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Nitrates: Administration of STENDRA® (avanafil) with any form of organic nitrates, either regularly and/or intermittently, is contraindicated. STENDRA has been shown to potentiate the hypotensive effects of nitrates.
Concomitant Guanylate Cyclase (GC) Stimulators: Do not use STENDRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including STENDRA, may potentiate the hypotensive effects of GC stimulators.
Hypersensitivity Reactions: STENDRA is contraindicated in patients with a known hypersensitivity to any component of the tablet. Hypersensitivity reactions such as pruritus and eyelid swelling have been reported.
Cardiovascular Risks: Treatments for ED, including STENDRA, should not be used in men who have underlying cardiovascular conditions, or for whom sexual activity is inadvisable due to cardiovascular issues.
STENDRA is not recommended for the following:
Concomitant Use of CYP3A4 Inhibitors: Inhibitors of CYP3A4 may reduce STENDRA clearance and increase plasma concentrations of avanafil. For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, and telithromycin), do not use STENDRA. For patients taking concomitant moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of STENDRA is 50 mg, not to exceed once every 24 hours.
Prolonged Erection: Prolonged erection longer than 4 hours and priapism (painful erections longer than 6 hours in duration) have been reported with other PDE5 inhibitors. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If not treated immediately, penile tissue damage and permanent loss of potency could result.
STENDRA should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
Effects on the Eye: Physicians should advise patients to stop use of all PDE5 inhibitors, including STENDRA, and seek medical attention if a sudden loss of vision occurs in 1 or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Individuals with "crowded" optic disc are also considered at greater risk for NAION.
Sudden Hearing Loss: Use of PDE5 inhibitors has been associated with sudden decrease or loss of hearing, which may be accompanied by tinnitus or dizziness. Patients experiencing these symptoms should be advised to stop taking STENDRA and seek prompt medical attention.
Alpha-Blockers and Other Antihypertensives: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including STENDRA, and alpha-adrenergic blocking agents are both vasodilators with blood pressure-lowering effects. When used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these 2 drug classes can lower blood pressure significantly, leading to symptomatic hypotension (eg, dizziness, lightheadedness, fainting).
Alcohol: Patients should be made aware that both alcohol and PDE5 inhibitors, including STENDRA, act as vasodilators. When taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Physicians should inform patients that substantial consumption of alcohol (eg, greater than 3 units) in combination with STENDRA may increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.
Combination with Other PDE5 Inhibitors or ED Therapies: The safety and efficacy of combinations of STENDRA with other treatments for ED have not been studied. The use of such combinations is not recommended.
Effects on Bleeding: The safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration.
Counseling Patients About Sexually Transmitted Diseases: The use of STENDRA offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including human immunodeficiency virus (HIV), should be considered.
Adverse reactions ≥2% with STENDRA 50 mg, 100 mg, and 200 mg vs placebo, respectively: headache (5.1%, 6.9%, 10.5% vs 1.7%); flushing (3.2%, 4.3%, 4.0% vs 0.0%); nasal congestion (1.8%, 2.9%, 2.0% vs 1.1%); nasopharyngitis (0.9%, 2.6%, 3.4% vs 2.9%); and back pain (3.2%, 2.0%, 1.1% vs 1.1%).
STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
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