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These values represent the range for the difference.

Figure 6: Mean change from

baseline

Figure 7: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 10 mg, vardenafil 20 mg or placebo with tamsulosin. The 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 LEVITRA (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 LEVITRA (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 LEVITRA compared to placebo was 5 beats/minute and with an 80 mg dose of LEVITRA the mean increase was 6 beats/minute. Mean QT and QT c changes in msec (90% CI) from baseline relative to placebo at 1 hour post-dose with different methodologies to correct for the effect of heart rate.

Drug/Dose QT Uncorrected (msec) Fridericia QT Correction (msec) Individual QT Correction (msec) Vardenafil 10 mg -2 (-4, 0) 8 (6, 9) 4 (3, 6) Vardenafil 80 mg -2 (-4, 0) 10 (8, 11) 6 (4, 7) Moxifloxacin a 400 mg 3 (1, 5) 8 (6, 9) 7 (5, 8) a) Active control (drug known to prolong QT) 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 ].

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 QT c F (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 WARNINGS AND PRECAUTIONS ]. 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 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).

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.

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. 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. Two patients on vardenafil in the trial reported episodes of transient cyanopsia (objects appear blue).

There was no effect on sperm motility or morphology after single 20 mg oral doses of vardenafil in healthy volunteers. The pharmacokinetics of vardenafil are approximately dose proportional over the recommended dose range..

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 LEVITRA Dose. Vardenafil 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 cialis online without rx high-fat meals caused a reduction in Cmax by 18%-50%. The 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. Vardenafil 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. This

metabolite

that

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).

LEVITRA is not indicated for use in pediatric patients.

Vardenafil trials were not conducted in the pediatric population. In a healthy volunteer study of elderly males (?65 years) and younger males (18–45 years), mean Cmax and AUC were 34% and 52% higher, respectively, in the elderly males [see Use In Specific Populations ].

In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax 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 Cmax 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 , WARNINGS AND PRECAUTIONS and Use In Specific Populations ] Renal Impairment.

In male volunteers with CL cr = 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 CL cr = 30.50 mL/min or CL cr 80 mL/min).

Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis. [See DOSAGE AND ADMINISTRATION , WARNINGS AND PRECAUTIONS and Use In Specific Populations ].

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 erectile dysfunction (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

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

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 more severe disease). LEVITRA (5 mg, 10 mg, and 20 mg) was effective in all age categories ( PATIENT INFORMATION.

Read the Patient Information about LEVITRA before you start taking it and again each time you get a refill. You may also find it helpful to share this information with your partner. This leaflet does not take the place of talking with your doctor.

You and your doctor should talk about LEVITRA when you start taking it and at regular checkups.

If you do not understand the information, or have questions, talk with your doctor or pharmacist. WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT LEVITRA?

LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.

Do not take LEVITRA if you: Take any medicines called “nitrates” (often used to control chest pain, also known as angina).

Use recreational drugs called “poppers” like amyl nitrate and butyl

nitrate

Take riociguat (Adempas ® ), a guanulate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. (See "Who Should Not Take LEVITRA?") Tell all your healthcare providers that you take LEVITRA .

If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took LEVITRA. LEVITRA is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.

ED is a condition where the penis does not harden and expand

when

LEVITRA does not: Cure ED Increase a man’s sexual desire Protect a man or his partner from sexually transmitted diseases, including HIV.

Speak to your doctor about ways to guard against sexually transmitted diseases. When a man is sexually stimulated, his body’s normal physical response is to increase blood flow to his penis. LEVITRA helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity.

Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Talk to your doctor to decide if LEVITRA is right for you. LEVITRA has been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes or who have undergone prostatectomy.

Do not take LEVITRA if you: Take any medicines called “nitrates” (See “What important information should you know about LEVITRA?”). Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.

Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches.

Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate.

Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrate and butyl nitrate.

Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates. Take riociguat, a guanylate cyclase stimulator, a medicine that treats pulmonary arterial hypertension and chronic-throembolic pulmonary hypertension.

Have been told by your healthcare provider to not have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING LEVITRA?

Before taking LEVITRA, tell your doctor about all your medical problems, including if you: Have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack.

Ask your doctor if it is safe for you to have sexual activity. Have low blood pressure or have high blood pressure that is not controlled. Or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome). Have retinitis pigmentosa, a rare genetic (runs in families) eye disease Have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION).

Have had an erection that lasted more than 4 hours.

Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take any of the following: Medicines called nitrates (see “What important information should you know about LEVITRA?”). Ketoconazole or itraconazole (such as Nizoral ® or Sporanox ® ).

Ritonavir (Norvir ® ) cialis online without rx or indinavir sulfate (Crixivan ® ) saquinavir (Fortavase ® or Invirase ® ) or atazanavir (Reyataz ® ). These include Hytrin ® (terazosin HCl), Flomax ® (tamsulosin HCl), Cardura ® (doxazosin mesylate), Minipress ® (prazosin HCl), Rapaflo ® (silodosin) or Uroxatral ® (alfuzosin HCl).

Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure.

In some patients the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to fainting.

You should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider.

These include quinidine, procainamide, amiodarone and sotalol.

Some men can only take a low dose of LEVITRA because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you.

If

you

If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of LEVITRA.

If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of LEVITRA in a 72-hour (3 days) period.

Take 1 LEVITRA tablet about 1 hour (60 minutes) before sexual activity. Some form of sexual stimulation is needed for an erection to happen with LEVITRA.

Do not change your dose of LEVITRA without talking to your doctor. Your doctor

may

Call your doctor or emergency room immediately if you accidentally took more LEVITRA than prescribed.

The most common side effects with LEVITRA are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness or back pain.

These side effects usually go away after a few hours.

Call your doctor if you get a side effect that bothers you or one that will not go away.

LEVITRA may uncommonly cause: An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away.

Priapism must be treated as soon as possible or lasting damage can happen to your penis including the inability to have erections.

Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green.

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including LEVITRA) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including LEVITRA, and call a doctor right away. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including LEVITRA.