Dosing & Uses
Dosage Forms & Strengths
tablet, film coated (generic)
- 2.5mg
- 5mg
- 10mg
- 20mg
Erectile Dysfunction
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
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) or cobicistat: 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)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (56)
- adagrasib
adagrasib, vardenafil. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. 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.
- alfuzosin
vardenafil increases effects of alfuzosin by pharmacodynamic synergism. Contraindicated. Risk of hypotension.
- amisulpride
amisulpride and vardenafil both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- amyl nitrite
amyl nitrite, vardenafil. Mechanism: additive vasodilation. Avoid or Use Alternate Drug. Potentially fatal hypotension.
- anagrelide
anagrelide and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- 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.
- asenapine
asenapine and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- asenapine transdermal
asenapine transdermal 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.
- buprenorphine
buprenorphine and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine buccal
buprenorphine buccal and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine subdermal implant
buprenorphine subdermal implant and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine transdermal
buprenorphine transdermal and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine, long-acting injection
buprenorphine, long-acting injection and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- 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.
- clarithromycin
clarithromycin and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- crizotinib
crizotinib and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- 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.
- eribulin
eribulin and vardenafil both increase QTc interval. 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.
- 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
- isoflurane
isoflurane and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- itraconazole
itraconazole and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- 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. - 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.
- 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.
- oxaliplatin
oxaliplatin and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- 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 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.
- sevoflurane
sevoflurane and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- silodosin
vardenafil increases effects of silodosin by pharmacodynamic synergism. Contraindicated. Risk of hypotension.
- siponimod
siponimod and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- 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.
- tetrabenazine
tetrabenazine and vardenafil both increase QTc interval. Avoid or Use Alternate Drug.
- 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 (164)
- adagrasib
adagrasib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- amiodarone
amiodarone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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. Modify Therapy/Monitor Closely. Limit vardenafil dose to 2.5 mg/24 hr
- 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.
- bicalutamide
bicalutamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- ceritinib
ceritinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- chloramphenicol
chloramphenicol will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- cimetidine
cimetidine will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- citalopram
vardenafil and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.
- clarithromycin
clarithromycin will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limit vardenafil dose to 2.5 mg/24 hr
- clozapine
clozapine and vardenafil both increase QTc interval. Use Caution/Monitor.
- cobicistat
cobicistat will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limit vardenafil dose to 2.5 mg/72 hr
- conivaptan
conivaptan will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- cortisone
cortisone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- crizotinib
crizotinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. 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. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors.
- cyclosporine
cyclosporine will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- darunavir
darunavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration may increase PDE-5 inhibitor adverse effects including hypotension, syncope, visual changes, and prolonged erection; do not exceed vardenafil 2.5 mg q72hr.
- 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. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- 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. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- doxycycline
doxycycline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- dronedarone
dronedarone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- eliglustat
eliglustat and vardenafil both increase QTc interval. Use Caution/Monitor.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect 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.
- entacapone
entacapone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- erythromycin base
erythromycin base will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limit vardenafil dose to 5 mg/24 hr
- erythromycin ethylsuccinate
erythromycin ethylsuccinate will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limit vardenafil dose to 5 mg/24 hr
- erythromycin lactobionate
erythromycin lactobionate will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limit vardenafil dose to 5 mg/24 hr
- erythromycin stearate
erythromycin stearate will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limit vardenafil dose to 5 mg/24 hr
- 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.
- 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. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- fexinidazole
fexinidazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- fluvoxamine
fluvoxamine will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- fosamprenavir
fosamprenavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- fosaprepitant
fosaprepitant will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- fosphenytoin
fosphenytoin will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- fostamatinib
fostamatinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- fostemsavir
vardenafil and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.
- gemifloxacin
gemifloxacin and vardenafil both increase QTc interval. Use Caution/Monitor.
- gilteritinib
gilteritinib and vardenafil both increase QTc interval. Use Caution/Monitor.
- granisetron
granisetron and vardenafil both increase QTc interval. Use Caution/Monitor.
- 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.
haloperidol will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors - hydrocortisone
hydrocortisone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- hydroxyzine
hydroxyzine and vardenafil both increase QTc interval. Use Caution/Monitor.
