Cookeville, TN 3850620111027AW, LEVITRA (Luh-VEE-Trah)(vardenafil HCl) Tablets. 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. Blood pressure and pulse were evaluated over the 6-hour interval after vardenafil dosing. Vardenafil or placebo was given simultaneously with tamsulosin. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. [7] 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. For more information you can also visit www.LEVITRA.com, or call 1-866-LEVITRA. Sildenafil, sold under the brand name Viagra, among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. Generic name: tadalafil [ ta-DAL-a-fil ] Brand names: Adcirca, Cialis Drug class: Impotence agents Medically reviewed by Sanjai Sinha, MD. 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 should be taken approximately 60 minutes before sexual activity. 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). Blood pressure effects (standing SBP) in normotensive men on stable dose 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 3. View Labeling Archives, Sexual stimulation is required for a response to treatment. [8] It is taken by mouth or by injection into a vein. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. 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. 67544-507-04, October 26, 2011. It's no longer sold under the brand name Levitra, but it's available as generic tablets and orally disintegrating tablets (ODTs). LEVITRA was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. 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). You and your doctor should talk about LEVITRA when you start taking it and at regular checkups. 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. 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. Ketoconazole (200 mg once daily) produced a 10-fold increase in vardenafil AUC and a 4-fold increase in Cmax when co-administered with LEVITRA (5 mg) in healthy volunteers. 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. Before prescribing LEVITRA, it is important to note the following: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. National Institute of Diabetes and Digestive and Kidney Diseases, What causes erectile dysfunction? Prescribing Erectile Dysfunction Medications., U.S. National Library of Medicine. you have been told by your healthcare provider to not have sexual activity because of health problems. is this? If you do not understand the information, or have questions, talk with your doctor or pharmacist. You may need emergency treatment if you get an erection that lasts for more than 4 hours and happens without any sexual excitement. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. 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). Healthy Sex Life: Better Health Evaluator from WebMD, If you are allergic to any medications, including other ED medications, About any prescription or nonprescription medications you take, as well as any herbal and, If you are scheduled for surgery, even dental surgery. One patient after simultaneous treatment with 5 mg vardenafil and 10 mg terazosin exhibited symptomatic hypotension with standing blood pressure of 80/60 mmHg occurring one hour after administration and subsequent mild dizziness and moderate lightheadedness lasting for 6 hours. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). being able to get an erection, but not having it last long enough for sex. It is recommended not to exceed a single 5 mg dose of LEVITRA in a 24-hour period when used in combination with erythromycin. Levitra is not a cure for ED and you still need to be aroused . Since higher doses of ketoconazole (400 mg daily) may result in higher increases in Cmax and AUC, a single 2.5 mg dose of LEVITRA should not be exceeded in a 24-hour period when used in combination with ketoconazole 400 mg daily (see WARNINGS and DOSAGE AND ADMINISTRATION). For BP results see Table 3. Other CYP3A4 inhibitors: Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase vardenafil exposure. The clinical impact of these QT changes is unknown (see PRECAUTIONS, Congenital or Acquired QT Prolongation). I buy the 20mg tablet and split it into four . We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at the lowest recommended starting dose (see DOSAGE and ADMINISTRATION). Also get emergency treatment with any of the following: If youre having chest pain and have taken Viagra in the past 24 hours or Cialis in the past 48 hours, dont take nitroglycerin. This protein binding is reversible and independent of total drug concentrations. 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. Sildenafil (Viagra), vardenafil (Levitra, Staxyn), tadalafil (Cialis) and avanafil (Stendra) are oral medications that reverse erectile dysfunction by enhancing the effects of nitric oxide, a natural chemical your body produces that relaxes muscles in the penis. There were 3 cases of dizziness observed with concomitant administration of terazosin and vardenafil. These effects were not observed when LEVITRA 20 mg was taken 24 hours before the NTG. If you experience these symptoms, stop taking LEVITRA and contact a doctor right away. 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). LEVITRA is indicated for the treatment of erectile dysfunction. You should also avoid these medications if you have uncontrolled high or low blood pressure or if you get chest pain while having sex. I have found a source of generic Levitra which reduces the cost considerably. Events, (What 67544-507-02, The Levitra brand name has been discontinued in the U.S. Medically reviewed by Sophia Entringer, PharmD. The findings were most evident one hour after administration, diminishing but still present 6 hours after administration. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. The combination can cause dangerously low blood pressure. LEVITRA is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and Schering Corporation. Physicians should discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors. 