No abstract available.
Drug Eruptions* ; Sildenafil Citrate*

No abstract available.
Cicatrix* ; Sildenafil Citrate* ; Ulcer*

No abstract available.
Korea* ; Marketing* ; Sildenafil Citrate*

No abstract available.
Korea* ; Marketing* ; Sildenafil Citrate*

PURPOSE: We investigated the efficacy and safety of oral sildenafil, and the selection rate of sildenafil, for the continuous treatment of erectile dysfunction (ED) in patients who received intracavernous injection (ICI) therapy. MATERIALS AND METHODS: A total of 69 ED patients (55.1+/-12.3 years) who received ICI therapy, with trimix (papaverine 18.75mg+phentolamine 0.625mg+PGE1 6.25microgram/ ml) for more than 6 months, were recruited for this study. All patients received a starting dose of 50mg sildenafil. The dose was adjusted to 100mg or 25mg based on its efficacy and tolerability. The erection quality, side effects, and selection rates of sildenafil for the continuous treatment, with reasons for its selection, were compared with those of ICI. RESULTS: Good erectile responses, to both trimix and sildenafil, were noted in 52 (75.4%) patients. There were no differences in the age, frequency of associated diseases, dose of trimix, duration of the injection therapy, and IIEF Q3 or Q4 on the ICI between sildenafil-responders and -nonresponders. The dose of sildenafil in the responders was 100mg, 50mg and 25mg in 37, 14 and 1, respectively. Of the 52 sildenafil-responders, the erectile quality with ICI was better than with the sildenafil in 46 (88.5%), whereas only 2 showed a better quality, and 4 showed similar responses. Among the 52 responders, 18 (34.6%) preferred to continue the oral drug, 18 (34.6%) used both treatment alternatively, and 16 (30.8%) returned to the ICI. The main reason for selecting sildenafil was its easier administration (88.9%), whereas that for the ICI was its better erection quality (74.3%). The most common adverse reactions to the sildenafil included, hot flushes (17.4%) and headaches (13%). CONCLUSIONS: Patients with ED on the ICI therapy are likely to have similar erectile responses and adverse reactions to those on sildenafil from their comparison with other clinical trials on sildenafil. However, the selection rate of ICI for the continuous treatment in sildenafil-responders was high due to its better erection quality.
Erectile Dysfunction ; Headache ; Humans ; Male ; Sildenafil Citrate

PURPOSE: The aim of our study was to assess whether an intracavernous injection test can predict the effectiveness of sildenafil oral medication in patients with erectile dysfunction (ED). MATERIALS AND METHODS: A total of 80 patients with ED underwent an intracavernous injection test with trimix (papaverine 18.75 mg+phentolamine 0.625 mg+PGE1 6.25microgram/ml) 0.2 ml. Patients were divided into 2 groups according to rigidity formation following trimix injection: group I had no rigidity formation, group II had some rigidity formation. All patients received a starting dose of 50 mg sildenafil. The dose was adjusted to 100 mg based on its efficacy and tolerability. Erectile function was measured before and during the therapy using the International Index of Erectile Function (IIEF) questionnaire. RESULTS: All patients had erection function (EF) domain scores of the IIEF less than 16, denoting moderate to severe ED (group I, 50 patients; group II, 30 patients). The response rates with sildenafil 50 mg were 24% (12/50) in group I and 87% (26/30) in group II. The overall response rates with sildenafil (50 mg or 100 mg) were 68% (34/50) in group I and 93% (28/30) in group II. The change in ED domain score was significantly higher in group II (9.87+/-3.18 to 15.40+/-4.50; p<0.001) compared to group I (7.80+/-2.43 to 9.08+/-3.84). CONCLUSIONS: The erectile response from the intracavernosal injection test was correlated with the sildenafil response rate. This result implies that intracavernosal injection test may predict the erectile response to oral phosphodiesterase type 5 inhibitor.
Erectile Dysfunction* ; Humans ; Male ; Sildenafil Citrate

