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Clinicamente, isto se reflete em inicio de acao da atividade eretil a partir de 12 minutos, podendo ter efeito por ate 12 horas 5 ( B ). A vardenafila tem Tmax proxima de 40 minutos e meia-vida em torno de quatro horas 7 ( D ). Clinicamente, isto tambem se reflete em inicio de acao da atividade eretil a partir de 15 minutos, podendo ter efeito por ate 12 horas 6 ( B ). A tadalafila tem Tmax de duas horas (30 minutos a 4 horas) e uma meia-vida de, aproximadamente, 17,5 horas, podendo ter efeito por ate 24 a 36 horas apos a administracao do medicamento 3 ( A ). *A Tabela 1 esta disponivel na diretriz, versao completa, acessivel em www.projetodiretrizes.org.br. Estudos clinicos mostraram eficacia estatisticamente superior ao placebo, dose-dependente, em homens com DE em populacao nao selecionada e nas seguintes subpopulacoes: de causa psicologica 8 ( A ); com diabetes tipo I e II 8 ( A ); pos-lesao medular 8 ( A ); com doencas cardiovasculares 8 ( A ); apos prostatectomia radical 8 ( A ); com depressao leve nao tratada 8 ( A ); com mal de Parkinson 9 ( B ); pos-transplante renal 10 ( B ); pos-braquiterapia e radioterapia 11 ( B ); com insuficiencia renal em vigencia de dialise 12 ( A ). Estudos clinicos mostraram eficacia estatisticamente superior ao placebo, dose-dependente, em homens com DE em populacao nao selecionada 13 ( B ) e nas seguintes subpopulacoes: de causa psicologica 14 ( A ); com dislipidemia 14 ( A ); em uso de anti-hipertensivos 14 ( A ); pos-prostatectomia radical 15 ( A ); com diabete mellitus tipo 1 e 2 16 ( A ). Estudos clinicos mostraram eficacia estatisticamente superior ao placebo, dose-dependente, em homens com DE em populacao nao selecionada 17 ( A ) e nas seguintes subpopulacoes: de causa psicologica; com diabetes mellitus 18 ( A ); pos-prostatectomia radical. Ate o presente momento, nao existem evidencias de maior eficacia de um desses medicamentos sobre outro. Os efeitos colaterais costumam ser transitorios e de leve intensidade. Os mais frequentes sao: cefaleia, rubor facial, epigastralgia e congestao nasal 17,19,20 ( A ) 21 ( B ) 22 ( D ). Dor lombar e mialgia sao mais frequentes com o uso da tadalafila 19 ( A ). Todos os tres medicamentos sao seguros do ponto de vista cardiovascular, nao apresentando efeitos negativos sobre a funcao cardiaca, nem piorando o quadro clinico de pacientes com insuficiencia coronariana estavel 23 ( A ) 24-27 ( B ). Outrossim, as alteracoes no eletrocardiograma nao foram consideradas significantes 28 ( B ). O uso de iF5 nao aumentou a incidencia de acidentes vasculares 29 ( D ). Tambem nao causam alteracao significativa da pressao arterial sistolica e diastolica, nem na frequencia cardiaca 30 ( D ). Na insuficiencia cardiaca congestiva, sildenafila, alem de bem tolerada, aumentou a capacidade destes pacientes aos exercicios 31,32 ( B ). A tadalafila apresenta alta seletividade para a fosfodiesterase tipo 11, existente nos testiculos e na hipofise 33 ( D ). No entanto, o uso diario da tadalafila nao mostrou alteracao significativa na concentracao, morfologia ou motilidade dos espermatozoides. Tambem nao houve alteracao dos niveis plasmaticos de testosterona, LH e FSH 34 ( A ). Os iF5 sao metabolizados primariamente pela via do citocromo CYP3A4. Desta maneira, outras drogas metabolizadas por esta via, como cetonoconazol, inibidores da protease (ritonavir, saquinavir), que sao inibidores deste citocromo, retardam a metabolizacao desses medicamentos, aumentando seus niveis plasmaticos. Ja a rifampicina, que e um indutor seletivo do CYP3A4, pode reduzir os niveis dos iF5 35 ( D ). O uso da iF5 concomitante com os alfabloqueadores pode produzir um efeito hipotensor sem, no entanto, contra-indicar sistematicamente a sua prescricao 36 ( B ). A administracao de iF5 em pacientes em uso de um ou mais anti-hipertensivos nao traz alteracoes significantes dos niveis pressoricos 37 ( B ). As unicas contra-indicacoes absolutas do iF5 sao sensibilidade a eles e uso concomitante com nitratos 1 ( B ). O texto completo da diretriz " Disfuncao eretil: tratamento com drogas inibidoras da fosfodiesterase tipo 5" esta disponivel em www.projetodiretrizes.org.br . Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. Padma-Nathan H, Christ G, Adaikan G, Becher E, Brock G, Carson C, et al. Sexual medicine: sexual dysfunctions in men and women In: Lue TF, Basson R, Rosen R, Giuliano F, Khoury S, Montorsi F, editors. Porst H, Padma-Nathan H, Giuliano F, Anglin G, Varanese L, Rosen R. Efficay of tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: a randomized controlled trial. Sildenafil, a novel effective oral therapy for male erectile dysfunction. Onset and duration of action of sildenafil for the treatment of erectile dysfunction. Valiquette L,Montorsi F, Hellstrom WJ, Giuliano F, Homering M, Taylor T, et al. Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis. Vardenafil preclinical trial data: potency, pharmacodynamics, pharmacokinetics, and adverse events. Fink HA,Mac Donald R, Rutks IR, Nelson DB, Wilt TJ. Sildenafil for male erectile dysfunction: a systematic review and metaanalysis. Hussain IF, Brady CM, Swinn MJ, Mathias CJ, Fowler CJ. Treatment of erectile dysfunction with sildenafil (Viagra) in parkinsonism due to parkinson's disease or multiple system atrophy with observations on orthostatic hypotension. Zhang Y, Guan DL, Ou TW, Wang Y, Chen X, Xing NZ, et al. Sildenafil citrate treatment for erectile dysfunction after kidney transplantation. The efficacy of sildenafil citrate following radiation therapy for prostate cancer: temporal considerations. Seibel I, Poli de Figueiredo CE, Teloken C, Moraes JF. Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction. Giuliano F,Donatucci C, Montorsi F, Auerbach S, Karlin G, Norenberg C, et al. Vardenafil is effective and well tolerated for treating erectile dysfunction in a broad population of men, irrespective of age. Efficacy and tolerability of vardenafil for treatment of erectile dysfunction in patient subgroups. Nehra A, Grantmyre J, Nadel A, Thibonnier M, Brock G. Vardenafil improved patient satisfaction with erectile hardness, orgasmic function and sexual experience in men with erectile dysfunction following nerve sparing radical prostatectomy. Goldstein I, Young JM, Fischer J, Bangerter K, Segerson T, Taylor T. Vardenafil, a new PDE5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study. Eardley I, Gentile V, Austoni E, Hackett G, Lembo D, Wang C, et al. Efficacy and safety of tadalafil in Western European population of men with erectile dysfunction. Effect of tadalafil on erectile dysfunction in men with diabetes. Skoumal R, Chen J,Kula K, Breza J, Calomfirescu N, Basson BR, et al. Efficacy and treatment satisfaction with on-demand tadalafil (Cialis) in men with erectile dysfunction. Nehra A, Grantmyre J, Nadel A, Thibonnier M, Brock G. Vardenafil improved patient satisfaction with erectile hardness, orgasmic function and sexual experience in men with erectile dysfunction following nerve sparing radical prostatectomy. Deveci S, Peskircioglu L, Aygun C, Tekin MI, Dirim A, Ozkardes H. Sublingual sildenafil in the treatment of erectile dysfunction: faster onset of action with less dose. Padma-Nathan H, Eardley I, Kloner RA, Laties AM, Montorsi F. A 4-tear update on the safety of sildenafil citrate (Viagra). DeBusk RF, Pepine CJ, Glasser DB, Shpilsky A, DeRiesthal H, Sweeney M. Efficacy and safety of sildenafil citrate in men with erectile dysfunction and stable coronary artery disease. Thadani U, Smith W, Nash S, Bittar N, Glasser S, Narayan P, et al. The effect of vardenafil, a potent and highly selective phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction, on the cardiovascular response to exercise in patients with coronary artery disease. Rosano GM, Marazzi G, Patrizi R, Cerquetani E, Vitale C, Volterrani M, et al. Comparison of trimetazidine plus sildenafil to chronic nitrates in the control of myocardial ischemia during sexual activity in patients with coronary artery disease. Efficacy and safety of sildenafil citrate for the treatment of erectile dysfunction in men with cardiovascular disease. Rosano GM, Aversa A, Vitale C, Fabbri A, Fini M, Spera G. Chronic treatment with tadalafil improves endothelial function in men with increased cardiovascular risk. Sildenafil citrate does not affect QT intervals and QT dispersion: an important observation for drug safety. Shakir SA, Wilton LV, Boshier A, Layton D, Heeley E. Cardiovascular events in users of sildenafil: results form first phase of prescription event monitoring in England. Cardiovascular effects of the 3 phosphodiesterase-5 inhibitors approved for the treatment of erectile dysfunction. Bocchi EA, Guimaraes G, Mocelin A, Bacal F, Belloti G, Ramires JF. Sildenafil effects on exercise, neurohormonal activation, and erectile dysfunction in congestive heart failure: a double-blind, placebo-controlled, randomized study followed by a prospective treatment for erectile dysfunction. Use of sildenafil for safe improvement of erectile function and quality of life in men with New York Heart Association classes II and III congestive heart failure: a prospective, placebocontrolled, double-blind crossover trial. Phosphodiesterase 11 (PDE11): is it a player in human testicular function? Hellstrom W, Overstreet J, Yu A, Saikalik, Shen W, Beastey C, et al. Tadalafil has no detrimental effect on human spermatogenesis or reproductive hormones. The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. Kloner RA, Jackson G, Emmick JT, Mitchell MI, Bedding A, Warner MR, et al. Interaction between the phosphodiesterase 5 inhibitor, tadalafil