Do not take this medicine with any of the following medications: bepridil, certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole, cisapride, droperidol, grepafloxacin, medicines for irregular heartbeat like dronedarone, dofetilide, methscopolamine nitrate, nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, nitroprusside, other medicines for erectile dysfunction like avanafil, sildenafil, Tadalafil, pimozide, thioridazine, ziprasidone.
This medicine may also interact with the following medications: antiviral medicines for HIV or AIDS, certain antibiotics like erythromycin and clarithromycin, certain drugs for high blood pressure, medicines for prostate problems, other medicines that prolong the QT interval (cause an abnormal heart rhythm)
Consistent with its known effects on the nitric oxide/cGMP pathway, vardenafil may potentiate the hypotensive effects of nitrates. In vivo studies show that vardenafil potentiates the blood pressure lowering effects of nitrates when sublingual nitroglycerin is taken 1, 4, and 8 hours after vardenafil (20 mg). These effects were not observed when vardenafil was taken 24 hours before nitroglycerin. Potentiation of the hypotensive effects of nitrates by vardenafil for patients with ischemic heart disease has not been studied. Deaths have been reported in men who were using a similar agent, sildenafil, while taking nitrate or nitrite therapy for angina. Vardenafil administration to patients who are concurrently using organic nitrates or nitrites in any form is contraindicated.
The safety and efficacy of tadalafil administered concurrently with any other phosphodiesterase (PDE5) inhibitors, such as vardenafil, has not been studied. The manufacturer of tadalafil recommends to avoid the use of tadalafil with any other PDE5 inhibitors.
Concurrent use of phosphodiesterase (PDE5) inhibitors and alpha-blockers may lead to symptomatic hypotension in some patients. Vardenafil, other PDE5 inhibitors, and alpha-blockers are systemic vasodilators which can lower blood pressure. If vasodilators are used in combination, an additive effect on blood pressure is anticipated. Patients should be stable on alpha-blocker therapy before starting PDE5 inhibitor therapy. If hemodynamic instability is evident on alpha-blocker therapy alone, there is an increased risk of symptomatic hypotension with concomitant PDE5 inhibitor therapy. For patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be started at the lowest recommended dose. If a patients is currently receiving an optimized dose of a PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. In general, patients should not be initiated on the orally disintegrating vardenafil tablets while on alpha-blocker therapy; however, if patients have previously used the film-coated tablets, this may be changed to the orally disintegrating tablets upon the advice of the healthcare provider. Stepwise increases in the alpha-blocker dose may be associated with further hypotension when taking a PDE5 inhibitor. Other variables, such as intravascular volume depletion and other antihypertensive drugs, may affect the safety of concomitant use of PDE5 inhibitors and alpha-blockers. Studies have been conducted to determine the effects of vardenafil on the potentiation of the blood-pressure-lowering effects of the alpha-blockers terazosin and tamsulosin. When vardenafil 10 or 20 mg was administered to healthy subjects taking terazosin (10 mg daily), an alpha-1-blocker, there was significant augmentation of the hypotensive effects of terazosin on standing systolic blood pressure. In contrast, coadministration of a single 10 or 20 mg dose of vardenafil to healthy subjects taking 0.4 mg once daily of tamsulosin, a selective antagonist of alpha-1a receptors, resulted in no significant decreases in blood pressure.
Coadministration of vardenafil and other organic nitrates has been shown to potentiate the hypotension effects of nitrates. Many methscopolamine-containing products list methscopolamine nitrate as an ingredient. Coadministration of methscopolamine nitrate and vardenafil has not been studied. Therefore, the concomitant use of vardenafil and products which contain methscopolamine nitrate is not recommended.
It may be prudent to avoid the use of vardenafil in patients being treated with erythromycin. If these drugs must be used together, do so with extreme caution; dose adjustments of vardenafil are necessary. The vardenafil orally disintegrating tablets (ODTs) provide increased exposure as compared to the regular tablets; therefore, do not use the orally disintegrating tablets with moderate or potent CYP3A4 inhibitors, such as erythromycin. Erythromycin is generally considered by experts to have an established risk for QT prolongation and torsades de pointes (TdP). Vardenafil, at therapeutic (10 mg) and supratherapeutic (80 mg) doses, produces increases in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction). Coadministration could lead to the risk of additive QT prolongation. Additionally, erythromycin inhibits CYP3A4. Vardenafil is metabolized by CYP3A4. Coadministration of erythromycin (500 mg tid) increased the AUC and Cmax of vardenafil 4-fold and 3-fold, respectively; increased vardenafil concentrations further increase the risk for serious side effects.
