Label: VARDENAFIL tablet, orally disintegrating

Two patients on vardenafil in the trial reported episodes of transient cyanopsia (objects appear blue). There was no effect on sperm motility or morphology after single 20 mg oral doses of vardenafil film-coated tablets in healthy volunteers. The pharmacokinetics of vardenafil and its M1 metabolite from vardenafil hydrochloride orally disintegrating tablets have been evaluated in healthy male volunteers (18 to 50 years) and in young (18 to 45 years) and elderly (≥ 65 years) erectile dysfunction patients.

• Vardenafil is ineffective without sexual arousal.
• It does not protect against sexually transmitted infections.
• Avoid excessive mental or physical exertion while on medication.
• Consult a healthcare professional if unsure about interactions.
• Don't take vardenafil if you've had recent heart attack.
• Use with caution if you have a bleeding disorder.
• Medication may cause a temporary drop in blood pressure.
• Avoid using if you have a known hypersensitivity.
• The pill should be taken as part of a treatment plan.
• Keep track of how you respond to the medication.

Studies have shown that vardenafil hydrochloride orally disintegrating tablets provides higher systemic exposure of vardenafil compared to vardenafil 10 mg film-coated tablets. Mean vardenafil plasma concentrations measured after the administration of a single oral dose vardenafil hydrochloride orally disintegrating tablets to patients with erectile dysfunction (18 to 45 years) are depicted in Figure 8. Figure 8: Vardenafil Plasma Concentration (Mean ± SD) Profile for Vardenafil Hydrochloride Orally Disintegrating Tablets in men age 18to 45 years with erectile dysfunction Vardenafil was not found to accumulate in plasma when vardenafil hydrochloride orally disintegrating tablets was dosed daily over ten days. Effect of food: A high fat meal had no effect on vardenafil AUC and Tmax from vardenafil hydrochloride orally disintegrating tablets in healthy volunteers and reduced Cmax by 35%. Effect of water: When vardenafil hydrochloride orally disintegrating tablets were swallowed with water, the AUC of vardenafil was reduced by 29% and median Tmax was shortened by 60 minutes while Cmax was not affected. Vardenafil hydrochloride orally disintegrating tablets should be taken without liquid. Following a single oral dose of 20 mg vardenafil film-coated tablet in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing.

• Vardenafil 10 mg is a selective phosphodiesterase type 5 inhibitor.
• It can improve the ability to achieve an erection.
• Maintain open communication with your healthcare provider.
• Use with caution in elderly patients.
• Report any unusual side effects promptly.
• The medication should not be used recreationally.
• Not recommended for use with certain antihypertensives.
• Effectiveness depends on correct timing and dosage.
• Avoid taking if you have severe liver disease.
• Always read the patient information leaflet.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityCarcinogenesisVardenafil 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.MutagenesisVardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V79 cells.

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13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityCarcinogenesisVardenafil 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.MutagenesisVardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V79 cells. Vardenafil was not clastogenic as assessed in either the in vitro chromosomal aberration test or the in vivo mouse micronucleus test.Impairment of FertilityVardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in males, and for 14 days prior to mating and through day 7 of gestation in females. 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.

Does vardenafil interact with other medicines (drug interactions)?

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 V79 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 males, and for 14 days prior to mating and through day 7 of gestation in females. 14 CLINICAL STUDIES The efficacy and safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials (studies sex pills for women 1 and 2). Vardenafil hydrochloride orally disintegrating tablets were dosed without regard to meals on an as-needed basis in men with erectile dysfunction (ED), many of whom had multiple other medical conditions. Vardenafil was not clastogenic as assessed in either the in vitro chromosomal aberration test or the in vivo mouse micronucleus test.Impairment of FertilityVardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in males, and for 14 days prior to mating and through day 7 of gestation in females. 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.

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Vardenafil was not carcinogenic in rats and mice when administered daily for 24 months.

Dose Adjustments

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 V79 cells.

• Vardenafil 10 mg is a popular choice for ED treatment.
• Dose can be adjusted by a healthcare provider.
• Avoid using vardenafil with recreational drugs like poppers.
• Do not use after consuming large amounts of alcohol.
• The pill is generally taken before planned intercourse.
• Its effects are dose-dependent and subject to individual variation.
• Adherence to prescribed dose helps prevent adverse effects.
• The medication can be used long-term if prescribed.
• Regular checkups can help monitor effectiveness and safety.
• Never double the dose if the first does not work immediately.

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 males, and for 14 days prior to mating and through day 7 of gestation in females. 14 CLINICAL STUDIES The efficacy and safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials (studies sex pills for women 1 and 2). Vardenafil hydrochloride orally disintegrating tablets were dosed without regard to meals on an as-needed basis in men with erectile dysfunction (ED), many of whom had multiple other medical conditions.

