Important Safety Information for Levitra® (vardenafil)

(Including Branded and Generic Options)

What is Vardenafil?

Vardenafil is a phosphodiesterase-5 (PDE5) inhibitor approved for the treatment of erectile dysfunction (ED). It works by enhancing blood flow to the penis during sexual stimulation, helping men achieve and maintain an erection.


Who Should NOT Use Vardenafil?

Do not use vardenafil if:

  • You are taking nitrates or nitric oxide donors, such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or recreational drugs known as “poppers.” Combining these with vardenafil can cause a severe drop in blood pressure, which can be life-threatening.
  • You are allergic to vardenafil or any of its ingredients.
  • You take guanylate cyclase (GC) stimulators, such as riociguat, as vardenafil can amplify their blood pressure-lowering effects.

How to Use Vardenafil

As-Needed Use:

  • Take 1 tablet approximately 25 to 60 minutes before sexual activity.
  • Do not exceed 1 dose in a 24-hour period.
  • Important Notes:
    • Vardenafil can be taken with or without food, but avoid high-fat meals as they may reduce the effectiveness.
    • Avoid consuming large amounts of alcohol (more than 5 drinks) as it may increase the risk of side effects.
    • Do not mix vardenafil with other ED medications or PDE5 inhibitors.

What Should You Tell Your Healthcare Provider?

Before starting vardenafil, provide a complete medical history, including:

  • All medications you are currently taking, including over-the-counter drugs, supplements, and herbal remedies.
  • Your medical conditions, especially if you have a history of:
    • Heart problems, such as angina, heart failure, irregular heartbeat, or recent heart attack.
    • Low or high blood pressure or conditions affecting blood pressure regulation.
    • Stroke or life-threatening arrhythmia in the last 6 months.
    • Kidney or liver disease, which may require dosage adjustments.
    • Vision problems, such as non-arteritic anterior ischemic optic neuropathy (NAION).
    • Hearing issues, such as sudden hearing loss or tinnitus.
    • Bleeding disorders or stomach ulcers.
    • Priapism, a condition causing painful, prolonged erections.

Possible Drug Interactions

Vardenafil may interact with certain medications or substances, increasing the risk of side effects or altering drug efficacy:

  • Nitrates and Alpha-Blockers: Can cause severe drops in blood pressure.
  • CYP3A4 Inhibitors: Medications like ritonavir, ketoconazole, and erythromycin may increase vardenafil levels, leading to adverse effects.
  • Alcohol: Consuming large quantities may amplify blood pressure-lowering effects and increase dizziness.

Always consult your healthcare provider for guidance before combining vardenafil with any other medications.


Serious Risks and Side Effects

If you experience the following, stop taking vardenafil and seek immediate medical attention:

  1. Prolonged Erection (Priapism): Erections lasting more than 4 hours can cause permanent damage to the penis.
  2. Vision Changes: Sudden loss of vision may indicate non-arteritic anterior ischemic optic neuropathy (NAION).
  3. Hearing Changes: Sudden hearing loss, often with ringing in the ears, requires urgent medical attention.
  4. Severe Allergic Reactions: Symptoms include rash, swelling, or difficulty breathing.

Most Common Side Effects

Vardenafil is generally well-tolerated. Common side effects include:

  • Headache
  • Flushing (warmth or redness in the face, neck, or chest)
  • Nasal congestion
  • Indigestion
  • Back pain
  • Dizziness
  • Vision changes (e.g., blue-tinted vision, sensitivity to light)

Important Precautions

  • Sexual Activity: Patients with heart conditions should discuss whether it is safe to engage in sexual activity.
  • Not for Protection Against STDs: Vardenafil does not prevent sexually transmitted infections. Practice safe sex.
  • Missed Dose: Vardenafil is not intended for regular daily use. Take as prescribed for sexual activity.

Reporting Side Effects

If you experience side effects, report them to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, consult the full prescribing information or contact your healthcare provider.

TOP
Bestsellers:
SHOPPING BAG 0
RECENTLY VIEWED 0