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Vilitra ( Vardenafil )
Vilitra is a brand of vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction in adult men. It works by relaxing blood vessels in the penis and increasing blood flow, but only when you are sexually stimulated. Vilitra is available in 10 mg, 20 mg, 40 mg, and 60 mg tablets; however, the standard recommended starting dose is 10 mg taken 25 to 60 minutes before sexual activity, with a maximum recommended dose of 20 mg once daily. Note that vardenafil is sold in Canada under other brand names, such as Levitra and Mylan-Vardenafil, and the 40 mg and 60 mg strengths are not standard approved doses in Canada. Always follow your doctor or pharmacist's instructions.
Buy Vilitra (Vardenafil) without prescription in Canada
Vilitra (Vardenafil 10 mg, 20 mg, 40 mg, 60 mg): Comprehensive Patient Information for Canada
Basic Product Information
| Generic Name (INN) | Vardenafil (as vardenafil hydrochloride trihydrate) |
| Canadian Brand Names / Trade Names | Levitra (brand name no longer sold in Canada); generic vardenafil available as MYLAN-VARDENAFIL, JAMP-VARDENAFIL, JAMP-VARDENAFIL ODT, AG-VARDENAFIL, SANIS VARDENAFIL, and other generic formulations. Vilitra is a brand name used in some international markets. |
| ATC Code | G04BE09 |
| Available Dosage Forms and Strengths | Film-coated tablets: 5 mg, 10 mg, and 20 mg (standard approved strengths in Canada). Orally disintegrating tablets (ODT): 10 mg. Note: 40 mg and 60 mg strengths are not standard approved doses in Canada and are not recommended. |
| Manufacturers | Mylan Pharmaceuticals ULC, Jamp Pharma, Sanis Health Inc., and other generic manufacturers in Canada |
| Prescription Status | Prescription only in Canada |
Mechanism of Action
In simple terms: Vardenafil is a medication used to treat erectile dysfunction (ED). It works by increasing blood flow to the penis during sexual stimulation. When you become sexually aroused, your body releases a natural chemical called nitric oxide, which triggers a series of events that relax the blood vessels in the penis and allow more blood to flow in, creating an erection. Vardenafil helps this process by blocking an enzyme called PDE5 that normally breaks down the chemical responsible for keeping those blood vessels relaxed. Vardenafil will only help you get an erection if you are sexually stimulated.
For specialists: Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), the predominant PDE in the human corpus cavernosum. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells, activating guanylate cyclase and increasing cGMP synthesis. cGMP triggers smooth muscle relaxation, allowing increased blood flow into the penis and resulting in erection. Vardenafil inhibits PDE5, thereby increasing cGMP levels and enhancing erectile function. Because sexual stimulation is required to initiate the local release of nitric oxide, PDE5 inhibition has no effect in the absence of sexual stimulation. In vitro studies have shown that vardenafil is more selective for PDE5 than for other known phosphodiesterases, with greater than 15-fold selectivity relative to PDE6, greater than 130-fold relative to PDE1, greater than 300-fold relative to PDE11, and greater than 1,000-fold relative to PDE2, 3, 4, 7, 8, 9, and 10.
Pharmacokinetics
- Absorption: Vardenafil is rapidly absorbed after oral administration, with peak plasma concentrations reached in approximately 30 to 120 minutes (median approximately 60 minutes) in the fasting state. The absolute bioavailability is approximately 15%. The pharmacokinetics are approximately dose proportional over the recommended dose range. A high-fat meal reduces peak plasma concentration and delays time to peak concentration.
- Metabolism: Vardenafil is eliminated predominantly by hepatic metabolism, mainly by CYP3A4 and to a minor extent by CYP3A5 and CYP2C isoforms. The primary circulating metabolite (M1) is formed by CYP3A4 and has approximately 28% of the PDE5 inhibitory activity of vardenafil.
- Elimination: The total body clearance of vardenafil is 56 L/h. The terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4 to 5 hours. Approximately 91 to 95% of vardenafil and M1 are bound to plasma proteins.
- Onset of Action: Vardenafil typically takes effect within 25 to 60 minutes after administration. Some patients may respond as early as 15 to 30 minutes.
- Duration of Action: The duration of action is approximately 4 to 6 hours.
Uses in Daily Life and Best Practice Advice
Vardenafil is prescribed in Canada for the treatment of erectile dysfunction. Your physician will determine the appropriate dose and use based on your specific medical situation.