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). Clinical Trials, In the warfarin study, vardenafil had no effect on the prothrombin time or other pharmacodynamic parameters. Renal Insufficiency: In volunteers with mild renal impairment (CLcr = 50-80 ml/min), the pharmacokinetics of vardenafil were similar to those observed in a control group with normal renal function. Last updated on Mar 29, 2023. You may also know them by their generic names: sildenafil ( Viagra) tadalafil (. If you are older than 65 or have liver problems, your doctor may start you on a lower dose of LEVITRA. Excluded from this list are those events that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug. Prescription 5mg tadalafil (Cialis) (30 tablets) edit Choose your pharmacy Near A rare vision problem called NAION -- short for nonarteritic anterior ischemic optic neuropathy -- has been reported by a few men using these drugs. Patients should be advised to contact the prescribing physician if new medications that may interact with LEVITRA are prescribed by another healthcare provider. Currently, there are generic forms of both drugs. Presence in Breast Milk, Medline Plus, Blood pressure effects in patients on stable alpha-blocker treatment: Two clinical pharmacology studies were conducted in patients with benign prostatic hyperplasia (BPH) on stable-dose alpha-blocker treatment for at least four weeks. These side effects usually go away after a few hours. 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). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula: Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. But there are other situations that may make these medications unsafe as well. Three patients reported dizziness following vardenafil 20 mg. Consequently, it is recommended not to exceed a single 2.5 mg LEVITRA dose in a 72-hour period when used in combination with ritonavir (see WARNINGS and DOSAGE AND ADMINISTRATION). For most men, the recommended starting dose is 10 mg. Take LEVITRA no more than once a day. protect a man or his partner from sexually transmitted diseases, including HIV. Overall mortality risk. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. 67544-512-12, [1] It is taken by mouth . Figure 1: Plasma Vardenafil Concentration (Mean SD) Curve for a Single 20 mg LEVITRA Dose. 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. There are no controlled clinical data on the safety or efficacy of LEVITRA in the following patients; and therefore its use is not recommended until further information is available. The generic form of Cialis is called tadalafil. 67544-507-52, Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma. 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 (20 mg) did not potentiate the hypotensive effects of alcohol during the 4-hour observation period in healthy volunteers when administered with alcohol (0.5 g/kg body weight). Retinal function was measured by ERG and FM-100 test 2, 6 and 24 hours after dosing. Files, All Mapping The design was a randomized, double blind, two-period cross-over study. or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome), have kidney problems and require dialysis, 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. View NDC Code(s)NEW! LEVITRA must be used only under a doctors care. LEVITRA may help a man with ED get and keep an erection when he is sexually excited. In these patients whose hypertension was controlled with nifedipine, LEVITRA 20 mg produced mean additional supine systolic/diastolic blood pressure reductions of 6/5 mmHg compared to placebo. The plasma concentration of M1 is approximately 26% that of the parent compound. In most (7/8) of these subjects, instances of standing SBP <85 mmHg were not associated with symptoms. The drugs are phosphodiesterase 5 (PDE5) inhibitors, and their brand and generic names, respectively, are Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), and Stendra (avanafil). Do not change your dose of LEVITRA without talking to your doctor. Vardenafil has not been administered to patients with bleeding disorders or significant active peptic ulceration. Speak to your doctor about ways to guard against sexually transmitted diseases. Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing. Super Vilitra Tablets 350/ Stripe. amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using LEVITRA. General: In humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. LEVITRA has not been evaluated in patients on renal dialysis (see CLINICAL PHARMACOLOGY, Metabolism and Excretion and PRECAUTIONS). [8] In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. Based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg. TOLL-FREE PHONE: 1-866-539-5330 Left Ventricular Outflow Obstruction: Patients with left ventricular outflow obstruction, e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors. 67544-512-06, Single doses of gatifloxacin 400mg resulted in a placebo-subtracted mean change from baseline QTcF of 4 msec (90% CI: 1,7). Ritonavir and indinavir: Upon concomitant administration of 5 mg of LEVITRA with 600 mg BID ritonavir, the Cmax and AUC of ritonavir were reduced by approximately 20%. Elderly males age 65 years and older have higher vardenafil plasma concentrations than younger males (18 45 years), mean Cmax and AUC were 34% and 52% higher, respectively (see CLINICAL PHARMACOLOGY,Pharmacokinetics in Special Populations, and DOSAGE AND ADMINISTRATION). Concomitant use with potent CYP3A4 inhibitors such as ritonavir, indinavir, ketoconazole, as well as moderate CYP3A inhibitors such as erythromycin results in significant increases of plasma levels of vardenafil (see PRECAUTIONS, WARNINGS and DOSAGE AND ADMINISTRATION). Chewable Sildenafil. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents (see PRECAUTIONS, Drug Interactions). There were no cases of syncope. The trial was designed to detect changes in retinal function that might occur in more than 10% of patients. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. Especially tell your doctor if you take any of the following: Take LEVITRA exactly as your doctor prescribes. In combination with sexual stimulation, vardenafil works by increasing blood flow to the penis to help a man get and keep an erection.This drug does not protect against sexually transmitted. It's in the same class of drugs as other popular ED medications, including Viagra and Cialis.. Therefore, M1 accounts for approximately 7% of total pharmacologic activity. Phosphodiesterase Type 5 (PDE5) inhibitors, including LEVITRA, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects. READ MORE The typicaldose of Viagra is 50 mg. Levitra (vardenafil hydrochloride) is an oral medication taken to treat erectile dysfunction (ED). However, there are subtle differences in how long they stay effective and how quickly they begin to work. Figure 3: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 5 mg or placebo with stable dose tamsulosin 0.4 mg in normotensive BPH patients (Study 1), Figure 4: Mean change from baseline in standing systolic blood pressure (mmHg) over 6 hour interval following simultaneous or 6 hr separation administration of vardenafil 5 mg or placebo with stable dose terazosin (5 or 10 mg) in normotensive BPH patients (Study 1). Of the CYP3A4 inhibitors that have been studied, ritonavir causes the most significant drug-drug interaction with vardenafil. Levitra Prices, Coupons and Patient Assistance Programs. Prescription 100mg sildenafil (30 tablets) edit Choose your pharmacy Near boydton, VA Food Lion Walgreens The most potent inhibitory activity was observed for vardenafil metabolite M1, which had a Ki of 1.4 M toward CYP3A4, which is about 20 times higher than the M1 Cmax values after an 80 mg LEVITRA dose. Get Label RSS Feed, maximal change in baseline in systolic blood pressure (mmHg) following vardenafil 10 and 20 mg in healthy volunteers on daily alpha-blocker therapy, Table 5: Adverse Events Reported By 2% of Patients Treated with LEVITRA and More Frequent on Drug than Placebo in Fixed and Flexible. Two food-effect studies were conducted which showed that high-fat meals caused a reduction in Cmax by 18%-50%. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Blood pressure effects in normotensive men after forced titration with alpha-blockers: Two randomized, double blind, placebo-controlled clinical pharmacology studies with healthy normotensive volunteers (age range, 45-74 years) were performed after forced titration of the alpha-blocker terazosin to 10 mg daily over 14 days (n=29), and after initiation of tamsulosin 0.4 mg daily for five days (n=24). Alcohol: Alcohol (0.5 g/kg body weight: approximately 40 mL of absolute alcohol in a 70 kg person) and vardenafil plasma levels were not altered when dosed simultaneously. LEVITRA may be taken with or without meals. Vardenafil is eliminated predominantly by hepatic metabolism, mainly by CYP3A4 and to a minor extent, CYP2C isoforms. All rights reserved. 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. But these medications work the same basic way, so youre likely to have similar results. use recreational drugs called poppers like amyl nitrate and butyl nitrate. Consideration should be given to the following: In volunteers with moderate impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased 130% and 160%, respectively, compared to healthy control subjects. The design was a randomized, double blind, cross-over study with four treatments: vardenafil 5 mg or placebo administered simultaneously with the alpha-blocker and vardenafil 5 mg or placebo administered 6 hours after the alpha-blocker. Do not use LEVITRA for a condition for which it was not prescribed. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors (see POST-MARKETING EXPERIENCE, Ophthalmologic). A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. [4] [5] [7] It is taken by mouth. In many cases, medical follow-up information was limited. 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. Cases of sudden decrease or loss of hearing have been reported post-marketing in temporal association with the use of PDE5 inhibitors, including LEVITRA. Keep LEVITRA and all medicines out of the reach of children. Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment. Erectile dysfunction (impotence) Treatment., NIH. Call your doctor if you get a side effect that bothers you or one that will not go away. In some patients, concomitant use of these two drug classes can lower blood pressure significantly (see PRECAUTIONS,Alpha-blockers and Drug Interactions) leading to symptomatic hypotension (e.g., fainting). Instances of outlier blood pressure values (defined as standing SBP <85 mmHg and/or a decrease from baseline of standing SBP >30 mmHg) were observed in 9/24 subjects receiving tamsulosin and 19/29 receiving terazosin. Get Quote. Weak inhibitory effects toward other isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) were found, but Ki values were in excess of plasma concentrations achieved following dosing. Common side effects of vardenafil include headache, flushing, and stuffy nose. 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). Levitra (generic name: Vardenafil HCl) is an efficient oral medication for the treatment of erectile dysfunction (ED), also known as impotence. For alpha-blockers, caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with alpha-blockers because of the potential for an additive effect on blood pressure. Drugs & Supplements Levitra (Vardenafil) Generic Name: Vardenafil Reviewed: March 21, 2023 Vardenafil is used in adult men to treat erectile dysfunction (impotence). 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. Side effects are not common, but they can happen. (current), vardenafil 10 MG (vardenafil hydrochloride 11.85 MG) Oral Tablet, vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral Tablet, Levitra (as vardenafil hydrochloride) 10 MG Oral Tablet, Levitra (as vardenafil HCl) 20 MG Oral Tablet, unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within the last 6 months); severe cardiac failure, end stage renal disease requiring dialysis, known hereditary degenerative retinal disorders, including retinitis pigmentosa. 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