and 2 alphablockers, doxazosin and tamsulosin in healthy normotensive men. Effect of sildenafil citrate on blood pressure and heart rate in men with erectile dysfunction taking concomitant antihypertensive medication. All the contents of sildenafil teva 25 mg this journal, except where otherwise noted, is licensed under a Creative Commons Attribution License. Sao Carlos do Pinhal, 324 01333-903 Sao Paulo SP - Brazil Tel: +55 11 3178-6800 Fax: +55 11 3178-6816. Vardenafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body. Vardenafil is used to treat erectile dysfunction (impotence). Vardenafil may also be used for purposes not listed in this medication guide. What is the most important information I should know about Levitra ? You should not use vardenafil if you are allergic to it, or if you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas). Vardenafil is not approved for men younger than 18 years old. Do not take vardenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking vardenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure. Tell your doctor if you have ever had: heart disease, heart rhythm problems; a heart attack, stroke, or congestive heart failure; long QT syndrome (in you or a family member); high or low blood pressure; seizures; liver disease, kidney disease (or if you are on dialysis); a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia; a bleeding disorder such as hemophilia; a stomach ulcer; hearing or vision problems, vision loss; an eye disorder such as retinitis pigmentosa (an inherited condition of the eye); a physical deformity of the penis (such as Peyronie's disease); or if you have been told you should not have sexual intercourse for health reasons. Vardenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoked or were over 50 years old. It is not clear whether vardenafil is the actual cause of vision loss. Talk to your doctor before using this form of vardenafil if you have phenylketonuria (PKU). Vardenafil is not for use in women, and the effects of this medicine during pregnancy or in breastfeeding women are unknown. Vardenafil (Levitra®) is the second oral phosphodiesterase inhibitor approved for erectile dysfunction. 1, 2 As well as sildenafil (Viagra®), this drug acts by relaxing blood vessels and muscles in the penis, allowing increased blood flow into the penis to produce an erection. The most important hazard adverse effect related with this therapy is the promotion of a profound hypotension and myocardial ischemia when combined with nitrates. Cases of atrial fibrillation had been related with sildenafil 3, 4 but, with vardenafil therapy, this arrhythmia was not described yet. We report a case with a first-detected, symptomatic paroxysmal atrial fibrillation in a healthy patient after a self-medication with vardenafil. A 50 year old man presented to sildenafil citrate liquid for sale the emergency room with a persistent palpitation, lasting for 2 hours, began 15 minutes after ingesting, as self-medication, a single 10 mg tablet of vardenafil. He denied other symptoms or the use of ethanol or other medicines. He had no significant history for erectile dysfunction, and justified the self-medication to improve his sexual performance. He had already used sildenafil previously without complication. At physical examination, an irregular and tachycardic heart rhythm was evidenced, around 140 beats/minute, with no other pathological findings. The electrocardiogram revealed atrial fibrillation with rapid ventricular rate and was without ST segment or T wave abnormalities. Chest radiograph and routine laboratories including cardiac enzymes were normal. Beyond rest, he was medicated with oral diazepam, and the arrhythmia coursed with conversion to normal sinus rhythm after four hours. He obtained hospital discharge without antiarrhythmic medication. It was performed on outpatient cardiovascular investigation. The transthoracic Doppler echocardiography disclosed a structurally normal heart, with left atrial diameter of 2.8 cm and left ventricular ejection fraction of 0.76. The 24 hour ambulatory electrocardiographic monitoring did not present cardiac arrhythmias, and the treadmill exercise testing was negative for myocardial ischemia. After a follow-up of 7 months, the patient was asymptomatic, without medication. The temporal relationship between the ingestion of vardenafil and new onset atrial fibrillation in a patient with no cardiovascular diseases suggests that the drug caused the arrhythmia. Cremers and colleagues 5 demonstrated that sildenafil has a potent vasodilatory action but has no direct influence on human myocardial contractility or proarrhythmic effects in vitro . Thus, a possible mechanism involved with the induction of atrial fibrillation is hypotension leading to a reflex tachycardia through catecholamine excess. Han and Hoffman 3 reported a case with atrial fibrillation in a patient with normal heart after taking sildenafil. In this case, the patient presented after a syncopal episode, and antiarrhythmic therapy with ibutilide failed to restore normal heart rhythm, which was spontaneously obtained 2 days later. In the other report of atrial fibrillation after sildenafil therapy, Awan et al 4 treated a patient with hypertrophic obstructive cardiomyopathy. In our case, antiarrhythmic treatment was not necessary to restore normal sinus rhythm as well as for the prevention of recurrences. We believe that patients who have a clear trigger for atrial fibrillation should not undergo antiarrhythmic therapy to restore normal sinus rhythm if the episode is well tolerated. In such cases, the initiation of rate control drugs might be the best approach. This report strengthens the risk of self-medication with phosphodiesterase inhibitors in a patient without significant erectile dysfunction. This therapy should be restricted for patients with organic urologic dysfunctions and not as a recreational drug. Initially, 10 mg PO approximately 60 minutes before sexual activity. For males 65 years of age or older, consider a lower starting dose of 5 mg PO. ADJUSTMENTS: Coadministration of certain drugs may need to be avoided or vardenafil dosage adjustments may be necessary; review drug interactions. Vardenafil dosage reductions are required in patients taking moderate or potent CYP3A4 inhibitors. If coadministering with an alpha-blocker, patients should be stable on alpha blocker therapy before starting vardenafil, and the initial vardenafil dose should be reduced to 5 mg (or 2.5 mg if given with certain CYP3A4 inhibitors). PDE5 inhibitors are first-line agents for ED according to guidelines. Although associated with high rates of success, approximately 35% of ED patients fail to respond to PDE5 inhibitor therapy. A course of an alternate PDE5 inhibitor may be considered if a patient does not respond to a PDE5 inhibitor trial; a treatment failure may be deemed after at least 4 unsuccessful trials. Patients refractory to PDE5 inhibitors should be counseled on appropriate use, potentially modifiable factors (e.g. hormonal abnormalities, food or drug interactions, lack of adequate sexual stimulation, heavy alcohol use, and the patient's relationship with his partner), and the risks and benefits of other therapies. Second-line treatment options include intracavernous injection and intra-urethral therapy. Follow-up visits for ED patients, regardless of therapy, are necessary to determine whether therapy continues to be effective and whether cardiovascular health has significantly changed. A single dose of 2.5 mg PO should not be exceeded in a 72-hour period. A single dose of 2.5 mg PO should not be exceeded in a 24-hour period. A single dose of 5 mg PO should not be exceeded in a 24-hour period. If the patient is also taking an alpha-blocker, the initial dose should be 2.5 mg PO. 10 mg PO, taken approximately 60 minutes before sexual activity (Max dose: 10 mg/day PO). Patients requiring a lower dose of vardenafil should use the film-coated tablets. Do not use the orally disintegrating tablets with concomitant moderate or potent CYP3A4 inhibitors (e.g., ritonavir, indinavir, atazanavir, saquinavir, clarithromycin, ketoconazole, itraconazole, erythromycin). Vardenafil 10 mg orally disintegrating tablets provide higher systemic exposure compared to vardenfil 10 mg film-coated tablets, and these dosage forms are not interchangeable. PDE5 inhibitors are first-line agents for ED according to guidelines. Although associated with high rates of success, approximately 35% of ED patients fail to respond to PDE5 inhibitor therapy. A course of an alternate PDE5 inhibitor may be considered if a patient does not respond to a PDE5 inhibitor trial; a treatment failure may be deemed after at least 4 unsuccessful trials. Patients refractory to PDE5 inhibitors should be counseled on appropriate use, potentially modifiable factors (e.g. hormonal abnormalities, food or drug interactions, lack of adequate sexual stimulation, heavy alcohol use, and the patient's relationship with his partner), and the risks and benefits of other therapies. Second-line treatment options include intracavernous injection and intra-urethral therapy. Follow-up visits for ED patients, regardless of therapy, are necessary to determine whether therapy continues to be effective and whether cardiovascular health has significantly changed. For orally disintegrating tablets (e.g., Staxyn), 10 mg/day PO. For orally disintegrating tablets (e.g., Staxyn), 10 mg/day PO. Patients with mild hepatic impairment (Child-Pugh class A): No dose adjustment is required. Patients with moderate hepatic impairment (Child-Pugh class B): Decrease starting dose to 