WARNINGS AND PRECAUTIONS
Blood pressure effects (standing SBP) in normotensive men on stable dose terazosin (5 mg or 10 mg) following simultaneous administration of vardenafil 5 mg or placebo, or following administration of vardenafil 5 mg or placebo separated by 6 hours, are shown in Figure 3. Figure 2: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 5 mg or placebo with stable dose tamsulosin 0.4 mg in normotensive BPH patients (study 1) Figure 3: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 5 mg or placebo with stable dose terazosin (5 or 10 mg) in normotensive BPH patients (study 1) Study 2: This study was designed to evaluate the effect of 10 mg vardenafil (film-coated tablets) (stage 1) and 20 mg vardenafil (film-coated tablets) (stage 2) compared to placebo, when administered to a single cohort of BPH patients (n=23) on stable therapy with tamsulosin 0.4 mg or 0.8 mg daily for at least four weeks. Table 3: Mean (95% CI) maximal change from baseline in systolic blood pressure (mmHg) following vardenafil 10 and 20 mg (film-coated tablets) in BPH patients on stable alpha-blocker therapy with tamsulosin 0.4 or 0.8 mg daily (study 2) Blood pressure effects (standing SBP) in normotensive men on stable dose of tamsulosin 0.4 mg following simultaneous administration of vardenafil 10 mg, vardenafil 20 mg or placebo are shown in Figure 4. Figure 4: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous administration of vardenafil 10 mg film-coated tablet (stage 1), vardenafil 20 mg film-coated tablet (Stage 2), or placebo with stable dose tamsulosin 0.4 mg in normotensive BPH patients (study 2) Study 3: This study was designed to evaluate the effect of single doses of 5 mg vardenafil (stage 1) and 10 mg vardenafil (stage 2) compared to placebo, when administered to a single cohort of BPH patients (n=24) on stable therapy with alfuzosin 10 mg daily for at least four weeks.
| 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 |
Table 4: Mean (95% C.I.) maximal change from baseline in systolic blood pressure (mmHg) following vardenafil 5 and 10 mg in BPH patients on stable alpha-blocker therapy with alfuzosin 10 mg daily (Study 3) One patient experienced decreases from baseline in standing systolic blood pressure >30 mm Hg after administration of vardenafil 5 mg film-coated tablets and vardenafil 10 mg film-coated tablets. Blood pressure effects (standing SBP) in normotensive men on a stable dose of alfuzosin 10 mg following administration of vardenafil 5 mg, vardenafil 10 mg, or placebo separated by 4 hours, are shown in Figure 5. Figure 5: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following 4 hr separation administration of vardenafil 5 mg (stage 1), vardenafil 10 mg (stage 2) or placebo with stable dose alfuzosin 10 mg in BPH patients (Study 3) Blood Pressure Effects in Normotensive Men After Forced Titration with Alpha-Blockers Table 5: Mean (95% CI) maximal change in baseline in systolic blood pressure (mmHg) following vardenafil 10 and 20 mg (film-coated tablets) in healthy volunteers on daily alpha-blocker therapy * Due to the sample size, confidence intervals may not be an accurate measure for these data.
What side effects can this medication cause?
13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis & Mutagenesis & Impairment of FertilityCarcinogenesisVardenafil was not carcinogenic in rats and mice when administered daily for 24 months. In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite were approximately 400-and 170-fold for male and female rats, respectively, and 21-and 37-fold for male and female mice, respectively, the exposures observed in human males given the maximum recommended human dose (MRHD) of 20 mg.MutagenesisVardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V79 cells. These values represent the range for the difference. Figure 6: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg and 20 mg (film-coated tablets) or placebo with terazosin (10 mg) in healthy volunteers Figure 7: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg and 20 mg (film-coated tablets) or placebo with tamsulosin (0.4 mg) in healthy volunteers The effect of 10 mg and 80 mg vardenafil, administered as film-coated tablets, on QT interval was evaluated in a single-dose, double-blind, randomized, placebo-and active-controlled (moxifloxacin 400 mg) crossover study in 59 healthy males (81% White, 12% Black, 7% Hispanic) aged 45–60 years. In this study, the mean increase in heart rate associated with a 10 mg dose of vardenafil, administered as a film-coated tablet, compared to placebo was 5 beats/minute and with an 80 mg dose of vardenafil the mean increase was 6 beats/minute. Table 6: Mean QT and QTc changes in msec (90% CI) from baseline relative to placebo at 1 hour post-dose with different methodologies to correct for the effect of heart rate * Active control (drug known to prolong QT) Therapeutic and supratherapeutic doses of vardenafil and the active control moxifloxacin produced similar increases in QTc interval. The clinical impact of these QTc changes is unknown [see Warnings and Precautions (5)]. In a separate postmarketing study of 44 healthy volunteers, single doses of 10 mg vardenafil (film-coated tablet) resulted in a placebo-subtracted mean change from baseline of QTcF (Fridericia correction) of 5 msec (90% CI: 2,8). The clinical impact of these QT changes is online levitra pharmacy unknown [see Warnings and Precautions (5.7)].
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 10mg | 270 + 10 Pills | 338.09€ 321.99€ | |
| Levitra Soft Tabs | 20mg | 90 + 6 Pills | 241.31€ 229.82€ | |
| Levitra Generic | 40mg | 60 + 4 Pills | 162.37€ 154.64€ | |
| Levitra Original | 20mg | 8 Pills | 65.05€ 61.95€ | |
| Levitra Professional | 20mg | 10 Pills | 62.37€ 59.40€ | |
| Levitra Generic | 20mg | 20 Pills | 52.63€ 50.12€ | |
| Levitra Generic | 40mg | 10 Pills | 41.37€ 39.40€ | |
| Levitra Soft Tabs | 20mg | 30 + 2 Pills | 99.17€ 94.45€ | |
| Levitra Professional | 20mg | 360 + 6 Pills | 914.63€ 871.08€ | |
| Levitra Professional | 20mg | 30 Pills | 119.12€ 113.45€ | |
| Levitra Generic | 20mg | 270 + 10 Pills | 376.33€ 358.41€ | |
| Levitra Original | 20mg | 64 + 4 Pills | 298.45€ 284.24€ | |
| Levitra Generic | 10mg | 90 + 8 Pills | 150.58€ 143.41€ |
Effects on Exercise Treadmill Test in Patients with Coronary Artery Disease (CAD) In two independent trials that assessed 10 mg (n=41) and 20 mg (n=39) vardenafil (film-coated tablets), respectively, vardenafil did not alter the total treadmill exercise time compared to placebo. The patient population included men aged 40–80 years with stable exercise-induced angina documented by at least one of the following: 1) prior history of myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), or stenting (not within 6 months); 2) positive coronary angiogram showing at least 60% narrowing of the diameter of at least one major coronary artery; or 3) a positive stress echocardiogram or stress nuclear perfusion study.
Brand names
Vardenafil orally disintegrating tablet can be taken with or without food. Effect of water: When vardenafil orally disintegrating tablet was swallowed with water, the AUC of vardenafil was reduced by 29% and median Tmax was shortened by 60 minutes while Cmax was not affected. Vardenafil orally disintegrating tablet should be taken without liquid. The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. Following a single oral dose of 20 mg vardenafil film-coated tablet in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing.
Pseudoephedrine HCl (Sudafed)
Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. The mean terminal half-life of vardenafil in patients receiving vardenafil orally disintegrating tablets varied between about 4–6 hours. Vardenafil is a high clearance drug with a plasma clearance of 56.4 L/h following intravenous administration. Vardenafil AUC and Cmax in elderly patients (65 years or older) taking vardenafil orally disintegrating tablets were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below [see Use in Specific Populations (8.5)]. [See Dosage and Administration (2.3), Warnings and Precautions (5.8), and Use in Specific Populations (8.6).] In volunteers with mild renal impairment (CLcr = 50–80 mL/min), the pharmacokinetics of vardenafil were similar to those observed in a control group with normal renal function. Results of these studies showed that vardenafil did not alter the total treadmill exercise time compared to placebo (vardenafil 10 mg vs. placebo: 433±109 and 426±105 seconds, respectively; 20 mg vardenafil vs. placebo: 414±114 and 411±124 seconds, respectively). The total time to 1 mm or greater ST-segment depression was similar to placebo in both the 10 mg and the 20 mg vardenafil groups (10 mg vardenafil vs. placebo: 380±108 and 334±108 seconds; 20 mg vardenafil vs. placebo: 364±101 and 366±105 seconds, respectively). In another double-blind, placebo-controlled clinical trial, at least 15 doses of 20 mg vardenafil were administered over 8 weeks versus placebo to 52 males.
2.2 Use with Food
placebo: 380±108 and 334±108 seconds; 20 mg vardenafil vs. placebo: 364±101 and 366±105 seconds, respectively). In another double-blind, placebo-controlled clinical trial, at least 15 doses of 20 mg vardenafil were administered over 8 weeks versus placebo to 52 males. The pharmacokinetics of vardenafil and its M1 metabolite from vardenafil orally disintegrating tablet have been evaluated in healthy male volunteers (18–50 years) and in young (18–45 years) and elderly (≥ 65 years) erectile dysfunction patients. Studies have shown that vardenafil orally disintegrating tablet provides higher systemic exposure of vardenafil compared to vardenafil 10 mg film-coated tablets.