Particular caution should be used when prescribing phosphodiesterase type 5 (PDE5) inhibitors to patients receiving ritonavir. Coadministration of ritonavir with vardenafil results in a 20% decrease in ritonavir AUC and a 49-fold increase in vardenafil AUC. Substantially increased vardenafil plasma concentrations may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection. If coadministered, use vardenafil regular tablets at reduced doses of no more than 2.5 mg every 72 hours with increased monitoring for adverse reactions.1918 The vardenafil orally disintegrating tablets provide increased exposure as compared to the regular tablets; therefore, do not use the orally disintegrating tablets with moderate or potent CYP3A4 inhibitors, such as ritnonavir.3 No change in ritonavir dose is required.
Clarithromycin is associated with an established risk for QT prolongation and torsades de pointes (TdP). Clarithromycin is also a known inhibitor of the hepatic cytochrome isozyme CYP3A4. Vardenafil is also associated with potential QT prolongation and is primarily metabolized by CYP3A4. The manufacturer of clarithromycin recommends against concomitant use. However, if coadministered, use vardenafil at reduced doses of 2.5 mg, every 24 hours when used with clarithromycin or every 72 hours when used with ritonavir-‘boosted’ clarithromycin, with increased monitoring for adverse reactions.2 The vardenafil orally disintegrating tablets provide increased exposure as compared to the regular tablets; therefore, do not use the orally disintegrating tablets with moderate or potent CYP3A4 inhibitors, such as clarithromycin.
Vardenafil is associated with QT prolongation. Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produce an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction). 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. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with vardenafil include: abarelix, alfuzosin, amoxapine, apomorphine, aripiprazole, arsenic trioxide, artemether; lumefantrine, asenapine, azithromycin, bedaquiline, beta-agonists, chloroquine, chlorpromazine, ofloxacin, ciprofloxacin, citalopram, clozapine, cyclobenzaprine, degarelix, dolasetron, droperidol, eribulin, escitalopram, ezogabine, fingolimod, flecainide, fluphenazine, gemifloxacin, granisetron, halogenated anesthetics, haloperidol, iloperidone, levofloxacin, maprotiline, mefloquine, methadone, moxifloxacin, norfloxacin, octreotide, olanzapine, ondansetron, paliperidone, pasireotide, systemic pentamidine, perflutren lipid microspheres, perphenazine, prochlorperazine, propafenone, quetiapine, dextromethorphan; quinidine, regadenoson, rilpivirine, risperidone, romidepsin, solifenacin, sorafenib, sunitinib, tacrolimus, telavancin, tetrabenazine, tolterodine, toremifene, trazodone, tricyclic antidepressants, trifluoperazine, vandetanib, vemurafenib, venlafaxine, and vorinostat.
Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction). The effect of vardenafil on the QT interval should be considered when prescribing the drug. Acute cardiotoxicity can occur during administration of daunorubicin, doxorubicin, epirubicin, and idarubicin; cumulative, dose-dependent cardiomyopathy may also occur. Acute ECG changes during anthracycline therapy are usually transient and include ST-T wave changes, QT prolongation, and changes in QRS voltage. Sinus tachycardia is the most common arrhythmia, but other arrhythmias such as supraventricular tachycardia (SVT), ventricular tachycardia, heart block, and premature ventricular contractions (PVCs) have been reported during anthracycline therapy.
Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction). The effect of vardenafil on the QT interval should be considered when prescribing the drug. Because of the potential for torsade de pointes (TdP), use of the following drugs with vardenafil is contraindicated: astemizole, bepridil, bretylium, cisapride, dofetilide, dronedarone, grepafloxacin, halofantrine, levomethadyl, mesoridazine, pimozide, probucol, sparfloxacin, terfenadine, thioridazine, and ziprasidone
Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction). The effect of vardenafil on the QT interval should be considered when prescribing the drug. In addition, vardenafil is a substrate for CYP3A4. Inhibitors of CYP3A4 can reduce vardenafil clearance. Increased systemic exposure to vardenafil may result in an increase in vardenafil-induced adverse effects. Therefore, it is advisable to closely monitor for adverse events when vardenafil is coadministered with drugs that inhibit CYP3A4 and prolong the QT interval. Drugs that prolong that QT and are CYP3A4 inhibitors include: crizotinib, dasatinib, lapatinib, mifepristone, RU-486, nilotinib, pazopanib, ranolazine, telithromycin, and voriconazole.
Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction). he effect of vardenafil on the QT interval should be considered when prescribing the drug. The manufacturer recommends that vardenafil be avoided in patients taking Class IA antiarrhythmics
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