LEVITRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION. Sudden Hearing Loss: Patients should stop LEVITRA and seek medical attention in the event of sudden decrease or loss in hearing. Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered 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). QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using LEVITRA. Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. To report SUSPECTED ADVERSE REACTIONS, contact BayerHealthCare Pharmaceuticals1-888-84-BAYER or FDA at 1-800-FDA-1088 or LEVITRA can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. LEVITRA® is indicated for the treatment of erectile dysfunction. For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity.
LEVITRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION. Sudden Hearing Loss: Patients should stop LEVITRA and seek medical attention in the event of sudden decrease or loss in hearing. Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered 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).
QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using LEVITRA. Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. To report SUSPECTED ADVERSE REACTIONS, contact BayerHealthCare Pharmaceuticals1-888-84-BAYER or FDA at 1-800-FDA-1088 or LEVITRA can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. LEVITRA® is indicated for the treatment of erectile dysfunction.
For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment. Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years of age [see Use in Specific Populations (8.5)]. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment. Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients ≥ 65 years of age [see Use in Specific Populations (8.5)]. Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg LEVITRA is recommended.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 60mg | 60 + 4 Pills | 198.85€ 189.38€ | |
| Levitra Generic | 20mg | 90 + 8 Pills | 180.78€ 172.17€ | |
| Levitra Generic | 60mg | 120 + 8 Pills | 372.33€ 354.60€ | |
| Levitra Generic | 10mg | 270 + 10 Pills | 338.09€ 321.99€ | |
| Levitra Generic | 20mg | 360 + 10 Pills | 458.44€ 436.61€ | |
| Levitra Generic | 60mg | 270 + 10 Pills | 714.53€ 680.50€ | |
| Levitra Generic | 20mg | 30 + 4 Pills | 70.59€ 67.23€ | |
| Levitra Generic | 10mg | 20 Pills | 46.54€ 44.32€ | |
| Levitra Generic | 10mg | 90 + 8 Pills | 150.58€ 143.41€ | |
| Levitra Soft Tabs | 20mg | 30 + 2 Pills | 99.17€ 94.45€ | |
| Levitra Professional | 20mg | 60 + 2 Pills | 223.11€ 212.49€ | |
| Levitra Original | 20mg | 92 + 4 Pills | 406.22€ 386.88€ | |
| Levitra Original | 20mg | 8 Pills | 65.05€ 61.95€ | |
| Levitra Generic | 20mg | 60 + 6 Pills | 131.11€ 124.87€ |
The maximum dose in patients with moderate hepatic levitra price costco impairment should not exceed 10 mg. Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C) [see Warnings and Precautions (5.8), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Renal Impairment: Do not use LEVITRA in patients on renal dialysis [see Warnings and Precautions (5.9), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Nitrates: Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see Contraindications (4.1)]. Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated [see Contraindications (4.2)].
| Feature | Description |
|---|---|
| Drug Name | Levitra Professional 20mg |
| Active Ingredient | Vardenafil |
| Dosage Strength | 20 milligrams |
| Form | Tablet |
| Manufacturer | Bayer Healthcare |
CYP3A4 Inhibitors: The dosage of LEVITRA may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions (7.2)]. For ritonavir, a single dose of 2.5 mg LEVITRA should not be exceeded in a 72-hour period. For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg LEVITRA should not be exceeded in a 24-hour period. For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg LEVITRA should not be exceeded in a 24-hour period. Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy.
Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg LEVITRA is recommended. The maximum dose in patients with moderate hepatic levitra price costco impairment should not exceed 10 mg. Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C) [see Warnings and Precautions (5.8), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Renal Impairment: Do not use LEVITRA in patients on renal dialysis [see Warnings and Precautions (5.9), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Nitrates: Concomitant use with nitrates and nitric oxide donors 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: The dosage of LEVITRA may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions (7.2)]. For ritonavir, a single dose of 2.5 mg LEVITRA should not be exceeded in a 72-hour period. For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg LEVITRA should not be exceeded in a 24-hour period. For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg LEVITRA should not be exceeded in a 24-hour period.
Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors). [See Warnings and Precautions (5.6) and Drug Interactions (7.1).] A time interval between dosing should be considered when Levitra is prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)]. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors). [See Warnings and Precautions (5.6) and Drug Interactions (7.1).] A time interval between dosing should be considered when Levitra is prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2)]. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “5”, “10” and “20” on the other side corresponding to 5 mg, 10 mg, and 20 mg of vardenafil, respectively.
Administration of LEVITRA 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 LEVITRA, may potentiate the hypotensive effects of nitrates.
Physicians should advise patients to stop taking all PDE5 inhibitors, including LEVITRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing. A suitable time interval following dosing of LEVITRA for the safe administration of nitrates or nitric oxide donors has not been determined. The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment. Before prescribing LEVITRA, it is important to note the following: 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 LEVITRA, 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. 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. LEVITRA 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 LEVITRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Dosage adjustment is necessary when LEVITRA is administered with certain CYP3A4 inhibitors [see Dosage and Administration (2.4), Drug Interactions (7.2)]. Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors. 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.
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. LEVITRA 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 levitra generic no prescription 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 LEVITRA, 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 non-arteritic 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 2.5–11.8 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, 5.20). 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 LEVITRA, 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 LEVITRA, for this uncommon condition. LEVITRA 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. 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. LEVITRA 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 levitra generic no prescription predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “5”, “10” and “20” on the other side corresponding to 5 mg, 10 mg, and 20 mg of vardenafil, respectively. Administration of LEVITRA 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 LEVITRA, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of LEVITRA for the safe administration of nitrates or nitric oxide donors has not been determined. The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment.
Before prescribing LEVITRA, it is important to note the following: 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 LEVITRA, 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. 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. LEVITRA 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 LEVITRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Dosage adjustment is necessary when LEVITRA is administered with certain CYP3A4 inhibitors [see Dosage and Administration (2.4), Drug Interactions (7.2)]. Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors. 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. In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including LEVITRA, 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 non-arteritic 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 2.5–11.8 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.
| Side Effect | Frequency | Severity |
|---|---|---|
| Headache | Common | Mild |
| Flushing | Common | Mild |
| Nasal Congestion | Common | Mild |
| Dyspepsia | Less frequent | Mild |
| Dizziness | Less frequent | Mild |
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, 5.20).
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 LEVITRA, 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 LEVITRA, for this uncommon condition. LEVITRA 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 LEVITRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing.