( 7.1)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 11/2025 Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
12.3 Pharmacokinetics
In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). ( 2.4, 5.6)QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride tablets. ( 5.7, 12.2)Phenylketonurics: Contains Phenylalanine ( 5.13)ADVERSE REACTIONSMost common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. ( 6.1)To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or INTERACTIONSVardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives. Vardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 20mg | 30 + 4 Pills | 68.05€ 64.81€ | |
| Viagra Generic | 50mg | 360 + 10 Pills | 225.33€ 214.60€ | |
| Levitra Original | 20mg | 12 Pills | 81.99€ 78.09€ | |
| Viagra Professional | 100mg | 360 + 6 Pills | 527.09€ 501.99€ | |
| Kamagra Polo | 100mg | 120 + 6 Pills | 327.15€ 311.57€ | |
| Kamagra Effervescent Tablets | 100 mg | 42 + 7 Pills | 122.97€ 117.11€ | |
| Viagra Original | 100mg | 8 Pills | 59.84€ 56.99€ | |
| Cialis Black | 80mg | 180 + 10 Pills | 356.64€ 339.66€ | |
| Tadalista Super Active | 20mg | 120 + 16 Pills | 382.15€ 363.95€ | |
| Cialis Generic | 40mg | 120 + 8 Pills | 206.98€ 197.12€ | |
| Levitra Generic | 60mg | 120 + 8 Pills | 372.33€ 354.60€ | |
| Viagra Generic | 100mg | 270 + 10 Pills | 270.47€ 257.59€ | |
| Cialis Original | 20mg | 4 Pills | 41.99€ 39.99€ | |
| Cialis Professional | 40mg | 180 + 4 Pills | 618.23€ 588.79€ |
A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥ 65 years of age. Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity.
- Vardenafil 10mg is used primarily to improve erectile function in men.
- It’s important to avoid taking multiple doses in a 24-hour period.
- The tablet should be taken with water, not crushed or chewed.
- Potential side effects include headache, flushing, and indigestion.
- Rare but serious reactions include sudden vision or hearing loss.
- Consult your doctor immediately if adverse reactions occur.
- Men with certain health conditions should undergo evaluation before use.
- The drug works by relaxing blood vessels to increase blood flow.
- Avoid excessive alcohol consumption while on vardenafil.
- Store away from light, moisture, and away from children’s reach.
The maximum recommended dosing frequency is one tablet per day.
Vardenafil Clinical Trials
Grapefruit and Seville oranges may interact with vardenafil and cause side effects. Avoid consuming grapefruit products and orange marmalades. Drinking alcohol can increase certain side effects of vardenafil. Do not use any other medicine to treat impotence unless your doctor tells you to. Do not use vardenafil with similar medications such as avanafil (Stendra), sildenafil (Viagra), or tadalafil (Cialis).
Usual Adult Dose for:
Tell your doctor about all other medications you use for erectile dysfunction. This list is not complete and many other drugs may affect vardenafil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Vardenafil hydrochloride tablets may be taken with or without food.
5.9 Renal Impairment
( 2.1)Vardenafil hydrochloride tablets may be taken with or without food. ( 2.2)If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows ( 2.4, 5.2, 7.2): Ritonavir: No more than 2.5 mg in a 72-hour periodCobicistat: No more than 2.5 mg in a 72-hour periodIndinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour periodKetoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period.In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil hydrochloride tablets is 5 mg ( 2.4, 5.6)The recommended starting dose of vardenafil hydrochloride tablets is 5 mg in patients with moderate hepatic impairment (Child-Pugh B). The maximum dose in patients with moderate hepatic impairment should not exceed buy cenforce pills 10 mg. ( 2.3, 8.6)DOSAGE FORMS AND STRENGTHSVardenafil hydrochloride tablets 2.5 mg, 5 mg, 10 mg, 20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSCardiovascular Effects: Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due to cardiovascular status. ( 5.1)Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows ( 2.4, 5.2, 7.2): Ritonavir: No more than 2.5 mg in a 72-hour periodCobicistat: No more than 2.5 mg in a 72-hour periodIndinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour periodKetoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period.
See also:
It is not clear whether vardenafil is the actual cause of vision loss. Staxyn (vardenafil disintegrating tablets) may contain phenylalanine. Vardenafil is not approved for use in women, and the effects of vardenafil during pregnancy or in breastfeeding women are unknown. Staxyn (vardenafil disintegrating tablets) should not be used in place of Levitra (vardenafil regular tablets). Avoid medication errors by using only the form and strength your doctor prescribes.
Symptoms of overdose may include:
Follow all directions on your prescription label and read all medication guides or instruction sheets. Vardenafil can be taken with or without food. Remove an orally disintegrating (Staxyn) tablet from the package only when you are ready to use the medicine. Place the tablet in your mouth and allow it to dissolve without chewing. Swallow several times as the tablet dissolves. In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil hydrochloride tablets is 5 mg ( 2.4, 5.6) The recommended starting dose of vardenafil hydrochloride tablets is 5 mg in patients with moderate hepatic impairment (Child-Pugh B).
