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avanafil (Rx)Brand and Other Names:Stendra

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablets

  • 50mg
  • 100mg
  • 200mg
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Erectile Dysfunction

100 mg PO initially as early as 15 min before sexual activity; not to exceed 1 dose/day

Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as ~15 minutes before sexual activity, or decreased to 50 mg taken ~30 minutes before sexual activity

Use lowest effective dose

Dosage Modifications

Coadministration with strong CYP3A4 inhibitors or nitrates: Contraindicated

Coadministration with moderate CYP3A4 inhibitors: Not to exceed dose of 50 mg/24 hr

Coadministration with stable alpha-blocker therapy: Initiate therapy at 50 mg/24 hr

Renal Impairment

  • Mild-to-moderate (CrCl ≥30 mL/min): Dose adjustment not necessary
  • Severe impairment (CrCl 15-29 mL/min): Safety and efficacy not established; do not use

Hepatic impairment

  • Mild to moderate impairment: Dose adjustment not necessary
  • Severe impairment: Safety and efficacy not established; do not use

Safety and efficacy not established

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Interactions

Interaction Checker

avanafil and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >2%

            Headache (5.6%)

            Flushing (3.5%)

            Nasal congestion (2.1%)

            Nasopharyngitis (3.4%)

            Back pain (2.5%)

            Upper respiratory infection (<2%)

            Bronchitis (<2%)

            Influenza (<2%)

            Sinusitis (<2%)

            Sinus congestion (<2%)

            Hypertension (<2%)

            Dyspepsia (<2%)

            Nausea (<2%)

            Constipation (<2%)

            Rash (<2%)

            <1%

            Peripheral edema

            Fatigue

            Angina

            Deep vein thrombosis

            Palpitations

            Gastritis

            Gastroesophageal reflux disease

            Hypoglycemia

            Hyperglycemia

            Oropharyngeal pain

            Stomach discomfort

            Vomiting

            Depression

            Insomnia

            Cough

            Dyspnea exertional

            Epistaxis

            Wheezing

            Pruritus

            Urinary tract infection

            Pollakiuria

            Nephrolithiasis

            Hematuria

            Increased erection

            Balanitis

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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

            Potential for cardiovascular risk during sexual activity in patients with underlying cardiovascular conditions

            Monitor patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis)

            Dose should not exceed 50 mg/24hr when taking avanafil concomitantly with moderate CYP3A4 inhibitors

            Initiate therapy at 50 mg/24hr if coadministered with antihypertensive medications like alpha-blockers

            Priapism may occur especially in patients with predisposed conditions (eg, sickle cell anemia, multiple myeloma, or leukemia)

            Discontinue therapy if sudden loss of vision in one or both eyes occur (could be a sign of non-arteritic anterior ischemic optic neuropathy)

            Safety and efficacy not established in patients with hereditary retinal disorders, including retinitis pigmentosa (use not recommended)

            Sudden hearing loss may occur; discontinue therapy if tinnitus symptoms occur

            Alcohol may increase risk for orthostatic hypotension; may increase heart rate and cause dizziness and headache

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Safety and efficacy not established

            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 the corpus cavernosum; nitric oxide activates the enzyme guanylate cyclase, which in turn increases cGMP levels; increase in cGMP levels causes smooth muscle relaxation.

            Phosphodiesterase type 5 inhibitors enhance the effects of nitric oxide in smooth muscle relaxation of the corpus cavernosum by inhibiting the degradation of cGMP.

            Pharmacokinetics

            Half-life elimination: 5 hr

            Peak Plasma Time: 30-45 min

            Protein Bound: 99%

            Metabolism: Liver (via CYP3A4 [major] and CYP2C [minor])

            Metabolites: M4 (4% active) and M16 (inactive) are the major circulating metabolites

            Excretion: Feces (62%); urine (21%); semen (<0.0002%)

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            Administration

            Instructions

            May take with or without food

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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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            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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