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Vardenafil

Medical and Pharmacy Editor:

Brand Name: Levitra, Staxyn ODT

Generic Name: Vardenafil

Drug Class: Phosphodiesterase-5 Enzyme Inhibitors

What Is Vardenafil and How Does It Work?

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.

Dosages of Vardenafil

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

What Are Side Effects Associated with Using Vardenafil?

Common side effects of vardenafil include:

Less common side effects of vardenafil include:

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.

What Other Drugs Interact with Vardenafil?

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:

Vardenafil has serious interactions with at least 36 different drugs.

Vardenafil has moderate interactions with at 105 different drugs.

Mild interactions of vardenafil include:

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.

What Are Warnings and Precautions for Vardenafil?

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

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.
Reviewed on 1/4/2018

References:
Medscape. Vardenafil.
https://reference.medscape.com/drug/levitra-staxyn-odt-vardenafil-342872
RxList. Levitra Side Effects Center.
https://www.rxlist.com/levitra-side-effects-drug-center.ht

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