What are the contraindications to taking Vardenafil (Levitra)?

Contraindications to Vardenafil

Vardenafil is absolutely contraindicated in patients taking nitrates or nitric oxide donors, and in patients with known hypersensitivity to any component of the tablet. 1

Absolute Contraindications

Nitrate Use (Most Critical)

• Never prescribe vardenafil to any patient using nitrates in any form—oral, sublingual, transdermal, or topical—as this combination causes potentially fatal hypotension. 1, 2
• The combination of vardenafil with nitrates potentiates hypotensive effects through the nitric oxide/cGMP pathway, leading to profound blood pressure drops that can result in myocardial infarction and death. 1
• A safe time interval for nitrate administration after vardenafil use has not been definitively established, but wait at least 24 hours after vardenafil before administering nitrates under close medical supervision. 3
• This contraindication applies equally to all nitrate formulations, including nitroglycerin ointment (Nitro-BID), sublingual tablets, patches, and sprays. 3

Hypersensitivity

• Vardenafil is contraindicated in patients with known hypersensitivity to vardenafil or any tablet component. 1

Conditions Requiring Avoidance (Practical Contraindications)

Congenital or Acquired QT Prolongation

• Patients with congenital QT prolongation or those taking Class IA antiarrhythmics (quinidine, procainamide) or Class III antiarrhythmics (amiodarone, sotalol) should avoid vardenafil. 1, 4
• Vardenafil at therapeutic (10 mg) and supratherapeutic (80 mg) doses produces QTc interval increases similar to moxifloxacin, and combining vardenafil with other QT-prolonging drugs produces additive effects. 1

Severe Hepatic Impairment

• Vardenafil has not been evaluated in patients with severe hepatic impairment (Child-Pugh C) and should not be used in this population. 1
• In moderate hepatic impairment (Child-Pugh B), vardenafil exposure increases by 130-160%, requiring dose reduction to 5 mg starting dose with 10 mg maximum. 1

High Cardiovascular Risk (Defer Treatment)

• Do not prescribe vardenafil to high-risk cardiac patients until their condition is stabilized. 5, 6
• High-risk patients include those with:
  • Unstable or refractory angina 5, 6
  • Uncontrolled hypertension 5, 6
  • Left ventricular dysfunction/CHF (NYHA class II or greater) 5, 6
  • MI or stroke within the previous 2 weeks 5, 6
  • High-risk arrhythmias 5, 6
  • Hypertrophic obstructive cardiomyopathies 5, 6
  • Moderate-to-severe valvular disease 5, 6

Critical Safety Screening Before Prescribing

Mandatory Questions to Ask Every Patient

• Always explicitly ask about all forms of nitrate use before prescribing vardenafil, including recreational "poppers" (amyl nitrite). 7
• Verify the patient is not taking Class IA or Class III antiarrhythmics. 1, 4
• Assess cardiovascular risk using the Princeton Consensus Panel criteria to stratify patients into low, intermediate, or high-risk categories. 5, 6

Patients Requiring Cardiology Referral Before Treatment

• Patients with indeterminate cardiovascular risk should undergo cardiology evaluation before receiving vardenafil. 5, 7
• Patients unable to perform moderate physical activity require cardiology clearance before starting PDE5 inhibitors. 7

Special Precautions (Not Absolute Contraindications)

Alpha-Blocker Use

• Vardenafil can be used with alpha-blockers but requires special caution due to risk of significant hypotension. 2, 4
• Start with the lowest recommended vardenafil dose (5 mg) in patients taking alpha-blockers. 1

Renal Impairment

• Moderate to severe renal impairment (CrCl <50 mL/min) increases vardenafil exposure by 20-30%, but no specific contraindication exists. 1
• Vardenafil has not been studied in dialysis patients. 1

Conditions Predisposing to Priapism

• Use vardenafil with caution in patients with anatomical penile deformation (angulation, cavernosal fibrosis, Peyronie's disease) or conditions predisposing to priapism (sickle cell anemia, multiple myeloma, leukemia). 1

Common Pitfalls to Avoid

• Never assume topical or transdermal nitrates are safer—all nitrate formulations carry the same absolute contraindication. 3
• In emergency situations with chest pain, always ask about recent PDE5 inhibitor use before administering nitroglycerin. 3
• Do not combine vardenafil with other ED treatments, as safety and efficacy of such combinations have not been established. 1