- Typical Uses: Treatment of erectile dysfunction in adult men. Vardenafil has also been studied in the management of ureteral stent-related symptoms, showing promising results in controlling these symptoms and potentially serving as an alternative or adjunct medication to tamsulosin.
- Administration: Take vardenafil orally approximately 25 to 60 minutes before sexual activity. The maximum recommended dosing frequency is once per day. Vardenafil may be taken with or without food, but a high-fat meal may reduce its effectiveness.
- Monitoring: No routine laboratory monitoring is required. Your physician will assess your response to treatment and adjust the dose if necessary.
- Do Not Use Without Sexual Stimulation: Vardenafil will only help you get an erection if you are sexually stimulated. It does not cause spontaneous erections and does not affect libido.
Morning vs. Evening Dosing
Vardenafil is taken as needed, approximately 25 to 60 minutes before sexual activity. There is no specific recommendation for morning versus evening dosing. Choose a time that is convenient for you and allows sufficient time for the medication to take effect. Always follow the guidance of your physician.
- As-Needed Use: Vardenafil is not taken on a fixed daily schedule. It is taken when sexual activity is anticipated.
- Consistency: The maximum recommended dosing frequency is once per day. Do not take more than one dose in a 24-hour period.
- Missed Dose: Vardenafil is taken as needed, so missed-dose schedules do not apply. Take it only when you plan to have sexual activity.
- Professional Guidance: Your healthcare provider may adjust the timing based on your response and any other medications you are taking.
Administration With or Without Food
Vardenafil may be taken with or without food. However, a high-fat meal can reduce the peak plasma concentration and delay the time to peak concentration, which may reduce the effectiveness of the medication. For best results, avoid taking vardenafil after a heavy, high-fat meal.
- Take vardenafil with a full glass of water.
- Avoid high-fat meals before taking vardenafil, as they may reduce its effectiveness.
- Do not crush, chew, or split the tablet unless directed by your physician or pharmacist. For orally disintegrating tablets, follow the specific instructions provided with the product.
- Avoid drinking grapefruit juice during treatment, as it may increase vardenafil levels in the blood and cause unpredictable side effects.
Interaction Warnings
| Interaction | Advice |
|---|---|
| Nitrates (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate) | Contraindicated. Concomitant use can cause a dangerous, potentially life-threatening drop in blood pressure. Do not use vardenafil if you are taking any nitrate medication. |
| Guanylate Cyclase Stimulators (e.g., riociguat) | Contraindicated. Concurrent use with PDE5 inhibitors, including vardenafil, is contraindicated due to additive blood pressure-lowering effects. |
| Alpha-Blockers (e.g., tamsulosin, alfuzosin, doxazosin) | May cause symptomatic hypotension in some patients. In patients on stable alpha-blocker therapy, the recommended starting dose of vardenafil is 5 mg. Use with caution and under medical supervision. |
| Strong CYP3A4 Inhibitors (e.g., ritonavir, indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin, cobicistat) | Significant increases in vardenafil plasma levels. Dose adjustments are required. For ritonavir and cobicistat, no more than 2.5 mg in a 72-hour period. For other strong inhibitors, no more than 2.5 mg in a 24-hour period. |
| Moderate CYP3A4 Inhibitors (e.g., erythromycin, ketoconazole 200 mg daily, itraconazole 200 mg daily) | Increased vardenafil plasma levels. Dose adjustment is required. No more than 5 mg in a 24-hour period. |
| Other Erectile Dysfunction Therapies | Combination with other PDE5 inhibitors or other ED treatments is not recommended. Safety and efficacy of combination therapy have not been established. |
| Grapefruit Juice | Avoid grapefruit and grapefruit juice during treatment. Grapefruit can increase vardenafil levels in the blood and cause unpredictable side effects. |
| Alcohol | Avoid excessive alcohol consumption. Alcohol may increase the risk of dizziness and low blood pressure. |
Indications for Vardenafil
| Condition | Status |
|---|---|
| Erectile dysfunction | Approved (Health Canada) |
| Ureteral stent-related symptoms | Off-label / Under investigation; has shown promising results in clinical studies |
"Off-label" means use outside the official approved indication, usually based on current medical guidelines and scientific evidence.
