Label: VARDENAFIL HYDROCHLORIDE tablet

2.3 Use in Specific Populations
Key Takeaways
Vardenafil Patient Counseling
Other uses for this medicine
2.1 General Dose Information
What side effects can this medication cause?
14.2 Trial in Patients with ED and Diabetes Mellitus

There were no other instances of outlier blood pressure values (standing SBP <85 mmHg or decrease from baseline in standing SBP of >30 mmHg). Three patients reported dizziness following vardenafil 20 mg. There were no cases of syncope.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.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. 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. 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.

Vardenafil interacts with certain blood pressure medicines, affecting efficacy.
The medication can be used by men of most adult age groups.
Women who are pregnant or breastfeeding should not use vardenafil.
It’s advisable to avoid grapefruit or grapefruit juice when on vardenafil.
Always complete your prescribed course even if symptoms improve.
Seek medical attention if you notice symptoms of allergic reaction.
Vardenafil is not intended for use by individuals with recent stroke or heart attack.
Sexual activity may be dangerous for some men with cardiovascular issues.
The medication is not approved for use in women or children.
Use caution when combining vardenafil with other erectile dysfunction drugs.

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. 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.

2.3 Use in Specific Populations

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.

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There were 3 cases of dizziness observed with concomitant administration of terazosin and vardenafil.

Storage Parameter	Recommended Condition	Notes
Temperature	Below 25°C (77°F)	Store in a cool, dry place
Humidity	Avoid excessive moisture	Keep away from water
Light exposure	Keep in original container, protect from light	Prevent degradation
Shelf life	2-3 years from manufacturing date	Check expiration date

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.

Key Takeaways

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.

Vardenafil Patient Counseling

Sample Use Guides

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).

Visual disturbances

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. 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. Of the CYP3A4 inhibitors that have been studied, ritonavir causes the most significant drug-drug interaction with vardenafil.

Vardenafil HCl 10mg can be effective in treating erectile dysfunction symptoms.
It’s important to avoid unprescribed or counterfeit versions of the drug.
Consult a healthcare provider for proper diagnosis before starting treatment.
Discontinue medication and seek medical help if serious side effects occur.
The medication’s effects depend on proper timing and dosage adherence.
It’s safe for most men but always needs individual health assessment.
Mild side effects may diminish over time or with dose adjustment.
Use caution with other medications that affect blood pressure or blood flow.
Do not use vardenafil if you are allergic to similar medications like sildenafil.
Always inform your doctor of any other medications you are taking.

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.

Parameter	Value	Notes
Absorption Time	30-60 minutes	After oral intake
Peak Plasma	60 minutes	Approximate peak
Half-life	4-5 hours	Duration of effect
Bioavailability	~15%	Oral bioavailability

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).

Other uses for this medicine

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 ed tablets hydrochloride tablets vs. 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.

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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. 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.

storage condition

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. Single doses of gatifloxacin 400mg resulted in a placebo-subtracted mean change from baseline QTcF of 4 msec (90% CI: 1,7).

2.1 General Dose Information

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.

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

placebo: 433±109 and 426±105 seconds, respectively; 20 mg vardenafil ed tablets hydrochloride tablets vs.

Vardenafil 10mg is used primarily to improve erectile function in men.
It’s important to avoid taking multiple doses in a 24-hour period.
The tablet should be taken with water, not crushed or chewed.
Potential side effects include headache, flushing, and indigestion.
Rare but serious reactions include sudden vision or hearing loss.
Consult your doctor immediately if adverse reactions occur.
Men with certain health conditions should undergo evaluation before use.
The drug works by relaxing blood vessels to increase blood flow.
Avoid excessive alcohol consumption while on vardenafil.
Store away from light, moisture, and away from children’s reach.

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.

What side effects can this medication cause?

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.

Biochem/physiol Actions

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. 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.

What is vardenafil used for?

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 QTcF of 4 msec (90% CI: 1,7). 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. 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. 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. 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 10mg should be used only under medical supervision.
Overdose may cause serious side effects like priapism or sudden vision loss.
The medication is available by prescription and not for recreational use.
Male patients with heart issues should consult a doctor before use.
Vardenafil may interact with other medications like antibiotics or antifungals.
Alcohol consumption can increase the risk of side effects when taking vardenafil.
It’s important to follow the prescribed dosage strictly for safety.
Use caution if you have liver or kidney problems while taking vardenafil.
Women and children should avoid using vardenafil, as it's designed for men.
Discuss all health conditions and medications with your healthcare provider first.

Vardenafil did not produce clinically significant ERG or FM-100 effects in healthy men compared to placebo.

14.2 Trial in Patients with ED and Diabetes Mellitus

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. 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).

storage temp.

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.

Vardenafil compared to other PDE5 inhibitors

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. 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.