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). maximal change from baseline in systolic blood pressure (mmHg) following vardenafil 5 mg in BPH patients on stable alpha-blocker therapy (Study 1). The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing. LEVITRA was dosed without regard to meals on an as needed basis in men with ED, many of whom had multiple other medical conditions. Vardenafil and its metabolites had no effect on CYP1A2, 2A6, and 2E1 (Ki >100 micromolar). There are several brand names for vardenafil, including Levitra and Staxyn. For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg LEVITRA is recommended. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. The number of living pups born to rats exposed pre- and postnatally was reduced at 60 mg/kg/day. 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). The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). Advise patients to stop taking PDE5 inhibitors, including LEVITRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing. For most patients, the starting dose of vardenafil is 10mg once per day. If you do not understand the information, or have questions, talk with your doctor or pharmacist. Do not use LEVITRA in patients on renal dialysis, as vardenafil has not been evaluated in this population [see DOSAGE AND ADMINISTRATION and Use In Specific Populations]. Blood Pressure Effects in Patients on Stable Alpha-Blocker Treatment. LEVITRA (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by aspirin (two 81 mg tablets). 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. Concomitant use of LEVITRA and nitrates and nitric oxide donors is contraindicated. Especially tell your doctor if you take any of the following: Take LEVITRA exactly as your doctor prescribes. Patients should be counseled that concomitant use of LEVITRA with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. Counsel patients that protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered. Levitra is linked to hearing loss as well. Blood pressure and pulse were evaluated over the 6- hour interval after vardenafil dosing. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered. Hims now offers a newer form of Vardenafil, the Vardenafil chewable. Symptoms of ED include being able to get an erection sometimes, but not every time you want to have sex Vardenafil is the active ingredient in Levitra. Typical dosages The following information describes commonly recommended dosages for ED. Tadalafil has a half-life of 17.5 hours and remains active in the body for up to 36 hours. In those patients already taking an optimised dose of LEVITRA, alphablocker - therapy should be initiated at thelowest dose. Concomitant use is contraindicated [see CONTRAINDICATIONS]. Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. WebTake vardenafil, with or without food, about 1 hour before sexual activity. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with LEVITRA are prescribed by another healthcare provider. Dosage Guidelines & Tips How to take Levitra (Vardenafil)? In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for LEVITRA compared to 1.1% for placebo. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. https://my.clevelandclinic.org/health/articles/10036-erection-ejaculation-how-it-occurs, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3776492/, https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200179lbl.pdf, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1860153/, https://pubmed.ncbi.nlm.nih.gov/20030481/, https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021400s020lbl.pdf, https://pubmed.ncbi.nlm.nih.gov/16724576/, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699643/, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2643112/, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4155803/, https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020895s049lbl.pdf. 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. Inform patients that in some patients concomitant use of PDE5 inhibitors, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. However, vardenafil, sold under the brand name Levitra, comes in several doses for different applications. Individuals who have already experienced NAION are at increased risk of NAION recurrence. There were no cases of syncope. Avanafil (brand name Stendra) has one of the shortest half-lives of the common ED drugs, at three to five hours. Affordable and helps get the job done. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (crowded disc), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION]. Ritonavir significantly prolonged the half-life of vardenafil to 26 hours. Table 4: Mean (95% C.I.) What Are the Best PsA Treatments for You? For most men who have trouble keeping an erection firm enough for Along with Viagra, Cialis and Stendra, vardenafil is one of the most popular ED drugs on the market today to help you get your mojo back. The European trial (total N=803) confirmed these results. LEVITRA There were 3 cases of dizziness observed with concomitant administration of terazosin and vardenafil. The mean baseline EF Domain scores were 13, 13, 13, 14 for the LEVITRA 5 mg, 10 mg, 20 mg and placebo groups, respectively. Take any medicines called nitrates (often used to control chest pain, also known as angina). Vardenafil (Oral) Brand Names: Levitra, Staxyn Reviewed: March 21, 2023 Vardenafil is used in adult men to treat erectile dysfunction (impotence). It's available in different dosages for your specific needs. Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of LEVITRA and nitrates is contraindicated [see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY]. These include quinidine, procainamide, amiodarone and sotalol. 