Vardenafil 5 mg

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). 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 is classified as a PDE5 inhibitor, similar to sildenafil.
• It’s important to follow dosage instructions to avoid adverse effects.
• Recreational use of vardenafil without prescription is illegal in Canada.
• Vardenafil may interact with medications like nitrates and alpha-blockers.
• Pharmacists in Canada can provide guidance on vardenafil availability.
• Patients should inform their doctor of any health conditions before use.

Vardenafil hydrochloride orally disintegrating tablets, USP are packaged into blister packs and supplied as a 4 tablet unit.

Optimizing Vardenafil's Effectiveness: Timing and Lifestyle Tips

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 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). 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.

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The patient should be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing.

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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.

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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). 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). Significant improvements in the EF Domain were shown erectile dysfunction treatment 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). See FDA-approved patient labeling (Patient Information) Inform patients that vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil film-coated tablets (LEVITRA) as it provides higher systemic exposure.

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The plasma concentration of M1 is approximately 26% that of the parent compound. This metabolite shows a phosphodiesterase selectivity profile similar to that of vardenafil and an in vitro inhibitory potency for PDE5 28% of that of vardenafil. Therefore, M1 accounts for approximately 7% of total pharmacologic activity. Excretion The mean terminal half-life of vardenafil in patients receiving vardenafil hydrochloride orally disintegrating tablets varied between about 4 to 6 hours. The elimination half-life of the metabolite M1 is between 3 to 5 hours.

Potential Interactions: What to Watch Out For:

After oral administration, vardenafil is excreted as metabolites predominantly in the feces (approximately 91 to 95% of administered oral dose) and to a lesser extent in the urine (approximately 2 to 6% of administered oral dose). Vardenafil is a high clearance drug with a plasma clearance of 56.4 L/h following intravenous administration. Pediatrics Vardenafil hydrochloride orally premature ejaculation treatment disintegrating tablets are not indicated for use in pediatric patients. Vardenafil trials were not conducted in the pediatric population. Geriatrics Vardenafil AUC and Cmax in elderly patients (65 years or older) taking vardenafil hydrochloride orally disintegrating tablets were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below [see Use in Specific Populations (8.5)]. They should also discuss that the maximum dosage is one vardenafil hydrochloride orally disintegrating tablets tablet per 24 hours.

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Clinical trials for vardenafil hydrochloride orally disintegrating tablets were conducted without regard to meals. 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. In clinical trials, dosing was done without water. Vardenafil hydrochloride orally disintegrating tablets should be taken without liquid. Distribution The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution.

Chapter 38

Vardenafil and its major circulating metabolite, M1, are highly bound to plasma proteins (about 95% for parent drug and M1). This protein binding is reversible and independent of total drug concentrations. 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. Metabolism Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil. Discuss with patients that vardenafil hydrochloride orally disintegrating tablets are contraindicated with regular and/or intermittent use of organic nitrates.

• Vardenafil is sometimes used off-label for pulmonary arterial hypertension.
• Canadian clinics may offer testing and prescription for vardenafil.
• Always verify the legitimacy of the online store before purchasing.
• The drug’s patent status affects the availability of generics in Canada.
• Some men find vardenafil more suitable than other PDE5 inhibitors.
• Regular medical check-ups are advised during erectile dysfunction treatment.

Patients should be counseled that concomitant use of vardenafil with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

Status	Description	Enforcement Level	Notes
Prescription-Only	Requires valid prescription to buy legally	Strict	Prescribed for erectile dysfunction
Online Purchase	Limited to regulated online pharmacies	Moderate	Must verify pharmacy license
Import Laws	Personal import possible but regulated	Strict	Customs may seize unapproved imports

Inform patients that vardenafil hydrochloride orally disintegrating tablets are contraindicated in patients who use guanylate cyclase stimulators, such as riociguat.

Comparing Vardenafil and Levitra: Efficacy and Side Effects

Hepatic Impairment In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil (film-coated tablets) dose were increased by 22% and 17%, respectively, compared to healthy control subjects. Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment [see Dosage and Administration (2.3), Warnings and Precautions (5.8), and Use in Specific Populations (8.6).] Renal Impairment In volunteers with mild renal impairment (CLcr = 50 to 80 mL/min), the pharmacokinetics of vardenafil were similar to those observed in a control group with normal renal function. Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis [see Dosage and Administration (2.3), Warnings and Precautions (5.9), and Use in Specific Populations (8.7)]. 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.

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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. 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. 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. Discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors.

Year	Market Share (%)	Price Reduction (%)	Notable Brands	Regulatory Notes
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Concomitant Use with Drugs which Lower Blood Pressure Inform patients that in some patients concomitant use of PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).

Drug Class	Interaction Effect	Example Drugs	Caution Level
Nitrates	Severe hypotension	Nitroglycerin	High
Alpha-blockers	Increased risk of hypotension	Tamsulosin, Doxazosin	Moderate
CYP3A4 Inhibitors	Increased Vardenafil levels, side effects	Ketoconazole, Ritonavir	High