In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets.
Are erectile dysfunction medicines safe?
(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).
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 10mg | 60 + 6 Pills | 112.98€ 107.60€ | |
| Viagra Oral Jelly | 100mg | 90 + 8 Sachets | 258.02€ 245.73€ | |
| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Cialis Generic | 40mg | 270 + 10 Pills | 382.19€ 363.99€ | |
| Cialis Generic | 2.5mg | 180 + 10 Pills | 154.86€ 147.49€ | |
| Kamagra Polo | 100 mg | 20 Pills | 83.56€ 79.58€ | |
| Viagra Generic | 200mg | 360 + 10 Pills | 481.98€ 459.03€ | |
| Levitra Soft Tabs | 20mg | 60 + 4 Pills | 178.40€ 169.90€ | |
| Kamagra Gold | 100 mg | 32 Pills | 121.24€ 115.47€ | |
| Levitra Generic | 10mg | 120 + 10 Pills | 178.59€ 170.09€ | |
| Viagra Soft Tabs | 100mg | 30 + 4 Pills | 83.06€ 79.10€ | |
| Levitra Generic | 20mg | 120 + 10 Pills | 224.15€ 213.48€ |
• 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 ed tablets 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.
8.7 Renal Impairment
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 libido booster for women 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. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil.
How is vardenafil supplied (dosage forms)?
Lower doses of vardenafil film-coated tablets should be used as initial therapy in these patients [see Dosage and Administration (2.4)]. Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may change to vardenafil hydrochloride orally disintegrating tablets at the advice of their healthcare provider [see Warnings and Precautions (5.6) and Drug Interactions (7.1). ]A time interval between dosing should be considered when vardenafil hydrochloride orally disintegrating tablets are prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)]. Vardenafil hydrochloride orally disintegrating tablets are available in 10 mg orally disintegrating tablets. 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.
Solid electrodes in electroanalytical chemistry: Present applications and prospects for high throughput screening of drug compounds
Sexual stimulation is required for a response to treatment. Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. 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)]. • 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.
What should you do if you take too much vardenafil?
• 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.
12.2 Pharmacodynamics
• 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.
What should I do if I get chest pain after taking vardenafil?
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. 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.
Dosage for people with kidney disease
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. • Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria.
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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.
Sensitive determination of anticancer drug imatinib in spiked human urine samples by differential pulse voltammetry on anodically pretreated boron-doped diamond electrode
(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. • The maximum recommended dosing frequency is one tablet per day.
More common
• 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 ed tablets 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. 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.
Side effects of Vardenafil
• 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. 2 DOSAGE AND ADMINISTRATION 2.1 GeneralVardenafil hydrochloride orally disintegrating tablets are available in 10 mg orally disintegrating tablets.
- Unlike some ED medications, vardenafil may work in the presence of fatty foods.
- It requires sexual stimulation to produce an effect.
- Alcohol can increase the risk of side effects.
- Avoid combining with recreational drugs.
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 libido booster for women tongue where it will disintegrate. The tablet should be taken without liquid.
8.5 Geriatric Use
Drug Interactions
Anal. Chim. Acta
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. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil. Lower doses of vardenafil film-coated tablets should be used as initial therapy in these patients [see Dosage and Administration (2.4)]. Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may change to vardenafil hydrochloride orally disintegrating tablets at the advice of their healthcare provider [see Warnings and Precautions (5.6) and Drug Interactions (7.1). ]A time interval between dosing should be considered when vardenafil hydrochloride orally disintegrating tablets are prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)]. Vardenafil hydrochloride orally disintegrating tablets are available in 10 mg orally disintegrating tablets.
| Drug Category | Potential Interaction | Effect |
|---|---|---|
| Nitrates | Dangerous hypotension | Severe decrease in blood pressure |
| CYP3A4 Inhibitors | Increased vardenafil levels | Increased side effects |
| Alpha-blockers | Risk of hypotension | Dizziness, fainting |
| Pesticides (e.g., erythromycin) | Possible increased plasma levels | Enhanced side effects |
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. Sexual stimulation is required for a response to treatment. Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. It should be taken immediately upon removal from the blister.
- Vardenafil is effective for up to 4-5 hours.
- Do not use if allergic to vardenafil or similar drugs.
- Overdose symptoms may include prolonged erections.
- Medical advice is essential for any severe side effects.
Those patients who require a lower or higher dose of vardenafil need to be prescribed vardenafil film-coated tablets [see Patient Counseling Information (17)].
| Parameter | Value | Notes |
|---|---|---|
| Absorption Time | 30-60 minutes | Peak plasma concentration reached during this time |
| Half-life | 4-5 hours | Duration of drug activity |
| Bioavailability | Approximately 15% | Oral absorption efficiency |
| Metabolism | Via CYP3A4 enzyme | Liver processing of drug |
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