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vardenafil (Rx)Brand and Other Names:Levitra, Staxyn ODT

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet, film coated

  • 2.5mg
  • 5mg
  • 10mg
  • 20mg

tablet, orally disintegrating

  • 10mg
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Erectile Dysfunction

Film-coated tablet: 10 mg PO ~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 PO placed on tongue ~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

Dosing Considerations

Coadministration with strong CYP3A4 inhibitor

  • 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 q12hr): Vardenafil dosage not to exceed 2.5 mg/72 hr

Coadministration with moderate CYP3A4 inhibitor

  • Erythromycin 500 mg q8hr: Vardenafil dosage not to exceed 5 mg/day

Coadministration with alpha blocker

  • Stabilized on alpha-blocker therapy (eg, alfuzosin, terazosin, tamsulosin): 5 mg/day PO initially
  • Stabilized on alpha-blocker therapy and taking moderate-to-strong CYP3A4 inhibitor: 2.5 mg/day PO 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 PO ~1 hour before sexual activity; not to exceed 10 mg once daily; ODT not recommended
  • Child-Pugh class C: Not recommended

Not indicated

Erectile Dysfunction

5 mg PO ~1 hour before sexual activity

AUC and Cmax increased by 39% and 21%, respectively, in elderly men (compared with men <45 years)

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Interactions

Interaction Checker

vardenafil and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (15%)

            Flushing (11%)

            1-10%

            Rhinitis (9%)

            Dyspepsia (4%)

            Flulike syndrome (3%)

            Sinusitis (3%)

            Back pain (2%)

            Dizziness (2%)

            Increased creatine phosphokinase (2%)

            Nausea (2%)

            <1%

            Anaphylaxis

            Angina

            Insomnia

            Myocardial infarction (MI)

            Postural hypotension

            Priapism

            Pruritus

            Rash

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            Warnings

            Contraindications

            Hypersensitivity

            Soluble guanylate cyclase (sGC) stimulators (eg, 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

            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 (eg, sildenafil, tadalafil)

            Concomitant use of alpha blockers increases risk of 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

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Unknown whether drug is distributed into breast milk; indicated for males

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Sexual stimulation causes nitric oxide to be released in corpus cavernosum, and nitric oxide activates guanylate cyclase, which in turn increases cyclic guanosine monophosphate (cGMP), thus causing smooth-muscle relaxation; PDE-5 inhibitors enhance smooth muscle-relaxing effects of nitric oxide in corpus cavernosum by inhibiting degradation of cGMP

            Absorption

            Rapidly absorbed

            Bioavailability: 15%

            Onset: 60 min

            Peak plasma time: 30-120 min

            Peak plasma concentration: 8-19% lower for ODT than for film-coated tablet

            Distribution

            Protein bound: 95%

            Vd: 208 L

            Metabolism

            Metabolized in liver by CYP3A4 and (in minor amounts) CYP2C9

            Metabolites: M1 (active; plasma concentration 26% of parent compound)

            Elimination

            Half-life: 3-6 hr

            Total body clearance: 56 L/hr

            Excretion: Feces (95%), urine (5%)

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            Administration

            Instructions

            Oral tablet or orally disintegrating tablet

            • Take about 60 minutes before sexual activity
            • Maximum dosing frequency is one tablet per day
            • May take with or without food

            Orally disintegrating tablet

            • Place on tongue where it will dissolve
            • Do not swallow
            • Take without liquid
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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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