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The maximum dosing frequency is one vardenafil hydrochloride orally disintegrating tablet per day.

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Therefore, treatment for erectile dysfunction, including vardenafil hydrochloride orally disintegrating tablets, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status.There are no controlled clinical data on the safety or efficacy of vardenafil in the following patients; and therefore its use is not recommended until further information is available: unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within the last 6 months); severe cardiac failure.Left Ventricular Outflow ObstructionPatients with left ventricular outflow obstruction (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors.Blood Pressure EffectsVardenafil has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic) [see Clinical Pharmacology (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing vardenafil hydrochloride orally disintegrating tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 InhibitorsConcomitant administration with strong CYP3A4 inhibitors (such as ritonavir, indinavir, ketoconazole and cobicistat) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of vardenafil. Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors [see Dosage and Administration (2.4), Drug Interactions (7.2) and Patient Counseling Information (17). ]5.3 Risk of PriapismThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil. In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

Who should not take vardenafil?

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.Vardenafil hydrochloride orally disintegrating tablets should be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).5.4 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes.

What are some side effects that I need to call my doctor about right away?

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.

  • 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.

Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil.

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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 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.

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 cenforce 200 tablets for a response to treatment.

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Hepatic 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)]. Nitrates: 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)].

What are some other side effects of this drug?

Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. 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 tadalista 2 5 considered when vardenafil hydrochloride orally disintegrating tablets are prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)]. 4 CONTRAINDICATIONS 4.1 NitratesAdministration of vardenafil hydrochloride orally disintegrating tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)]. Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, may potentiate the hypotensive effects of nitrates. A suitable time interval following vardenafil hydrochloride orally disintegrating tablets dosing for the safe administration of nitrates or nitric oxide donors has not been determined.4.2 Guanylate Cyclase (GC) StimulatorsDo not use vardenafil hydrochloride orally disintegrating tablets in patients who are using a GC stimulator, such as riociguat.

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PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets may potentiate the hypotensive effects of GC stimulators. Administration of vardenafil hydrochloride orally disintegrating tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)]. A suitable time interval following vardenafil hydrochloride orally disintegrating tablets dosing for the safe administration of nitrates or nitric oxide donors has not been determined. Do not use vardenafil hydrochloride orally disintegrating tablets in patients who are using a GC stimulator, such as riociguat. 5 WARNINGS AND PRECAUTIONS The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment.Before prescribing vardenafil hydrochloride orally disintegrating tablets, it is important to note the following:5.1 Cardiovascular EffectsGeneralPhysicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. 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)].

5.8 Hepatic Impairment

Vardenafil hydrochloride orally disintegrating tablets can be taken with or without food.

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 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.

What are the most common side effects of 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. 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.

How does vardenafil work (mechanism of action)?

Sexual stimulation is required cenforce 200 tablets 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)]. Vardenafil hydrochloride orally disintegrating tablets can be taken with or without food. Hepatic 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)]. Nitrates: Concomitant use with nitrates in any form is contraindicated [see Contraindications (4.1)].

6.1 Clinical Studies Experience

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. 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 tadalista 2 5 considered when vardenafil hydrochloride orally disintegrating tablets are prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)]. 4 CONTRAINDICATIONS 4.1 NitratesAdministration of vardenafil hydrochloride orally disintegrating tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)]. Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, may potentiate the hypotensive effects of nitrates. A suitable time interval following vardenafil hydrochloride orally disintegrating tablets dosing for the safe administration of nitrates or nitric oxide donors has not been determined.4.2 Guanylate Cyclase (GC) StimulatorsDo not use vardenafil hydrochloride orally disintegrating tablets in patients who are using a GC stimulator, such as riociguat.

  • The safety profile of vardenafil is well established.
  • It is not recommended for use with other ED drugs.
  • Physical activity while on vardenafil may enhance effectiveness.
  • Notify your doctor if you experience severe pain.

PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets may potentiate the hypotensive effects of GC stimulators. Administration of vardenafil hydrochloride orally disintegrating tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see Clinical Pharmacology (12.2)]. A suitable time interval following vardenafil hydrochloride orally disintegrating tablets dosing for the safe administration of nitrates or nitric oxide donors has not been determined.

  • Vardenafil is available in tablet form, usually 5-20 mg.
  • It is designed to be taken as needed, not regularly.
  • Effects may vary based on age and health condition.
  • Always follow your healthcare provider’s instructions.

Do not use vardenafil hydrochloride orally disintegrating tablets in patients who are using a GC stimulator, such as riociguat.

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

5 WARNINGS AND PRECAUTIONS The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment.Before prescribing vardenafil hydrochloride orally disintegrating tablets, it is important to note the following:5.1 Cardiovascular EffectsGeneralPhysicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatment for erectile dysfunction, including vardenafil hydrochloride orally disintegrating tablets, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status.There are no controlled clinical data on the safety or efficacy of vardenafil in the following patients; and therefore its use is not recommended until further information is available: unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within the last 6 months); severe cardiac failure.Left Ventricular Outflow ObstructionPatients with left ventricular outflow obstruction (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors.Blood Pressure EffectsVardenafil has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic) [see Clinical Pharmacology (12.2)]. While this normally would be expected to be of little consequence in most patients, prior to prescribing vardenafil hydrochloride orally disintegrating tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 InhibitorsConcomitant administration with strong CYP3A4 inhibitors (such as ritonavir, indinavir, ketoconazole and cobicistat) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of vardenafil. Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors [see Dosage and Administration (2.4), Drug Interactions (7.2) and Patient Counseling Information (17). ]5.3 Risk of PriapismThere have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil. In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.Vardenafil hydrochloride orally disintegrating tablets should be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).5.4 Effects on the EyePhysicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes.