Label: VARDENAFIL HYDROCHLORIDE tablet

In a corresponding 1-month rat toxicity study, this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg. Vardenafil was not carcinogenic in rats and mice when administered daily for 24 months.

• Vardenafil HCl 10mg can be effective in treating erectile dysfunction symptoms.
• It’s important to avoid unprescribed or counterfeit versions of the drug.
• Consult a healthcare provider for proper diagnosis before starting treatment.
• Discontinue medication and seek medical help if serious side effects occur.
• The medication’s effects depend on proper timing and dosage adherence.
• It’s safe for most men but always needs individual health assessment.
• Mild side effects may diminish over time or with dose adjustment.
• Use caution with other medications that affect blood pressure or blood flow.
• Do not use vardenafil if you are allergic to similar medications like sildenafil.
• Always inform your doctor of any other medications you are taking.

In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite were approximately 400- and 170-fold for male and female rats, respectively, and 21- and 37-fold for male and female mice, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 20 mg. Vardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V 79 cells. Vardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in male, and for 14 days prior to mating and through day 7 of gestation in females. 14 CLINICAL STUDIES Vardenafil hydrochloride tablets were evaluated in four major double-blind, randomized, placebo-controlled, fixed-dose, parallel design, multicenter trials in 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black, 2% Asian, 3% Hispanic and 10% Other/Unknown). The doses of vardenafil hydrochloride tablets in these studies were 5 mg, 10 mg, and 20 mg. Two of these trials were conducted in the general erectile dysfunction (ED) population and two in special ED populations (one in patients with diabetes mellitus and one in post-prostatectomy patients). Vardenafil hydrochloride tablets were dosed without regard to meals on an as needed basis in men with ED, many of whom had multiple other medical conditions.

What happens if I overdose?

The mean baseline EF Domain score in these trials was 11.8 (scores range from 0-30 where lower scores represent more severe disease). Vardenafil hydrochloride tablets (5 mg, 10 mg, and 20 mg) were effective in all age categories (<45, 45 to <65, and ≥65 years) and was also effective regardless of race (White, Black, Other).14.1 Trials in a General Erectile Dysfunction PopulationIn the major North American fixed-dose trial, 762 patients (mean age 57, range 20-83 years; 79% White, 13% Black, 4% Hispanic, 2% Asian and 2% Other) were evaluated. The mean baseline EF Domain scores were 13, 13, 13, 14 for the vardenafil hydrochloride tablets 5 mg, 10 mg, 20 mg and placebo groups, respectively. There was significant improvement (p <0.0001) at 3 months with vardenafil hydrochloride tablets (EF Domain scores of 18, 21, 21, for the 5 mg, 10 mg, and 20 mg dose groups, respectively) sexual tablets for women compared to the placebo group (EF Domain score of 15). The European trial (total N=803) confirmed these results.

What should I do if I miss a dose of vardenafil?

The improvement in mean score was maintained at all doses at 6 months in the North American trial.In the North American trial, vardenafil hydrochloride tablets significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo group at 3 months; p <0.0001). The European trial confirmed these results.Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively, compared to 32% on placebo; p <0.0001) at 3 months in the North American trial. This improvement in mean score was maintained at all doses at 6 months in the North American trial.14.2 Trial in Patients with ED and Diabetes MellitusVardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81; 80% White, 9% Black, 8% Hispanic, and 3% Other).Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg vardenafil hydrochloride tablets and 19 on 20 mg vardenafil hydrochloride tablets compared to 13 on placebo; p <0.0001).Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10 mg and 64% on 20 mg vardenafil hydrochloride tablets compared to 36% on placebo; p <0.0001).Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (49% on 10 mg, 54% on 20 mg vardenafil hydrochloride tablets compared to 23% on placebo; p <0.0001).14.3 Trial in Patients with ED after Radical ProstatectomyVardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other).Significant improvements in the EF Domain were shown in this study (EF Domain scores of 15 on 10 mg vardenafil hydrochloride tablets and 15 on 20 mg vardenafil hydrochloride tablets compared to 9 on placebo; p <0.0001).Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (47% on 10 mg and 48% on 20 mg vardenafil hydrochloride tablets compared to 22% on placebo; p <0.0001).Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (37% on 10 mg, 34% on 20 mg vardenafil hydrochloride tablets compared to 10% on placebo; p <0.0001). Vardenafil hydrochloride tablets were evaluated in four major double-blind, randomized, placebo-controlled, fixed-dose, parallel design, multicenter trials in 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black, 2% Asian, 3% Hispanic and 10% Other/Unknown). The primary endpoints were assessed at 3 months. The primary endpoints were assessed at 3 months.Primary efficacy assessment in all four major trials was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful intercourse (SEP3).In all four fixed-dose efficacy trials, vardenafil hydrochloride tablets showed clinically meaningful and statistically significant improvement in the EF Domain, SEP2, and SEP3 scores compared to placebo. The mean baseline EF Domain score in these trials was 11.8 (scores range from 0-30 where lower scores represent more severe disease).