8.1 Pregnancy

Two patients on vardenafil in the trial reported episodes of transient cyanopsia (objects appear blue). There was no effect on sperm motility or morphology after single 20 mg oral doses of vardenafil film-coated tablets in healthy volunteers. The pharmacokinetics of vardenafil and its M1 metabolite from vardenafil hydrochloride orally disintegrating tablets have been evaluated in healthy male volunteers (18 to 50 years) and in young (18 to 45 years) and elderly (≥ 65 years) erectile dysfunction patients. Studies have shown that vardenafil hydrochloride orally disintegrating tablets provides higher systemic exposure of vardenafil compared to vardenafil 10 mg film-coated tablets. Mean vardenafil plasma concentrations measured after the administration of a single oral dose vardenafil hydrochloride orally disintegrating tablets to patients with erectile dysfunction (18 to 45 years) are depicted in Figure 8.

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

Figure 8: Vardenafil Plasma Concentration (Mean ± SD) Profile for Vardenafil Hydrochloride Orally Disintegrating Tablets in men age 18to 45 years with erectile dysfunction Vardenafil was not found to accumulate in plasma when vardenafil hydrochloride orally disintegrating tablets was dosed daily over ten days. Effect of food: A high fat meal had no effect on vardenafil AUC and Tmax from vardenafil hydrochloride orally disintegrating tablets in healthy volunteers and reduced Cmax by 35%. Effect of water: When vardenafil hydrochloride orally disintegrating tablets were swallowed with water, the AUC of vardenafil was reduced by 29% and median Tmax was shortened by 60 minutes while Cmax was not affected. Vardenafil hydrochloride orally disintegrating tablets should be taken without liquid. Following a single oral dose of 20 mg vardenafil film-coated tablet in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing. In both pivotal studies, randomization was stratified so that approximately 50% of patients were ≥65 years old. Primary efficacy assessment 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).

Advice Point	Explanation
Take on an empty stomach	Food, especially high-fat, may delay absorption
Do not combine with nitrates	Can cause severe hypotension
Avoid alcohol consumption	Can impair effectiveness and cause side effects
Follow prescribed dosage	To minimize side effects and interactions

The primary endpoints were assessed at 3 months.Study 1 evaluated 355 mainly European (Belgium, France, Germany, Spain, South Africa, and Netherlands) patients (mean age 61.9; 67% White, 4% Black, 3% Asian, 26% Unknown). The mean baseline EF domain scores were 13 for both placebo and vardenafil hydrochloride orally disintegrating tablets groups. Study 2 evaluated 331 mainly North American (USA, Canada, Mexico, and Australia) patients (mean age 61.7; 69% White, 5% Black, 4% Asian, 22% Hispanic). The mean baseline EF domain scores were 12 for vardenafil hydrochloride orally disintegrating tablets and 13 for placebo.In both studies vardenafil hydrochloride orally disintegrating tablets demonstrated clinically meaningful and statistically significant improvements over placebo in all 3 primary efficacy variables (see Table 7).Table 7: Change from Baseline for the Primary Efficacy Variables in Studies 1 and 214.1 Other Vardenafil Clinical Trials Using Film-Coated TabletsPatients with ED and Diabetes MellitusVardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose [10 and 20 mg vardenafil film-coated tablets], double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33 to 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 and 19 on 20 mg vardenafil compared to 13 on placebo; p <0.0001).Vardenafil 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 compared to 36% on placebo; p <0.0001).Vardenafil 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 compared to 23% on placebo; p <0.0001).Patients with ED after Radical ProstatectomyVardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose 10 and 20 mg vardenafil film-coated tablets, double-blind, placebo-controlled trial in postprostatectomy patients (n=427, mean age 60, range 44 to 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 and 15 on 20 mg vardenafil compared to 9 on placebo; p <0.0001).Vardenafil 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 compared to 22% on placebo; p <0.0001).Vardenafil 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 compared to 10% on placebo; p <0.0001). The efficacy and safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials (studies 1 and 2).

Contraindication	Reason	Alternative Action
Use with Nitrates	Severe hypotension risk	Seek alternative ED treatment
Severe Liver Impairment	Reduced metabolism, increased risk	Dose adjustment or avoidance
Hypotension (<90/60 mm Hg)	Risk of significant blood pressure drop	Monitor blood pressure
Concomitant Potent CYP3A4 Inhibitors	Increased Vardenafil levels	Dose reduction

The primary endpoints were assessed at 3 months. Study 1 evaluated 355 mainly European (Belgium, France, Germany, Spain, South Africa, and Netherlands) patients (mean age 61.9; 67% White, 4% Black, 3% Asian, 26% Unknown). The mean baseline EF domain scores were 12 for vardenafil hydrochloride orally disintegrating tablets and 13 for placebo.

Parameter	Result	Notes
Absorption Time	30-60 minutes	Time to peak plasma concentration (Tmax)
Bioavailability	~15%	Percentage of dose reaching systemic circulation
Half-life	4-5 hours	Duration of effect
Metabolism	Liver (CYP3A4 enzyme)	Mainly via hepatic pathways
Excretion	Feces (~60%), Urine (~20%)	Primary routes

In both studies vardenafil hydrochloride orally disintegrating tablets demonstrated clinically meaningful and statistically significant improvements over placebo in all 3 primary efficacy variables (see Table 7).

