Generic Vardenafil

Vardenafil
Vardenafil is used to treat erectile dysfunction, which is a man's inability to maintain an erection. It works by relaxing muscles in the penis, allowing more blood to flow to it. The active ingredient in Levitra is vardenafil. The medication was first made available in 2003, and in the United States, you can only obtain it with a prescription. Levitra is taken on an as-needed basis, about one hour before you want to have sex. Alcohol and grapefruit should be avoided when taking this medication as they can produce severe side effects.
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Buy Generic Vardenafil () without prescription in Canada

In our Canadian pharmacy, you can buy Vardenafil without a prescription, with delivery across Canada within 5‑14 days. Discreet and anonymous packaging.

Vardenafil is a potent oral phosphodiesterase type 5 (PDE5) inhibitor used for the treatment of erectile dysfunction (ED). It works by relaxing the smooth muscles of the penile arteries and corpus cavernosum, increasing blood flow to the penis during sexual stimulation and thereby helping to produce and maintain an erection sufficient for satisfactory sexual activity. Vardenafil is the active ingredient originally marketed under the brand name Levitra®; it is now available as a cost‑effective generic in Canada in the standard 10 mg and 20 mg strengths. Higher strengths of 40 mg and 60 mg are not approved by Health Canada but are accessible internationally through our pharmacy for patients who have been specifically prescribed these doses by a specialist.

Usual adult dose: The recommended starting dose is 10 mg taken orally as needed, approximately 25 to 60 minutes before anticipated sexual activity. Depending on efficacy and tolerability, the dose may be increased to a maximum of 20 mg or decreased to 5 mg (using a scored tablet). The maximum dosing frequency is once daily. Doses above 20 mg (40 mg and 60 mg) are not routinely recommended and are used only under specialist direction for patients who have shown an inadequate response to the 20 mg dose and who tolerate the medication well. Sexual stimulation is required for an erection to occur.

Dosage form: Oral film‑coated tablets: 10 mg and 20 mg (Canadian‑approved strengths); 40 mg and 60 mg (internationally sourced generic strengths available through our pharmacy). An orally disintegrating tablet is also available in 10 mg strength.

Onset of action: Vardenafil is rapidly absorbed, with peak plasma concentrations reached within 30 to 120 minutes (median 60 minutes) under fasting conditions. Some men may notice an effect in as little as 15 to 25 minutes. A high‑fat meal may delay absorption, so taking it on an empty stomach or after a light meal provides the fastest onset.

Duration of action: The therapeutic effect for ED persists for approximately 4 to 6 hours after a single dose. The elimination half‑life of vardenafil is about 4 to 5 hours.

Alcohol recommendation: Alcohol consumption should be limited or avoided while taking Vardenafil. Drinking alcohol can temporarily reduce the ability to get an erection and may increase the risk of side effects such as headache, dizziness, flushing, and orthostatic hypotension. Heavy alcohol intake is particularly discouraged, especially at higher doses.

Most common side effects: Headache (up to 15%), flushing (up to 11%), dyspepsia (indigestion, up to 4%), nasal congestion (up to 10%), dizziness (up to 2%), and nausea. These effects are generally mild to moderate and temporary. At higher doses, the incidence and severity of these effects increase. Rare but serious side effects include priapism (a prolonged, painful erection lasting more than 4 hours), sudden vision loss (non‑arteritic anterior ischaemic optic neuropathy, NAION), and sudden hearing loss.

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General Information about Vardenafil

