DOSAGE AND ADMINISTRATION

7.3 Effects of Vardenafil on Other Drugs
See also:
Overdose/Missed Dose
Warnings & Precautions
14.1 Trials in a General Erectile Dysfunction Population
Vardenafil Generic Name & Formulations
8.5 Geriatric Use

The design was a randomized, double blind, 3 period cross-over study.

Side Effect	Incidence Rate	Severity	Notes
Headache	Common	Mild to moderate	Usually temporary
Flushing	Common	Mild	Warm sensation
Nasal Congestion	Common	Mild	Sneezing, stuffy nose
Dizziness	Less frequent	Mild	When standing up quickly

Vardenafil or placebo was administered 4 hours after the administration of alfuzosin. Blood pressure and pulse were evaluated over a 10-hour interval after dosing of vardenafil or placebo. For BP results see Table 4.One patient experienced decreases from baseline in standing systolic blood pressure >30 mm Hg after administration of vardenafil 5 mg tablet and vardenafil 10 mg tablet. No instances of standing systolic blood pressure <85 mm Hg were observed during this study. Four patients, one dosed with placebo, two dosed with vardenafil 5 mg tablets and one dosed with vardenafil 10 mg tablets, reported dizziness. 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:Two randomized, double blind, placebo-controlled clinical pharmacology studies with healthy normotensive volunteers (age range, 45-74 years) were performed after forced titration of the alpha-blocker terazosin to 10 mg daily over 14 days (n=29), and after initiation of tamsulosin 0.4 mg daily for five days (n=24). There were no severe adverse events related to hypotension in either study. Symptoms of hypotension were a cause for withdrawal in 2 subjects receiving terazosin and in 4 subjects receiving tamsulosin. Instances of outlier blood pressure values (defined as standing SBP <85 mmHg and/or a decrease from baseline of standing SBP >30 mmHg) were observed in 9/24 subjects receiving tamsulosin and 19/29 receiving terazosin.

7.3 Effects of Vardenafil on Other Drugs

The incidence of subjects with standing SBP <85 mmHg given vardenafil and terazosin to achieve simultaneous T max led to early termination of that arm of the study. In most (7/8) of these subjects, instances of standing SBP <85 mmHg were not associated with symptoms. Among subjects treated with terazosin, outlier values were observed more frequently when vardenafil and terazosin were given to achieve simultaneous T max than when dosing was administered to separate T max by 6 hours. There were 3 cases of dizziness observed with concomitant administration of terazosin and vardenafil. Seven subjects experienced dizziness mainly occurring with simultaneous T max administration of tamsulosin.

storage temp.

There were no cases of syncope.Effects on Cardiac ElectrophysiologyThe effect of 10 mg and 80 mg vardenafil 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. The QT interval was measured at one hour post dose because this time point approximates the average time of peak vardenafil concentration. The 80 mg dose of vardenafil hydrochloride tablets (four times the highest recommended dose) was chosen because this dose yields plasma concentrations covering those observed upon co-administration of a low-dose of vardenafil hydrochloride tablets (5 mg) and 600 mg BID of ritonavir. Of the CYP3A4 inhibitors that have been studied, ritonavir causes the most significant drug-drug interaction with vardenafil. Table 6 summarizes the effect on mean uncorrected QT and mean corrected QT interval (QT c) with different methods of correction (Fridericia and a linear individual correction method) at one hour post-dose. The incidence of subjects with standing SBP <85 mmHg given vardenafil and terazosin to achieve simultaneous T max led to early termination of that arm of the study. In most (7/8) of these subjects, instances of standing SBP <85 mmHg were not associated with symptoms. Among subjects treated with terazosin, outlier values were observed more frequently when vardenafil and terazosin were given to achieve simultaneous T max than when dosing was administered to separate T max by 6 hours. There were 3 cases of dizziness observed with concomitant administration of terazosin and vardenafil. Seven subjects experienced dizziness mainly occurring with simultaneous T max administration of tamsulosin. There were no cases of syncope.Effects on Cardiac ElectrophysiologyThe effect of 10 mg and 80 mg vardenafil 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. The QT interval was measured at one hour post dose because this time point approximates the average time of peak vardenafil concentration. The 80 mg dose of vardenafil hydrochloride tablets (four times the highest recommended dose) was chosen because this dose yields plasma concentrations covering those observed upon co-administration of a low-dose of vardenafil hydrochloride tablets (5 mg) and 600 mg BID of ritonavir. Of the CYP3A4 inhibitors that have been studied, ritonavir causes the most significant drug-drug interaction with vardenafil.

