General: Physicians should consider the cardiovascular status of their patients, since
| Population Group | Typical Dose | Timing Before Activity | Usage Frequency |
|---|---|---|---|
| Adults | 20 mg | 30-60 minutes prior | Once per day |
| Elderly | 20 mg | 30-60 minutes prior | As needed |
| Patients with Liver impairment | 10-20 mg | 30-60 minutes | As directed |
| First-time Users | 10-20 mg | 30-60 minutes prior | As needed |
there is a degree of cardiac risk associated with sexual activity.
| Country | Approval Status | Regulatory Body | Notes |
|---|---|---|---|
| USA | Approved | FDA | Available by prescription |
| UK | Approved | MHRA | Sold legally with prescription |
| Canada | Approved | Health Canada | Available at pharmacies |
| Australia | Approved | TGA | Prescription required |
In men for whom sexual activity is not recommended because of their underlying
How Do Vardenafil and Viagra Compare?
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, LEVITRA 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 order levitra without prescription more severe disease). LEVITRA (5 mg, 10 mg, and 20 mg) was effective in all age categories (<45, 45 to <65, and ≥65 years) and was also effective regardless of race (White, Black, Other).
How Long Do They Last?
Trials in a General Erectile Dysfunction Population: In 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 LEVITRA 5 mg, 10 mg, 20 mg and placebo groups, respectively. There was significant improvement (p <0.0001) at 3 months with LEVITRA (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 trial. cardiovascular status, any treatment for erectile dysfunction, including LEVITRA, generally should not be used.
| Parameter | Value | Notes |
|---|---|---|
| Absorption Rate | Fast | Starts within 30-60 minutes |
| Peak Plasma Concentration | 1.0-2.0 hours | Max nivel around 60 mins |
| Half-life | Approximately 4-5 hours | Duration of effect |
| Metabolism | Liver (CYP3A4 enzyme) | Requires caution with interacting drugs |
Left Ventricular Outflow Obstruction: Patients with left ventricular outflow obstruction, e.g., aortic stenosis and idiopathic
- Levitra 20 mg is prescribed for erectile dysfunction management.
- The package contains 4 precisely dosed tablets.
- Take 20 mg about 30-60 minutes prior to sex.
- The medication’s effects can last several hours.
- Do not use Levitra if taking organic nitrates.
- Side effects include flushing, headaches, and stuffy nose.
- Do not alter or crush the tablets before use.
- Always consult your doctor about your health conditions.
- Store in a cool, dry, and dark place.
- Avoid using with fatty or heavy meals to improve absorption.
- Use Levitra responsibly for safe and effective results.
hypertrophic subaortic stenosis, can be sensitive to the
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action of vasodilators including Type 5 phosphodiesterase inhibitors.
What is Levitra?
In the North American trial, LEVITRA 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%, 75%, and 80%, respectively, compared to a 52% response in the placebo group at 3 months; p <0.0001). LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (51% on 5 mg, 64% on 10 mg, and 65% on 20 mg, respectively, compared to 32% on placebo; p <0.0001) at 3 months in the North American trial. This improvement in mean score was maintained at all doses at 6 months in the North American trial. Trial in Patients with ED and Diabetes Mellitus: LEVITRA demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg LEVITRA), double-blind, placebo-controlled trial of patients with diabetes mellitus (n=439; mean age 57 years, range 33-81; 80% White, 9% Black, 8% Hispanic, and 3% Other). Significant improvements in the EF Domain were shown in this study (EF Domain scores of 17 on 10 mg LEVITRA and 19 on 20 mg LEVITRA compared to 13 on placebo; p <0.0001). Blood Pressure Effects: LEVITRA has systemic vasodilatory properties
Vardenafil (Generic Levitra®) FAQs
LEVITRA significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (61% on 10 mg and 64% on 20 mg LEVITRA compared to 36% on placebo; p <0.0001). LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (49% on 10 mg, 54% on 20 mg LEVITRA compared to 23% on placebo; p <0.0001). Trial in Patients with ED after Radical Prostatectomy: LEVITRA demonstrated clinically meaningful and statistically significant improvement in erectile function in a prospective, fixed-dose (10 and 20 mg LEVITRA), double-blind, placebo-controlled trial in post-prostatectomy patients (n=427, mean age 60, range 44-77 years; 93% White, 5% Black, 2% Other). Significant improvements in the EF Domain were shown in this study (EF Domain scores of 15 on 10 mg LEVITRA and 15 on 20 mg LEVITRA compared to 9 on placebo; p <0.0001). LEVITRA significantly improved the overall per-patient rate of achieving an erection sufficient for penetration (SEP2) (47% on 10 mg and 48% on 20 mg LEVITRA compared to 22% on placebo; p <0.0001). that resulted in transient decreases in supine blood pressure
- Levitra 20 mg enhances blood flow for stronger erections.