  • INN (International Nonproprietary Name): Vardenafil (as vardenafil hydrochloride trihydrate).
  • Brand names available in Canada: Levitra® (Bayer Inc.) is the original brand‑name product. Generic versions are widely available and include APO‑Vardenafil (Apotex Inc.), TEVA‑Vardenafil (Teva Canada Limited), Sandoz Vardenafil (Sandoz Canada Inc.), and others. The 40 mg and 60 mg strengths are not marketed in Canada and are obtained internationally through our pharmacy.
  • ATC code: G04BE09 (urologicals, drugs used in erectile dysfunction).
  • Dosage forms and strengths: Oral film‑coated tablets: 10 mg and 20 mg (Canadian‑approved); 40 mg and 60 mg (internationally sourced). Orally disintegrating tablet: 10 mg.
  • Manufacturers in Canada: Bayer Inc. (Levitra), Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., and other generic manufacturers. Higher strengths are manufactured internationally and imported for personal use.
  • Registration status in Canada: Approved by Health Canada for the 10 mg and 20 mg film‑coated tablets and the 10 mg orally disintegrating tablet (DINs: 02247836, 02247837, 02247838, 02247839, 02307224). The 40 mg and 60 mg strengths are not approved by Health Canada but are available internationally; our pharmacy supplies them through the international supply chain for personal importation.
  • OTC / Rx classification: Prescription only (Rx). Vardenafil is a Schedule I drug under the Controlled Drugs and Substances Act. It requires a valid prescription from a licensed Canadian healthcare professional. Our pharmacy fulfills this prescription for both Canadian‑approved and internationally sourced products.

Mechanism of Action and Pharmacology

Vardenafil is a potent, selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)‑specific phosphodiesterase type 5 (PDE5). During sexual stimulation, nitric oxide (NO) is released from nerve endings and endothelial cells in the corpus cavernosum of the penis. NO activates guanylate cyclase, which increases intracellular cGMP concentrations, leading to relaxation of the smooth muscle of the penile arteries and corpus cavernosum, thereby allowing blood to flow in and produce an erection. PDE5 normally degrades cGMP; by inhibiting PDE5, vardenafil allows cGMP to accumulate and persist, enhancing and prolonging the erectile response. Vardenafil is approximately 15‑fold more potent in vitro than sildenafil at inhibiting PDE5, which accounts for its lower effective milligram dose. Vardenafil also inhibits PDE6 (found in the retina) but with a selectivity margin that generally results in a low incidence of visual disturbances. Unlike tadalafil, vardenafil does not significantly inhibit PDE11, an enzyme found in skeletal muscle and the testes, which may contribute to its different side‑effect profile.

Vardenafil is rapidly absorbed after oral administration, with peak plasma concentrations achieved at a median of 60 minutes (range 30‑120 minutes) under fasting conditions. The absolute bioavailability is approximately 15%. A high‑fat meal reduces the peak concentration by 18‑50% and delays the time to peak concentration by about 1 hour; therefore, to achieve the fastest onset, it should be taken on an empty stomach or after a light meal. Vardenafil is metabolized predominantly by the cytochrome P450 3A4 (CYP3A4) enzyme, with minor contributions from CYP3A5 and CYP2C9. The major circulating metabolite, M1, is formed by desethylation and contributes approximately 7% of the pharmacologic activity. The elimination half‑life of vardenafil is approximately 4 to 5 hours. Vardenafil and its metabolites are excreted primarily in the faeces (approximately 91‑95%) and to a lesser extent in the urine. At higher doses (40 mg, 60 mg), systemic exposure increases in a dose‑proportional manner, but the incidence and severity of adverse effects, including headache, flushing, and hypotension, also increase. These doses are used only under specialist monitoring.

Indications

  • Erectile Dysfunction (ED): Vardenafil is indicated for the treatment of erectile dysfunction in adult men, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. Vardenafil is effective across a broad range of ED aetiologies, including organic, psychogenic, and mixed causes. It is active only in the presence of sexual stimulation.
  • Vardenafil is not indicated for the treatment of benign prostatic hyperplasia (BPH), pulmonary arterial hypertension (PAH), or any condition other than ED.
  • Not indicated for use in women or in children and adolescents under 18 years of age.

