Label: VARDENAFIL HYDROCHLORIDE tablet

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)

• 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.

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.

8.5 Geriatric Use

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 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).

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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. 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. Blood pressure effects (standing SBP) in normotensive men on a stable dose of alfuzosin 10 mg following administration

Drug Label Information

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.

Hazard Classifications

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. 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)

6.2 Postmarketing Experience

Study 1: This study was designed to evaluate the effect of 5 mg vardenafil compared to placebo when administered to BPH patients on chronic alpha-blocker therapy in two separate cohorts: tamsulosin 0.4 mg daily (cohort 1, n=21) and terazosin 5 or 10 mg daily (cohort 2, n=21). Blood pressure effects (standing SBP) in normotensive men on stable dose of tamsulosin 0.4 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 2. Blood pressure effects (standing SBP) in normotensive men on stable dose terazosin (5 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. Study 2: This study was designed to evaluate the effect of 10 mg vardenafil (stage 1) and 20 mg vardenafil (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. 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. 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

Vardenafil Warnings/Precautions

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. 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.

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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. 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 fildena super active 100 in a control group with CLcr >80 mL/min. pharmacology studies with healthy normotensive volunteers (age range, 45-74 years) were performed after

How should I take vardenafil?

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.

What are the serious side effects of vardenafil?

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)] . Effects on Blood Pressure and Heart Rate when Vardenafil Hydrochloride Tablets are Combined with Nitrates A study was conducted in which the blood pressure and heart rate response to 0.4 mg nitroglycerin (NTG) sublingually was evaluated in 18 healthy subjects following pretreatment with vardenafil hydrochloride tablets 20 mg at various times before NTG administration. Figure 1: Placebo-subtracted point estimates (with 90% CI) of mean maximal blood pressure and heart rate effects of pre-dosing with vardenafil 20 mg at 24, 8, 4, and 1 hour before 0.4 mg NTG sublingually Because the disease state of patients requiring nitrate therapy is anticipated to increase the likelihood of hypotension, the use of vardenafil by patients on nitrate therapy or on nitric oxide donors is contraindicated [see Contraindications (4.1)] . Blood Pressure Effects in Patients on Stable Alpha-Blocker Treatment Three clinical pharmacology studies were conducted in patients with benign prostatic hyperplasia (BPH) on stable-dose alpha-blocker treatment, consisting of alfuzosin, tamsulosin or terazosin. forced titration of the alpha-blocker terazosin to 10 mg daily over 14 days

• Vardenafil 10mg is available by prescription only, ensure your doctor’s approval.
• It is intended for use in adult men diagnosed with erectile dysfunction.
• Be cautious with dosing if you have kidney or liver problems.
• Remember that sexual activity carries health risks for some men.
• Report any adverse effects, especially chest pain or prolonged erections.
• It’s important to discuss your complete medical history before use.
• The medication does not protect against sexually transmitted infections.
• Do not share your medication with others to prevent misuse.
• Use vardenafil only as directed to avoid potential health hazards.
• Pharmacist or doctor can clarify any questions about proper use.

(n=29), and after initiation of tamsulosin 0.4 mg daily for five days (n=24).

• Vardenafil HCl 10mg is used to treat erectile dysfunction in men.
• It belongs to the phosphodiesterase type 5 inhibitors class.
• Vardenafil enhances blood flow to the penis during arousal.
• The usual recommended dose is 10mg taken about 60 minutes before activity.
• It can be taken with or without food, but high-fat meals may delay effects.
• Common side effects include headache, flushing, and nasal congestion.
• Vardenafil is generally safe when used as prescribed by a doctor.
• Do not combine vardenafil with nitrates or alpha-blockers without medical advice.
• It may cause dizziness or vision changes; avoid driving if affected.
• Store vardenafil in a cool, dry place out of reach of children.