Vardenafil 10mg - 4 Tablets

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.

Warnings & Precautions

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)].

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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 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 sex for man tablet 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. 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.

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Sexual stimulation is required for a response to treatment. Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate.

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

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)].

Drug Label Information

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.

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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. 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)]. 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 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 sex for man tablet 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.

• Vardenafil 10 mg should not be used with certain medications.
• Grapefruit or grapefruit juice may have interactions.
• Inform your doctor about all health conditions before use.
• The medication may cause vision changes or sensitivity.
• Do not use vardenafil if you have liver or kidney issues.
• The pill helps achieve and maintain an erection.
• Follow prescribed dosage to avoid complications.
• Not effective as an aphrodisiac without sexual stimulation.
• Avoid using recreational drugs along with vardenafil.
• Regular medical check-ups are recommended during use.

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. 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. 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. Such an event may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors.

• Vardenafil 10 mg is one of several ED treatment options.
• It is generally well-tolerated when used properly.
• Take care to follow your healthcare provider’s instructions.
• Possible interactions with antihypertensive drugs exist.
• Do not drive or operate machinery if feeling dizzy.
• Keep a record of any side effects experienced.
• The medication is not a cure for erectile dysfunction.
• Combining vardenafil with other ED drugs is dangerous.
• Take the tablet with a full glass of water.
• Consult your doctor for dose adjustments if needed.

Based on published literature, the annual incidence of NAION is 2.5 to 11.8 cases per 100,000 in males aged ≥50.An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period.

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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 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.

Who should not take 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. 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. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34).

Parameter	Result	Notes
Absorption Time	30-60 minutes	Time to peak plasma concentration (Tmax)
Bioavailability	~15%	Percentage of dose reaching systemic circulation
Half-life	4-5 hours	Duration of effect
Metabolism	Liver (CYP3A4 enzyme)	Mainly via hepatic pathways
Excretion	Feces (~60%), Urine (~20%)	Primary routes

A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.2). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions (6.2)].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence.

Vardenafil (Generic Levitra®) FAQs

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. Such an event may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Based on published literature, the annual incidence of NAION is 2.5 to 11.8 cases per 100,000 in males aged ≥50.An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.2).

What are the serious side effects of vardenafil?

Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE5 inhibitor use and NAION [see Adverse Reactions (6.2)].Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, for this uncommon condition.Vardenafil hydrochloride orally disintegrating tablets have not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients.5.5 Sudden Hearing LossPhysicians should advise patients to stop taking all PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. Therefore, PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with “crowded” optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, for this uncommon condition.Vardenafil hydrochloride orally disintegrating tablets have not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients.5.5 Sudden Hearing LossPhysicians should advise patients to stop taking all PDE5 inhibitors, including vardenafil hydrochloride orally disintegrating tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing.