Levitra (Vardenafil)
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).
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Since higher doses of ketoconazole (400 mg daily) may result in higher increases in Cmax and AUC, a single 2.5 mg dose of LEVITRA should not be exceeded in a 24-hour period when used in combination with ketoconazole 400 mg daily. [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS] Indinavir (800 mg t.i.d.) co-administered with LEVITRA 10 mg resulted in a 16-fold increase in vardenafil AUC, a 7-fold increase in vardenafil Cmax and a 2-fold increase in vardenafil half-life. It is recommended not to exceed a single 2.5 mg LEVITRA dose in a 24-hour period when used in combination with indinavir. [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS] Ritonavir (600 mg b.i.d.) co-administered with LEVITRA 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13- fold increase in vardenafil Cmax. The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a HIV protease inhibitor and a highly strong CYP3A4 inhibitor, which also inhibits CYP2C9.
Prescription Notice
Ritonavir significantly prolonged the half-life of vardenafil to 26 hours. Consequently, it is recommended not to exceed a single 2.5 mg LEVITRA dose in a 72-hour period when used in combination with ritonavir. [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]. Cobicistat with LEVITRA can result in increased plasma concentrations, therefore it is recommended that a single 2.5 mg dose of LEVITRA should not be exceeded in a 72-hour period. [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS] Erythromycin (500 mg t.i.d.) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax when coadministered with LEVITRA 5 mg in healthy volunteers. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.
- The onset of action is usually within 30-60 minutes.
- Generic Levitra 20mg is widely available online and in pharmacies.
- Some patients may experience nasal congestion or upset stomach.
- Do not drive or operate machinery until you know how it affects you.
- It’s important to stay well-hydrated when taking the medication.
- Do not share your medication with others.
- It’s advisable to avoid grapefruit juice when using this drug.
- Use only as directed by your healthcare provider.
- The medication should not be used with certain medications like anti-arrhythmics.
- Women should avoid handling tablets to prevent accidental exposure.
- Discontinue use if you notice allergic reactions like rash or swelling.
- Maintaining a healthy lifestyle can enhance the medication’s effect.
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]. 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.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 10mg | 270 + 10 Pills | 338.09€ 321.99€ | |
| Levitra Generic | 40mg | 180 + 10 Pills | 405.06€ 385.77€ | |
| Levitra Generic | 60mg | 270 + 10 Pills | 714.53€ 680.50€ | |
| Levitra Professional | 20mg | 20 Pills | 101.00€ 96.19€ | |
| Levitra Professional | 20mg | 120 + 4 Pills | 348.44€ 331.85€ | |
| Levitra Generic | 10mg | 30 + 4 Pills | 62.39€ 59.42€ | |
| Levitra Generic | 10mg | 120 + 10 Pills | 178.59€ 170.09€ | |
| Levitra Original | 20mg | 14 + 2 Pills | 102.27€ 97.40€ | |
| Levitra Soft Tabs | 20mg | 270 + 10 Pills | 521.78€ 496.93€ | |
| Levitra Generic | 10mg | 10 Pills | 28.93€ 27.55€ | |
| Levitra Generic | 40mg | 90 + 6 Pills | 234.73€ 223.55€ |
Therefore, PDE5 inhibitors, including LEVITRA, should be used with caution in these patients and only when the anticipated benefits outweigh the risks.
Active Ingredient and Mechanism
It is recommended not to exceed a single 5 mg dose of LEVITRA in a 24-hour period when used in combination with erythromycin. [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS] Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase vardenafil exposure. No pharmacokinetic interactions were observed between vardenafil and the following drugs: glyburide, warfarin, digoxin, an antacid based on magnesium-aluminum hydroxide, and ranitidine. In the warfarin study, vardenafil had no effect on the prothrombin time or other pharmacodynamic parameters. Weak inhibitory effects toward other isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) were found, but Ki values were in excess of plasma concentrations achieved following dosing.
How does vardenafil work (mechanism of action)?
The most potent inhibitory activity was observed for vardenafil metabolite M1, which had a Ki of 1.4 micromolar toward CYP3A4, which is about 20 times higher than the M1 Cmax values after an 80 mg vardenafil dose. In vitro data suggest that vardenafil has the potential to inhibit P-glycoprotein (P-gp) at therapeutic doses. While concomitant use of LEVITRA did not significantly increase plasma concentrations of digoxin, a P-gp substrate, the effect on plasma concentrations of P-gp substrates that are more sensitive than digoxin (e.g. Vardenafil 20 mg, when co-administered with slow-release nifedipine 30 mg or 60 mg once daily, did not affect the AUC or Cmax of nifedipine, a drug that is metabolized via CYP3A4. Nifedipine did not alter the plasma levels of LEVITRA when taken in combination. 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.
| Use Case | Benefits | Onset (minutes) | Duration (hours) |
|---|---|---|---|
| Erectile Dysfunction (ED) | Improved firmness and control | 30-60 | Up to 36 |
| Pulmonary Arterial Hypertension | Increased exercise capacity | 15-30 | 4-6 |
| BPH symptom relief | Reduced urinary symptoms | Varies | Not specified |
| Off-label uses | Enhanced sexual confidence | 30-60 | Up to 36 |
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. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including vardenafil.
Side effects of Vardenafil
In these patients whose hypertension was controlled with nifedipine, LEVITRA 20 mg produced mean additional supine systolic/diastolic blood pressure reductions of 6/5 mmHg compared to placebo. Upon concomitant administration of 5 mg of LEVITRA with 600 mg BID ritonavir, the Cmax and AUC of ritonavir were reduced by approximately 20%. Upon administration of 10 mg of LEVITRA with 800 mg TID indinavir, the Cmax and AUC of indinavir were reduced by 40% and 30%, respectively. LEVITRA (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by aspirin (two 81 mg tablets). LEVITRA had no effect on the pharmacodynamics of glyburide (glucose and insulin concentrations) and warfarin (prothrombin time or other pharmacodynamic parameters).
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Included as part of the "PRECAUTIONS" Section 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. 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].
- Generic Levitra 20mg is used to treat erectile dysfunction in men.
- It contains the active ingredient Vardenafil, similar to Levitra brand.
- Typically taken orally about 30 minutes before sexual activity.
- The effects can last up to 4-5 hours per dose.
- Do not consume more than one tablet in 24 hours.
- Consult a doctor before use if taking nitrates or other medications.
- Possible side effects include headaches, flushing, and dizziness.
- Do not use if you have a history of heart problems without medical advice.
- Store in a cool, dry place away from children.
- Generic variants offer a cost-effective alternative to brand-name Levitra.
- The medication enhances blood flow to the penis for improved erection.
- Overdose may cause serious side effects like prolonged erection or chest pain.
PDE5 inhibitors, including LEVITRA, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
| Region | Price for 20mg Generic Levitra (per pill) | Typical Cost for Box of 30 |
|---|---|---|
| North America | $0.50 - $1.50 | $15 - $45 |
| Europe | €0.40 - €1.20 | €12 - €36 |
| Asia | $0.30 - $1.00 | $9 - $30 |
| Australia | AUD 1.00 - AUD 2.50 | AUD 30 - AUD 75 |
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.
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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]. 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 and DRUG INTERACTIONS]. Long-term safety information is not available levitra 10mg tablets 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.
Can Levitra 20mg be taken daily?
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 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 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.