SAFETY AND PHARMACOKINETICS OF VARDENAFIL INHALATION POWDER (RT234) FOLLOWING ORAL INHALATION IN HEALTHY ADULT VOLUNTEERS

clarithromycinclarithromycin and vardenafil both increase QTc interval. clarithromycin and vardenafil both increase QTc interval. danazoldanazol will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. danazol will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. doxazosinvardenafil increases effects of doxazosin by pharmacodynamic synergism. vardenafil increases effects of doxazosin by pharmacodynamic synergism. entrectinib and vardenafil both increase QTc interval. eribulin and vardenafil vardenafil pills both increase QTc interval. Avoid coadministration of fexinidazole with drugs known to block potassium channels and/or prolong QT interval. givinostatvardenafil and givinostat both increase QTc interval. If unable to avoid coadministration, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Withhold if QTc interval >500 ms or a change from baseline >60 ms. vardenafil and givinostat both increase QTc interval. hydroxychloroquine sulfate and vardenafil both increase QTc interval. idelalisibidelalisib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

• Vardenafil contact info for adverse events reporting.
• It is one of several PDE5 inhibitors on the market.
• The medication requires sexual arousal to be effective.
• Take Vardenafil approximately 30 minutes before intimacy.
• Do not share your medication with others.
• Ensure proper hydration to help with absorption.
• The half-life of Vardenafil is around 4-5 hours.
• Do not use Vardenafil if you have had recent stroke or MI.
• Inform your doctor about all health conditions before use.
• Use Vardenafil responsibly to prevent dependency.
• Follow prescribed dosage for optimal results.

Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates idelalisib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates iloperidonevardenafil and iloperidone both increase QTc interval. isoflurane and vardenafil both increase QTc interval. itraconazoleitraconazole and vardenafil both increase QTc interval. itraconazole and vardenafil both increase QTc interval. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation. macimorelinmacimorelin and vardenafil both increase QTc interval. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia.

Initial Information

PDE5 inhibitors have been shown to potentiate the hypotensive effects of organic nitrates. vardenafil increases effects of nitroglycerin rectal by additive vasodilation. Either increases effects of the other by additive vasodilation. Coadministration of PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil) and guanylate cyclase stimulators (eg, riociguat) is contraindicated due to risk of additive hypotension. Either increases effects of the other by pharmacodynamic synergism.

6.2 Managing Expectations

Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects. Either increases effects of the other by QTc interval. Each drug prolongs the QTc interval, which may increased the risk of Torsade de pointes, other serious arryhthmias, and sudden death. If coadministration unavoidable, more frequent monitoring is recommended for such patients. alfuzosinvardenafil increases effects of alfuzosin by pharmacodynamic synergism. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin. macimorelin and vardenafil both increase QTc interval. mefloquinemefloquine increases toxicity of vardenafil by QTc interval.

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Mefloquine may enhance the QTc prolonging effect of high risk QTc prolonging agents. mefloquine increases toxicity of vardenafil by QTc interval. vardenafil and milsaperidone both increase QTc interval. moxisylytevardenafil increases effects of moxisylyte by pharmacodynamic synergism. vardenafil increases effects of moxisylyte by pharmacodynamic synergism. ondansetronondansetron and vardenafil both increase QTc interval.

Country	Legal Status	Purchase Regulations
United States	Prescription-only medication	Requires prescription from licensed physician
European Union	Prescription required	Available at licensed pharmacies
India	Over-the-counter in some regions	Varies by jurisdiction
Australia	Prescription-only medication	Prescription required

ondansetron and vardenafil both increase QTc interval. oxaliplatin and vardenafil both increase QTc interval. phenoxybenzaminevardenafil increases effects of phenoxybenzamine by pharmacodynamic synergism. vardenafil increases effects of phenoxybenzamine by pharmacodynamic synergism. phentolaminevardenafil increases effects of phentolamine by pharmacodynamic synergism. vardenafil increases effects of phentolamine by pharmacodynamic synergism. prazosinvardenafil increases effects of prazosin by pharmacodynamic synergism. vardenafil increases effects of prazosin by pharmacodynamic synergism. ribociclibribociclib increases toxicity of vardenafil by QTc interval. ribociclib increases toxicity of vardenafil by QTc interval.