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Table 6 summarizes the effect on mean uncorrected QT and mean corrected QT interval (QT c) with different methods of correction (Fridericia and a linear individual correction method) at one hour post-dose. No single correction method is known to be more valid than the other. In this study, the mean increase in heart rate associated with a 10 mg dose of vardenafil hydrochloride tablets compared to placebo was 5 beats/minute and with an 80 mg dose of vardenafil hydrochloride tablets the mean increase was 6 beats/minute.Therapeutic and supratherapeutic doses of vardenafil and the active control moxifloxacin produced similar increases in QT c interval.

Overdose/Missed Dose

No single correction method is known to be more valid than the other. In this study, the mean increase in heart rate associated with a 10 mg dose of vardenafil hydrochloride tablets compared to placebo was 5 beats/minute and with an 80 mg dose of vardenafil hydrochloride tablets the mean increase was 6 beats/minute.Therapeutic and supratherapeutic doses of vardenafil and the active control moxifloxacin produced similar increases in QT c interval. This study, however, was not designed to make direct statistical comparisons between the drug or the dose levels. The clinical impact of these QT c changes is unknown [see Warnings and Precautions (5)] .In a separate postmarketing study of 44 healthy volunteers, single doses of 10 mg vardenafil hydrochloride tablets resulted in a placebo- subtracted mean change from baseline of QTcF (Fridericia correction) of 5 msec (90% CI: 2,8). Single doses of gatifloxacin 400mg resulted in a placebo-subtracted mean change from baseline sex tablet 100mg QTcF of 4 msec (90% CI: 1,7).

Vardenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

When vardenafil hydrochloride tablets 10mg and gatifloxacin 400 mg were co-administered, the mean QTcF change from baseline was additive when compared to either drug alone and produced a mean QTcF change of 9 msec from baseline (90% CI: 6,11). The clinical impact of these QT changes is 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, 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.Results of these studies showed that vardenafil hydrochloride tablets did not alter the total treadmill exercise time compared to placebo (10 mg vardenafil hydrochloride tablets vs. placebo: 433±109 and 426±105 seconds, respectively; 20 mg vardenafil hydrochloride tablets vs. placebo: 414±114 and 411±124 seconds, respectively). When vardenafil hydrochloride tablets 10mg and gatifloxacin 400 mg were co-administered, the mean QTcF change from baseline was additive when compared to either drug alone and produced a mean QTcF change of 9 msec from baseline (90% CI: 6,11). The clinical impact of these QT changes is 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, 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.Results of these studies showed that vardenafil hydrochloride tablets did not alter the total treadmill exercise time compared to placebo (10 mg vardenafil hydrochloride tablets vs. placebo: 433±109 and 426±105 seconds, respectively; 20 mg vardenafil hydrochloride tablets vs.

Warnings & Precautions

The design was a randomized, double blind, 3 period cross-over study. Vardenafil or placebo was administered 4 hours after the administration of alfuzosin. Blood pressure and pulse were evaluated over a 10-hour interval after dosing of vardenafil or placebo. For BP results see Table 4.One patient experienced decreases from baseline in standing systolic blood pressure >30 mm Hg after administration of vardenafil 5 mg tablet and vardenafil 10 mg tablet. No instances of standing systolic blood pressure <85 mm Hg were observed during this study.

How should I store vardenafil?

