Label: VARDENAFIL HYDROCHLORIDE tablet

There was significant improvement (p <0.0001) at 3 months with vardenafil hydrochloride tablets (EF Domain scores of 18, 21, 21, for

the 5 mg, 10 mg, and 20 mg dose groups, respectively) compared to the placebo group (EF Domain score of 15).

The European trial (total N=803) confirmed these results. The improvement in mean score was maintained at all doses at 6 months in the North American

Usual Geriatric Dose for Erectile Dysfunction

Single 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. 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 delayed ejaculation pills 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. Two patients on vardenafil in the trial reported episodes of transient cyanopsia (objects appear blue). The pharmacokinetics of vardenafil are approximately dose proportional over the recommended dose range.

Pharmacological Class

Mean 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 Dose Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. Two food-effect studies were conducted which showed that high- fat meals caused a reduction in C max by 18%-50%. The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution. This protein binding is reversible and independent of total drug concentrations. trial.In the North American trial, vardenafil hydrochloride tablets significantly improved the rates of achieving an erection sufficient

for penetration (SEP2) at doses of 5 mg, 10 mg, and 20 mg compared to placebo (65%,

Renal Dose Adjustments

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 V 79 cells. Vardenafil was not clastogenic as assessed in either the in vitro chromosomal aberration test or the in vivo mouse micronucleus test.Impairment of FertilityVardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in male, and for 14 days prior to mating and through day 7 of gestation in females. In a corresponding 1-month rat toxicity study, this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg. Vardenafil 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.

Storage Class

Vardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V 79 cells. Vardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in male, and for 14 days prior to mating and through day 7 of gestation sex pills for women in females. 14 CLINICAL STUDIES Vardenafil hydrochloride tablets were evaluated in four major double-blind, randomized, placebo-controlled, fixed-dose, parallel design, multicenter trials in 2431 men aged 20-83 (mean age 57 years; 78% White, 7% Black, 2% Asian, 3% Hispanic and 10% Other/Unknown). The doses of vardenafil hydrochloride tablets in these studies were 5 mg, 10 mg, and 20 mg. Two of these trials were conducted in the general erectile dysfunction (ED) population and two in special ED populations (one in patients with diabetes mellitus and one in post-prostatectomy patients). 75%, and 80%, respectively, compared to a 52% response in the placebo group at 3 months; p <0.0001).

Dose Adjustments

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). 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.

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

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 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). The European trial confirmed these results.Vardenafil hydrochloride tablets demonstrated a clinically meaningful and statistically

Generic vs Brand

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. Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. Therefore, M1 accounts for approximately 7% of total pharmacologic activity. The 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).

Who should not take vardenafil?

Vardenafil trials were not blue sex pills conducted in the pediatric population. In 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)]. In 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. [See Dosage and Administration (2.3), Warnings and Precautions (5.8), and Use in Specific Populations (8.6).] In 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. [See Dosage and Administration (2.3), Warnings and Precautions (5.9), and Use in Specific Populations (8.7).] 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityCarcinogenesisVardenafil was not carcinogenic in rats and mice when administered daily for 24 months. significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3)

• Vardenafil 10mg can help improve sexual confidence and satisfaction.
• Use it responsibly to maintain health and efficacy.
• Check for any medication allergies before use.
• Inform your doctor about all health conditions prior to starting.
• Do not take vardenafil if you have recent cardiovascular events.
• Avoid excessive alcohol, which can worsen side effects.
• Report any unexpected symptoms to your healthcare provider.
• Follow your doctor’s instructions for dosage and timing.
• Be aware of the medication’s interaction with other drugs.
• Proper storage ensures the medication’s effectiveness and safety.

(51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively,

• 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.

compared to 32% on placebo; p <0.0001) at 3 months in the North American trial.

Common side effects of vardenafil

Vardenafil hydrochloride tablets were dosed without regard to meals on an as needed basis in men with ED, many of whom had multiple other medical conditions. The primary endpoints were assessed at 3 months.Primary efficacy assessment in all four major trials was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful intercourse (SEP3).In all four fixed-dose efficacy trials, vardenafil hydrochloride tablets showed clinically meaningful and statistically significant improvement in the EF Domain, SEP2, and SEP3 scores compared to placebo. The mean baseline EF Domain score in these trials was 11.8 (scores range from 0-30 where lower scores represent more severe disease). Vardenafil hydrochloride tablets (5 mg, 10 mg, and 20 mg) were effective in all age categories (<45, 45 to <65, and ≥65 years) and was also effective regardless of race (White, Black, Other).14.1 Trials in a General Erectile Dysfunction PopulationIn the major North American fixed-dose trial, 762 patients (mean age 57, range 20-83 years; 79% White, 13% Black, 4% Hispanic, 2% Asian and 2% Other) were evaluated. The mean baseline EF Domain scores were 13, 13, 13, 14 for the vardenafil hydrochloride tablets 5 mg, 10 mg, 20 mg and placebo groups, respectively.