5 mg/day PO using the regular tablets; the maximum dose should not exceed 10 mg/day PO. Do not use vardenafil orally disintegrating tablets in patients with moderate hepatic impairment. Patients with severe hepatic impairment (Child-Pugh class C): Do not use. CrCl 30 mL/minute or more: No dosage adjustments are needed. Hemodialysis Do not use vardenafil in patients requiring dialysis; vardenafil has not been studied in these patients. Vardenafil is administered orally approximately 1 hour before expected intercourse. Orally disintegrating tablets: Place on tongue where tablet will disintegrate. Administer immediately upon removal from blister packaging. Levitra: - Store at 77 degrees F; excursions permitted to 59-86 degrees F Staxyn: - Store at 77 degrees F; excursions permitted to 59-86 degrees F. Vardenafil is contraindicated in patients with a known hypersensitivity to any component of the tablet. The safety and efficacy of combinations of vardenafil with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. The safe and effective use of vardenafil in combination with other agents for treating erectile dysfunction has not been studied. Therefore, the use of such combinations is not recommended. Vardenafil is contraindicated in patients who are currently on nitrate/nitrite therapy. Consistent with its known effects on the nitric oxide/cGMP pathway, vardenafil may potentiate the hypotensive effects of organic nitrates and nitrites. Patients receiving nitrates in any form are not to receive vardenafil. This includes any patient who receives intermittent nitrate therapies. It is unknown if it is safe for patients to receive nitrates once vardenafil has been administered. A suitable time interval following vardenafil dosing for safe administration of nitrates or nitric oxide donors has not been determined. Vardenafil tablets are not recommended in patients with severe hepatic disease (Child-Pugh class C) or end stage renal disease requiring dialysis (severe renal impairment or renal failure). There are no controlled clinical studies on the safety and efficacy of vardenafil in these patients; therefore, vardenafil use is not recommended until further information is available. Patients with moderate hepatic impairment require a reduction in the starting dose of the regular tablets and a lower maximum dosage (see Indications/Dosage). Patients with mild hepatic impairment or mild to moderate renal impairment do not require adjustments in the vardenafil regular tablet dosage. The concomitant use of certain potent hepatic cytochrome P450 3A4 inhibitors may result in a requirement to adjust the vardenafil dosage (see Dosage and Drug Interactions). Vardenafil orally disintegrating tablets provide increased exposure as compared to the regular tablets; therefore, the orally disintegrating tablets should not be used in patients with moderate or severe hepatic disease (Child-Pugh class B or C) or in patients on hemodialysis. Patients who require lower doses of vardenafil should use the regular tablets. Lower starting doses of vardenafil regular tablets should be considered for geriatric patients (>= 65 years) because elderly patients have higher plasma concentrations than younger males (18—45 years) (see Indications/Dosage). In phase III clinical trials of the regular tablets, 834 elderly patients participated and there was no difference in safety or effectiveness compared to younger patients. In trials with the orally disintegrating tablets, the vardenafil AUC in elderly patients (>= 65 years) was increased by 39% and the Cmax was increased by 21% as compared to patients 170/110); patients with cardiac disease, severe heart failure or coronary artery disease (CAD) which causes unstable angina including those with left ventricular outflow obstruction (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis). Based on recommendations for sildenafil by the American College of Cardiology, it is recommended that vardenafil be used with caution in the following: patients with active coronary ischemia who are not taking nitrates (e.g., positive exercise test for ischemia); patients with congestive heart failure and borderline low blood pressure and borderline low volume status; patients on a complicated, multidrug, antihypertensive program; and patients taking drugs that can prolong the half-life of vardenafil. Vardenafil is contraindicated in patients currently on nitrate/nitrite therapy. In a double-blind, crossover, single-dose study of patients with stable CAD, vardenafil did not cause any impairment in exercise capabilities at levels equivalent to or greater than that achieved during sexual intercourse. The effects of vardenafil on QT prolongation were evaluated in 59 healthy males using moxifloxacin (400 mg) as an active control.
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