DOSAGE AND ADMINISTRATION

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.

• Vardenafil is used to treat erectile dysfunction in men.
• It works by increasing blood flow to the penis.
• Vardenafil is marketed under the brand name Levitra.
• The drug typically takes effect within 25-60 minutes.

(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. (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.

• Vardenafil efficacy depends on proper dosage and timing.
• It is generally safe when used as directed.
• Patients should avoid heavy meals before intake.
• Follow-up with your healthcare provider regularly.

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).

What should you do if you take too much vardenafil?

Sexual stimulation is required for a response to treatment.Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. The tablet should be taken without liquid. It should be taken immediately upon removal from the blister.Those patients who require a lower or higher dose of vardenafil need to be prescribed vardenafil film-coated tablets [see Patient Counseling Information (17)].2.2 Use with FoodVardenafil hydrochloride orally disintegrating tablets can be taken with or without food.2.3 Use in Special PopulationsHepatic Impairment: Do not use vardenafil hydrochloride orally disintegrating tablets in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.8) and Clinical Pharmacology (12.3)].Renal Impairment: Do not use vardenafil hydrochloride orally disintegrating tablets in patients on renal dialysis [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.3)].2.4 Concomitant MedicationsNitrates: Concomitant use with nitrates in any form is contraindicated [see Contraindications (4.1)].Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications (4.2)].CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets with strong or moderate CYP3A4 inhibitors such as cobicistat, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin and erythromycin [see Warnings and Precautions (5.2) and Drug Interactions (7.2)].Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. 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.

5.11 Effects on Bleeding

(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.

Electroanalytical application of carbon based electrodes to the pharmaceuticals

(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 erectile dysfunction treatment 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.

Usual Adult Dose for:

• 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). (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 erectile dysfunction treatment 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. • Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.

5.3 Risk of Priapism

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.

What are the most common side effects of vardenafil?

(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.

Brand Names: Canada

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. • 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. • 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. • 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. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

What other information should I know?

• 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.

What do I do if I miss a dose?

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. 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 General2.2 Use with Food2.3 Use in Special 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 Phenylketonurics5.14 Sexually Transmitted Disease6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Orally Disintegrating 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 Other Vardenafil Clinical Trials Using Film-Coated Tablets16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Recommended Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed.

What are some things I need to know or do while I take this drug?

2 DOSAGE AND ADMINISTRATION 2.1 GeneralVardenafil hydrochloride orally disintegrating tablets are available in 10 mg orally disintegrating tablets. 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) [see Clinical Pharmacology (12.3). ]Vardenafil hydrochloride orally disintegrating tablets should be taken orally, as needed, approximately 60 minutes before sexual activity. The maximum dosing frequency is one vardenafil hydrochloride orally disintegrating tablet per day. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 General2.2 Use with Food2.3 Use in Special 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 Phenylketonurics5.14 Sexually Transmitted Disease6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Orally Disintegrating 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 Other Vardenafil Clinical Trials Using Film-Coated Tablets16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Recommended Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 GeneralVardenafil hydrochloride orally disintegrating tablets are available in 10 mg orally disintegrating tablets. 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) [see Clinical Pharmacology (12.3). ]Vardenafil hydrochloride orally disintegrating tablets should be taken orally, as needed, approximately 60 minutes before sexual activity. The maximum dosing frequency is one vardenafil hydrochloride orally disintegrating tablet per day.

Sexual stimulation is required for a response to treatment.Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. The tablet should be taken without liquid. It should be taken immediately upon removal from the blister.Those patients who require a lower or higher dose of vardenafil need to be prescribed vardenafil film-coated tablets [see Patient Counseling Information (17)].2.2 Use with FoodVardenafil hydrochloride orally disintegrating tablets can be taken with or without food.2.3 Use in Special PopulationsHepatic Impairment: Do not use vardenafil hydrochloride orally disintegrating tablets in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions (5.8) and Clinical Pharmacology (12.3)].Renal Impairment: Do not use vardenafil hydrochloride orally disintegrating tablets in patients on renal dialysis [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.3)].2.4 Concomitant MedicationsNitrates: Concomitant use with nitrates in any form is contraindicated [see Contraindications (4.1)].Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications (4.2)].CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets with strong or moderate CYP3A4 inhibitors such as cobicistat, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin and erythromycin [see Warnings and Precautions (5.2) and Drug Interactions (7.2)].Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose.