ischemic event and who have taken Viagra within the past 24 hours, administration of nitrates should be avoided.

We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, and mixed causes. In vivo pharmacokinetic performance of the selected system ME6 (with no nasal ciliotoxicity) was evaluated in a group of six rabbits in a randomized crossover study and compared to the marketed oral tablets.

Meta-analyses based on random-effects model were also performed.

Interactions may occur under single dose conditions or only at steady state. The aqueous solubility and permeability of sildenafil as a function of solution pH were theoretically derived from the individual contributions of all species (cationic, neutral and anionic). In the sildenafil group, the improvement in the mean Self-Esteem subscale score correlated with improvements in the mean Erectile Function domain score (r = 0.6338, P < 0.0001). However, most patients were controlled with 1 antihypertensive agent, and only a small number were controlled with 3 antihypertensive agents.

To overcome the problem of bitter taste of SIL, an artificial sweetener, acesulfame (Acs), was used to form a sweet SIL salt (SIL-Acs) using an effective reaction crystallization process to prepare phase pure bulk SIL-Acs with a high yield. These items focused on erectile function and intercourse satisfaction. One ODF formulation of sildenafil was characterized by a shorter Tonset and could potentially increase patient satisfaction following treatment. Statistical heterogeneity was explored. Less pronounced pharmacokinetic interactions may still be clinically important for drugs with a steep concentration-response relationship or narrow therapeutic index. Twenty patients received placebos and the other 20 patients received 20 mg sublingual sildenafil in a double blind randomized design.

An optimized formulation was prepared and characterized once more for its vesicle size, EE, in vitro permeation and deformability index. The second was a microemulsion system (ME6) containing Oleic acid: Labrasol/Transcutol/water (8.33:33.3:16.66:41.66% w/w). In short-term trials, men with ED randomized to sildenafil had an increased risk of all-cause any AEs, headache, flushing, dyspepsia, and visual disturbances. JAMA 1993; 280 : 83-90.Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunctionRosen RC, Capelleri JC, Smith MD, Lipsky J, Pena BM. In most cases, the extent of drug interaction varies markedly among individuals; this is likely to be dependent on interindividual differences in CYP3A4 tissue content, pre-existing medical conditions and, possibly, age.

The pharmacokinetics of radiolabelled [14C]-sildenafil were consistent with rapid absorption, first-pass metabolism and primarily faecal elimination of N-demethylated metabolites.To determine the absolute bioavailability, dose proportionality and the effects of food on the pharmacokinetics of single oral doses of sildenafil citrate. For nasal application, sildenafil citrate was formulated in two different systems: the first was a cosolvent system (S3) of benzyl alcohol/ethanol/water/Transcutol/ taurodeoxy cholate/Tween 20 (0.5:16.8:47.7:15.9:1:18.1% w/w).