Four patients, one dosed with placebo, two dosed with vardenafil 5 mg tablets and one dosed with vardenafil 10 mg tablets, reported dizziness. 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:Two randomized, double blind, placebo-controlled clinical pharmacology studies with healthy normotensive volunteers (age range, 45-74 years) were performed after forced titration of the alpha-blocker terazosin to 10 mg daily over 14 days (n=29), and after initiation of tamsulosin 0.4 mg daily for five days (n=24). There were no severe adverse events related to hypotension in either study. Symptoms of hypotension were a cause for withdrawal in 2 subjects receiving terazosin and in 4 subjects receiving tamsulosin. Instances of outlier blood pressure values (defined as standing SBP <85 mmHg and/or a decrease from baseline of standing SBP >30 mmHg) were observed in 9/24 subjects receiving tamsulosin and 19/29 receiving terazosin. placebo: 414±114 and 411±124 seconds, respectively). The total time to angina was not altered by vardenafil hydrochloride tablets when compared to placebo (10 mg vardenafil hydrochloride tablets vs. placebo: 291±123 and 292±110 seconds; 20 mg vardenafil hydrochloride tablets vs.

Vardenafil 10mg is one of the options for treating ED, alongside others like sildenafil.
The pill should be taken as directed; do not split or crush it.
It should not be taken by those with hypersensitivity to its components.
Consult your healthcare provider before starting vardenafil if unsure about safety.
The medication may improve quality of life and intimate relationships.
Regular medical evaluation is important to ensure safe medication use.
Not all men respond to vardenafil; some may require alternative treatments.
Side effects like dizziness can impair your ability to operate machinery.
Avoid using vardenafil if you are taking medications that contain nitrates.
Always keep track of your medication usage and report adverse effects.

placebo: 354±137 and 347±143 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 hydrochloride tablet groups (10 mg vardenafil hydrochloride tablets vs. placebo: 380±108 and 334±108 seconds; 20 mg vardenafil hydrochloride tablets vs.

14.1 Trials in a General Erectile Dysfunction Population

Vardenafil 10mg can improve confidence and sexual satisfaction.
Use it responsibly to avoid dependency or misusage.
Discuss any allergies to medications with your healthcare provider.
Always follow the prescribed regimen for optimal results.
It’s important to inform your doctor about any recent surgeries or health issues.
Certain foods and beverages may affect the medication’s effectiveness.
Vardenafil should not be used in combination with recreational drugs.
Notify your doctor if you experience persistent pain or erection.
Be aware of potential vision changes, including blurred or blue-tinted vision.
Store medication safely to prevent accidental ingestion by children.

The findings were most evident one hour after administration, diminishing but still present 6 hours after administration. In a single dose study in 25 normal males, vardenafil hydrochloride tablets 40 mg, twice the maximum daily recommended dose, did not alter visual acuity, intraocular pressure, fundoscopic and slit lamp findings.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. Thirty-two (32) males (62%) of the patients completed the trial. Retinal function was measured by ERG and FM-100 test 2, 6 and 24 hours after dosing. The trial was designed to detect changes in retinal function that might occur in more than 10% of patients. Vardenafil did not produce clinically significant ERG or FM-100 effects in healthy men compared to placebo. Two patients on vardenafil in the trial reported episodes of transient cyanopsia (objects appear blue).12.3 PharmacokineticsThe pharmacokinetics of vardenafil are approximately dose proportional over the recommended dose range.AbsorptionMean vardenafil plasma concentrations measured after the administration of a single oral dose of 20 mg to healthy male volunteers are depicted in Figure 8.Figure 8: Plasma Vardenafil Concentration (Mean ± SD) Curve for a Single 20 mg Vardenafil Hydrochloride Tablets DoseVardenafil is rapidly absorbed with absolute bioavailability of approximately 15%.