• Vardenafil dosage adjustments may be needed for older adults.
• It may pose risks in men with low blood pressure.
• Always adhere to the prescribed therapeutic regimen.
• It is not recommended to exceed 20 mg per dose.
• Vardenafil is not intended for use with other ED medications.
• Precise timing of doses ensures efficacy and safety.
• The drug may improve sexual confidence and satisfaction.
• Side effects are usually temporary and dose-related.
• Alcohol and high-fat foods can delay onset of action.
• Avoid using Vardenafil if allergies to it are known.
• Proper hydration can enhance its effectiveness.

rifabutinrifabutin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. rifabutin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. rifampinrifampin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

4. Clinical Efficacy and Comparative Advantages

artemether and vardenafil both increase QTc interval. asenapineasenapine and vardenafil both increase QTc interval. asenapine and vardenafil both increase QTc interval. asenapine transdermalasenapine transdermal and vardenafil both increase QTc interval. asenapine transdermal and vardenafil both increase QTc interval.

Health News

Either increases effects of the other by Other (see comment). Comment: Avoid combination; duplicate therapy is not recommended. buprenorphinebuprenorphine and vardenafil both increase QTc interval. buprenorphine and vardenafil both increase QTc interval. buprenorphine buccalbuprenorphine buccal and vardenafil both increase QTc interval. rifampin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. sevofluranesevoflurane and vardenafil both increase QTc interval. sevoflurane and vardenafil both increase QTc interval. silodosinvardenafil increases effects of silodosin by pharmacodynamic synergism. vardenafil increases effects of silodosin by pharmacodynamic synergism. siponimod and vardenafil both increase QTc interval. St John's WortSt John's Wort will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. St John's Wort will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. terazosinvardenafil increases effects of terazosin by pharmacodynamic synergism. vardenafil increases effects of terazosin by pharmacodynamic synergism. tetrabenazinetetrabenazine and vardenafil both increase QTc interval. tetrabenazine and vardenafil both increase QTc interval. tovorafenibtovorafenib will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid coadministration of tovorafenib (a weak CYP3A4 inducer) with CYP3A substrates where minimal concentration changes may lead to serious therapeutic failures. If unavoidable, monitor patients for loss of efficacy unless otherwise recommended in the CYP3A4 substrate prescribing information. tovorafenib will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

About this article

buprenorphine buccal and vardenafil both increase QTc interval. buprenorphine subdermal implantbuprenorphine subdermal implant and vardenafil both increase QTc interval. buprenorphine subdermal implant and vardenafil both increase QTc interval. buprenorphine transdermalbuprenorphine transdermal and vardenafil both increase QTc interval. buprenorphine transdermal and vardenafil both increase QTc interval.

Medications & Supplements

buprenorphine, long-acting injectionbuprenorphine, long-acting injection and vardenafil both increase QTc interval. buprenorphine, long-acting injection and vardenafil both increase QTc interval. carbamazepinecarbamazepine will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. carbamazepine will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ceritinib and vardenafil both increase QTc interval. tucatinibtucatinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling. tucatinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

In case of emergency/overdose

vardenafil increases effects of alfuzosin by pharmacodynamic synergism. amisulprideamisulpride and vardenafil both increase QTc interval. amisulpride and vardenafil both increase QTc interval. anagrelide and vardenafil both increase QTc interval. apalutamideapalutamide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Peak Efficacy:

Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed. apalutamide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated. vardenafil increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended. vilanterol/fluticasone furoate inhaledvardenafil increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval.

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Fabienne Heyne
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