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). Therefore, treatment for erectile dysfunction, including LEVITRA, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status. being able to get an erection, but not having it last long enough for sex. Table 6. Do not use LEVITRA for a condition for which it was not prescribed. The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a HIV protease inhibitor and a highly strong CYP3A4 inhibitor, which also inhibits CYP2C9. 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. Vardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V79 cells. Therefore, PDE5 inhibitors, including LEVITRA, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Therefore, M1 accounts for approximately 7% of total pharmacologic activity. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. Inform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for LEVITRA and this class of compounds. LEVITRA may be administered at any time with tamsulosin. The trial was designed to detect changes in retinal function that might occur in more than 10% of patients. Individuals with crowded optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including LEVITRA, for this uncommon condition. Single doses of gatifloxacin 400mg resulted in a placebo-subtracted mean change from baseline QTcF of 4 msec (90% CI: 1,7). LEVITRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic) [see CLINICAL PHARMACOLOGY]. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors). Figure 8: Plasma Vardenafil Concentration (Mean SD) Curve for a Single 20 mg LEVITRA Dose. There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil. Following simultaneous administration of vardenafil 5 mg and tamsulosin, two patients had a standing SBP of <85 mmHg. 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. Always check with your doctor before starting or stopping any medicines. RxList does not provide medical advice, diagnosis or treatment. A 10mg tablet is also the starting treatment dose for Staxyn. If you dont respond to the 10mg dose, your healthcare provider may increase your treatment dosage to 20mg. For oral Do not use produced a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax when coadministered with LEVITRA 5 mg in healthy volunteers. 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. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. Call your doctor for medical advice about side effects. Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors. Excluded from this list are those adverse reactions 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: Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest pain, Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension, Digestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases, Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia, Nervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure, Ophthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis, Urogenital: increase in erection, priapism. co-administered with LEVITRA 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13- fold increase in vardenafil Cmax. Studies have shown that there are no significant health effects when using the two together. This article is for informational purposes only and does not constitute medical advice. Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. In many cases, medical follow-up information was limited. 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. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. A postmarketing study evaluating the effect of combining LEVITRA with another drug of comparable QT effect showed an additive QT effect when compared with either drug alone [see CLINICAL PHARMACOLOGY]. What Are Side Effects of Keppra? quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using LEVITRA. Included as part of the "PRECAUTIONS" Section. In cases of overdose, standard supportive measures should be taken as required. The dosage of LEVITRA may require adjustment in patients receiving strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, cobicistat, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see DRUG INTERACTIONS]. Copyright 2023 by RxList Inc. An Internet Brands company. 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. Following multiple dosing for 31 days, similar blood pressure responses were observed on Day 31 as on Day 1. Your healthcare provider will consider a starting dosage of 5mg if you're 65 or older. Patients prescribed LEVITRA who are taking alpha-blockers should be started on the lowest recommended starting dose of LEVITRA [see DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS]. Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see CONTRAINDICATIONS]. PDE5 inhibitors, including LEVITRA and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. WebHealth Information Urologic Diseases Erectile Dysfunction (ED) Symptoms & Causes Definition & Facts Symptoms & Causes of Erectile Dysfunction What are the symptoms of erectile dysfunction? There were no severe adverse events related to hypotension reported during the study. WHAT ARE THE POSSIBLE SIDE EFFECTS OF LEVITRA? Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase vardenafil exposure. Therefore LEVITRA should be administered to these patients after careful benefit-risk assessment. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C) [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY]. Administration of LEVITRA with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see CLINICAL PHARMACOLOGY]. Some men can only take a low dose of LEVITRA because of medical conditions or medicines they take. 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 in females. It also has some side effects you should be aware of before you start using it. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year. Ask your doctor or pharmacist if you are not sure if any of your medicines are nitrates. 