Important Warnings and Precautions

At‑risk groups

  • Pregnancy and breastfeeding: Vardenafil is not indicated for use by women. There are no adequate and well‑controlled studies of vardenafil in pregnant or breastfeeding women.
  • Paediatrics (< 18 years): Vardenafil is not approved for use in children or adolescents for the treatment of ED.
  • Elderly (≥ 65 years): No dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the vasodilatory effects of vardenafil, and the risk of orthostatic hypotension may be increased. A starting dose of 5 mg may be considered. Higher doses should be used with caution.
  • Cardiovascular disease: Sexual activity carries a degree of cardiac risk for patients with pre‑existing cardiovascular disease. Vardenafil has vasodilatory properties and can cause mild and transient decreases in blood pressure. It is contraindicated in patients with severe cardiovascular disease, including unstable angina, severe heart failure, and recent myocardial infarction or stroke (within the last 6 months).
  • Use with nitrates: Vardenafil potentiates the hypotensive effects of nitrates and nitric oxide donors (e.g., nitroglycerin, isosorbide mononitrate, amyl nitrate). Concomitant use is absolutely contraindicated and can lead to a life‑threatening drop in blood pressure. This applies to all doses, including higher doses.
  • Use with guanylate cyclase stimulators: Concomitant use of vardenafil with riociguat (Adempas®) is contraindicated due to the risk of severe hypotension.
  • Priapism: Prolonged erection (longer than 4 hours) has been reported rarely with PDE5 inhibitors. This is a medical emergency that can lead to permanent penile tissue damage and impotence. Men who experience an erection lasting more than 4 hours should seek immediate medical attention. The risk may increase with higher doses.
  • Vision loss: Non‑arteritic anterior ischaemic optic neuropathy (NAION), a cause of sudden vision loss, has been reported rarely in temporal association with PDE5 inhibitor use. The risk may be increased in patients with a small cup‑to‑disc ratio, those with hypertension or diabetes, and smokers. Men who experience sudden vision loss should stop taking the drug and seek immediate medical care.
  • Hearing loss: Sudden decrease or loss of hearing has been reported. Patients should discontinue vardenafil and seek prompt medical attention if this occurs.
  • Renal impairment: No dose adjustment is required in patients with mild, moderate, or severe renal impairment. Vardenafil has not been studied in patients on dialysis.
  • Hepatic impairment: In patients with mild hepatic impairment (Child‑Pugh A), no dose adjustment is required; the recommended starting dose is 10 mg. In moderate hepatic impairment (Child‑Pugh B), the starting dose is 5 mg, and the maximum dose is 10 mg. Vardenafil is contraindicated in patients with severe hepatic impairment (Child‑Pugh C). Higher doses (40 mg, 60 mg) should not be used in any degree of hepatic impairment.
  • QT prolongation: Vardenafil may cause small, clinically insignificant increases in the QT interval. It should be used with caution in patients with congenital long QT syndrome, those taking Class IA or III antiarrhythmics, and those with conditions predisposing to arrhythmias. Higher doses may increase this risk.
  • Alpha‑blockers: Concomitant use of vardenafil with alpha‑adrenergic blocking agents (e.g., tamsulosin, doxazosin, terazosin, alfuzosin) may lead to additive vasodilation and symptomatic hypotension. When vardenafil is prescribed to patients taking alpha‑blockers, the patient should be stable on alpha‑blocker therapy before initiating vardenafil, and vardenafil should be started at the lowest recommended dose of 5 mg. Higher doses increase this risk significantly. The concomitant use of vardenafil with alpha‑blockers is not recommended for patients with cardiovascular disease or in the elderly.
  • Anatomical deformation of the penis: Use with caution in patients with anatomical deformation (e.g., Peyronie’s disease, angulation, cavernosal fibrosis) or conditions predisposing to priapism (e.g., sickle cell anaemia, multiple myeloma, leukaemia).
  • Allergy: Do not take Vardenafil if you have a known hypersensitivity to vardenafil hydrochloride or any of the tablet’s excipients.

Driving and alcohol

Vardenafil may cause dizziness, blurred vision, or fatigue. Patients should be aware of how they react to the medication before driving or operating heavy machinery. Alcohol consumption should be limited, as it may impair the ability to achieve an erection, lower blood pressure, and increase the risk of side effects such as headache, dizziness, and orthostatic hypotension. Heavy alcohol intake is particularly discouraged with vardenafil, especially at higher doses.