- Comes in a small pack of four tablets, easy for travel.
- Take with water, 30 minutes before planned intimate activity.
- Do not take more than one tablet per day to avoid side effects.
- Avoid fatty meals and alcohol to maximize effectiveness.
- Check with your doctor about potential drug interactions.
- Not suitable for use by women or children.
- Store away from direct sunlight and humidity.
- Contact a healthcare professional if adverse reactions occur.
- Always follow the dosing instructions provided.
- Keep Levitra 20 mg in a secure place to prevent misuse.
in healthy volunteers (mean maximum decrease of 7 mmHg
Before Using
LEVITRA demonstrated a clinically meaningful and statistically significant increase in the overall per-patient rate of maintenance of erection to successful intercourse (SEP3) (37% on 10 mg, 34% on 20 mg LEVITRA compared to 10% on placebo; p <0.0001). Nitrates: Administration of LEVITRA with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated (see CLINICAL PHARMACOLOGY, Pharmacodynamics, Effects on Blood Pressure and Heart Rate when LEVITRA is Combined with Nitrates). Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates. A suitable time interval following LEVITRA dosing for the safe administration of nitrates or nitric oxide donors has not been determined. Hypersensitivity: LEVITRA is contraindicated for patients with a known hypersensitivity to any component of the tablet. systolic and 8 mmHg diastolic) (see CLINICAL PHARMACOLOGY, Pharmacodynamics).
Overdose/Missed Dose
The clinical impact of these QTc changes is unknown (see PRECAUTIONS). In a separate postmarketing study of 44 healthy volunteers, single doses of 10 mg LEVITRA 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 LEVITRA 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 PRECAUTIONS, Congenital or Acquired QT Prolongation).
Does vardenafil interact with foods or drinks?
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 MI, CABG, 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 LEVITRA did not alter the total treadmill exercise time compared to placebo (10 mg LEVITRA vs. placebo: 433±109 and 426±105 seconds, respectively; 20 mg LEVITRA vs. placebo: 414±114 and 411±124 seconds, respectively). While this normally would be expected to be of little consequence in most patients, prior to prescribing LEVITRA,
- Levitra 20 mg helps men achieve and maintain an erection.
- 4 tablets in each pack make dosing straightforward.
- Take one tablet with a glass of water, about 30 minutes before sex.
- Avoid heavy meals and alcohol when using Levitra.
- Do not take more than one tablet daily.
- Check for possible drug interactions with your doctor.
- Levitra 20 mg is not recommended for women.
- Store in a dry, cool place away from sunlight.
- Talk to a healthcare professional if you experience adverse effects.
- Do not share your medication with others.
- Always complete your prescribed course of treatment.
physicians should carefully consider whether their patients with underlying
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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.
Does Food Affect How ED Drugs Work?
Two patients on vardenafil in the trial reported episodes of transient cyanopsia (objects appear blue). LEVITRA was 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 LEVITRA in these studies were 5 mg, 10 mg, and 20 mg. Two of these trials were conducted in the general ED population and two in special ED populations (one in patients with diabetes mellitus and one in post-prostatectomy patients). LEVITRA was dosed without regard to meals on an as needed basis in men with erectile dysfunction (ED), many of whom had multiple other medical conditions. cardiovascular disease could be affected adversely by such vasodilatory effects.
Side Effects
The total time to angina was not altered by LEVITRA when compared to placebo (10 mg LEVITRA vs. placebo: 291±123 and 292±110 seconds; 20 mg LEVITRA 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 LEVITRA groups (10 mg LEVITRA vs. placebo: 380±108 and 334±108 seconds; 20 mg LEVITRA vs.
Missed dose of Levitra
placebo: 364±101 and 366±105 seconds, respectively). 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. 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, LEVITRA 40 mg, twice the maximum daily recommended dose, did not alter visual acuity, intraocular pressure, fundoscopic and slit lamp findings.