1 INDICATIONS AND USAGE
Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Tell your doctor if you have ever had: a heart attack, stroke, or congestive heart failure; a heart attack, stroke, or congestive heart failure; long QT syndrome (in you or a family member); long QT syndrome (in you or a family member); a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia; a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia; an eye disorder such as retinitis pigmentosa (an inherited condition of the eye); an eye disorder such as retinitis pigmentosa (an inherited condition of the eye); a physical deformity of the penis (such as Peyronie's disease); a physical deformity of the penis (such as Peyronie's disease); if you have been told you should not have sexual intercourse for health reasons; or if you have been told you should not have sexual intercourse for health reasons; or liver disease, kidney disease (or if you are on dialysis). liver disease, kidney disease (or if you are on dialysis). Vardenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss.
- Vardenafil 10 mg may be used by men over 18 years.
- The medication is not approved for use in women or children.
- May be contraindicated in patients with certain eye conditions.
- Use caution if you have a history of stroke.
- The drug’s chemical action involves improving blood flow.
- It is important to distinguish ED causes before treatment.
- Use only medications prescribed by a healthcare professional.
- Avoid combining with other erectile dysfunction medications.
- Keep medication out of sunlight and moisture.
- Seek emergency medical help for severe side effects.
This has occurred in a small number of people, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoked or were over 50 years old. 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. Follow all directions on your prescription label lovegra tablet 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.
How to Order
Swallow several times as the tablet dissolves. 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.
How is vardenafil supplied (dosage forms)?
This medicine does not prevent the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV). 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.
What is vardenafil used for?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 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. 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). 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.
- Vardenafil is ineffective without sexual arousal.
- It does not protect against sexually transmitted infections.
- Avoid excessive mental or physical exertion while on medication.
- Consult a healthcare professional if unsure about interactions.
- Don't take vardenafil if you've had recent heart attack.
- Use with caution if you have a bleeding disorder.
- Medication may cause a temporary drop in blood pressure.
- Avoid using if you have a known hypersensitivity.
- The pill should be taken as part of a treatment plan.
- Keep track of how you respond to the medication.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
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Grapefruit and Seville oranges may interact with vardenafil and cause side effects.
Key Financial Metrics and Trends Summary
(6.1)To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or INTERACTIONS• Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. (7.1)• Do not use vardenafil hydrochloride orally disintegrating tablets with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations. (7.2)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 7/2025 Warnings and Precautions (5.2) 4/2023 • Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. • Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). • Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. Avoid consuming grapefruit products and orange marmalades. Drinking alcohol can increase certain side effects of vardenafil.
Proper Use
(2.1)• Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. (2.1)• Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food. (2.2)DOSAGE FORMS AND STRENGTHS• Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONS• Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. (5.1)• Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. (5.2, 7.2)• Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.
What are the most common side effects of vardenafil?
(5.3)• Effects on the Eye: Patients should stop use of vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Vardenafil hydrochloride orally disintegrating 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 orally disintegrating 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 coadministered with alpha-blockers.
How does vardenafil work (mechanism of action)?
In some patients, concomitant use of these two drug classes can lower increase libido in women blood pressure significantly leading to symptomatic hypotension (for example, fainting). In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets. (2.4, 5.6)• QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets. (5.7, 12.2)• Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. (5.12)ADVERSE REACTIONSAdverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. Do not use any other medicine to treat impotence unless your doctor tells you to.
Generic vs Brand
Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Tell your doctor if you have ever had: a heart attack, stroke, or congestive heart failure; a heart attack, stroke, or congestive heart failure; long QT syndrome (in you or a family member); long QT syndrome (in you or a family member); a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia; a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia; an eye disorder such as retinitis pigmentosa (an inherited condition of the eye); an eye disorder such as retinitis pigmentosa (an inherited condition of the eye); a physical deformity of the penis (such as Peyronie's disease); a physical deformity of the penis (such as Peyronie's disease); if you have been told you should not have sexual intercourse for health reasons; or if you have been told you should not have sexual intercourse for health reasons; or liver disease, kidney disease (or if you are on dialysis). liver disease, kidney disease (or if you are on dialysis). Vardenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss.