Dosing According to Clinical Indication
| Indication | Standard Approved Doses (Canada) | Special Populations |
|---|---|---|
| Erectile dysfunction (general) | Starting dose: 10 mg, taken as needed approximately 25–60 minutes before sexual activity. May be increased to 20 mg or decreased to 5 mg based on efficacy and tolerability. Maximum: one dose per day. | Patients ≥65 years: consider starting dose of 5 mg. Patients on stable alpha-blocker therapy: starting dose of 5 mg. Patients with moderate hepatic impairment (Child-Pugh B): starting dose of 5 mg, maximum 10 mg. |
| Erectile dysfunction (with CYP3A4 inhibitors) | Ritonavir or cobicistat: no more than 2.5 mg in a 72-hour period. Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: no more than 2.5 mg in a 24-hour period. Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: no more than 5 mg in a 24-hour period. | Close monitoring is recommended. |
| Vilitra 40 mg and 60 mg | Not approved in Canada. These strengths are not standard approved doses. Clinical studies with 40 mg once daily for 4 weeks have been conducted, but 40 mg twice daily was associated with severe back pain. The maximum recommended dose is 20 mg once daily. Do not exceed the recommended dose. | Not applicable. |
Doses should always be adjusted according to the advice of your physician and depending on your health condition. Do not exceed the maximum recommended dose of 20 mg once daily.
Side Effects and Safety Profile
| Common (>10%) | Occasional (1–10%) | Rare / Serious (<1%) | Warnings |
|---|---|---|---|
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Guidelines for Correct Use
- Take vardenafil exactly as prescribed by your physician. Do not change your dose without medical advice.
- Take the tablet approximately 25 to 60 minutes before sexual activity. The maximum recommended dosing frequency is once per day.
- Swallow the tablet whole with water. For orally disintegrating tablets, follow the specific instructions provided with the product.
- Do not take vardenafil more than once per day.
- Do not use vardenafil if you are taking nitrates or guanylate cyclase stimulators.
- Avoid drinking grapefruit juice during treatment.
- Avoid excessive alcohol consumption.
- Inform every healthcare provider (including dentists, surgeons, and pharmacists) that you are taking vardenafil.
- Seek immediate medical attention if you experience an erection lasting more than 4 hours, sudden vision loss, or sudden hearing loss.
- If you are pregnant, planning to become pregnant, or breastfeeding, vardenafil is not indicated for use in women. Consult your physician for alternative options.
- Keep out of reach of children. Store at room temperature in a dry place.
Alternative Treatment Options
- Sildenafil (Viagra, generic): Another PDE5 inhibitor taken as needed. Onset of action is approximately 30 to 60 minutes. Duration of action is approximately 4 hours. Available in generic form in Canada and widely covered.
- Tadalafil (Cialis, generic): A longer-acting PDE5 inhibitor available in both as-needed and once-daily dosing. Duration of action is up to 36 hours. Available in generic form in Canada.
- Avanafil (Stendra): A newer PDE5 inhibitor with a faster onset of action (as early as 15 minutes). Available by prescription in Canada.
- Alprostadil: Available as an injectable or intraurethral suppository for men who do not respond to oral PDE5 inhibitors. Requires medical supervision.
- Testosterone Replacement Therapy: For men with documented hypogonadism, testosterone replacement may improve erectile function, particularly when combined with a PDE5 inhibitor.
- Vacuum Erection Devices and Penile Implants: Mechanical and surgical options for men who cannot take or do not respond to oral medications.
Comparison: Vardenafil is similar in efficacy to sildenafil and tadalafil. It has a slightly faster onset than sildenafil in some patients and is available as an orally disintegrating tablet, which may be convenient for some users. However, vardenafil is generally not covered by provincial drug plans for erectile dysfunction, and generic vardenafil may be more difficult to find and more expensive than generic sildenafil or tadalafil. Your physician will determine the best option for your specific needs and health status.
Legal Status, Registration, and Coverage in Canada
- Registration: Vardenafil is authorized for sale in Canada by Health Canada as a prescription drug. Generic vardenafil products are available from multiple manufacturers. The brand name Levitra is no longer sold in Canada, but generic vardenafil provides the same active ingredient, dosage, and therapeutic effects.
- Prescription Status: Prescription only in Canada.