Vardenafil hydrochloride tablets (5 mg, 10 mg, and 20 mg) were effective in all age categories (<45, 45 to <65, and ≥65 years) and was also effective regardless of race (White, Black, Other).14.1 Trials in a General Erectile Dysfunction PopulationIn the major North American fixed-dose trial, 762 patients (mean age 57, range 20-83 years; 79% White, 13% Black, 4% Hispanic, 2% Asian and 2% Other) were evaluated. The mean baseline EF Domain scores were 13, 13, 13, 14 for the vardenafil hydrochloride tablets 5 mg, 10 mg, 20 mg and placebo groups, respectively. There was significant improvement (p <0.0001) at 3 months with vardenafil hydrochloride tablets (EF Domain scores of 18, 21, 21, for the 5 mg, 10 mg, and 20 mg dose groups, respectively) sexual tablets for women compared to the placebo group (EF Domain score of 15). The European trial (total N=803) confirmed these results.

How should this medicine be used?

Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10 mg and 64% on 20 mg vardenafil hydrochloride tablets compared to 36% on placebo; p <0.0001). Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (49% on 10 mg, 54% on 20 mg vardenafil hydrochloride tablets compared to 23% on placebo; p <0.0001). Vardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other).

What is vardenafil used for?

The improvement in mean score was maintained at all doses at 6 months in the North American trial.In the North American trial, vardenafil hydrochloride tablets significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo group at 3 months; p <0.0001).

The European trial confirmed these results.Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively, compared to 32% on placebo; p <0.0001) at 3 months in the North American trial.

Vardenafil Warnings/Precautions

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This improvement in mean score was maintained at all doses at 6 months in the North American trial.14.2 Trial in Patients with ED and Diabetes MellitusVardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81; 80% White, 9% Black, 8% Hispanic, and 3% Other).Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg vardenafil hydrochloride tablets and 19 on 20 mg vardenafil hydrochloride tablets compared to 13 on placebo; p <0.0001).Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10 mg and 64% on 20 mg vardenafil hydrochloride tablets compared to 36% on placebo; p <0.0001).Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (49% on 10 mg, 54% on 20 mg vardenafil hydrochloride tablets compared to 23% on placebo; p <0.0001).14.3 Trial in Patients with ED after Radical ProstatectomyVardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other).Significant improvements in the EF Domain were shown in this study (EF Domain scores of 15 on 10 mg vardenafil hydrochloride tablets and 15 on 20 mg vardenafil hydrochloride tablets compared to 9 on placebo; p <0.0001).Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (47% on 10 mg and 48% on 20 mg vardenafil hydrochloride tablets compared to 22% on placebo; p <0.0001).Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (37% on 10 mg, 34% on 20 mg vardenafil hydrochloride tablets compared to 10% on placebo; p <0.0001).

• Vardenafil HCl 10mg can be an effective treatment when used responsibly.
• Always follow the prescribed dosing schedule for safety and efficacy.
• The medication may need to be adjusted based on individual response.
• Use with caution if you have a history of cardiovascular disease.
• Discuss all current medications with your doctor to avoid interactions.
• Vardenafil is not recommended for use by women or children.
• Be aware of possible side effects and seek medical help when needed.
• Alcohol and fatty foods can interfere with the drug’s performance.
• Proper sexual stimulation is required for the drug to work effectively.
• Regular follow-up with your healthcare provider is encouraged.