Dosage Instructions

  • Erectile Dysfunction — As‑Needed Use: The recommended starting dose is 10 mg taken orally as needed, approximately 25 to 60 minutes before anticipated sexual activity. Based on individual efficacy and tolerability, the dose may be increased to a maximum of 20 mg or decreased to 5 mg. The maximum dosing frequency is once daily. Doses above 20 mg (40 mg, 60 mg) are not recommended by Health Canada and are used only under specialist direction for patients who have demonstrated an inadequate response to 20 mg and who have been carefully assessed for tolerability. These higher doses should be taken as a single dose, not exceeding once daily.
  • Elderly patients (≥ 65 years): Consider a starting dose of 5 mg. The maximum recommended dose for elderly patients is 20 mg; higher doses should be used with extreme caution, if at all.
  • Hepatic impairment: In mild hepatic impairment (Child‑Pugh A), the starting dose is 10 mg, with a maximum of 20 mg. In moderate impairment (Child‑Pugh B), the starting dose is 5 mg, with a maximum of 10 mg. Vardenafil is contraindicated in severe hepatic impairment (Child‑Pugh C).
  • Concomitant use with CYP3A4 inhibitors: For patients taking moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, fluconazole), the starting dose of vardenafil should not exceed 5 mg, and the maximum dose is 10 mg. For potent CYP3A4 inhibitors (e.g., ritonavir, indinavir, ketoconazole, itraconazole), vardenafil is contraindicated at the 10 mg, 20 mg, and higher doses; the only approved dose when taken with ritonavir is 2.5 mg once daily (as the orally disintegrating tablet) or 2.5 mg film‑coated tablet, and not more than once every 72 hours. Higher doses of vardenafil (40 mg, 60 mg) must not be taken with any CYP3A4 inhibitor.
  • Administration: Swallow the tablet whole with a glass of water. Vardenafil may be taken with or without food; however, a high‑fat meal may delay the onset of action. For the fastest effect, take on an empty stomach. The orally disintegrating tablet should be placed on the tongue and allowed to dissolve; it should not be taken with liquid. Do not take more than one dose per day. Tablets are not scored and should not be split unless under the direct instruction of a pharmacist or physician.
  • Missed dose: Vardenafil is taken as needed, not on a fixed daily schedule, so a missed dose is not applicable.

Side Effects and Contraindications

  • Very common side effects (≥ 10%): Headache (up to 15%).
  • Common side effects (1‑10%): Flushing (11%), nasal congestion (10%), dyspepsia (up to 4%), dizziness (up to 2%), nausea, and back pain. At doses above 20 mg, the frequency and severity of headache, flushing, and nasal congestion increase; hypotension and visual disturbances may also be more prominent.
  • Uncommon but serious side effects: Priapism (prolonged, painful erection lasting more than 4 hours), sudden vision loss (NAION), sudden decrease or loss of hearing, and serious cardiovascular events (myocardial infarction, stroke, ventricular arrhythmia) occurring in temporal association with sexual activity and vardenafil use. Hypotension and syncope have also been reported, particularly with higher doses or in patients taking concomitant antihypertensives or alpha‑blockers. QT prolongation may occur, especially in patients with risk factors or at higher doses.
  • Post‑marketing experience: Hypersensitivity reactions including Stevens‑Johnson syndrome, exfoliative dermatitis, and angioedema have been reported rarely. Cases of priapism and prolonged erections have been observed.
  • Contraindications: Concomitant use of organic nitrates in any form (e.g., nitroglycerin, isosorbide mononitrate) or nitric oxide donors (e.g., amyl nitrite). Concomitant use of riociguat (a guanylate cyclase stimulator). Known hypersensitivity to vardenafil or any component of the product. Severe cardiovascular disease or conditions in which sexual activity is inadvisable. Recent myocardial infarction (within 6 months) or stroke. Severe hepatic impairment (Child‑Pugh C). Concomitant use with potent CYP3A4 inhibitors (e.g., ritonavir, indinavir, ketoconazole, itraconazole) at doses above 2.5 mg once daily. The contraindications apply regardless of the dose strength.

