Sildera Special Precautions

Decreases in blood pressure may occur due to vasodilator effects; use with caution in patients with left ventricular outflow obstruction (aortic stenosis or hypertrophic obstructive cardiomyopathy); may be more sensitive to hypotensive actions. Concurrent use with alpha-adrenergic antagonist therapy or substantial ethanol consumption may cause symptomatic hypotension; patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose. Use with caution in patients with hypotension (<90/50 mmHg); uncontrolled hypertension (>170/110 mmHg); life-threatening arrhythmias, stroke or MI within the last 6 months; cardiac failure or coronary artery disease causing unstable angina; safety and efficacy have not been studied in these patients. There is a degree of cardiac risk associated with sexual activity; therefore, physicians should consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction.
Sildenafil should be used with caution in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis, or Peyronie's disease) and in patients who have conditions which may predispose them to priapism (sickle cell anemia, multiple myeloma, leukemia). All patients should be instructed to seek medical attention if erection persists >4 hours.
Vision loss may occur rarely and be a sign of nonarteritic anterior ischemic optic neuropathy (NAION) . Risk may be increased with history of vision loss. Other risk factors for NAION include low cup-to-disc ratio ("crowded disc"), coronary artery disease, diabetes, hypertension, hyperlipidemia, smoking, and age >50 years. May cause dose related impairment of color discrimination. Use caution in patients with retinitis pigmentosa; a minority have genetic disorders of retinal phosphodiesterases (no safety information available). Sudden decrease or loss of hearing has been reported rarely; hearing changes may be accompanied by tinnitus and dizziness. A direct relationship between therapy and vision or hearing loss has not been determined.
The potential underlying causes of erectile dysfunction should be evaluated prior to treatment. The safety and efficacy of sildenafil with other treatments for erectile dysfunction have not been established; use is not recommended. Use with caution in patients taking strong CYP3A4 inhibitors or alpha-blockers. Concomitant use with all forms of nitrates is contraindicated. If nitrate administration is medically necessary, it is not known when nitrates can be safety administered following the use of sildenafil (per manufacturer) the ACC/AHA 2007 guidelines supports administration of nitrates only if 24 hours have elapsed.
Use caution in patients with bleeding disorders or with active peptic ulcer disease; safety and efficacy have not been established. Use with caution in the elderly, or patients with renal or hepatic dysfunction; dose adjustment may be needed.