Label: VARDENAFIL HYDROCHLORIDE tablet

-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. 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. 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 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. ( 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.

• 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.

( 2.1)The maximum recommended dosing frequency is one tablet per day. ( 2.1)Vardenafil hydrochloride tablets may be taken with or without food.

8.6 Hepatic Impairment

-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.

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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.

How does vardenafil work (mechanism of action)?

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. ( 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 cenforce 200 mg impairment should not exceed 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.

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( 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.

Available Strengths & Forms

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. ( 1)DOSAGE AND ADMINISTRATIONVardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily.

How should I store vardenafil?

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. ( 2.1)Vardenafil hydrochloride tablets may be taken with or without food.

Storage Class

( 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 cenforce 200 mg impairment should not exceed 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. ( 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). ( 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. 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. ( 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.

• Vardenafil 10mg should be used only under medical supervision.
• Overdose may cause serious side effects like priapism or sudden vision loss.
• The medication is available by prescription and not for recreational use.
• Male patients with heart issues should consult a doctor before use.
• Vardenafil may interact with other medications like antibiotics or antifungals.
• Alcohol consumption can increase the risk of side effects when taking vardenafil.
• It’s important to follow the prescribed dosage strictly for safety.
• Use caution if you have liver or kidney problems while taking vardenafil.
• Women and children should avoid using vardenafil, as it's designed for men.
• Discuss all health conditions and medications with your healthcare provider first.

Vardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. 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. The maximum recommended dosing frequency is one tablet per day. Vardenafil hydrochloride tablets may be taken with or without food.

• Vardenafil HCl 10mg improves erectile response by increasing blood flow.
• Avoid combining it with other ED medications unless prescribed.
• Potential for interactions with certain heart and blood pressure medicines.
• Use vardenafil with caution under doctor supervision if you have health issues.
• It’s not suitable for women, children, or individuals without ED diagnosis.
• Store in a cool, dry place away from direct sunlight.
• Do not take if you recently used nitric oxide donors.
• Be mindful of timing; take about an hour before intimacy.
• The medication does not produce an erection without sexual stimulation.
• Always adhere to your prescribed dose for best results.

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 10 mg. ( 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. Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.

6.1 Clinical Studies Experience

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 10 mg. ( 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. Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.

Drug Interactions

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). 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. QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride tablets. Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. 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).

What are the Patent Expirations and Regulatory Status?

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. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).

Sample Use Guides

( 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. ( 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.

Incidence not known

Vardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. 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. The maximum recommended dosing frequency is one tablet per day. Vardenafil hydrochloride tablets may be taken with or without food. Sudden Hearing Loss: Patients should stop vardenafil hydrochloride tablets and seek medical attention in the event of sudden decrease or loss in hearing.

• Vardenafil HCl 10mg can be effective in treating erectile dysfunction symptoms.
• It’s important to avoid unprescribed or counterfeit versions of the drug.
• Consult a healthcare provider for proper diagnosis before starting treatment.
• Discontinue medication and seek medical help if serious side effects occur.
• The medication’s effects depend on proper timing and dosage adherence.
• It’s safe for most men but always needs individual health assessment.
• Mild side effects may diminish over time or with dose adjustment.
• Use caution with other medications that affect blood pressure or blood flow.
• Do not use vardenafil if you are allergic to similar medications like sildenafil.
• Always inform your doctor of any other medications you are taking.

Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride tablets.

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

Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.

Overdose/Missed Dose

To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or Vardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 General Dose Information2.2 Use with Food2.3 Use in Specific Populations2.4 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular Effects5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors5.3 Risk of Priapism5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-Blockers5.7 Congenital or Acquired QT Prolongation5.8 Hepatic Impairment5.9 Renal Impairment5.10 Combination with Other Erectile Dysfunction Therapies5.11 Effects on Bleeding5.12 Sexually Transmitted Disease5.13 Risks in Patients with Phenylketonuria6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Tablets7.2 Effect of Other Drugs on Vardenafil7.3 Effects of Vardenafil on Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES14.1 Trials in a General Erectile Dysfunction Population14.2 Trial in Patients with ED and Diabetes Mellitus14.3 Trial in Patients with ED after Radical Prostatectomy16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or Vardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 General Dose Information2.2 Use with Food2.3 Use in Specific Populations2.4 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular Effects5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors5.3 Risk of Priapism5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-Blockers5.7 Congenital or Acquired QT Prolongation5.8 Hepatic Impairment5.9 Renal Impairment5.10 Combination with Other Erectile Dysfunction Therapies5.11 Effects on Bleeding5.12 Sexually Transmitted Disease5.13 Risks in Patients with Phenylketonuria6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Tablets7.2 Effect of Other Drugs on Vardenafil7.3 Effects of Vardenafil on Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES14.1 Trials in a General Erectile Dysfunction Population14.2 Trial in Patients with ED and Diabetes Mellitus14.3 Trial in Patients with ED after Radical Prostatectomy16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.

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