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  • Stendra
    (Avanafil) - Vivus

    THERAPEUTIC CLASS

    Phosphodiesterase type 5 inhibitor

    DEA CLASS

    RX

    INDICATIONS

    Treatment of erectile dysfunction (ED).

    ADULT DOSAGE

    Adults: Initial: 100mg PO PRN approximately 30 min before sexual activity. Titrate: May increase to a max dose of 200mg or decrease to 50mg. Max Frequency: Dose qd. Use the lowest dose that provides benefit. Sexual stimulation is required for response to treatment. With α-Blockers: Should be stable on α-blocker therapy prior to initiation of therapy. Initial: 50mg/day. With Moderate CYP3A4 Inhibitors: Max: 50mg, not to exceed once q24h.

    HOW SUPPLIED

    Tab: 50mg, 100mg, 200mg

    CONTRAINDICATIONS

    Organic nitrates, either taken regularly and/or intermittently, in any form.

    WARNINGS/PRECAUTIONS

    Potential for cardiac risk during sexual activity in patients with preexisting cardiovascular disease (CVD); avoid in men for whom sexual activity is inadvisable due to underlying CV status. Patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis) and severely impaired autonomic control of BP can be particularly sensitive to the actions of vasodilators (eg, avanafil). Not recommended in patients with myocardial infarction, stroke, life-threatening arrhythmia, coronary revascularization within the last 6 months, resting hypotension (BP <90/50 mmHg) or HTN (BP >170/100 mmHg), unstable angina, angina with sexual intercourse, NYHA Class 2 or greater congestive heart failure, and in patients with known hereditary degenerative retinal disorders (including retinitis pigmentosa). Prolonged erection (>4 hrs) and priapism (painful erections >6 hrs in duration) reported; caution with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, or Peyronie's disease), or conditions that may predispose to priapism (eg, sickle cell anemia, multiple myeloma, leukemia). Non-arteritic anterior ischemic optic neuropathy (NAION) rarely reported; d/c if sudden loss of vision is experienced in one or both eyes. Sudden decrease or loss of hearing, which may be accompanied by tinnitus or dizziness, reported; d/c if occurs. Does not protect against sexually transmitted diseases (eg, HIV). Avoid in patients with severe renal disease, on renal dialysis, or with severe hepatic disease.

    ADVERSE REACTIONS

    Headache, flushing, nasopharyngitis, nasal congestion, back pain, upper respiratory infection, ECG abnormal.

    DRUG INTERACTIONS

    See Contraindications. Not recommended with other PDE-5 inhibitors or ED therapy combinations. Not recommended with CYP inducers. Caution with α-blockers; may augment BP-lowering effect of α-blockers and other antihypertensives. May increase the risk of orthostatic signs/symptoms with substantial alcohol consumption. Avoid use with strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, nefazodone). Increased levels with moderate CYP3A4 inhibitors (eg, erythromycin, amprenavir, diltiazem, fluconazole), other CYP3A4 inhibitors (eg, grapefruit juice). May increase levels of desipramine, omeprazole, and rosiglitazone. Amlodipine may increase levels. May potentiate the antiaggregatory effect of sodium nitroprusside.

    PREGNANCY

    Category C, safety not known in nursing.

    MECHANISM OF ACTION

    PDE-5 inhibitor; has no direct relaxant effect on isolated human corpus cavernosum, but enhances effect of nitric oxide by inhibiting PDE-5, which is responsible for degradation of cGMP in the corpus cavernosum.

    PHARMACOKINETICS

    Absorption: Rapid; (fasted) Tmax=30-45 min. Distribution: Plasma protein binding (99%). Metabolism: Extensive; CYP3A4 (major), CYP2C isoform (minor); M4 and M16 (major circulating metabolites). Elimination: Feces (62% metabolites), urine (21% metabolites); T1/2=5 hrs.

    ASSESSMENT

    Assess for hypersensitivity to the drug, preexisting CVD, any other conditions where treatment is contraindicated/cautioned, and possible drug interactions. Assess to identify potential underlying causes of ED as well as treatment options.

    MONITORING

    Monitor for hypersensitivity reactions, NAION (eg, loss of vision), prolonged erection, priapism, cardiac risk, decrease or loss of hearing, and other adverse reactions.

    PATIENT COUNSELING

    Instruct to take as ud; discuss the appropriate use and its anticipated benefits. Instruct to seek medical assistance if prolonged erection persists >4 hrs. Inform of potential BP-lowering effect with α-blockers and other antihypertensive drugs. Inform of the potential cardiac risk of sexual activity in patients with preexisting CV risk factors. Inform that regular and/or intermittent use of organic nitrates is contraindicated. Advise to contact physician if new medications are prescribed by another healthcare provider. Advise to stop taking PDE-5 inhibitors and seek medical attention in the event of sudden loss of vision in one or both eyes or when sudden decrease or loss of hearing occurs. Inform patients that substantial consumption of alcohol (eg, >3 units) in combination with the medication may increase the potential for orthostatic signs/symptoms. Counsel patients about the protective measures necessary to guard against sexually transmitted diseases (eg, HIV).

    ADMINISTRATION/STORAGE

    Administration: Oral route. Take with or without food. Storage: 20-25°C (68-77°F); excursions permitted to 30°C (86°F). Protect from light.