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 may cause visual disturbances in some users.
- Patients with liver or kidney problems should seek medical advice before use.
- Exercise caution if combining vardenafil with other medications.
- Do not use vardenafil if you are taking medications containing nitrates.
- In Canada, it’s illegal to sell vardenafil without a prescription.
- Always complete the prescribed course of vardenafil as directed.
In both pivotal studies, randomization was stratified so that approximately 50% of patients were ≥65 years old.
- 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.
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).
Final Words
The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil. 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.
Chapter 37
The elimination half-life of the metabolite M1 is between 3 to 5 hours. 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 disintegrating tablets are not indicated for use in pediatric patients. Vardenafil trials were not conducted in the pediatric population. The primary endpoints were assessed at 3 months.
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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).
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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%. 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.
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Distribution The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. 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 sex with tablet predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. The mean baseline EF domain scores were 13 for both placebo and vardenafil hydrochloride orally disintegrating tablets groups.
| Side Effect | Percentage of Users | Severity | Frequency |
|---|---|---|---|
| Headache | 15% | Mild | Common |
| Flushing | 10% | Mild | Common |
| Nasal Congestion | 8% | Mild | Moderate |
| Dizziness | 5% | Mild | Less common |
| Visual Disturbances | 3% | Mild to Moderate | Rare |
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).
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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)]. 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. The mean baseline EF domain scores were 12 for vardenafil hydrochloride orally disintegrating tablets and 13 for placebo.
Addressing Concerns and FAQs: Key Insights on Vardenafil
placebo: 380±108 and 334±108 seconds; 20 mg vardenafil vs. placebo: 364±101 and 366±105 seconds, respectively). Single oral doses of phosphodiesterase inhibitors have demonstrated transient dose-related impairment of color discrimination (blue/green) using the Farnsworth-Munsell 100-hue (FM-100) test and reductions in electroretinogram (ERG) b-wave amplitudes, with peak effects near the time of peak plasma levels. These findings are consistent with the inhibition of PDE6 in rods and cones, which is involved in phototransduction in the retina. The findings were most evident one hour after administration, diminishing but still present 6 hours after administration.
Factors Accelerating or Delaying Effectiveness:
In a single dose study in 25 normal males, vardenafil (film-coated tablets) 40 mg, twice the maximum daily recommended dose, did not alter visual acuity, intraocular pressure, fundoscopic and slit lamp findings. In another double-blind, placebo-controlled clinical trial, at least 15 doses of 20 mg vardenafil were administered over 8 weeks versus placebo to 52 males. Thirty-two (32) males (62% of the patients) completed the trial. Retinal function was measured by ERG and FM-100 test 2, 6 and 24 hours after dosing. The trial was designed to detect changes in retinal function that might occur in more than 10% of patients. 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).
The Mechanism of Action: How Vardenafil and Levitra Work
Vardenafil did not produce clinically significant ERG or FM-100 effects in healthy men compared to placebo. 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.
Chapter 89
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 The median time to reach Cmax (Tmax) in patients receiving vardenafil hydrochloride orally disintegrating tablets in the fasted state was 1.5 h [range: 0.75 to 2.5 h]. After administration of vardenafil hydrochloride orally disintegrating tablets to elderly (≥ 65 years) and young (18 to 45 years) patients with erectile dysfunction, mean vardenafil AUC was increased by 21 to 29%, respectively while mean Cmax was lower by 19% and 8%, respectively, in comparison to 10 mg vardenafil (film-coated tablets). In a study of healthy male volunteers (18 to 50 years), the mean Cmax and AUC of vardenafil from vardenafil hydrochloride orally fildena 100mg disintegrating tablets were higher by 15% and 44%, respectively compared to 10 mg vardenafil film-coated tablets. Vardenafil was not found to accumulate in plasma when vardenafil hydrochloride orally disintegrating tablets was dosed daily over ten days. Table 7: Change from Baseline for the Primary Efficacy Variables in Studies 1 and 2
| 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 |
Vardenafil demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose [10
Introduction to Vardenafil and Levitra
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 cenforce tablets 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). 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).
- Vardenafil is a prescription medication used to treat erectile dysfunction.
- It is available in Canada under various brand names like Levitra.
- Canadian pharmacies often offer vardenafil at lower prices than in the USA.
- Buying vardenafil in Canada requires a valid prescription from a licensed doctor.
- Vardenafil works by increasing blood flow to the penis during arousal.
- It typically starts working within 30 minutes and lasts up to 4-5 hours.
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