Drug Interactions

  • Nitrates and nitric oxide donors — contraindicated: Co‑administration with any organic nitrate or nitrite is absolutely contraindicated because it can cause profound hypotension that may result in fainting, shock, or death. If a patient taking vardenafil requires emergency nitrate administration for angina, at least 24 hours should elapse after the last dose of vardenafil (though the manufacturer recommends a longer interval for higher doses). Nitrates should be administered only under close medical supervision with appropriate haemodynamic monitoring.
  • Guanylate cyclase stimulators — contraindicated: Riociguat (Adempas®) should not be co‑administered with vardenafil due to the risk of additive hypotensive effects.
  • Alpha‑blockers: Concomitant use may lead to additive vasodilation and symptomatic hypotension. Vardenafil should be initiated at 5 mg in patients stable on alpha‑blocker therapy, and the combination is not recommended in patients with cardiovascular disease or in the elderly. Higher doses of vardenafil increase this risk and should generally be avoided.
  • Potent CYP3A4 inhibitors: Ritonavir, indinavir, saquinavir, ketoconazole, itraconazole, and other potent CYP3A4 inhibitors significantly increase vardenafil plasma levels. With ritonavir, the maximum vardenafil dose is 2.5 mg once every 72 hours. With other potent inhibitors, vardenafil doses above 2.5 mg are not recommended. Higher vardenafil doses (10 mg, 20 mg, 40 mg, 60 mg) must not be combined with any potent CYP3A4 inhibitor.
  • Moderate CYP3A4 inhibitors: Erythromycin, clarithromycin, and fluconazole increase vardenafil exposure. The starting dose of vardenafil should not exceed 5 mg, and the maximum dose is 10 mg. Higher doses should be avoided.
  • Antihypertensives: Vardenafil may produce additive blood‑pressure‑lowering effects. Most patients tolerate this combination without significant adverse effects; however, those with pre‑existing hypotension should be cautious, and higher vardenafil doses may increase the risk.
  • Alcohol: Alcohol may increase the risk of headache, dizziness, and hypotension. Patients taking higher vardenafil doses should be particularly cautious about alcohol consumption. Heavy alcohol intake (e.g., five or more drinks) may increase the risk of orthostatic hypotension.
  • Grapefruit juice: Grapefruit juice is a weak CYP3A4 inhibitor; no dose adjustment is required, but it should be consumed in moderation, especially at higher vardenafil doses.

Practical Advice

  • Administration: Take Vardenafil exactly as prescribed by your doctor. Swallow the tablet whole with a glass of water. For the fastest onset, take on an empty stomach approximately 25 to 60 minutes before sexual activity. If you are prescribed an orally disintegrating tablet, place it on the tongue and let it dissolve without water. Do not take more than one dose per day. If you are prescribed a higher dose (40 mg or 60 mg), follow your specialist’s instructions precisely, and do not take this dose more than once daily. Sexual stimulation is required for vardenafil to be effective.
  • Monitoring: No routine laboratory monitoring is required. Men with underlying cardiovascular risk factors should have a medical evaluation before starting treatment for ED, especially if a dose higher than 20 mg is being considered. If you experience chest pain during sexual activity, stop immediately and seek medical attention. Monitor for any visual or hearing changes, and report them to your doctor promptly.
  • Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and heat. Keep the orally disintegrating tablets in their original blister packaging until use. Keep out of the reach and sight of children. Higher‑dose tablets sourced internationally should be stored according to the manufacturer’s recommendation on the packaging.
  • Lifestyle: Vardenafil is a treatment for erectile dysfunction, not a cure. Addressing underlying causes—such as quitting smoking, reducing alcohol consumption, losing weight, and controlling diabetes and hypertension—can improve erectile function. Never share your medication, and do not take Vardenafil with other PDE5 inhibitors (e.g., sildenafil, tadalafil) or other vardenafil‑containing products.
  • Emergency information: If you develop an erection that lasts longer than 4 hours (priapism) or experience sudden vision or hearing loss, stop taking Vardenafil and go to the nearest emergency department immediately. If you need to be seen by a doctor for any reason, always tell them you are taking vardenafil, and specify the dose, particularly if you are taking a dose above 20 mg. If you experience chest pain, do not take nitrates without first informing the treating physician that you have taken vardenafil.
  • Disposal: Return unused or expired tablets to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

  • Sildenafil (Viagra®): The first oral PDE5 inhibitor, with a duration of action of 4‑6 hours. It is effective for ED and is available as a generic in Canada. It may be a suitable alternative for men who prefer a shorter‑acting agent. The maximum approved dose is 100 mg.
  • Tadalafil (Cialis®): A PDE5 inhibitor with a much longer duration of action (up to 36 hours). It is available for on‑demand use (10 mg, 20 mg) and once‑daily use (2.5 mg, 5 mg). Its long half‑life provides greater spontaneity.
  • Avanafil (Stendra®): A fast‑acting PDE5 inhibitor that can start working in as little as 15 minutes. It is available as a brand‑name prescription drug in Canada. The maximum dose is 200 mg.
  • Alprostadil (Caverject®): An injectable or intraurethral pellet that stimulates an erection directly by relaxing penile smooth muscle. It is used when oral PDE5 inhibitors are ineffective or contraindicated, and it does not rely on PDE5 inhibition, so it can be used in patients taking nitrates.
  • Non‑pharmacological options: Vacuum erection devices (VEDs), penile implants, and psychological counselling for psychogenic ED are alternatives or adjuncts to drug therapy. Treating underlying cardiovascular risk factors is also a cornerstone of long‑term ED management.

Clinical Efficacy

The efficacy of vardenafil for the treatment of erectile dysfunction has been demonstrated in numerous randomized, double‑blind, placebo‑controlled clinical trials. In fixed‑dose studies, vardenafil 10 mg and 20 mg significantly improved the ability to achieve and maintain erections compared with placebo, with response rates of approximately 70‑80% across a broad range of ED severities and aetiologies. In a head‑to‑head comparative trial, vardenafil 20 mg was shown to be non‑inferior to sildenafil 100 mg, with a similar efficacy profile and a slightly faster onset in some analyses. Vardenafil is also effective in patients who have not responded to sildenafil; in a study of sildenafil non‑responders, vardenafil 20 mg produced a successful intercourse rate of 62% compared with 26% for placebo. Higher doses (40 mg, 60 mg) have been studied in limited clinical settings and in specific patient populations (e.g., men with severe ED, those on concomitant medications that reduce vardenafil exposure, or those who have failed to respond to 20 mg). These doses produce greater pharmacodynamic effects but are associated with an increased incidence and severity of adverse events, particularly headache, flushing, and hypotension. They are not part of the standard treatment algorithm and are reserved for patients under specialist care. Generic vardenafil, including internationally sourced products, is bioequivalent to branded Levitra. Vardenafil remains a well‑tolerated and effective first‑line therapy for ED, offering a slightly more rapid onset than sildenafil and a higher potency per milligram.

Important:

Vardenafil is a prescription medication that should be used only under the supervision of a qualified healthcare professional. The most critical safety warning is that vardenafil must never be taken with any form of organic nitrate (e.g., nitroglycerin, isosorbide mononitrate, “poppers”) as this combination can cause a severe, sudden, and potentially fatal drop in blood pressure. This contraindication applies to all doses. If you experience chest pain or an erection lasting longer than 4 hours (priapism), stop using the medication and seek emergency medical attention immediately. High doses (40 mg and 60 mg) increase the risk of adverse effects and should only be used under specialist direction. Sexual activity carries a risk to the heart in patients with pre‑existing cardiovascular disease. This product is for adult men and is not intended for use by women or children. Do not take vardenafil with other PDE5 inhibitors or with CYP3A4 inhibitors without your doctor’s guidance; the dose must be adjusted. If you are taking alpha‑blockers, the starting dose of vardenafil must be reduced. Do not drink large amounts of alcohol. If you experience sudden vision loss, sudden hearing loss, or a prolonged erection, seek immediate medical attention. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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