Drugs and Foods to Avoid:
Mean vardenafil plasma concentrations measured after the administration of a single oral dose vardenafil levitra 20 brand orally disintegrating tablet to patients with erectile dysfunction (18-45 years) are depicted in Figure 8. The median time to reach Cmax (Tmax ) in patients receiving vardenafil orally disintegrating tablet in the fasted state was 1.5 h [range: 0.75 – 2.5 h]. In a study of healthy male volunteers (18–50 years), the mean Cmax and AUC of vardenafil from vardenafil orally disintegrating tablet were higher by 15% and 44%, respectively compared to 10 mg vardenafil film-coated tablets. Vardenafil was not found to accumulate in plasma when vardenafil orally disintegrating tablet was dosed daily over ten days. Effect of food: A high fat meal had no effect on vardenafil AUC and Tmax from vardenafil orally disintegrating tablet in healthy volunteers and reduced Cmax by 35%. The pharmacokinetics of vardenafil and its M1 metabolite from vardenafil orally disintegrating tablet have been evaluated in healthy male volunteers (18–50 years) and in young (18–45 years) and elderly (≥ 65 years) erectile dysfunction patients.
WHY is this medicine prescribed?
Studies have shown that vardenafil orally disintegrating tablet provides higher systemic exposure of vardenafil compared to vardenafil 10 mg film-coated tablets.
In case of emergency/overdose
Blood pressure effects (standing SBP) in normotensive men on stable dose terazosin (5 mg or 10 mg) following simultaneous administration of vardenafil 5 mg or placebo, or following administration of vardenafil 5 mg or placebo separated by 6 hours, are shown in Figure 3. Figure 2: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 5 mg or placebo with stable dose tamsulosin 0.4 mg in normotensive BPH patients (study 1) Figure 3: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 5 mg or placebo with stable dose terazosin (5 or 10 mg) in normotensive BPH patients (study 1) Study 2: This study was designed to evaluate the effect of 10 mg vardenafil (film-coated tablets) (stage 1) and 20 mg vardenafil (film-coated tablets) (stage 2) compared to placebo, when administered to a single cohort of BPH patients (n=23) on stable therapy with tamsulosin 0.4 mg or 0.8 mg daily for at least four weeks. Table 3: Mean (95% CI) maximal change from baseline in systolic blood pressure (mmHg) following vardenafil 10 and 20 mg (film-coated tablets) in BPH patients on stable alpha-blocker therapy with tamsulosin 0.4 or 0.8 mg daily (study 2) Blood pressure effects (standing SBP) in normotensive men on stable dose of tamsulosin 0.4 mg following simultaneous administration of vardenafil 10 mg, vardenafil 20 mg or placebo are shown in Figure 4. Figure 4: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous administration of vardenafil 10 mg film-coated tablet (stage 1), vardenafil 20 mg film-coated tablet (Stage 2), or placebo with stable dose tamsulosin 0.4 mg in normotensive BPH patients (study 2) Study 3: This study was designed to evaluate the effect of single doses of 5 mg vardenafil (stage 1) and 10 mg vardenafil (stage 2) compared to placebo, when administered to a single cohort of BPH patients (n=24) on stable therapy with alfuzosin 10 mg daily for at least four weeks. Table 4: Mean (95% C.I.) maximal change from baseline in systolic blood pressure (mmHg) following vardenafil 5 and 10 mg in BPH patients on stable alpha-blocker therapy with alfuzosin 10 mg daily (Study 3) One patient experienced decreases from baseline in standing systolic blood pressure >30 mm Hg after administration of vardenafil 5 mg film-coated tablets and vardenafil 10 mg film-coated tablets.
Coping with ED
Blood pressure effects (standing SBP) in normotensive men on a stable dose of alfuzosin 10 mg following administration of vardenafil 5 mg, vardenafil 10 mg, or placebo separated by 4 hours, are shown in Figure 5. Figure 5: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following 4 hr separation administration of vardenafil 5 mg (stage 1), vardenafil 10 mg (stage 2) or placebo with stable dose alfuzosin 10 mg in BPH patients (Study 3) Blood Pressure Effects in Normotensive Men After Forced Titration with Alpha-Blockers Table 5: Mean (95% CI) maximal change in baseline in systolic blood pressure (mmHg) following vardenafil 10 and 20 mg (film-coated tablets) in healthy volunteers on daily alpha-blocker therapy * Due to the sample size, confidence intervals may not be an accurate measure for these data. These values represent the range for the difference. Figure 6: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg and 20 mg (film-coated tablets) or placebo with terazosin (10 mg) in healthy volunteers Figure 7: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg and 20 mg (film-coated tablets) or placebo with tamsulosin (0.4 mg) in healthy volunteers The effect of 10 mg and 80 mg vardenafil, administered as film-coated tablets, on QT interval was evaluated in a single-dose, double-blind, randomized, placebo-and active-controlled (moxifloxacin 400 mg) crossover study in 59 healthy males (81% White, 12% Black, 7% Hispanic) aged 45–60 years. In this study, the mean increase in heart rate associated with a 10 mg dose of vardenafil, administered as a film-coated tablet, compared to placebo was 5 beats/minute and with an 80 mg dose of vardenafil the mean increase was 6 beats/minute. Mean vardenafil plasma concentrations measured after the administration of a single oral dose vardenafil levitra 20 brand orally disintegrating tablet to patients with erectile dysfunction (18-45 years) are depicted in Figure 8. The median time to reach Cmax (Tmax ) in patients receiving vardenafil orally disintegrating tablet in the fasted state was 1.5 h [range: 0.75 – 2.5 h].