Drug Class	Interaction Type	Effect	Recommendation
Nitrates	Additive hypotension	Risk of severe low blood pressure	Do not combine
CYP3A4 inhibitors	Increased Vardenafil levels	Potential side effects	Adjust dosage if necessary
Alpha-blockers	Enhanced hypotensive effect	Dizziness, fainting	Use with caution
Alpha-adrenergic agents	Blood pressure changes	Fluctuations in BP	Monitor blood pressure closely

Maximum observed plasma concentrations after a single 20 mg dose in healthy volunteers are usually reached between 30 minutes and 2 hours (median 60 minutes) after oral dosing in the fasted state. Two food-effect studies were conducted which showed that high- fat meals caused a reduction in C max by 18%-50%.DistributionThe mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. Vardenafil and its major circulating metabolite, M1, are highly bound to plasma proteins (about 95% for parent drug and M1).

Vardenafil Generic Name & Formulations

Retinal function was measured by ERG and FM-100 test 2, 6 and 24 hours after dosing. The trial was designed to detect changes in retinal function that might occur in more than 10% of patients. Vardenafil did not produce clinically significant ERG or FM-100 effects in healthy men compared to placebo. Two patients on vardenafil in the trial reported episodes of transient cyanopsia (objects appear blue).12.3 PharmacokineticsThe pharmacokinetics of vardenafil are approximately dose proportional over the recommended dose range.AbsorptionMean vardenafil plasma concentrations measured after the administration of a single oral dose of 20 mg to healthy male volunteers are depicted in Figure 8.Figure 8: Plasma Vardenafil Concentration (Mean ± SD) Curve for a Single 20 mg Vardenafil Hydrochloride Tablets DoseVardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. Maximum observed plasma concentrations after a single 20 mg dose in healthy volunteers are usually reached between 30 minutes and 2 hours (median 60 minutes) after oral dosing in the fasted state.

What should I tell my healthcare provider before taking vardenafil?

Two food-effect studies were conducted which showed that high- fat meals caused a reduction in C max by 18%-50%.DistributionThe mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. Vardenafil and its major circulating metabolite, M1, are highly bound to plasma proteins (about 95% for parent drug and M1). This protein binding is reversible and independent of total drug concentrations.Following a single oral dose of 20 mg vardenafil in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing.MetabolismVardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil. The plasma concentration of M1 is approximately 26% that of the parent compound. This protein binding is reversible and independent of total drug concentrations.Following a single oral dose of 20 mg vardenafil in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing.MetabolismVardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms.

8.5 Geriatric Use

The total time to angina was not altered by vardenafil hydrochloride tablets when compared to placebo (10 mg vardenafil hydrochloride tablets vs. placebo: 291±123 and 292±110 seconds; 20 mg vardenafil hydrochloride tablets vs. placebo: 354±137 and 347±143 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 hydrochloride tablet groups (10 mg vardenafil hydrochloride tablets vs. placebo: 380±108 and 334±108 seconds; 20 mg vardenafil hydrochloride tablets vs.

How is vardenafil supplied (dosage forms)?

placebo: 364±101 and 366±105 seconds, respectively).Effects on EyeSingle oral doses of phosphodiesterase inhibitors have demonstrated transient dose-related impairment of color discrimination (blue/green) using the Farnsworth-Munsell 100-hue test and reductions in electroretinogram (ERG) b-wave amplitudes, with peak effects near the time of peak plasma levels. These findings are consistent with the inhibition of PDE6 in rods and cones, which is involved in phototransduction in the retina. The findings were most evident one hour after administration, diminishing but still present 6 hours after administration. In a single dose study in 25 normal males, vardenafil hydrochloride tablets 40 mg, twice the maximum daily recommended dose, did not alter visual acuity, intraocular pressure, fundoscopic and slit lamp findings.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. Thirty-two (32) males (62%) of the patients completed the trial. The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil. The plasma concentration of M1 is approximately 26% that of the parent compound. This metabolite shows a phosphodiesterase selectivity profile similar to that of vardenafil and an in vitro inhibitory potency for PDE5 28% of that of vardenafil. Therefore, M1 accounts for approximately 7% of total pharmacologic activity.ExcretionThe total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours.