Note: Oral disintegrating tablets should not be used interchangeably with film-coated tablets; patients requiring a dose other than 10 mg should use the film-coated tablets.
Erectile dysfunction:
Film-coated tablet (Levitra): Oral: 10 mg administered ~60 minutes prior to sexual activity; dosing range: 5 to 20 mg as a single dose (not more than once daily); maximum: 20 mg/day.
Oral disintegrating tablet (Staxyn): Oral: 10 mg administered ~60 minutes prior to sexual activity; maximum: 10 mg/day.
Pulmonary arterial hypertension (off-label use): Oral: 5 mg once daily for 4 weeks, then increase to target dose of 5 mg twice daily if tolerated (Jing 2011).
Raynaud phenomenon (off-label use): Oral: 10 mg twice daily (Caglayan 2006; Caglayan 2012).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult Drug Interactions database for more information.
Mild, moderate, or severe impairment: No dosage adjustment necessary.
Hemodialysis: Use is not recommended.
Erectile dysfunction:
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate impairment (Child-Pugh class B):
Film-coated tablet (Levitra): Oral: Initial: 5 mg administered ~60 minutes prior to sexual activity (maximum: 10 mg/day).
Oral disintegrating tablet (Staxyn): Use is not recommended.
Severe impairment (Child-Pugh class C): Use is not recommended (has not been studied).
Erectile dysfunction: Film-coated tablet (Levitra): Oral: Consider a lower initial dose of 5 mg administered ~60 minutes prior to sexual activity.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Levitra: 2.5 mg [DSC], 5 mg [DSC], 10 mg [DSC], 20 mg [DSC]
Generic: 2.5 mg, 5 mg, 10 mg, 20 mg
Tablet Disintegrating, Oral:
Staxyn: 10 mg [DSC] [contains aspartame; peppermint flavor]
Generic: 10 mg
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Levitra: 5 mg [DSC], 10 mg, 20 mg
Generic: 5 mg, 10 mg, 20 mg
Tablet Disintegrating, Oral:
Staxyn: 10 mg [contains aspartame]
Generic: 10 mg
May be administered with or without food, approximately 60 minutes prior to sexual activity.
Oral disintegrating tablet should not be removed from blister pack until administered. Using dry hands, place immediately on tongue. Tablet will dissolve rapidly; do not take with liquid. Do not crush, split, or chew.
Erectile dysfunction: Treatment of erectile dysfunction.
Pulmonary arterial hypertension; Raynaud phenomenon
Vardenafil may be confused with sildenafil, tadalafil
Levitra may be confused with Kaletra, Lexiva
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Flushing (8% to 11%)
Central nervous system: Headache (14% to 15%)
2% to 10%:
Central nervous system: Dizziness (2%)
Gastrointestinal: Dyspepsia (3% to 4%), nausea (2%)
Neuromuscular & skeletal: Back pain (2%), increased creatine phosphokinase (2%)
Respiratory: Rhinitis (9%), flu-like symptoms (3%), nasal congestion (3%), sinusitis (3%)
<2%, postmarketing, and/or case reports: Abdominal pain, abnormal hepatic function tests, allergic edema, anaphylaxis, angina pectoris, angioedema, arthralgia, auditory impairment, basal cell carcinoma (Loeb 2015), blurred vision, chest pain, chromatopsia, conjunctivitis, decreased visual acuity, diaphoresis, diarrhea, drowsiness, dysesthesia, dysphagia, dyspnea, ejaculatory disorder, epistaxis, erythema, esophagitis, eye discomfort, eye pain, facial edema, gastritis, gastroesophageal reflux disease, glaucoma, hearing loss, hypersensitivity reaction, hypertension, hypertonia, hypoesthesia, hypotension, increased gamma-glutamyl transferase, increased intraocular pressure, insomnia, ischemic heart disease, laryngeal edema, malignant melanoma (Loeb 2015), muscle cramps, myalgia, myocardial infarction, neck pain, anterior ischemic optic neuropathy (nonarteritic; NAION), ocular hyperemia, orthostatic hypotension, pain, palpitations, paresthesia, pharyngitis, photophobia, priapism, pruritus, retinal vein occlusion, seizure, skin photosensitivity, skin rash, sleep disorder, syncope, tachycardia, temporary amnesia (global), tinnitus, ventricular tachyarrhythmia, vertigo, vision color changes, vision loss (temporary or permanent), visual disturbance (including dim vision), visual field defect, vomiting, watery eyes, weakness, xerostomia
Coadministration with nitrates (either regularly and/or intermittently), nitric oxide donors, or guanylate cyclase stimulators (eg, riociguat).
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to vardenafil or any component of the formulation; concomitant use with cobicistat, indinavir, ritonavir, saquinavir, atazanavir, ketoconazole or itraconazole (Levitra, Staxyn), and erythromycin or clarithromycin (Staxyn); prior episode of non-arteritic anterior ischemic optic neuropathy.
Concerns related to adverse effects:
• Color discrimination: May cause dose-related impairment of visual color discrimination (blue/green).
• Hearing loss: Sudden decrease or loss of hearing has been reported rarely; hearing changes may be accompanied by tinnitus and dizziness. A direct relationship between therapy and hearing loss has not been determined.
• Hypotension: Decreases in blood pressure may occur due to vasodilator effects. Use with caution in patients with left ventricular outflow obstruction (aortic stenosis or hypertrophic cardiomyopathy with outflow tract obstruction); may be more sensitive to hypotensive actions. Concurrent use with alpha-adrenergic antagonist therapy may cause symptomatic hypotension; ensure hemodynamic stability prior to initiating film-coated tablets and use the lowest possible dose; do not initiate oral disintegrating tablet in patients taking alpha-adrenergic antagonists. Avoid or limit concurrent substantial ethanol consumption as this may increase the risk of symptomatic hypotension.
• Priapism: Painful erection >6 hours in duration has been reported (rarely). Instruct patients to seek immediate medical attention if erection persists >4 hours. Use with caution in patients who have conditions which may predispose them to priapism (sickle cell anemia, multiple myeloma, leukemia).
• Vision loss: Vision loss may occur rarely and be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Instruct patients to seek medical assistance for sudden loss of vision in one or both eyes. Patients who have already experienced NAION are at an increased risk of recurrence. Other risk factors for NAION include low cup-to-disc ratio (“crowded disc”), coronary artery disease, diabetes, hypertension, hyperlipidemia, smoking, and age >50 years; use with caution and only when the benefits outweigh the risks in these patients. Safety and efficacy were not studied in patients with known degenerative retinal disorders (eg, retinitis pigmentosa); use is not recommended.
Disease-related concerns:
• Anatomical penis deformation: Use with caution in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis, or Peyronie disease).
• Bleeding disorders: Use with caution in patients with bleeding disorders; safety and efficacy have not been established.
• Cardiovascular disease: Use is not recommended in patients with hypotension (resting systolic BP <90 mm Hg); uncontrolled hypertension (>170/100 mm Hg); unstable angina or angina during intercourse; life-threatening arrhythmias, stroke, or MI within the last 6 months; cardiac failure or coronary artery disease causing unstable angina. Safety and efficacy have not been studied in these patients. Use caution in patients with left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic cardiomyopathy with outflow tract obstruction). There is a degree of cardiac risk associated with sexual activity; therefore, physicians may wish to consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction.
• Congenital or acquired QT prolongation: Not recommended for use in patients with congenital or acquired (ie, medication induced) QT prolongation.
• Hepatic impairment: Use with caution in patients with moderate hepatic impairment (Child-Pugh class B); dosage adjustment is needed. Safety and efficacy have not been studied in patients with severe hepatic impairment (Child-Pugh class C); therefore, use in these patients is not recommended. Per the manufacturer, the oral disintegrating tablet should not be used in patients with moderate to severe hepatic impairment.
• Peptic ulcer disease: Use with caution in patients with active peptic ulcer disease; safety and efficacy have not been established.
• Renal impairment: Safety and efficacy have not been studied in patients with end-stage renal disease requiring dialysis; therefore, use in these patients is not recommended.
Concurrent drug therapy issues:
• Nitrates: Concomitant use with all forms of nitrates is contraindicated. If nitrate administration is medically necessary, it is not known when nitrates can be safely administered following the use of vardenafil; however, when a 20 mg (film-coated tablet) was administered 24 hours prior to a 0.4 mg sublingual dose of nitroglycerin, no changes in blood pressure or heart rate were detected.
Special populations:
• Older adult: Use with caution in older adults; dosage reduction may be necessary.
Dosage form specific issues:
• Phenylalanine: Some products may contain phenylalanine.
• Sorbitol: Some products may contain sorbitol; do not use in patients with fructose intolerance.
Other warnings/precautions:
• Appropriate use: Potential underlying causes of erectile dysfunction should be evaluated prior to treatment.
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alcohol (Ethyl): May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Alpha1-Blockers (Nonselective): Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Alpha1-Blockers (Nonselective). Management: Ensure patient is stable on one agent prior to initiating the other, and always initiate combination using the lowest possible dose of the drug being added. When tadalafil is used for treatment of BPH, concurrent alpha 1-blockers are not recommended. Risk D: Consider therapy modification
Alpha1-Blockers (Uroselective): May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Alprostadil: Phosphodiesterase 5 Inhibitors may enhance the adverse/toxic effect of Alprostadil. Risk X: Avoid combination
Amyl Nitrite: Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Amyl Nitrite. Risk X: Avoid combination
Blood Pressure Lowering Agents: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Bosentan: May decrease the serum concentration of Phosphodiesterase 5 Inhibitors. Phosphodiesterase 5 Inhibitors may increase the serum concentration of Bosentan. Risk C: Monitor therapy
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Vardenafil. Management: Limit Levitra (vardenafil) dose to a single 5 mg dose within a 24-hour period if combined with moderate CYP3A4 inhibitors. Avoid concomitant use of Staxyn (vardenafil) and moderate CYP3A4 inhibitors. Combined use is contraindicated outside of the US. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Vardenafil. Management: Limit Levitra (vardenafil) dose to a single 2.5 mg dose within a 24-hour period if combined with strong CYP3A4 inhibitors. Avoid concomitant use of Staxyn (vardenafil) and strong CYP3A4 inhibitors. Combined use is contraindicated outside of the US. Risk D: Consider therapy modification
Dapoxetine: May enhance the orthostatic hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
Etravirine: May decrease the serum concentration of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
Itraconazole: May increase the serum concentration of Vardenafil. Management: Limit Levitra (vardenafil) dose to 5 mg per 24 hours with itraconazole 200 mg/day and 2.5 mg per 24 hours with itraconazole 400 mg/day. Avoid concomitant use of Staxyn (vardenafil) and itraconazole. Combined use is contraindicated outside of the US. Risk D: Consider therapy modification
Ketoconazole (Systemic): May increase the serum concentration of Vardenafil. Management: Limit Levitra (vardenafil) dose to 5 mg per 24 hours with ketoconazole 200 mg/day and 2.5 mg per 24 hours with ketoconazole 400 mg/day. Avoid concomitant use of Staxyn (vardenafil) and ketoconazole. Combined use is contraindicated outside of the US. Risk D: Consider therapy modification
Lorcaserin (Withdrawn From US Market): May enhance the adverse/toxic effect of Phosphodiesterase 5 Inhibitors. Specifically, the risk of developing priapism may be increased. Risk C: Monitor therapy
Molsidomine: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
Nirmatrelvir and Ritonavir: May increase the serum concentration of Vardenafil. Management: Limit the dose of vardenafil tablets to a single 2.5 mg dose within a 72-hour period if combined with nirmatrelvir/ritonavir. Avoid concomitant use of vardenafil orally disintegrating tablets and nirmatrelvir/ritonavir. Risk D: Consider therapy modification
Nitroprusside: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Nitroprusside. Risk X: Avoid combination
Phosphodiesterase 5 Inhibitors: May enhance the adverse/toxic effect of other Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Riociguat: Phosphodiesterase 5 Inhibitors may enhance the hypotensive effect of Riociguat. Risk X: Avoid combination
Ritonavir: May increase the serum concentration of Vardenafil. Management: Limit the dose of vardenafil tablets to a single 2.5 mg dose within a 72-hour period if combined with ritonavir. Avoid concomitant use of vardenafil orally disintegrating tablets and ritonavir. Combined use is contraindicated outside of the US. Risk D: Consider therapy modification
Sapropterin: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Simeprevir: May increase the serum concentration of Phosphodiesterase 5 Inhibitors. Risk C: Monitor therapy
Vasodilators (Organic Nitrates): Phosphodiesterase 5 Inhibitors may enhance the vasodilatory effect of Vasodilators (Organic Nitrates). Risk X: Avoid combination
Vericiguat: May enhance the hypotensive effect of Phosphodiesterase 5 Inhibitors. Risk X: Avoid combination
High-fat meals decrease maximum serum concentration 18% to 50%. Serum concentrations/toxicity may be increased with grapefruit juice. Management: Do not take with a high-fat meal. Monitor for increased effects/toxicity with concomitant grapefruit consumption.
