vardenafil (Rx)

Brand and Other Names:Levitra, Staxyn ODT
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet, film coated

  • 2.5mg
  • 5mg
  • 10mg
  • 20mg

tablet, orally disintegrating

  • 10mg

Erectile Dysfunction

Film-coated tablet: 10 mg PO ~1 hour before sexual activity; may be increased to 20 mg or reduced to 5 mg, depending on effectiveness and tolerance; not to exceed 1 dose/day

Orally disintegrating tablet (ODT): 10 mg PO placed on tongue ~1 hour before sexual activity; not to exceed 1 dose/day

10-mg ODT not interchangeable with 10-mg film-coated tablet; ODT provides higher systemic exposure at same dose; if higher or lower doses are required, film-coated tablet should be prescribed

Dosage Modifications

Coadministration with strong CYP3A4 inhibitor

  • Ketoconazole 200 mg/day or itraconazole 200 mg/day: Vardenafil dosage not to exceed 5 mg/day
  • Ketoconazole 400 mg/day or itraconazole 400 mg/day: Vardenafil dosage not to exceed 2.5 mg/day
  • Indinavir, saquinavir, atazanavir, or clarithromycin: Vardenafil dosage not to exceed 2.5 mg/day
  • Ritonavir (600 mg q12hr): Vardenafil dosage not to exceed 2.5 mg/72 hr

Coadministration with moderate CYP3A4 inhibitor

  • Erythromycin 500 mg q8hr: Vardenafil dosage not to exceed 5 mg/day

Coadministration with alpha blocker

  • Stabilized on alpha-blocker therapy (eg, alfuzosin, terazosin, tamsulosin): 5 mg/day PO initially
  • Stabilized on alpha-blocker therapy and taking moderate-to-strong CYP3A4 inhibitor: 2.5 mg/day PO initially

Renal impairment

  • Mild, moderate, severe impairment: Dosage adjustment not necessary
  • Hemodialysis: Not recommended

Hepatic impairment

  • Child-Pugh class A: Dosage adjustment not necessary
  • Child-Pugh class B: Film-coated tablet, 5 mg PO ~1 hour before sexual activity; not to exceed 10 mg once daily; ODT not recommended
  • Child-Pugh class C: Not recommended

Pulmonary Arterial Hypertension (Orphan)

Orphan designation for treatment of pulmonary arterial hypertension

Orphan sponsor

  • Respira Therapeutics, Inc; 5901 Indian School Road NE, suite 107; Albuquerque, New Mexico 87110

Not indicated

Erectile Dysfunction

<65 years

Film-coated tablet: 10 mg PO ~1 hour before sexual activity; may be increased to 20 mg or reduced to 5 mg, depending on effectiveness and tolerance; not to exceed 1 dose/day

Orally disintegrating tablet (ODT): 10 mg PO placed on tongue ~1 hour before sexual activity; not to exceed 1 dose/day; not interchangeable with 10-mg film-coated tablet; if higher or lower doses required, film-coated tablet should be prescribed

>65 years

Consinder 5 mg starting dose

AUC and Cmax increased by 39% and 21%, respectively, in elderly men (compared with men <45 years)

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Interactions

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            Contraindicated (12)

            • isosorbide dinitrate

              isosorbide dinitrate, vardenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • isosorbide mononitrate

              isosorbide mononitrate, vardenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • lefamulin

              lefamulin will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.

            • nitroglycerin IV

              nitroglycerin IV, vardenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin PO

              nitroglycerin PO, vardenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin rectal

              vardenafil increases effects of nitroglycerin rectal by additive vasodilation. Contraindicated. Use of nitroglycerin within a few days of PDE5 inhibitors is contraindicated. PDE5 inhibitors have been shown to potentiate the hypotensive effects of organic nitrates.

            • nitroglycerin sublingual

              nitroglycerin sublingual, vardenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin topical

              nitroglycerin topical, vardenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin transdermal

              nitroglycerin transdermal, vardenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • nitroglycerin translingual

              nitroglycerin translingual, vardenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • riociguat

              vardenafil, riociguat. Either increases effects of the other by additive vasodilation. Contraindicated. Coadministration of PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil) and guanylate cyclase stimulators (eg, riociguat) is contraindicated due to risk of additive hypotension.

            • vericiguat

              vardenafil, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.

            Serious - Use Alternative (54)

            • abametapir

              abametapir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • alfuzosin

              vardenafil increases effects of alfuzosin by pharmacodynamic synergism. Contraindicated. Risk of hypotension.

            • amyl nitrite

              amyl nitrite, vardenafil. Mechanism: additive vasodilation. Avoid or Use Alternate Drug. Potentially fatal hypotension.