2.4 Concomitant Medications

What is the dosage for vardenafil?

Table 7: Change from Baseline for the Primary Efficacy Variables in Studies 1 and 2 Vardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose [10 and 20 mg vardenafil film-coated tablets], double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33 to 81; 80% White, 9% Black, 8% Hispanic, and 3% Other).

What happens if I overdose?

How should I store vardenafil?

Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg vardenafil and 19 on 20 mg vardenafil compared to 13 on placebo; p <0.0001).

7.2 Effect of Other Drugs on Vardenafil

In both pivotal studies, randomization was stratified so that approximately 50% of patients were ≥65 years old. Primary efficacy assessment 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). The primary endpoints were assessed at 3 months.Study 1 evaluated 355 mainly European (Belgium, France, Germany, Spain, South Africa, and Netherlands) patients (mean age 61.9; 67% White, 4% Black, 3% Asian, 26% Unknown). The mean baseline EF domain scores were 13 for both placebo and vardenafil hydrochloride orally disintegrating tablets groups. Study 2 evaluated 331 mainly North American (USA, Canada, Mexico, and Australia) patients (mean age 61.7; 69% White, 5% Black, 4% Asian, 22% Hispanic).

Consumer Information Use and Disclaimer

The mean baseline EF domain scores were 12 for vardenafil hydrochloride orally disintegrating tablets and 13 for placebo.In both studies vardenafil hydrochloride orally disintegrating tablets demonstrated clinically meaningful and statistically significant improvements over placebo in all 3 primary efficacy variables (see Table 7).Table 7: Change from Baseline for the Primary Efficacy Variables in Studies 1 and 214.1 Other Vardenafil Clinical Trials Using Film-Coated TabletsPatients with ED and Diabetes MellitusVardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose [10 and 20 mg vardenafil film-coated tablets], double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33 to 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 and 19 on 20 mg vardenafil compared to 13 on placebo; p <0.0001).Vardenafil 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 compared to 36% on placebo; p <0.0001).Vardenafil 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 compared to 23% on placebo; p <0.0001).Patients with ED after Radical ProstatectomyVardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose 10 and 20 mg vardenafil film-coated tablets, double-blind, placebo-controlled trial in postprostatectomy patients (n=427, mean age 60, range 44 to 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 and 15 on 20 mg vardenafil compared to 9 on placebo; p <0.0001).Vardenafil 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 compared to 22% on placebo; p <0.0001).Vardenafil 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 compared to 10% on placebo; p <0.0001). The efficacy and safety of vardenafil hydrochloride orally disintegrating tablets were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials (studies 1 and 2). The primary endpoints were assessed at 3 months. Study 1 evaluated 355 mainly European (Belgium, France, Germany, Spain, South Africa, and Netherlands) patients (mean age 61.9; 67% White, 4% Black, 3% Asian, 26% Unknown). The mean baseline EF domain scores were 12 for vardenafil hydrochloride orally disintegrating tablets and 13 for placebo. Vardenafil 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 compared to 36% on placebo; p <0.0001). Vardenafil 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 compared to 23% on placebo; p <0.0001).

• Side effects can include headache, flushing, or stomach upset.
• Serious side effects are rare but require immediate medical attention.
• Vardenafil may cause changes in color vision.
• Use caution if using other medication for blood pressure.
• The medication helps improve erectile function temporarily.
• Do not share tablets with others.
• Follow storage instructions to maintain efficacy.
• Report any allergic reactions promptly.
• The drug should be used only under medical supervision.
• Used responsibly, vardenafil can improve quality of life.

Vardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose 10 and 20 mg vardenafil film-coated tablets, double-blind, placebo-controlled trial in postprostatectomy patients (n=427, mean age 60, range 44 to 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 and 15 on 20 mg vardenafil compared to 9 on placebo; p <0.0001).

What happens if the prescriber decides treatment is not suitable?

In both studies vardenafil hydrochloride orally disintegrating tablets demonstrated clinically meaningful and statistically significant improvements over placebo in all 3 primary efficacy variables (see Table 7). Table 7: Change from Baseline for the Primary Efficacy Variables in Studies 1 and 2 Vardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose [10 and 20 mg vardenafil film-coated tablets], double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33 to 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 and 19 on 20 mg vardenafil compared to 13 on placebo; p <0.0001). Vardenafil 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 compared to 36% on placebo; p <0.0001). Vardenafil 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 compared to 23% on placebo; p <0.0001).

Related Disease Conditions

Vardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose 10 and 20 mg vardenafil film-coated tablets, double-blind, placebo-controlled trial in postprostatectomy patients (n=427, mean age 60, range 44 to 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 and 15 on 20 mg vardenafil compared to 9 on placebo; p <0.0001).