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  • Stendra
    (avanafil)

    THERAPEUTIC CLASS

    Phosphodiesterase type 5 inhibitor

    DEA CLASS

    RX

    INDICATIONS

    Treatment of erectile dysfunction (ED).

    ADULT DOSAGE

    Adults: Initial: 100mg PRN, as early as 15 min before sexual activity. Titrate: May increase to 200mg as early as 15 min before sexual activity, or decrease to 50mg 30 min before sexual activity, based on individual efficacy and tolerability. Max Frequency: QD. Use lowest effective dose. Sexual stimulation is required for response to treatment. Patients Stable on α-Blocker: Initial: 50mg. Concomitant Moderate CYP3A4 Inhibitors (eg, Erythromycin, Amprenavir, Diltiazem): Max: 50mg/24 hrs.

    ADMINISTRATION

    Oral route. Take with or without food.

    HOW SUPPLIED

    Tab: 50mg, 100mg, 200mg

    CONTRAINDICATIONS

    Concomitant use (regularly and/or intermittently) with organic nitrates.

    WARNINGS/PRECAUTIONS

    In a patient who has taken avanafil, where nitrate administration is necessary, allow at least 12 hrs to elapse after the last dose of therapy before considering nitrate administration; only administer under close medical supervision with appropriate hemodynamic monitoring. Potential for cardiac risk during sexual activity in patients with preexisting cardiovascular (CV) disease; avoid if sexual activity is inadvisable due to underlying CV status. Patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of BP may be sensitive to therapy. Not recommended in patients with myocardial infarction, stroke, life-threatening arrhythmia, or coronary revascularization within the last 6 months; resting hypotension (BP <90/50mmHg) or HTN (BP >170/100mmHg), or unstable angina, angina with sexual intercourse, or NYHA Class 2 or greater congestive heart failure. Has vasodilatory properties resulting in transient decreases in sitting BP. Prolonged erection >4 hrs and priapism reported; caution with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, Peyronie's disease), or conditions that may predispose to priapism (eg, sickle cell anemia, multiple myeloma, leukemia). Non-arteritic anterior ischemic optic neuropathy (NAION) reported (rare); d/c if sudden loss of vision in 1 or both eyes occurs. Caution with underlying NAION risk factors; increased risk with previous history of NAION and in individuals with "crowded" optic disc. Sudden decrease or loss of hearing that may be accompanied by tinnitus or dizziness reported; d/c if this occurs. 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 and Dosage. 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 BP-lowering effect of each compound with concomitant alcohol use and the risk of orthostatic signs/symptoms with substantial alcohol consumption. Do not use with strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, nefazodone). Increased levels with strong, moderate, and other CYP3A4 inhibitors (eg, grapefruit juice). May increase levels of desipramine or omeprazole. May affect rosiglitazone levels. Amlodipine may increase levels and prolong T1/2. May decrease amlodipine levels. May potentiate the antiaggregatory effect of sodium nitroprusside.

    PREGNANCY AND LACTATION

    Category C, safety not known in nursing.

    MECHANISM OF ACTION

    PDE-5 inhibitor; enhances effect of nitric oxide, which activates the enzyme guanylate cyclase resulting in increased levels of cGMP, producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.

    PHARMACOKINETICS

    Absorption: Rapid; (fasted) Tmax=30-45 min (median). Distribution: Plasma protein binding (99%). Metabolism: Liver (extensive); CYP3A4 (major), CYP2C (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, CV disease, left ventricular outflow obstruction, anatomical deformation of the penis, conditions that predispose to priapism, potential underlying causes of ED, risk for NAION, renal/hepatic impairment, any other conditions where treatment is contraindicated/cautioned, and possible drug interactions. Obtain baseline BP.

    MONITORING

    Monitor for hypersensitivity reactions, CV risk, priapism, changes in vision/hearing, and other adverse reactions.

    PATIENT COUNSELING

    Instruct to take ud and explain that sexual stimulation is required for an erection to occur. Inform about the contraindication of avanafil with regular and/or intermittent use of organic nitrates; instruct patients who experience anginal chest pain after taking medication to seek immediate medical attention. Inform patients with preexisting CV risk factors of the potential cardiac risk of sexual activity; advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention. Advise to contact prescribing physician if new medications that may interact with therapy are prescribed by another healthcare provider. Instruct to seek emergency medical attention if erection persists >4 hrs; inform that priapism, if not treated promptly, may result in irreversible erectile tissue damage. Inform of the increased risk of NAION with history of NAION in 1 eye and in patients with a "crowded" optic disc. Instruct to d/c and seek medical attention in the event of sudden loss of vision in 1 or both eyes, or if a sudden decrease or loss of hearing that may be accompanied by tinnitus and dizziness occurs. Inform that substantial alcohol consumption (eg, >3 units) in combination with medication may increase the potential for orthostatic signs/symptoms. Inform that drug does not protect against sexually transmitted diseases (STDs); counsel about protective measures necessary to guard against STDs, including HIV.

    STORAGE

    20-25°C (68-77°F); excursions permitted to 30°C (86°F). Protect from light.