            • apalutamide

              apalutamide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. 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.

            • artemether

              artemether and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.

            • avanafil

              vardenafil, avanafil. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid combination; duplicate therapy is not recommended.

            • carbamazepine

              carbamazepine will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ceritinib

              ceritinib and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.

            • chloramphenicol

              chloramphenicol will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • cimetidine

              cimetidine will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • clarithromycin

              clarithromycin will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              clarithromycin and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.

            • cobicistat

              cobicistat will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration may increase PDE-5 inhibitor adverse effects including hypotension, syncope, visual changes, and prolonged erection; do not exceed vardenafil 2.5 mg q72hr.

            • crizotinib

              crizotinib and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.

            • darunavir

              darunavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration may increase PDE-5 inhibitor adverse effects including hypotension, syncope, visual changes, and prolonged erection; do not exceed vardenafil 2.5 mg q72hr.

            • desflurane

              desflurane and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.

            • doxazosin

              vardenafil increases effects of doxazosin by pharmacodynamic synergism. Contraindicated. Risk of hypotension.

            • encorafenib

              encorafenib and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.

            • entrectinib

              entrectinib and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin base

              erythromycin base will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and vardenafil both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels and/or prolong QT interval.

              fexinidazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • glyceryl trinitrate pr

              glyceryl trinitrate pr, vardenafil. Mechanism: additive vasodilation. Avoid or Use Alternate Drug. Potentially fatal hypotension.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.

            • idelalisib

              idelalisib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

            • itraconazole

              itraconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              itraconazole increases levels of vardenafil by decreasing metabolism. Contraindicated. Greater risk in pts. over 75 yrs old.

            • ivosidenib

              ivosidenib and vardenafil both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

              ivosidenib will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. 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.

            • ketoconazole

              ketoconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              ketoconazole increases levels of vardenafil by decreasing metabolism. Contraindicated. Greater risk in pts. over 75 yrs old.

            • lonafarnib

              lonafarnib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

            • lopinavir

              lopinavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • macimorelin

              macimorelin and vardenafil both increase QTc interval. Avoid or Use Alternate Drug. 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. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

            • mefloquine

              mefloquine increases toxicity of vardenafil by QTc interval. Avoid or Use Alternate Drug. Mefloquine may enhance the QTc prolonging effect of high risk QTc prolonging agents.

            • mifepristone

              mifepristone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • mobocertinib

              mobocertinib and vardenafil both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.

            • moxisylyte

              vardenafil increases effects of moxisylyte by pharmacodynamic synergism. Contraindicated. Risk of hypotension.

            • nicorandil

              nicorandil, vardenafil. Mechanism: additive vasodilation. Avoid or Use Alternate Drug. Potentially fatal hypotension.

            • ondansetron

              ondansetron and vardenafil both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.

            • phenoxybenzamine

              vardenafil increases effects of phenoxybenzamine by pharmacodynamic synergism. Contraindicated. Risk of hypotension.

            • phentolamine

              vardenafil increases effects of phentolamine by pharmacodynamic synergism. Contraindicated. Risk of hypotension.

            • prazosin

              vardenafil increases effects of prazosin by pharmacodynamic synergism. Contraindicated. Risk of hypotension.

            • ribociclib

              ribociclib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              ribociclib increases toxicity of vardenafil by QTc interval. Avoid or Use Alternate Drug.

            • rifabutin

              rifabutin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifampin

              rifampin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • saquinavir

              saquinavir increases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Potential for increased toxicity. .

            • silodosin

              vardenafil increases effects of silodosin by pharmacodynamic synergism. Contraindicated. Risk of hypotension.

            • St John's Wort

              St John's Wort will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • terazosin

              vardenafil increases effects of terazosin by pharmacodynamic synergism. Contraindicated. Risk of hypotension.

            • tucatinib

              tucatinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. 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.

            • umeclidinium bromide/vilanterol inhaled

              vardenafil increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vemurafenib

              vemurafenib and vardenafil both increase QTc interval. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended.

            • vilanterol/fluticasone furoate inhaled

              vardenafil increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • voxelotor

              voxelotor will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            • zotepine

              vardenafil increases effects of zotepine by pharmacodynamic synergism. Contraindicated. Risk of hypotension.

            Monitor Closely (119)

            • albuterol

              albuterol and vardenafil both increase QTc interval. Use Caution/Monitor.

            • alfuzosin

              vardenafil and alfuzosin both increase QTc interval. Use Caution/Monitor.

              alfuzosin and vardenafil both increase QTc interval. Use Caution/Monitor.

            • amifostine

              amifostine, vardenafil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Monitor blood pressure response to phosphodiesterase type 5 (PDE5) inhibitors in patients receiving concurrent blood pressure lowering therapy.

            • amobarbital

              amobarbital will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • apomorphine

              apomorphine and vardenafil both increase QTc interval. Use Caution/Monitor.

            • aprepitant

              aprepitant will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • arformoterol

              arformoterol and vardenafil both increase QTc interval. Use Caution/Monitor.

            • aripiprazole

              aripiprazole and vardenafil both increase QTc interval. Use Caution/Monitor.

            • armodafinil

              armodafinil will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • artemether/lumefantrine

              artemether/lumefantrine will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • asenapine

              vardenafil increases effects of asenapine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Risk of hypotension.

            • atazanavir

              atazanavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              atazanavir increases levels of vardenafil by decreasing metabolism. Use Caution/Monitor.

            • atomoxetine

              atomoxetine and vardenafil both increase QTc interval. Use Caution/Monitor.

            • bedaquiline

              vardenafil and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely

            • benazepril

              vardenafil, benazepril. Either increases effects of the other by Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced hypotensive effects.

            • bosentan

              bosentan will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • budesonide

              budesonide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • butabarbital

              butabarbital will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • butalbital

              butalbital will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • captopril

              vardenafil, captopril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure. Monitor blood pressure.

            • citalopram

              vardenafil and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • clozapine

              clozapine and vardenafil both increase QTc interval. Use Caution/Monitor.

            • conivaptan

              conivaptan will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • cortisone

              cortisone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • crizotinib

              crizotinib increases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • crofelemer

              crofelemer increases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

            • cyclosporine

              cyclosporine will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dabrafenib

              dabrafenib will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • darifenacin

              darifenacin will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dasatinib

              dasatinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              dasatinib and vardenafil both increase QTc interval. Use Caution/Monitor.

            • deferasirox

              deferasirox will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • degarelix

              degarelix and vardenafil both increase QTc interval. Use Caution/Monitor.

            • deutetrabenazine

              deutetrabenazine and vardenafil both increase QTc interval. Use Caution/Monitor.

            • dexamethasone

              dexamethasone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • DHEA, herbal

              DHEA, herbal will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • diltiazem

              diltiazem will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dofetilide

              dofetilide increases toxicity of vardenafil by QTc interval. Use Caution/Monitor.

            • dolasetron

              dolasetron and vardenafil both increase QTc interval. Use Caution/Monitor.

            • donepezil

              donepezil and vardenafil both increase QTc interval. Use Caution/Monitor.

            • doxepin

              doxepin and vardenafil both increase QTc interval. Use Caution/Monitor.

            • dronedarone

              dronedarone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • duvelisib

              duvelisib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.

            • efavirenz

              efavirenz will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              efavirenz and vardenafil both increase QTc interval. Use Caution/Monitor.

            • elagolix

              elagolix decreases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust vardenafil dose for ED; not to exceed single dose of 2.5 mg in 72 hr.

            • encorafenib

              encorafenib, vardenafil. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • escitalopram

              escitalopram increases toxicity of vardenafil by QTc interval. Use Caution/Monitor.

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ethinylestradiol

              ethinylestradiol will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • etravirine

              etravirine will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fedratinib

              fedratinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              fedratinib will increase the level or effect of vardenafil by affecting hepatic enzyme CYP2E1 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • fingolimod

              fingolimod and vardenafil both increase QTc interval. Use Caution/Monitor.

            • fluconazole

              fluconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fludrocortisone

              fludrocortisone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fluoxetine

              vardenafil and fluoxetine both increase QTc interval. Modify Therapy/Monitor Closely.

            • fosamprenavir

              fosamprenavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fostemsavir

              vardenafil and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • grapefruit

              grapefruit will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • griseofulvin

              griseofulvin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • haloperidol

              haloperidol and vardenafil both increase QTc interval. Use Caution/Monitor.

            • hydrocortisone

              hydrocortisone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • iloperidone

              iloperidone increases levels of vardenafil by affecting hepatic enzyme CYP2E1 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

            • indacaterol, inhaled

              indacaterol, inhaled, vardenafil. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • indinavir

              indinavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • isoniazid

              isoniazid will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • lapatinib

              lapatinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • lumefantrine

              lumefantrine will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • maraviroc

              maraviroc, vardenafil. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of orthostatic hypotension.

            • marijuana

              marijuana will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • methylprednisolone

              methylprednisolone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • metronidazole

              metronidazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • miconazole vaginal

              miconazole vaginal will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • mifepristone

              mifepristone, vardenafil. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.

            • mitotane

              mitotane decreases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • modafinil

              modafinil will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nefazodone

              nefazodone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • nelfinavir

              nelfinavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nevirapine

              nevirapine will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nifedipine

              nifedipine will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nilotinib

              nilotinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nitroprusside sodium

              nitroprusside sodium, vardenafil. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Additive hypotensive effects.

            • olodaterol inhaled

              vardenafil and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias

            • osilodrostat

              osilodrostat and vardenafil both increase QTc interval. Use Caution/Monitor.

            • osimertinib

              osimertinib and vardenafil both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.

            • oxcarbazepine

              oxcarbazepine will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ozanimod

              ozanimod and vardenafil both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • pasireotide

              vardenafil and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • pentobarbital

              pentobarbital will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • phenobarbital

              phenobarbital will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • phenytoin

              phenytoin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • posaconazole

              posaconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • prednisone

              prednisone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • primidone

              primidone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • quetiapine

              quetiapine, vardenafil. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.

            • quinine

              vardenafil and quinine both increase QTc interval. Use Caution/Monitor.

            • quinupristin/dalfopristin

              quinupristin/dalfopristin will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifapentine

              rifapentine will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ritonavir

              ritonavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • rufinamide

              rufinamide will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • secobarbital

              secobarbital will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • selpercatinib

              selpercatinib increases toxicity of vardenafil by QTc interval. Use Caution/Monitor.

            • sodium sulfate/?magnesium sulfate/potassium chloride

              sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of vardenafil by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .

            • sodium sulfate/potassium sulfate/magnesium sulfate

              sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of vardenafil by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .

            • sorafenib

              sorafenib and vardenafil both increase QTc interval. Use Caution/Monitor.

            • stiripentol

              stiripentol, vardenafil. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

            • tadalafil

              vardenafil, tadalafil. Other (see comment). Use Caution/Monitor. Comment: Avoid combination; duplicate therapy is not recommended.

            • tamsulosin

              vardenafil, tamsulosin. Either increases effects of the other by additive vasodilation. Use Caution/Monitor. Risk of hypotension.

            • tazemetostat

              tazemetostat will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • tipranavir

              tipranavir increases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

            • tobramycin inhaled

              tobramycin inhaled and vardenafil both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity

            • topiramate

              topiramate will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • verapamil

              verapamil will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • voclosporin

              voclosporin, vardenafil. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            • voriconazole

              voriconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • zafirlukast

              zafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            Minor (5)

            • azithromycin

              azithromycin increases toxicity of vardenafil by QTc interval. Minor/Significance Unknown.

            • carvedilol

              vardenafil increases effects of carvedilol by pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypotension.

            • chloroquine

              chloroquine increases toxicity of vardenafil by QTc interval. Minor/Significance Unknown.

            • labetalol

              vardenafil increases effects of labetalol by pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypotension.

            • sapropterin

              sapropterin, vardenafil. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Possible additive vasorelaxation, leading to low blood pressure.

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            Adverse Effects

            >10%

            Headache (15%)

            Flushing (11%)

            1-10%

            Rhinitis (9%)

            Dyspepsia (4%)

            Flulike syndrome (3%)

            Sinusitis (3%)

            Back pain (2%)

            Dizziness (2%)

            Increased creatine phosphokinase (2%)

            Nausea (2%)

            <1%

            Anaphylaxis

            Angina

            Insomnia

            Myocardial infarction (MI)

            Postural hypotension

            Priapism

            Pruritus

            Rash

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            Warnings

            Contraindications

            Hypersensitivity

            Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension

            Coadministration with nitrates

            • Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors
            • Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates
            • A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined

            Cautions

            Use with caution in anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease), cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors, patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia)

            There have been rare reports of prolonged erections >4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil; in the event that an erection persists >4 hours, the patient should seek immediate medical assistance; if priapism is not treated immediately, penile tissue damage and permanent loss of potency may result

            Physicians should consider the cardiovascular status of their patients; there is a degree of cardiac risk associated with sexual activity; treatment for erectile dysfunction, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status

            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

            Until further information available, use is not recommended in unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within last 6 months); severe cardiac failure

            Consider counseling patients about protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV); drug offers no protection against sexually transmitted diseases

            Patients taking Class 1A (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using drug

            Safety and efficacy of drug used in combination with other treatments for erectile dysfunction not studied; use of such combinations not recommended

            Not to be taken with other phosphodiesterase (PDE)-5 inhibitors (eg, sildenafil, tadalafil)

            Vision loss may occur rarely and may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION); patient should seek medical assistance for sudden loss in one or both eyes; patients who have already experienced NAION are at increased risk of recurrence; use is not recommended in patients with known degenerative retinal disorders

