Label: VARDENAFIL tablet, orally disintegrating

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. Vardenafil is taken only when needed, about 60 minutes before sexual activity.

• Vardenafil 10 mg is a selective phosphodiesterase type 5 inhibitor.
• It can improve the ability to achieve an erection.
• Maintain open communication with your healthcare provider.
• Use with caution in elderly patients.
• Report any unusual side effects promptly.
• The medication should not be used recreationally.
• Not recommended for use with certain antihypertensives.
• Effectiveness depends on correct timing and dosage.
• Avoid taking if you have severe liver disease.
• Always read the patient information leaflet.

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.

Usual Geriatric Dose for Erectile Dysfunction

(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 libido booster for women or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations.

Erectile Dysfunction

(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. • 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.

What should I do if I accidentally take too much vardenafil?

• Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food. • Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3) • Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. • Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. • Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. • 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). Allow 24 hours to pass between doses.

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.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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). Tell your doctor about all other medications you use for erectile dysfunction.

Usual Geriatric Dose for:

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 information displayed on this page applies to your personal circumstances.

What are the serious side effects of vardenafil?

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 sexual enhancement pills 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). 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). 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 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 sexual enhancement pills 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). 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.

Shipping & Delivery

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.

Incidence not known

(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. (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.

Usual Adult Dose for:

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 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. (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. (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.

• Vardenafil is generally safe when used as prescribed.
• The tablet is typically taken around 30 minutes before sex.
• Alcohol may enhance side effects like dizziness.
• Do not use vardenafil if you are taking nitrates.
• Keep a schedule of your medication use.
• Inform your doctor about other medications you are taking.
• Use only prescribed dosage to prevent adverse effects.
• Avoid certain foods that may interfere with absorption.
• Healthcare providers may adjust doses based on response.
• Proper storage extends the shelf life of the medication.

(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 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 libido booster for women or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations.

5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors

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. Vardenafil is taken only when needed, about 60 minutes before sexual activity.

How should I store vardenafil?

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.

What is vardenafil used for?

-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 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. (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. • 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 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3) • Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. • Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors.

• Vardenafil 10 mg tablets treat erectile dysfunction in men.
• The medication works by increasing blood flow to the penis.
• Take vardenafil 10 mg about 30 minutes before activity.
• It can be taken with or without food, but high-fat meals may delay effects.
• Maximum recommended dose is one tablet per 24 hours.
• Vardenafil may cause side effects like headache or flushing.
• Do not use vardenafil if you take nitrates for chest pain.
• Consult a doctor before using vardenafil if you have heart problems.
• Store vardenafil tablets at room temperature, away from moisture.
• Alcohol can increase side effects of vardenafil.

• Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. • 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). • 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. • Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. • QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets.

What is vardenafil?

To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or • Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. • 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. • Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. Adverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or • Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.

Usual Adult Dose for Erectile Dysfunction

• 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. • Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. • QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets. • Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. Adverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. • 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.