- Coverage: Erectile dysfunction medications, including vardenafil, are not covered under the Ontario Drug Benefit (ODB) formulary. Coverage varies by province, territory, and private insurance plan. Generic vardenafil may be more affordable than brand-name products but is generally not covered by public drug plans for ED.
- Pharmacovigilance: Adverse reactions should be reported to Health Canada's MedEffect Canada program.
Recent Research and Clinical Guidelines (2022–2026)
- The American Urological Association (AUA) guideline (2018, reaffirmed 2025) and the European Association of Urology (EAU) 2026 guideline continue to recommend PDE5 inhibitors, including vardenafil, as first-line therapy for erectile dysfunction.
- A 2025 prospective comparative study evaluated vardenafil and tamsulosin in the management of ureteral stent-related symptoms. Vardenafil showed promising results in controlling stent-related symptoms and can be considered an alternative or adjunct medication to tamsulosin.
- A 2025 clinical proof-of-concept study is examining the combination of BAY60-4552 plus vardenafil for the treatment of erectile dysfunction in patients who are not sufficiently responsive to standard PDE5 inhibitor therapy.
- The PARTNER II study (2025) is a randomized, double-blind, parallel-group study of flexible-dose vardenafil versus placebo in males with erectile dysfunction and their female partners' sexual quality of life.
- Research has shown that vardenafil improves satisfaction rates, reduces depressive symptomatology, and improves self-confidence in men with erectile dysfunction compared with placebo.
Availability and Supply in Canada
| Packaging Format | Typical Price (CAD, per unit) | Availability |
|---|---|---|
| Vardenafil 10 mg tablet (generic) | Approximately $4–$15 per tablet | Available at pharmacies across Canada; prescription required |
| Vardenafil 20 mg tablet (generic) | Approximately $4–$15 per tablet | Available at pharmacies; multiple generic manufacturers |
| Vardenafil orally disintegrating tablets (ODT), 10 mg | Approximately $6–$17 per tablet | Available at pharmacies; prescription required |
| Vilitra 10 mg, 20 mg, 40 mg, 60 mg | Not applicable (not approved in Canada) | Not available through Canadian pharmacies. International sources may offer these strengths, but they are not approved for sale in Canada. |
Vardenafil costs between $28 and $50 CAD per month in Canada. The cheapest option is Costco at approximately $24.00 per month. A supply shortage of JAMP-VARDENAFIL was reported in April 2026 due to a disruption in the manufacture of the drug, with an estimated end date of October 2026. Prices and availability may vary by province, territory, and pharmacy. Check with your local pharmacy for current information.
Frequently Asked Questions (FAQ)
- What is the difference between the 10 mg and 20 mg doses of vardenafil?
The 10 mg dose is the recommended starting dose for most patients. The 20 mg dose is the maximum recommended dose and may be used if the 10 mg dose is not effective and is well tolerated. Your physician will determine the appropriate dose for you based on your response and any side effects you experience. - Is Vilitra 40 mg or 60 mg available in Canada?
No. Vilitra 40 mg and 60 mg strengths are not approved for sale in Canada. The maximum approved dose of vardenafil in Canada is 20 mg once daily. Do not use unapproved strengths or purchase vardenafil from unregulated sources. - How long does vardenafil take to work?
Vardenafil typically takes effect within 25 to 60 minutes after administration. Some patients may respond as early as 15 to 30 minutes. The medication will only help you get an erection if you are sexually stimulated. - Can I take vardenafil with food?
Yes, vardenafil may be taken with or without food. However, a high-fat meal may reduce its effectiveness. For best results, avoid taking vardenafil after a heavy, high-fat meal. - What should I do if I miss a dose of vardenafil?
Vardenafil is taken as needed, so missed-dose schedules do not apply. Take it only when you plan to have sexual activity. Do not take more than one dose in a 24-hour period. - Can I drink alcohol while taking vardenafil?
Moderate alcohol consumption is generally acceptable, but excessive alcohol use can increase the risk of dizziness and low blood pressure and should be avoided. - What are the signs of a serious side effect I should watch for?
Seek immediate medical attention if you experience an erection lasting more than 4 hours, sudden loss of vision in one or both eyes, sudden decrease or loss in hearing, or severe chest pain. These may be signs of a serious adverse event. - Is vardenafil covered by Canadian health insurance?
Erectile dysfunction medications, including vardenafil, are generally not covered by provincial drug plans. Some private insurance plans may provide partial coverage. Check with your insurance provider for details.
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