Are you currently using Vardenafil (Levitra, Staxyn)?
This has occurred in a small number of people, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoked or were over 50 years old. 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).
Does vardenafil interact with other medicines (drug interactions)?
Avoid medication errors by using only the form and strength your doctor prescribes. Follow all directions on your prescription label lovegra tablet 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. Do not use vardenafil with similar medications such as avanafil (Stendra), sildenafil (Viagra), or tadalafil (Cialis). 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. Always consult your healthcare provider to ensure the buy super p force jelly 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 ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS.VARDENAFIL HYDROCHLORIDE orally disintegrating tabletsInitial U.S. Approval: 2003RECENT MAJOR CHANGESWarnings and Precautions (5.2) 4/2023INDICATIONS AND USAGE• Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).DOSAGE AND ADMINISTRATION• Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA).
| Interacting Drug | Effect on Vardenafil | Potential Risk | Management |
|---|---|---|---|
| Nitrates | Potentiates effects | Severe hypotension | Avoid concurrent use |
| CYP3A4 Inhibitors (e.g., Ketoconazole) | Increased levels | Increased side effects | Dose reduction |
| Alpha-blockers | Additive hypotension | Monitor blood pressure | Administer with caution |
| Other PDE5 inhibitors | Cumulative effects | Increased adverse effects | Use with caution or avoid |
Vardenafil hydrochloride orally disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). (2.1)• Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. (2.1)• The maximum recommended dosing frequency is one tablet per day. (2.1)• Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. (2.1)• Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food. (2.2)DOSAGE FORMS AND STRENGTHS• Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONS• Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. (5.1)• Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. (5.2, 7.2)• Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.
Drug Label Information
Do not use vardenafil with similar medications such as avanafil (Stendra), sildenafil (Viagra), or tadalafil (Cialis). 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.
What should I tell my healthcare provider before taking vardenafil?
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. Always consult your healthcare provider to ensure the buy super p force jelly 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 ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS.VARDENAFIL HYDROCHLORIDE orally disintegrating tabletsInitial U.S.
What are the serious side effects of vardenafil?
Approval: 2003RECENT MAJOR CHANGESWarnings and Precautions (5.2) 4/2023INDICATIONS AND USAGE• Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).DOSAGE AND ADMINISTRATION• Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). (2.1)• Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. (2.1)• The maximum recommended dosing frequency is one tablet per day. (5.3)• Effects on the Eye: Patients should stop use of vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION).
- Vardenafil 10 mg is a popular choice for ED treatment.
- Dose can be adjusted by a healthcare provider.
- Avoid using vardenafil with recreational drugs like poppers.
- Do not use after consuming large amounts of alcohol.
- The pill is generally taken before planned intercourse.
- Its effects are dose-dependent and subject to individual variation.
- Adherence to prescribed dose helps prevent adverse effects.
- The medication can be used long-term if prescribed.
- Regular checkups can help monitor effectiveness and safety.
- Never double the dose if the first does not work immediately.
Vardenafil hydrochloride orally disintegrating 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 orally disintegrating 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 coadministered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower increase libido in women blood pressure significantly leading to symptomatic hypotension (for example, fainting). In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets. (2.4, 5.6)• QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets. (5.7, 12.2)• Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. (5.12)ADVERSE REACTIONSAdverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or INTERACTIONS• Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. (7.1)• Do not use vardenafil hydrochloride orally disintegrating tablets with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations. (7.2)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 7/2025 Warnings and Precautions (5.2) 4/2023 • Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. • Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). • Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity.
| Ingredient | Amount per Tablet | Purity | Source |
|---|---|---|---|
| Vardenafil Hydrochloride | 10 mg | 99.9% | Pharmacological grade |
| Lactose Monohydrate | 50 mg | – | Dairy-derived |
| Microcrystalline Cellulose | 20 mg | – | Plant fiber |
| Magnesium Stearate | 2 mg | – | Mineral source |
| Colloidal Silicon Dioxide | 1 mg | – | Silicon dioxide |
• The maximum recommended dosing frequency is one tablet per day. • Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate.
Vardenafil side effects
• The maximum recommended dosing frequency is one tablet per day. • Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. • Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food. • Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food.
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