- ibrexafungerp
ibrexafungerp will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- imatinib
imatinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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. Modify Therapy/Monitor Closely. Limit vardenafil dose to 2.5 mg/24 hr
- isavuconazonium sulfate
isavuconazonium sulfate will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- isoniazid
isoniazid will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- istradefylline
istradefylline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. 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.
- itraconazole
itraconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If coadministered with itraconazole 400 mg/day, limit vardenafil dose to 2.5 mg/24 hr. If coadministered with itraconazole 200 mg/day, limit vardenafil dose to 5 mg/24 hr.
- ivacaftor
ivacaftor will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- ketoconazole
ketoconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If coadministered with ketoconazole 400 mg/day, limit vardenafil dose to 2.5 mg/24 hr. If coadministered with ketoconazole 200 mg/day, limit vardenafil dose to 5 mg/24 hr.
- lapatinib
lapatinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- larotrectinib
larotrectinib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- lenacapavir
lenacapavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lencapavir may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors.
- levoketoconazole
levoketoconazole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limit vardenafil dose to 2.5 mg/24
- lithium
lithium and vardenafil both increase QTc interval. Use Caution/Monitor.
- lonafarnib
lonafarnib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors.
- lopinavir
lopinavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- 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. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- mifepristone
mifepristone, vardenafil. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.
mifepristone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors - mirtazapine
mirtazapine and vardenafil both increase QTc interval. Use Caution/Monitor.
- 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.
- nefazodone
nefazodone will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- nelfinavir
nelfinavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- netupitant/palonosetron
netupitant/palonosetron will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limit vardenafil dose to 2.5 mg/72 hr
- nitroprusside sodium
nitroprusside sodium, vardenafil. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Additive hypotensive effects.
- olanzapine
olanzapine and vardenafil both increase QTc interval. Use Caution/Monitor.
- 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. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- prednisone
prednisone will decrease the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- primaquine
primaquine and vardenafil both increase QTc interval. 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. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- ribociclib
ribociclib will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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. Modify Therapy/Monitor Closely. Limit vardenafil dose to 2.5 mg/72 hr
- 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.
- saquinavir
saquinavir increases levels of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limit vardenafil dose to 2.5 mg/24 hr.
- 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.
- sertraline
sertraline and vardenafil both increase QTc interval. Use Caution/Monitor.
sertraline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors - 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. .
- solifenacin
solifenacin and vardenafil both increase QTc interval. Use Caution/Monitor.
- 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.
- sunitinib
sunitinib and vardenafil both increase QTc interval. Use Caution/Monitor.
- tacrolimus
tacrolimus and vardenafil both increase QTc interval. Use Caution/Monitor.
- 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.
- tetracycline
tetracycline will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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.
- valbenazine
valbenazine and vardenafil both increase QTc interval. Use Caution/Monitor.
- verapamil
verapamil will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- 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. Modify Therapy/Monitor Closely. Vardenafil dose may need to be reduced if coadministered with moderate or strong CYP3A4 inhibitors
- vorinostat
vorinostat and vardenafil both increase QTc interval. Use Caution/Monitor.
- zafirlukast
zafirlukast will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
Minor (8)
- acetazolamide
acetazolamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- 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.
- cyclophosphamide
cyclophosphamide will increase the level or effect of vardenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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.
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
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, cobicistat, 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
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.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%)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| vardenafil oral - | 20 mg tablet |  | |
| vardenafil oral - | 10 mg tablet |  | |
| vardenafil oral - | 20 mg tablet |  | |
| vardenafil oral - | 10 mg tablet |  | |
| vardenafil oral - | 10 mg tablet |  | |
| vardenafil oral - | 2.5 mg tablet |  | |
| vardenafil oral - | 20 mg tablet |  | |
| vardenafil oral - | 5 mg tablet |  | |
| vardenafil oral - | 10 mg tablet |  | |
| vardenafil oral - | 2.5 mg tablet |  | |
| vardenafil oral - | 5 mg tablet |  | |
| vardenafil oral - | 5 mg tablet |  | |
| vardenafil oral - | 2.5 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 last or get worse, 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.Some products that may interact with this drug are: riociguat, vericiguat.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, 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 January 2023. Copyright(c) 2023 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.
Formulary
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.