- The liquid form can be flavored for better taste.
- Not suitable for individuals with certain health conditions.
- Medical supervision is essential for safe use.
In a study of healthy male volunteers (18–50 years), the mean Cmax and AUC of vardenafil from vardenafil orally disintegrating tablet were higher by 15% and 44%, respectively compared to 10 mg vardenafil film-coated tablets. Vardenafil was not found to accumulate in plasma when vardenafil orally disintegrating tablet was dosed daily over ten days. Effect of food: A high fat meal had no effect on vardenafil AUC and Tmax from vardenafil orally disintegrating tablet in healthy volunteers and reduced Cmax by 35%. Vardenafil orally disintegrating tablet can be taken with or without food. Effect of water: When vardenafil orally disintegrating tablet was swallowed with water, the AUC of vardenafil was reduced by 29% and median Tmax was shortened by 60 minutes while Cmax was not affected. Vardenafil orally disintegrating tablet should be taken without liquid. The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. Following a single oral dose of 20 mg vardenafil film-coated tablet in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing. Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. The mean terminal half-life of vardenafil in patients receiving vardenafil orally disintegrating tablets varied between about 4–6 hours.
- Liquid Levitra is an oral medication for erectile dysfunction.
- It is formulated for faster absorption than tablets.
- Typically administered with a liquid dose for convenience.
Vardenafil is a high clearance drug with a plasma clearance of 56.4 L/h following intravenous administration.
5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors
Table 6: Mean QT and QTc changes in msec (90% CI) from baseline relative to placebo at 1 hour post-dose with different methodologies to correct for the effect of heart rate * Active control (drug known to prolong QT) Therapeutic and supratherapeutic doses of vardenafil and the active control moxifloxacin produced similar increases in QTc interval. The clinical impact of these QTc changes is unknown [see Warnings and Precautions (5)]. In a separate postmarketing study of 44 healthy volunteers, single doses of 10 mg vardenafil (film-coated tablet) resulted in a placebo-subtracted mean change from baseline of QTcF (Fridericia correction) of 5 msec (90% CI: 2,8). The clinical impact of these QT changes is online levitra pharmacy unknown [see Warnings and Precautions (5.7)]. Effects on Exercise Treadmill Test in Patients with Coronary Artery Disease (CAD) In two independent trials that assessed 10 mg (n=41) and 20 mg (n=39) vardenafil (film-coated tablets), respectively, vardenafil did not alter the total treadmill exercise time compared to placebo.
Matrix effects
The patient population included men aged 40–80 years with stable exercise-induced angina documented by at least one of the following: 1) prior history of myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), or stenting (not within 6 months); 2) positive coronary angiogram showing at least 60% narrowing of the diameter of at least one major coronary artery; or 3) a positive stress echocardiogram or stress nuclear perfusion study. Results of these studies showed that vardenafil did not alter the total treadmill exercise time compared to placebo (vardenafil 10 mg vs. placebo: 433±109 and 426±105 seconds, respectively; 20 mg vardenafil vs. placebo: 414±114 and 411±124 seconds, respectively). The total time to 1 mm or greater ST-segment depression was similar to placebo in both the 10 mg and the 20 mg vardenafil groups (10 mg vardenafil vs. Vardenafil AUC and Cmax in elderly patients (65 years or older) taking vardenafil orally disintegrating tablets were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below [see Use in Specific Populations (8.5)]. [See Dosage and Administration (2.3), Warnings and Precautions (5.8), and Use in Specific Populations (8.6).] In volunteers with mild renal impairment (CLcr = 50–80 mL/min), the pharmacokinetics of vardenafil were similar to those observed in a control group with normal renal function. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis & Mutagenesis & Impairment of FertilityCarcinogenesisVardenafil was not carcinogenic in rats and mice when administered daily for 24 months. In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite were approximately 400-and 170-fold for male and female rats, respectively, and 21-and 37-fold for male and female mice, respectively, the exposures observed in human males given the maximum recommended human dose (MRHD) of 20 mg.MutagenesisVardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V79 cells.