- Vardenafil 10mg is available by prescription only, ensure your doctor’s approval.
- It is intended for use in adult men diagnosed with erectile dysfunction.
- Be cautious with dosing if you have kidney or liver problems.
- Remember that sexual activity carries health risks for some men.
- Report any adverse effects, especially chest pain or prolonged erections.
- It’s important to discuss your complete medical history before use.
- The medication does not protect against sexually transmitted infections.
- Do not share your medication with others to prevent misuse.
- Use vardenafil only as directed to avoid potential health hazards.
- Pharmacist or doctor can clarify any questions about proper use.
The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg.
| Active Ingredient | Dosage Strength | Form | Packaging |
|---|---|---|---|
| Vardenafil HCl | 10 mg | Tablet | Blister pack |
| Typical use | Onset of action | Duration | Approved uses |
| Erectile dysfunction | 30-60 minutes | Up to 4-6 hours | Male patients |
( 2.3, 8.6) Vardenafil hydrochloride tablets 2.5 mg, 5 mg, 10 mg, 20 mg ( 3) Cardiovascular Effects: Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due to cardiovascular status.
What should I avoid while taking vardenafil?
( 5.3)Effects on the Eye: Patients should stop use of vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Vardenafil hydrochloride tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. ( 5.4, 6.2)Sudden Hearing Loss: Patients should stop vardenafil hydrochloride tablets and seek medical attention in the event of sudden decrease or loss in hearing. ( 5.5, 6.2)Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.
- Vardenafil 10mg can help improve sexual confidence and satisfaction.
- Use it responsibly to maintain health and efficacy.
- Check for any medication allergies before use.
- Inform your doctor about all health conditions prior to starting.
- Do not take vardenafil if you have recent cardiovascular events.
- Avoid excessive alcohol, which can worsen side effects.
- Report any unexpected symptoms to your healthcare provider.
- Follow your doctor’s instructions for dosage and timing.
- Be aware of the medication’s interaction with other drugs.
- Proper storage ensures the medication’s effectiveness and safety.
Effects on the Eye: Patients should stop use of vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION).
- Vardenafil interacts with certain blood pressure medicines, affecting efficacy.
- The medication can be used by men of most adult age groups.
- Women who are pregnant or breastfeeding should not use vardenafil.
- It’s advisable to avoid grapefruit or grapefruit juice when on vardenafil.
- Always complete your prescribed course even if symptoms improve.
- Seek medical attention if you notice symptoms of allergic reaction.
- Vardenafil is not intended for use by individuals with recent stroke or heart attack.
- Sexual activity may be dangerous for some men with cardiovascular issues.
- The medication is not approved for use in women or children.
- Use caution when combining vardenafil with other erectile dysfunction drugs.
Sudden Hearing Loss: Patients should stop vardenafil hydrochloride tablets and seek medical attention in the event of sudden decrease or loss in hearing. Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers.
What Are Side Effects Associated with Using Vardenafil?
Vardenafil is taken only when needed, about 60 minutes before sexual activity. The medicine can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. If you receive medical care for heart problems, tell your caregivers when you last took vardenafil. This medicine does not prevent the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).
InChI key
Store at room temperature away from moisture and heat. -Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability.-Maximum dose: 20 mg once a dayPatients on stable alpha blocker therapy:-Initial dose: 5 mg orally once a dayComments:-Sexual stimulation is required for a response to treatment.-A time interval between dosing should be considered when administering this drug concomitantly with alpha-blockers.-Patients taking alpha-blockers should not initiate vardenafil therapy with the orally disintegrating tablet.Use: Erectile dysfunction 65 years or older:-Initial dose: 5 mg orally once a day, as needed, approximately 60 minutes before sexual activityComments: Sexual stimulation is required for a response to treatment.Use: Erectile dysfunction Since vardenafil is used as needed, you are not likely to be on a dosing schedule. Allow 24 hours to pass between doses. Seek pills for womens libido emergency medical attention or call the Poison Help line at 1-800-222-1222. QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride tablets.
7.2 Effect of Other Drugs on Vardenafil
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VARDENAFIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE TABLETS.VARDENAFIL HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 2003RECENT MAJOR CHANGESINDICATIONS AND USAGEVardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
Other Interactions
( 1)DOSAGE AND ADMINISTRATIONVardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability. ( 2.1)A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥ 65 years of age. ( 2.3)Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity. ( 2.1)The maximum recommended dosing frequency is one tablet per day. Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.
| Point | Explanation | Additional Advice |
|---|---|---|
| Take as prescribed | Usually 10 mg about 30-60 min before activity | Do not exceed recommended dose |
| Food interactions | High-fat meals may delay onset | Take on an empty stomach or low-fat meal |
| Alcohol consumption | May decrease effectiveness or increase side effects | Limit alcohol intake |
| Report side effects or adverse reactions | Such as vision changes, pain, prolonged erections | Seek medical attention immediately |