            May increase risk of rare sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician

            The drug 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); while this normally would be expected to be of little consequence in most patients, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects

            Physicians should advise patients to stop taking all PDE5 inhibitors, and seek prompt medical attention in event of sudden decrease or loss of hearing; these events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to intake of PDE5 inhibitors, including vardenafil; it is not possible to determine whether these events are related directly to use of PDE5 inhibitors or to other factors

            Alpha blocekrs (H4)

            • Caution advised when PDE5 inhibitors co-administered with alpha-blockers; PDE5 inhibitors, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects; when vasodilators are used in combination, an additive effect on blood pressure may be anticipated; in some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (eg, fainting)
            • Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor; patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors
            • In patients who are stable on alpha-blocker therapy, initiate PDE5 inhibitors at lowest recommended starting dose
            • In patients already taking optimized dose of PDE5 inhibitor, initiate alpha-blocker therapy at lowest dose; stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor
            • Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs

            Drug interaction overview(H4)

            • Concomitant administration with potent CYP3A4 inhibitors (such as ritonavir, indinavir, ketoconazole) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of drug; dosage adjustment is necessary when drug is administered with certain CYP3A4 inhibitors
            • Long-term safety information is not available on concomitant administration of drug with HIV protease inhibitors
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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Unknown whether drug is distributed into breast milk; indicated for males

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Sexual stimulation causes nitric oxide to be released in corpus cavernosum, and nitric oxide activates guanylate cyclase, which in turn increases cyclic guanosine monophosphate (cGMP), thus causing smooth-muscle relaxation; PDE-5 inhibitors enhance smooth muscle-relaxing effects of nitric oxide in corpus cavernosum by inhibiting degradation of cGMP

            Absorption

            Rapidly absorbed

            Bioavailability: 15%

            Onset: 60 min

            Peak plasma time: 30-120 min

            Peak plasma concentration: 8-19% lower for ODT than for film-coated tablet

            Distribution

            Protein bound: 95%

            Vd: 208 L

            Metabolism

            Metabolized in liver by CYP3A4 and (in minor amounts) CYP2C9

            Metabolites: M1 (active; plasma concentration 26% of parent compound)

            Elimination

            Half-life: 3-6 hr

            Total body clearance: 56 L/hr

            Excretion: Feces (95%), urine (5%)

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            Administration

            Instructions

            Oral tablet or orally disintegrating tablet

            • Take about 60 minutes before sexual activity
            • Maximum dosing frequency is one tablet per day
            • May take with or without food

            Orally disintegrating tablet

            • Place on tongue where it will dissolve
            • Do not swallow
            • Take without liquid
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            vardenafil oral
            -
            10 mg tablet
            vardenafil oral
            -
            10 mg tablet
            vardenafil oral
            -
            5 mg tablet
            vardenafil oral
            -
            2.5 mg tablet
            vardenafil oral
            -
            20 mg tablet
            vardenafil oral
            -
            20 mg tablet
            vardenafil oral
            -
            20 mg tablet
            vardenafil oral
            -
            10 mg tablet
            vardenafil oral
            -
            5 mg tablet
            vardenafil oral
            -
            2.5 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            vardenafil oral

            VARDENAFIL - ORAL

            (var-DEN-a-fil)

            COMMON BRAND NAME(S): Levitra

            USES: Vardenafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, vardenafil works by increasing blood flow to the penis to help a man get and keep an erection.This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Practice "safe sex" such as using latex condoms. Consult your doctor or pharmacist for more details.

            HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking vardenafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually as needed. Take vardenafil, with or without food, about 1 hour before sexual activity. Do not take more than once daily. Doses should be taken at least 24 hours apart.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.Tell your doctor if your condition does not improve.

            SIDE EFFECTS: Headache, flushing, stuffy/runny nose, or dizziness may occur. Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea.Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking vardenafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke.Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking vardenafil and get medical help right away if these effects occur.In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.Get medical help right away if you have any very serious side effects, including: seizures, temporary memory loss.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking vardenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease (dialysis), liver disease, high or low blood pressure, dehydration, penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION), bleeding disorders, active stomach ulcers.This drug may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication is not usually used in women. It is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.

            DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: riociguat.Vardenafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use vardenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite.If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of vardenafil to minimize your risk of low blood pressure.Other medications can affect the removal of vardenafil from your body, which may affect how vardenafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as indinavir, ritonavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), rifampin, among others.Do not take this medication with any other product that contains vardenafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil).

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: back/muscle pain, abnormal vision.

            NOTES: Do not share this medication with others.

            MISSED DOSE: Not applicable.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.