Label: VARDENAFIL HYDROCHLORIDE tablet

What should I avoid while taking vardenafil?
Vardenafil Dosage and Administration
2.3 Use in Specific Populations
5.12 Sexually Transmitted Disease
5.9 Renal Impairment
What Are Warnings and Precautions for 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

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.

Vardenafil HCl 10mg improves erectile response by increasing blood flow.
Avoid combining it with other ED medications unless prescribed.
Potential for interactions with certain heart and blood pressure medicines.
Use vardenafil with caution under doctor supervision if you have health issues.
It’s not suitable for women, children, or individuals without ED diagnosis.
Store in a cool, dry place away from direct sunlight.
Do not take if you recently used nitric oxide donors.
Be mindful of timing; take about an hour before intimacy.
The medication does not produce an erection without sexual stimulation.
Always adhere to your prescribed dose for best results.

This study, however, was not designed to make direct statistical comparisons between the drug or the dose levels.

What should I avoid while taking vardenafil?

[See Dosage and Administration (2.3), Warnings and Precautions (5.9), and Use in Specific Populations (8.7).] Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation. In vitro studies have shown that vardenafil is a selective inhibitor of PDE5. The inhibitory effect of vardenafil is more selective on PDE5 than for other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1,000-fold relative to PDE2, 3, 4, 7, 8, 9, and 10). Vardenafil may add to the blood pressure lowering effects of antihypertensive agents [see Drug Interactions (7)] .

What is vardenafil used for?

What are the serious side effects of vardenafil?

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. 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). The total time to angina was not altered by blue pillmen 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.

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placebo: 380±108 and 334±108 seconds; 20 mg vardenafil hydrochloride tablets vs.

Vardenafil HCl 10mg is available in tablet form, usually taken orally.
It’s important to follow your doctor’s instructions precisely for effectiveness.
Do not use vardenafil if you have a known allergy to similar drugs.
Alcohol can increase side effects, such as dizziness and low blood pressure.
Men with pre-existing eye conditions should proceed with caution.
Keep a record of any side effects experienced to inform your doctor.
Use of vardenafil should be part of a broader approach to managing ED.
Check for drug interactions with your pharmacist before starting therapy.
Certain health conditions may require dose adjustments or caution.
The medication is not intended for use as a performance enhancer.

Vardenafil Dosage and Administration

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.

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

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 QTcF of 4 msec (90% CI: 1,7).

Sample Use Guides

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). 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.

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.

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. 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 super p force 160mg 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.

Point	Explanation	Additional Advice
Take as prescribed	Usually 10 mg about 30-60 min before activity	Do not exceed recommended dose
Food interactions	High-fat meals may delay onset	Take on an empty stomach or low-fat meal
Alcohol consumption	May decrease effectiveness or increase side effects	Limit alcohol intake
Report side effects or adverse reactions	Such as vision changes, pain, prolonged erections	Seek medical attention immediately

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.

2.3 Use in Specific Populations

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. After oral administration, vardenafil is excreted as metabolites predominantly in the feces (approximately 91-95% of administered oral dose) and to a lesser extent in the urine (approximately 2-6% of administered oral dose).Pharmacokinetics in Specific PopulationsPediatricsVardenafil hydrochloride tablets are not indicated for use in pediatric patients. Vardenafil trials were not conducted in the pediatric population.GeriatricIn a healthy volunteer study of elderly males (≥65 years) and younger males (18–45 years), mean C max and AUC were 34% and 52% higher, respectively, in the elderly males [see Use in Specific Populations (8.5)].Hepatic ImpairmentIn volunteers with mild hepatic impairment (Child-Pugh A), the C max and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects. In volunteers with moderate hepatic impairment (Child-Pugh B), the C max and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects.

5.12 Sexually Transmitted Disease

Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment. [See Dosage and Administration (2.3), Warnings and Precautions (5.8), and Use in Specific Populations (8.6). ]Renal ImpairmentIn male volunteers with CLcr = 50–80 mL/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with CLcr >80 mL/min. In male volunteers with CLcr = 30–50 mL/min or CLcr <30 mL/min renal impairment groups, the AUC of vardenafil was 20–30% higher compared to that observed in a control group with CLcr >80 mL/min). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis. [See Dosage and Administration (2.3), Warnings and Precautions (5.9), and Use in Specific Populations (8.7).] Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation. In vitro studies have shown that vardenafil is a selective inhibitor of PDE5. The inhibitory effect of vardenafil is more selective on PDE5 than for other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1,000-fold relative to PDE2, 3, 4, 7, 8, 9, and 10).

5.9 Renal Impairment

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 super p force 160mg 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.

How does vardenafil work (mechanism of action)?

Adverse Reactions

What Are Warnings and Precautions for Vardenafil?

The total time to angina was not altered by blue pillmen 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.

Biochem/physiol Actions

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.