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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Vardenafil Hydrochloride
Brand Name
Vardenafil Hydrochloride
Generic Name
Vardenafil Hydrochloride
Active Ingredient
VardenafilCategory
Phosphodiesterase 5 Inhibitor [EPC]
Variants
31
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 20 mg/1 | TABLET | ORAL | 71335-9689 |
| 20 mg/1 | TABLET | ORAL | 71610-508 |
| 20 mg/1 | TABLET | ORAL | 72162-2236 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Vardenafil Hydrochloride, you must consult a qualified healthcare professional.
| 20 mg/1 | TABLET | ORAL | 33342-154 |
| 2.5 mg/1 | TABLET, FILM COATED | ORAL | 46708-236 |
| 20 mg/1 | TABLET, FILM COATED | ORAL | 71335-2357 |
| 10 mg/1 | TABLET | ORAL | 71335-9696 |
| 2.5 mg/1 | TABLET, FILM COATED | ORAL | 0093-7652 |
| 10 mg/1 | TABLET | ORAL | 42291-847 |
| 5 mg/1 | TABLET, FILM COATED | ORAL | 46708-237 |
| 20 mg/1 | TABLET, FILM COATED | ORAL | 62332-239 |
| 10 mg/1 | TABLET | ORAL | 72162-2235 |
+ 19 more variants
Detailed information about Vardenafil Hydrochloride
Vardenafil is a potent phosphodiesterase type 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. It works by enhancing the effects of nitric oxide to increase blood flow to the penis during sexual stimulation.
The dosage of vardenafil must be individualized based on efficacy and tolerability. Healthcare providers typically follow these general guidelines:
Vardenafil is NOT approved for use in pediatric patients (individuals under the age of 18). There is no clinical data regarding the safety or efficacy of vardenafil in children, and its use in this population is not recommended.
For patients aged 65 years and older, healthcare providers often recommend a starting dose of 5 mg of the film-coated tablet. This is due to the fact that vardenafil clearance decreases with age, leading to higher plasma concentrations compared to younger men.
To ensure the best results and safety when taking vardenafil, follow these specific instructions:
Since vardenafil is used on an as-needed basis for erectile dysfunction, you are not likely to be on a regular dosing schedule. If you miss a dose and still intend to engage in sexual activity, take it as soon as you remember, provided it is not more than once in a 24-hour period. Never take two doses at once to make up for a missed dose.
Signs of a vardenafil overdose may include severe back pain, muscle pain (myalgia), or vision problems. If you suspect an overdose, contact your local poison control center or seek emergency medical attention immediately. In cases of overdose, standard supportive measures should be adopted. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or frequency of use without medical guidance.
Like all medications, vardenafil can cause side effects, although not everyone experiences them. The most common side effects are generally mild to moderate and often diminish as the body adjusts to the medication. According to clinical trial data, common side effects include:
Before starting vardenafil, it is critical to provide your healthcare provider with a complete medical history. Vardenafil can cause a temporary drop in blood pressure, and for patients with certain underlying conditions, this can be dangerous. Sexual activity itself carries a potential cardiac risk for patients with pre-existing cardiovascular disease. Therefore, treatment for erectile dysfunction, including vardenafil, should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
No FDA black box warnings for Vardenafil. While vardenafil is considered safe for the general population when used as directed, it carries significant warnings regarding drug interactions and specific physical conditions.
Certain medications must NEVER be used with vardenafil due to the risk of life-threatening complications:
Absolute contraindications are conditions under which vardenafil must NEVER be used because the risks clearly outweigh any potential benefits:
Vardenafil is NOT indicated for use in women. It is classified by the FDA under Pregnancy Category B (old system). Animal reproduction studies have failed to demonstrate a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. There is no clinical reason for a pregnant woman to take vardenafil, and it is not used in fertility treatments for women.
It is not known whether vardenafil is excreted in human breast milk. Because vardenafil is not indicated for use in women, there is no clinical data on its effects on nursing infants. Women who are breastfeeding should not use this medication.
Vardenafil is not indicated for pediatric use. Safety and efficacy have not been established in individuals under 18 years of age. Use in children for off-label conditions (like pulmonary hypertension) must only be done under the strict guidance of a pediatric specialist.
Vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The molecular mechanism involves the protection of cGMP from degradation by PDE5 in the smooth muscle cells lining the blood vessels supplying the corpus cavernosum of the penis. When sexual stimulation triggers the release of nitric oxide (NO), vardenafil ensures that cGMP levels remain elevated, leading to prolonged smooth muscle relaxation and increased blood inflow. This biochemical pathway is highly specific to the erectile tissues, although PDE5 is also found in smaller concentrations in the systemic vasculature and platelets.
The pharmacodynamic effect of vardenafil is dependent on the presence of endogenous nitric oxide. In clinical studies using Rigiscan (a device to measure penile rigidity), vardenafil 20 mg produced erections considered sufficient for penetration (60% rigidity) in some men as early as 15 minutes after dosing. The median time to reach maximum effect is 60 minutes, and the window of efficacy typically extends to 4-5 hours post-dose.
| Parameter | Value |
Common questions about Vardenafil Hydrochloride
Vardenafil is a prescription medication used primarily to treat erectile dysfunction (ED) in adult men. It works by increasing blood flow to the penis during sexual stimulation, helping a man achieve and maintain an erection. It belongs to the class of drugs known as PDE5 inhibitors, which also includes medications like sildenafil and tadalafil. It is important to note that vardenafil does not cure ED or increase sexual desire; it only assists the physical process of an erection when a man is sexually aroused. Your doctor may prescribe it if they determine that your ED has a physical or psychological cause that can be managed with this therapy.
The most frequently reported side effects of vardenafil include headache, flushing (redness or warmth of the face), nasal congestion or a runny nose, and indigestion. These effects are usually mild and temporary, often resolving within a few hours as the medication leaves the system. Some users may also experience dizziness or a slight change in vision, such as a blue tint or sensitivity to light. If these side effects persist or become bothersome, you should consult your healthcare provider. Most patients tolerate the medication well, but individual reactions can vary based on dosage and underlying health.
Moderate alcohol consumption, such as one or two glasses of wine or a single serving of spirits, does not typically cause a significant interaction with vardenafil. However, both alcohol and vardenafil can lower your blood pressure by dilating your blood vessels. Drinking excessive amounts of alcohol while taking this medication can increase the risk of side effects like dizziness, headache, and a rapid heartbeat. Additionally, large amounts of alcohol can interfere with the ability to achieve an erection, potentially counteracting the benefits of the medication. It is best to limit alcohol intake to ensure the medication works effectively and safely.
Vardenafil is not indicated for use in women and has not been studied in pregnant or breastfeeding populations. While animal studies have not shown direct harm to a developing fetus, there is no clinical reason for a woman to take this medication. It is specifically designed and FDA-approved for the treatment of erectile dysfunction in men. If a woman were to accidentally ingest vardenafil, she should contact a healthcare provider, although significant harm is unlikely from a single dose. Always keep this and all medications out of the reach of children and those for whom it was not prescribed.
For most men, vardenafil starts to work within 30 to 60 minutes after taking the tablet. However, some clinical studies have shown that it can be effective in as little as 15 minutes for certain individuals. The medication's onset can be delayed if it is taken with a high-fat meal, which slows the absorption process in the stomach. It is generally recommended to take the dose about an hour before planned sexual activity to ensure maximum effectiveness. Remember that sexual stimulation is absolutely necessary for the medication to work; it will not produce an erection on its own without arousal.
Yes, you can stop taking vardenafil at any time without any risk of withdrawal symptoms or physical dependence. Vardenafil is taken on an as-needed basis, meaning it does not build up in your system in a way that requires a tapering schedule. If you decide to stop using it, the only effect will be that the assistance it provided for erectile function will no longer be present. If you are stopping the medication because of side effects or lack of efficacy, it is a good idea to discuss other treatment options with your doctor. They can help identify why the medication wasn't right for you and suggest alternatives.
Because vardenafil is used only when needed before sexual activity, there is no set dosing schedule to follow. If you intended to take a dose but forgot, you can take it as soon as you remember, provided you are still planning to be sexually active. However, you must never take more than one dose in a 24-hour period. Taking doses too close together can significantly increase the risk of severe side effects, such as a dangerous drop in blood pressure or a prolonged erection. If you miss a dose and no longer need it, simply skip it and wait until the next time you require it.
There is no clinical evidence to suggest that vardenafil causes weight gain. In the extensive clinical trials conducted for FDA approval, weight changes were not reported as a common or significant side effect. Vardenafil is taken intermittently and does not affect the metabolic processes or appetite-regulating hormones that typically lead to weight gain. If you experience sudden weight gain while taking vardenafil, it is likely due to other factors such as diet, lifestyle changes, or other underlying medical conditions. You should discuss any unexpected weight changes with your healthcare provider to determine the actual cause.
Vardenafil can interact with several types of medications, some of which can be very dangerous. It must never be taken with nitrates (often prescribed for chest pain) or guanylate cyclase stimulators, as this can cause a life-threatening drop in blood pressure. It may also interact with alpha-blockers used for prostate issues or high blood pressure, and certain antifungal or HIV medications that inhibit the CYP3A4 enzyme. Because of these potential interactions, it is vital to provide your doctor with a full list of all prescription drugs, over-the-counter medicines, and herbal supplements you are currently taking. Your doctor will determine if vardenafil is safe to combine with your current regimen.
Yes, vardenafil is available as a generic medication. The generic version contains the same active ingredient as the brand-name versions, Levitra and Staxyn, and is required by the FDA to meet the same standards for safety, strength, and quality. Generic vardenafil is typically much more affordable than the brand-name equivalents. It is available in the same strengths (2.5 mg, 5 mg, 10 mg, and 20 mg) and formulations (film-coated and orally disintegrating tablets). When your doctor writes a prescription for vardenafil, you can ask your pharmacist for the generic version to help reduce your out-of-pocket costs.
Other drugs with the same active ingredient (Vardenafil)
These side effects may occur in some individuals and should be discussed with a doctor if they become bothersome:
Rare but documented side effects include:
> Warning: Stop taking Vardenafil and call your doctor immediately or seek emergency care if you experience any of the following serious conditions:
Long-term clinical studies have generally shown that vardenafil is well-tolerated when used as directed over several years. There is no evidence that long-term use leads to physical dependence or a decrease in effectiveness (tolerance). However, patients with underlying cardiovascular disease should be regularly monitored by their healthcare provider to ensure that sexual activity remains safe for their heart health.
No FDA black box warnings for Vardenafil. However, the FDA requires strong warnings regarding the concomitant use of nitrates and the risk of sudden vision or hearing loss.
Report any unusual symptoms or persistent side effects to your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088.
Regular monitoring is usually not required for healthy individuals taking vardenafil. However, your doctor may request:
Because vardenafil can cause dizziness and vision changes in some people, you should be aware of how you react to the medication before driving or operating heavy machinery. If you experience dizziness or blurred vision, avoid these activities until your vision clears and you feel alert.
Moderate alcohol consumption (e.g., 2 units of wine or spirits) does not appear to significantly affect the plasma concentrations of vardenafil or its effect on blood pressure. However, both alcohol and vardenafil act as mild vasodilators. Consuming large amounts of alcohol while taking vardenafil may increase the risk of side effects such as dizziness, headache, and increased heart rate.
Vardenafil is used on an as-needed basis; therefore, there is no risk of withdrawal syndrome upon discontinuation. You can stop taking the medication at any time without a tapering schedule. If you find the medication is no longer needed or if you experience serious side effects, discuss discontinuation with your healthcare provider.
> Important: Discuss all your medical conditions, especially heart rhythm problems or eye diseases, with your healthcare provider before starting Vardenafil.
There are no known significant interactions between vardenafil and common laboratory tests. However, always inform your laboratory technician and doctor that you are taking vardenafil if you are undergoing diagnostic testing.
| Interaction Type | Mechanism | Clinical Consequence |
|---|---|---|
| Nitrates | Synergistic increase in cGMP | Severe, life-threatening hypotension |
| CYP3A4 Inhibitors | Decreased hepatic clearance | Increased vardenafil toxicity/side effects |
| Alpha-Blockers | Additive vasodilation | Symptomatic hypotension/fainting |
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking to avoid dangerous drug-drug interactions.
Relative contraindications require a careful risk-benefit analysis by a healthcare professional:
While there is no definitive data on cross-sensitivity between different PDE5 inhibitors, patients who have experienced a severe allergic reaction to sildenafil (Viagra) or tadalafil (Cialis) should be monitored closely if vardenafil is prescribed, as the structural similarities between these molecules may increase the risk of a cross-allergic response.
> Important: Your healthcare provider will evaluate your complete medical history, including your cardiovascular health and current medications, before determining if Vardenafil is safe for you.
In clinical trials, vardenafil concentrations were higher in elderly men (65 years and older) than in younger men. The mean Cmax and AUC were 34% and 52% higher, respectively, in the elderly. Despite these differences, the overall safety profile was similar between older and younger patients. However, because of the higher plasma levels, a lower starting dose of 5 mg is often recommended for patients over 65.
> Important: Special populations require individualized medical assessment. Always inform your doctor about any liver or kidney issues before starting treatment.
| Bioavailability | ~15% (due to first-pass metabolism) |
| Protein Binding | ~95% (to albumin and alpha-1 acid glycoprotein) |
| Half-life | 4 - 5 hours |
| Tmax | 0.5 - 2.0 hours (median 1 hour) |
| Metabolism | Hepatic (Primary CYP3A4, minor CYP3A5/2C) |
| Excretion | Fecal 91-95%, Renal 2-6% |
Vardenafil is a member of the phosphodiesterase type 5 inhibitor class. It is therapeutically categorized as an agent for erectile dysfunction. It shares this class with sildenafil, tadalafil, and avanafil. Compared to sildenafil, vardenafil has a modified piperazine ring and an imidazotriazinone nucleus instead of a pyrazolopyrimidinone nucleus, which contributes to its increased potency for the PDE5 enzyme.