Zydena Special Precautions

In order to diagnose the patient's erectile dysfunction and potential risks, patients should be examined and their medical history should be scrutinized. The use of Zydena should be limited to patients in need of clinical treatment on the basis of these objective diagnoses.
Physicians should consider the cardiovascular status of their patients, since there is a potential cardiac risk associated with sexual activity. Treatments for erectile dysfunction, including Zydena, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. Zydena should not be used in patients who have had stroke, cerebral hemorrhage or myocardial infarction within the last six months, and when used in patients with a history of stroke, cerebral hemorrhage or myocardial infarction, the presence of cardiovascular disease should be examined sufficiently.
Physicians should advise patients to stop use of all PDE5 inhibitors, including Zydena, and seek immediate medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of permanent non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, that has been reported rarely in post-marketing surveillance studies in PDE5 inhibitors and has been shown to be potentially associated with the administration of PDE5 inhibitors. It is not possible to determine whether adverse reactions are directly related to the administration of PDE5 inhibitors or other factors. Physicians should also inform the patients that the use of vasodilators such as PDE5 inhibitors in patients who have already experienced NAION in one eye may increase the risk.
Physicians should advise patients to stop use of all PDE5 inhibitors, including Zydena, and seek medical attention in the event of a sudden hearing loss or deafness, which may be accompanied by tinnitus and dizziness, in one or both ears.
Zydena has been shown to have systemic vasodilatory properties that result in transient decreases in blood pressure. This is of little or no consequence in most patients. However, prior to prescribing udenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis), or those with severely impaired autonomic control of blood pressure. Moreover, as Zydena presents blood pressure lowering effects by its vasodilating action, it may augment the blood pressure lowering effect of nitrate or nitric oxide donor drugs.
In case of patients with renal impairment, Zydena is not recommended for patients with moderate to severe renal impairment as the exposure of Zydena (AUC) is increased and as there is limited clinical data. The safety and efficacy have not been studied in patients with renal failure.
Zydena must be carefully administered in the professional judgment of the physician in patients with liver dysfunction (GOT, GPT more than three times the upper limit of normal) or renal impairment (serum creatinine >2.5 mg/dl). The safety and efficacy of Zydena have not been studied in patients with liver failure or kidney failure.
Agents for the treatment of erectile dysfunction 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). In clinical trials, no cases of priapism or erection lasting longer than 4 hours were reported with Zydena. However, erection lasting longer than 4 hours and priapism (painful erection lasting longer than 6 hours) have been rarely reported in PDE5 inhibitors. Patients who experience erection lasting longer than 4 hours should be instructed to seek immediate medical attention. If not treated, tissue damage and permanent loss of erection may occur. As Zydena is neither an aphrodisiac nor stamina enhancer, it cannot be used for purposes other than the treatment of erectile dysfunction.
In patients administering CYP450 3A4 inhibitors (erythromycin, itraconazole, ketoconazole), increase of plasma concentration has been observed. Therefore, they should be used with caution such as initial dose adjustment. Patients with active gastroesophageal reflux disease (GERD) or hiatal hernia associated with reflux esophagitis or taking alpha-blockers (It has been reported that the concomitant use of PDE5 inhibitors with alpha-blockers has caused symptomatic hypotension in some patients) also should be careful when administered with Zydena.
Zydena has not been studied for the patients with uncontrolled diabetes, spinal cord injury, radical prostatectomy or radical pelvic surgery, low sexual desire, chemotherapy, and anticoagulants.
Patients with proliferative diabetic retinopathy should be administered with caution.
Zydena contains Yellow No.5 (Sunset Yellow FCF). It should be used with caution in patients who have hypersensitivity to or a history of allergic reaction to the ingredient.
Effect on Ability to Drive and Use Machines: In clinical trials, dizziness and blurred vision have been reported when treated with Zydena. Therefore, patients should be cautious when driving or operating machinery.