PURPOSE: This study aimed to examine the effects of oral sildenafil on erectile function according to the number of accompanying cardiovascular risk factors. MATERIALS AND METHODS: The Q3 (the ability to achieve an erection) and Q4 (the ability to maintain an erection) scores of the International Index of Erectile Function (IIEF) were obtained, before and after the administration of oral sildenafil at least 4 times, in a total of 195 patients (mean age: 57.9 8.9 years) with erectile dysfunction. Of these, 125 had 1 (n=76), 2 (n=33) or 3 (n=16) cardiovascular risk factors. The effects of oral sildenafil for each group were compared by mean paired differences of the Q3 and Q4 scores after treatment. RESULTS: The mean Q3 and Q4 scores increased significantly in all patients, regardless of the presence and number of risk factors (p<0.001). The greater the number of risk factors, the lower the Q3 and Q4 scores, while the mean paired differences in the scores before and after treatment were not significantly different between patients without and with cardiovascular risk factors. CONCLUSIONS: Oral sildenafil improves the erectile function in patients with cardiovascular risk factors, and combined erectile dysfunction and the degree of improvement seem to be similar, regardless of the number of cardiovascular risk factors.
Cardiovascular Diseases ; Erectile Dysfunction ; Humans ; Male ; Risk Factors* ; Sildenafil Citrate

A simple, rapid, and reliable UPLC-MS/MS method was developed and validated for the determination of tadalafil in human plasma. The plasma samples were deproteinized with acetonitrile. Chromatographic separation was performed on a Shiseido C18 (100 × 2.1 mm, 2.7 µm) column with isocratic elution using 2.0 mM ammonium acetate and acetonitrile (55:45, v/v) with 0.1% formic acid at a flow rate of 0.7 mL/min. The total run time was 1 min per sample. The quantitative analysis was performed using multiple reaction monitoring at transition of m/z 390.4 → 268.3 for tadalafil and m/z 475.3 → 283.3 for sildenafil as an internal standard. The method was fully validated over a concentration range of 5–1,000 ng/mL with a lower quantification limit of 5 ng/mL. Intra- and inter-day precision (relative standard deviation, %RSD) were within 8.4% and accuracy (relative error, %RE) was lower than -3.2%. The developed and validated method was successfully applied to a pharmacokinetic study of tadalafil (20 mg) in Korean healthy male subjects (n = 12).
Ammonium Compounds ; Humans* ; Male ; Methods* ; Pharmacokinetics ; Plasma* ; Sildenafil Citrate ; Tadalafil*

Currently intracavernous pharmacotherapy is the second common therapeutic modality for erectile dysfunction after the introduction of Viagra. Nevertheless, intracavernous pharmacotherapy has increased in popularity for the past 15 years. While having an overwhelming safety after complete training in injection method, this treatment option can reveal unexpected complications related to self-injection. We report two cases of intracavernous needle breakage associated with alprostadil (Caverject , Pharmacia-Upjohn) and trimix self-injection therapy with a brief review of the literature.
Alprostadil ; Drug Therapy ; Erectile Dysfunction ; Male ; Needles* ; Sildenafil Citrate

UI14SDF100CW is a chewable tablet of sildenafil citrate, which was developed to improve compliance through convenience of administration. The purpose of this study was to compare the pharmacokinetic (PK) properties of sildenafil citrate chewable tablets (UI14SDF100CW) and conventional sildenafil citrate film-coated tablets (Viagra®, Pfizer). A randomized, open-label, single dose, two-treatment, two-period, two-way crossover study was conducted in 60 healthy male volunteers. In each period, the subjects received a single oral dose of UI14SDF100CW or Viagra® (both tablets contain 140.45 mg of sildenafil citrate, which is equivalent to 100 mg of sildenafil). Serial blood samples were collected up to 24 h post-dose for PK analysis. The plasma concentration of sildenafil was determined using a validated HPLC-MS/MS assay. PK parameters of sildenafil were calculated using non-compartmental methods. The plasma concentration-time profiles of sildenafil in both formulations were similar. For UI14SDF100CW, the C(max) and AUC(last) of sildenafil were 1068.69 ± 458.25 (mean ± standard deviation) mg/L and 3580.59 ± 1680.29 h·mg/L, and the corresponding values for Viagra® were 1146.84 ± 501.70 mg/L and 3406.35 ± 1452.31 h·/L, respectively. The geometric mean ratios (90% confidence intervals) of UI14SDF100CW to Viagra® for C(max) and AUC(last) were 0.933 (0.853–1.021) and 1.034 (0.969–1.108), respectively, which met the bioequivalence criteria of Korean regulatory agency. In conclusion, UI14SDF100CW and Viagra® showed similar PK properties. Therefore, UI14SDF100CW can be an alternative to sildenafil for the treatment of erectile dysfunction, providing better compliance.
Compliance ; Cross-Over Studies ; Erectile Dysfunction ; Humans ; Male* ; Pharmacokinetics ; Plasma ; Sildenafil Citrate* ; Tablets* ; Therapeutic Equivalency ; Volunteers