Vardenafil

Vardenafil is an erectile dysfunction drug that works by blocking a certain enzyme (phosphodiesterase-PDE5) used to treat erectile dysfunction (impotence).

Vardenafil is available under the following different brand names: Levitra and Staxyn ODT.

Adult and Pediatric Dosage Forms and Strengths

Tablet, film coated

• 2.5 mg
• 5 mg
• 10 mg
• 20 mg

Tablet, orally disintegrating

• 10 mg

Dosage Considerations – Should be Given as Follows:

Erectile Dysfunction

Adult:

• Film-coated tablet: 10 mg orally approximately 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 orally placed on tongue approximately 1 hour before sexual activity; not to exceed 1 dose/day
• 10-mg ODT not interchangeable with 10-mg film-coated tablet; ODT provides higher systemic exposure at same dose; if higher or lower doses are required, film-coated tablet should be prescribed

Geriatric:

• 5 mg orally approximately 1 hour before sexual activity
• AUC and Cmax increased by 39% and 21%, respectively, in elderly men (compared with men under 45 years)

Dosing Considerations

Coadministration with strong CYP3A4 inhibitor

Hepatic impairment: Use contraindicated in chronic or active liver disease

• 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 every 12 hours): Vardenafil dosage not to exceed 2.5 mg/72 hours

Coadministration with moderate CYP3A4 inhibitor

• Erythromycin 500 mg every 8 hours: Vardenafil dosage not to exceed 5 mg/day

Coadministration with alpha blocker

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

Dosing Modifications

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 orally approximately 1 hour before sexual activity; not to exceed 10 mg once daily; ODT not recommended
• Child-Pugh class C: Not recommended

Pediatric: Not indicated

Common side effects of vardenafil include:

• Headache
• Flushing (warmth or redness in your face, neck, or chest)
• Runny or stuffy nose
• Indigestion/heartburn
• Stomach upset
• Flulike syndrome
• Sinus infection (sinusitis)
• Back pain
• Dizziness
• Increased creatine phosphokinase CPK)
• Nausea

Less common side effects of vardenafil include:

• Chest pain (angina)
• Dizziness on standing
• Heart attack (myocardial infarction [MI])
• Insomnia
• Itching
• Painful or prolonged erection (priapism)
• Rash
• Severe allergic reaction (anaphylaxis)

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

• Severe interactions of vardenafil include:
  • isosorbide dinitrate
  • isosorbide mononitrate
  • nitroglycerin IV
  • nitroglycerin PO
  • nitroglycerin rectal
  • nitroglycerin sublingual
  • nitroglycerin topical
  • nitroglycerin transdermal
  • nitroglycerin translingual
  • riociguat
• Vardenafil has serious interactions with at least 36 different drugs.
• Vardenafil has moderate interactions with at 105 different drugs.
• Mild interactions of vardenafil include:
  • carvedilol
  • fluvoxamine
  • labetalol
  • sapropterin

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains vardenafil. Do not take Levitra or Staxyn ODT if you are allergic to vardenafil or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Soluble guanylate cyclase (sGC) stimulators (e.g., 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

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Vardenafil?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Vardenafil?"

Cautions

• Anatomic deformation of penis, cardiovascular disease, left ventricular outflow obstruction, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, conditions predisposing to priapism, concomitant use of CYP3A4 inhibitors.
• Avoid in patients with congenital QT prolongation or those taking class IA or III antiarrhythmics.
• Use in combination with other treatment for erectile dysfunction has not been studied and is not recommended.
• Not to be taken with other phosphodiesterase (PDE)-5 inhibitors (e.g., sildenafil, tadalafil).
• Concomitant use of alpha-blockers increases risk of low blood pressure (hypotension).
• May increase risk of rare sudden vision loss attributed to nonarteritic ischemic optic neuropathy; if vision problems arise, discontinue, and contact physician.
• Risk of sudden hearing loss.

Pregnancy and Lactation

• Vardenafil may be acceptable for use during pregnancy. Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk.
• It is unknown whether vardenafil is distributed into breast milk. Vardenafil indicated for males and is unlikely to be used in females.