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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 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 generic viagra cvs price 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 viagra cialis for sale 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 viagra buy near me 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.

Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produced similar increases in QTc interval (e.g., 4—6 msec calculated by individual QT correction) as moxifloxacin. When vardenafil (10 mg) was given with gatifloxacin (400 mg), an additive effect on the QT interval was observed.

The effect of vardenafil on the QT interval should be considered when prescribing the drug. The manufacturer recommends that vardenafil not be used in patients with congenital long QT syndrome and those taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs.

Further, use vardenafil with caution in patients with cardiac disease or other conditions that may increase the risk of QT prolongation including cardiac arrhythmias, heart failure, bradycardia, myocardial infarction, hypertension, coronary artery disease, hypomagnesemia, hypokalemia, hypocalcemia, or in patients receiving medications known to prolong the QT interval or cause electrolyte imbalances.

Females, geriatric patients, patients with diabetes mellitus, thyroid disease, malnutrition, alcoholism, or hepatic disease may also be at increased risk for QT prolongation. Prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been associated with PDE5 inhibitor administration.

Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. Vardenafil and other agents for the treatment of erectile dysfunction should be used with caution in patients with penile structural abnormality (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell disease, leukemia, multiple myeloma, polycythemia, or history of priapism). Patients should be reminded that vardenafil offers no protection against sexually transmitted disease. Counseling of patients about protective measures, including the prevention of transmission of human immunodeficiency virus (HIV) infection, should be considered.

Advise patients to stop use of all phosphodiesterase 5 (PDE5) inhibitors, including vardanafil, and seek medical attention for evaluation in the event of a sudden visual disturbance in 1 or both eyes.

Postmarketing reports with PDE5 inhibitors have included cases of visual disturbances including retinal vein occlusion, visual field defects, reduced visual acuity, and loss of vision (temporary or permanent). Vision loss is attributed to a condition known as non-arteritic anterior ischemic optic neuropathy (NAION), where blood flow is blocked to the optic nerve; this can cause permanent loss of vision; discontinue vardenafil if there is visual loss in 1 or both eyes.

Patients with a history of NAION are at increased risk for recurrence.

Only use a PDE5 inhibitor in these individuals if the anticipated benefit outweighs the risk. Patients with low cup to disc ratio ('crowded disc') are also at increased risk; however, this condition is uncommon, and there is insufficient evidence to support screening of prospective users of a PDE5 inhibitor. Vardenafil use is not recommended in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa. A minority of patients with the inherited condition retinitis pigmentosa have genetic disorders of retinal phosphodiesterases. Vardenafil use is not recommended in these patients until further information is available.

There are no adequate and well-controlled trials of vardenafil in humans during pregnancy.

In animal reproduction studies, no adverse developmental outcomes were observed during organogenesis at exposures for unbound vardenafil and its major metabolite at 100 and 29 times, respectively, the maximum recommended human dose (MRHD) of 20 mg.



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