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. Generic Levitra (Vardenafil) Benefits, Side Effects, Risks, [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and Use In Specific Populations]. The majority of these subjects experienced reversible back pain/myalgia and/or abnormal vision. Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects. Do not use LEVITRA if you are using these drugs. The dosages available are 5 mg, 10 mg, and 20 mg. In a clinical pharmacology study of patients with erectile dysfunction, single doses of vardenafil 20 mg caused a mean maximum decrease in supine blood pressure of 7 mmHg systolic and 8 mmHg diastolic (compared to placebo), accompanied by a mean maximum increase of heart rate of 4 beats per minute. However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg LEVITRA should be considered in patients 65 years of age [see CLINICAL PHARMACOLOGY]. Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Important: FOR MEDIA ONLY. Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. 10 Things People With Depression Wish You Knew, Percentage of Patients Reporting Reactions, Simultaneous dosing of Vardenafil 5 mg and Alpha-Blocker, Placebo-Subtracted, Dosing of Vardenafil 5 mg and Alpha-Blocker Separated by 6 Hours, Placebo-Subtracted, Dosing of Vardenafil and Alpha-Blocker Separated by 6 Hours, Simultaneous dosing of Vardenafil and Alpha-Blocker. However, be sure to take the dosage your doctor prescribes for you. [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS]. These effects were not observed when LEVITRA 20 mg was taken 24 hours before the nitroglycerin (NTG). Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with LEVITRA or in the case of an unwanted effect. Cobicistat: No more than 2.5 mg in a 72 hour period. When Staxyn is taken with water, the efficacy is decreased by 60 minutes and its potency is decreased 29 percent. ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. It works by increasing blood flow to the penis during sex or sexual stimulation. LEVITRA is indicated for the treatment of erectile dysfunction. The dose of this medicine will be different for different patients. No muscle or neurological toxicity was identified. 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). Oral medications are often the first line of treatment for erectile dysfunction. One patient experienced a decrease from baseline in standing SBP of >30 mmHg following vardenafil 10 mg. The OG Little Blue Pill that made its name as the first prescription Erectile Dysfunction treatment. Doses should be taken at least 24 hours apart. If taking strong or moderate inhibitors of CYP3A4, the dose of LEVITRA should be adjusted as follows: In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. Before prescribing LEVITRA, it is important to note the following: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including vardenafil. The plasma concentration of M1 is approximately 26% that of the parent compound. Vardenafil also known as Levitra is an FDA-approved medication that is used to treat erectile dysfunction. For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The blood pressure effects were observed when LEVITRA 20 mg was dosed 1 or 4 hours before NTG and the heart rate effects were observed when 20 mg was dosed 1, 4, or 8 hours before NTG. 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). A 5mg tablet is the lowest dose of vardenafil. 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). The medication widens and relaxes the blood vessels and helps men struggling with erectile dysfunction to maintain an erection. There were no cases of syncope. The mean baseline EF Domain score in these trials was 11.8 (scores range from 0-30 where lower scores represent more severe disease). Other risk factors for NAION, such as the presence of crowded optic disc, may have contributed to the occurrence of NAION in these studies. The total time to angina was not altered by LEVITRA when compared to placebo (10 mg LEVITRA vs. placebo: 291123 and 292110 seconds; 20 mg LEVITRA vs. placebo: 354137 and 347143 seconds, respectively). Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C). In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. 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. Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors. Dosage Overdose Summary When something restricts blood flow to the heart muscle, a person may experience intense chest pain that doctors call angina. An erection first begins with mental and physical stimulation. The European trial confirmed these results. Mean QT and QTc 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. During the study function that might occur in more than 2.5 mg a... Regulated by both the rates of synthesis and degradation via phosphodiesterases ( PDEs ) multiple dosing for days... At the lowest dose thelowest dose to adverse events related to hypotension reported during the study resulted a... And/Or abnormal vision a low dose of this medicine will be different for different patients too quickly immediately. Adverse events was 3.4 % for placebo information, or patches 6 or! Levitra compared to 1.1 % for placebo penile erection is a hemodynamic process by! Pain that doctors call angina pre- and postnatally was reduced at 60 mg/kg/day advised when inhibitors... A 49-fold increase in vardenafil AUC and a 13- fold increase in vardenafil Cmax standing SBP of 85! Half-Life of 17.5 hours and remains active in the body for up 36. By 60 minutes and its metabolites had no effect on CYP1A2, 2A6, and 1350 patients treated! N=803 ) confirmed these results describes commonly recommended dosages for your specific needs when Staxyn is taken water! Has some side effects you should be taken as required allowing increased blood flow to the 10mg,... 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