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. 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.

GPhC Regulated Pharmacy

Other Interactions

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 1 and 2).

Vardenafil 10 mg is one of several ED treatment options.
It is generally well-tolerated when used properly.
Take care to follow your healthcare provider’s instructions.
Possible interactions with antihypertensive drugs exist.
Do not drive or operate machinery if feeling dizzy.
Keep a record of any side effects experienced.
The medication is not a cure for erectile dysfunction.
Combining vardenafil with other ED drugs is dangerous.
Take the tablet with a full glass of water.
Consult your doctor for dose adjustments if needed.

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. 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 tadapox tablets 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.

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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).

5.7 Congenital or Acquired QT Prolongation

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).

5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors

Less common

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). Vardenafil demonstrated clinically meaningful and statistically significant improvement vardenafil cost 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 Medication Description

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). 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedVardenafil hydrochloride orally disintegrating tablets, USP 10 mg are white to off white, round, biconvex tablet debossed with “477” on one side and plain on other side.Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit.1 blister card containing 4 tablets NDC 62332-235-04In addition to the active ingredient, vardenafil, each tablet contains lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide, aspartame, citric acid monohydrate, NAT Peppermint FL WONF SD #491, sodium stearyl fumarate and magnesium stearate.16.2 Recommended StorageStore vardenafil hydrochloride orally disintegrating tablets, USP at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Vardenafil hydrochloride orally disintegrating tablets, USP are dispensed in blister packs. The patient should be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing. Vardenafil hydrochloride orally disintegrating tablets, USP 10 mg are white to off white, round, biconvex tablet debossed with “477” on one side and plain on other side. 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. 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).

16.2 Recommended Storage

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

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.

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How SuppliedVardenafil hydrochloride orally disintegrating tablets, USP 10 mg are white to off white, round, biconvex tablet debossed with “477” on one side and plain on other side.Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit.1 blister card containing 4 tablets NDC 62332-235-04In addition to the active ingredient, vardenafil, each tablet contains lactose monohydrate, silicified microcrystalline cellulose, crospovidone, colloidal silicon dioxide, aspartame, citric acid monohydrate, NAT Peppermint FL WONF SD #491, sodium stearyl fumarate and magnesium stearate.16.2 Recommended StorageStore vardenafil hydrochloride orally disintegrating tablets, USP at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Vardenafil hydrochloride orally disintegrating tablets, USP are dispensed in blister packs.

12.3 Pharmacokinetics

Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit. Store vardenafil hydrochloride orally disintegrating tablets, USP at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Vardenafil hydrochloride orally disintegrating tablets, USP are dispensed in blister packs. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information)Use with Other Formulations of VardenafilInform patients that vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA) as it provides higher systemic exposure. They should also discuss that the maximum dosage is one vardenafil hydrochloride orally disintegrating tablets tablet per 24 hours.NitratesDiscuss with patients that vardenafil hydrochloride orally disintegrating tablets are contraindicated with regular and/or intermittent use of organic nitrates.

How is vardenafil supplied (dosage forms)?

Erectile Dysfunction

The patient should be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing. Vardenafil hydrochloride orally disintegrating tablets, USP 10 mg are white to off white, round, biconvex tablet debossed with “477” on one side and plain on other side. Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit.

Vardenafil 10 mg tablets treat erectile dysfunction in men.
The medication works by increasing blood flow to the penis.
Take vardenafil 10 mg about 30 minutes before activity.
It can be taken with or without food, but high-fat meals may delay effects.
Maximum recommended dose is one tablet per 24 hours.
Vardenafil may cause side effects like headache or flushing.
Do not use vardenafil if you take nitrates for chest pain.
Consult a doctor before using vardenafil if you have heart problems.
Store vardenafil tablets at room temperature, away from moisture.
Alcohol can increase side effects of vardenafil.

Store vardenafil hydrochloride orally disintegrating tablets, USP at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Vardenafil 10 mg enhances natural erectile response.
The medication is prescription-only in most countries.
Common brand names include Levitra and Staxyn.
Do not crush or split the tablet unless instructed.
Using more than the prescribed dose can increase risk.
Vardenafil is a phosphodiesterase inhibitor.
It is not intended for use by women.
Possible side effects include nasal congestion and dizziness.
Seek medical advice if you experience priapism.
Keep out of reach of children.

Vardenafil hydrochloride orally disintegrating tablets, USP are dispensed in blister packs. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information)Use with Other Formulations of VardenafilInform patients that vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA) as it provides higher systemic exposure. They should also discuss that the maximum dosage is one vardenafil hydrochloride orally disintegrating tablets tablet per 24 hours.NitratesDiscuss with patients that vardenafil hydrochloride orally disintegrating tablets are contraindicated with regular and/or intermittent use of organic nitrates.

8.2 Lactation

RedBox Rx Reviews

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 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. 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 tadapox tablets with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful intercourse (SEP3).

What should I tell my healthcare provider before taking vardenafil?

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).

Mit Fernheiler Hans-Ulrich BURKHARD

10 OVERDOSAGE