No effects on sperm motility or morphology were observed in healthy males; increased sperm count and motility were observed in patients with oligozoospermia (Drobnis 2017).
Adverse events were not observed in animal reproduction studies.
Vardenafil has been evaluated for the treatment of pulmonary arterial hypertension (PAH) (Jing 2011). Untreated PAH in pregnancy increases the risk for heart failure, stroke, preterm delivery, and maternal/fetal death. Patients with PAH are encouraged to avoid becoming pregnant (ACCP [Klinger 2019]; Hemnes 2015). If treatment with a phosphodiesterase-5 enzyme inhibitor is needed for the treatment of PAH during pregnancy, agents other than vardenafil are suggested (ESC [Regitz-Zagrosek 2018], Hemnes 2015).
It is not known if vardenafil is present in breast milk.
Some products may contain phenylalanine. Some products may contain sorbitol; do not use in patients with fructose intolerance.
Monitor BP, heart rate, signs/symptoms of orthostasis; visual impairment (eg, vision loss, cyanopsia); hearing impairment; prolonged erection and/or priapism.
Does not directly cause penile erections, but affects the response to sexual stimulation. The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation and inflow of blood to the corpus cavernosum. Vardenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE-5), which is responsible for degradation of cGMP in the corpus cavernosum; when sexual stimulation causes local release of NO, inhibition of PDE-5 by vardenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum; at recommended doses, it has no effect in the absence of sexual stimulation.
Onset of action: ~60 minutes
Absorption: Rapid
Distribution: Vd: 208 L
Protein binding: ~95% (parent drug and metabolite)
Metabolism: Hepatic via CYP3A4 (major), CYP2C and 3A5 (minor); forms metabolite (active)
Bioavailability: ~15%
Film-coated tablet: Elderly (≥65 years): AUC increased by 52%; Hepatic impairment (moderate, Child-Pugh class B): AUC increased by 160%
Oral disintegrating tablet: Elderly (≥65 years): AUC increased by 21% more compared to film-coated tablet. When administered with water, AUC decreases by 29%.
Half-life elimination: Terminal: Vardenafil and metabolite: 4 to 6 hours
Time to peak, plasma: 0.5 to 2 hours
Excretion: Feces (~91% to 95% as metabolites); urine (~2% to 6%)
Altered kidney function: The AUC was 20% to 30% higher in moderate (CrCl 30 to 50 mL/minute) and severe (CrCl <30 mL/minute) renal impairment.
Hepatic function impairment: In patients with mild hepatic impairment (Child-Pugh class A), Cmax and AUC increased by 22% and 17%, respectively. In patients with moderate hepatic impairment (Child-Pugh class B), Cmax and AUC increased by 130% and 160%, respectively.
Older adult: In men ≥65 years of age, the Cmax and AUC are increased 34% and 52%, respectively, for Levitra and by 21% and 39%, respectively, for Staxyn compared with men <45 years.
Tablet, orally-disintegrating (Vardenafil HCl Oral)
10 mg (per each): $36.18
Tablets (Vardenafil HCl Oral)
2.5 mg (per each): $55.56 - $58.72
5 mg (per each): $55.56 - $58.72
10 mg (per each): $55.56 - $58.72
20 mg (per each): $55.56 - $58.72
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