Vardenafil hydrochloride tablets were evaluated in four major double-blind, randomized, placebo-controlled, fixed-dose, parallel design, multicenter trials in 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black, 2% Asian, 3% Hispanic and 10% Other/Unknown). The primary endpoints were assessed at 3 months. Primary efficacy assessment in all four major trials was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful best sex pills for women intercourse (SEP3). In all four fixed-dose efficacy trials, vardenafil hydrochloride tablets showed clinically meaningful and statistically significant improvement in the EF Domain, SEP2, and SEP3 scores compared to placebo.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Primary efficacy assessment in all four major trials was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful best sex pills for women intercourse (SEP3). In all four fixed-dose efficacy trials, vardenafil hydrochloride tablets showed clinically meaningful and statistically significant improvement in the EF Domain, SEP2, and SEP3 scores compared to placebo. Vardenafil hydrochloride tablets (5 mg, 10 mg, and 20 mg) were effective in all age categories (<45, 45 to <65, and ≥65 years) and was also effective regardless of race (White, Black, Other). In the major North American fixed-dose trial, 762 patients (mean age 57, range 20-83 years; 79% White, 13% Black, 4% Hispanic, 2% Asian and 2% Other) were evaluated. The improvement in mean score was maintained at all doses at 6 months in the North American trial.

Best Wholesale Price for VARDENAFIL HCL

In the North American trial, vardenafil hydrochloride tablets significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo group at 3 months; p <0.0001). Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively, compared to 32% on placebo; p <0.0001) at 3 months in the North American trial. This improvement in mean score was maintained at all doses at 6 months in the North American trial. Vardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81; 80% White, 9% Black, 8% Hispanic, and 3% Other). Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg vardenafil hydrochloride tablets and 19 on 20 mg vardenafil hydrochloride tablets compared to 13 on placebo; p <0.0001). Vardenafil hydrochloride tablets (5 mg, 10 mg, and 20 mg) were effective in all age categories (<45, 45 to <65, and ≥65 years) and was also effective regardless of race (White, Black, Other). In the major North American fixed-dose trial, 762 patients (mean age 57, range 20-83 years; 79% White, 13% Black, 4% Hispanic, 2% Asian and 2% Other) were evaluated. The improvement in mean score was maintained at all doses at 6 months in the North American trial. In the North American trial, vardenafil hydrochloride tablets significantly improved the rates of achieving an erection sufficient for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%, 75%, and 80%, respectively, compared to a 52% response in the placebo group at 3 months; p <0.0001). Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively, compared to 32% on placebo; p <0.0001) at 3 months in the North American trial.

This improvement in mean score was maintained at all doses at 6 months in the North American trial. Vardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81; 80% White, 9% Black, 8% Hispanic, and 3% Other). Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg vardenafil hydrochloride tablets and 19 on 20 mg vardenafil hydrochloride tablets compared to 13 on placebo; p <0.0001). Vardenafil hydrochloride tablets significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10 mg and 64% on 20 mg vardenafil hydrochloride tablets compared to 36% on placebo; p <0.0001). Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (49% on 10 mg, 54% on 20 mg vardenafil hydrochloride tablets compared to 23% on placebo; p <0.0001). Vardenafil hydrochloride tablets demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg vardenafil hydrochloride tablets), double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other).

What side effects can this medication cause?

In a corresponding 1-month rat toxicity study, this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg. Vardenafil was not carcinogenic in rats and mice when administered daily for 24 months. In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite were approximately 400- and 170-fold for male and female rats, respectively, and 21- and 37-fold for male and female mice, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 20 mg. Vardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V 79 cells. Vardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in male, and for 14 days prior to mating and through day 7 of gestation in females.

Are you currently using Vardenafil (Levitra, Staxyn)?

14 CLINICAL STUDIES Vardenafil hydrochloride tablets were evaluated in four major double-blind, randomized, placebo-controlled, fixed-dose, parallel design, multicenter trials in 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black, 2% Asian, 3% Hispanic and 10% Other/Unknown). The doses of vardenafil hydrochloride tablets in these studies were 5 mg, 10 mg, and 20 mg. Two of these trials were conducted in the general erectile dysfunction (ED) population and two in special ED populations (one in patients with diabetes mellitus and one in post-prostatectomy patients). Vardenafil hydrochloride tablets were dosed without regard to meals on an as needed basis in men with ED, many of whom had multiple other medical conditions. The primary endpoints were assessed at 3 months.Primary efficacy assessment in all four major trials was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful intercourse (SEP3).In all four fixed-dose efficacy trials, vardenafil hydrochloride tablets showed clinically meaningful and statistically significant improvement in the EF Domain, SEP2, and SEP3 scores compared to placebo.