Silatio 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), those on antihypertensive therapy, with resting hypotension (BP<90/50 mmHg), fluid depletion, or autonomic dysfunction; may be more sensitive to hypotensive actions.
Use with caution in patients with 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.
Use in patients with pulmonary veno-occlusive disease (PVOD) is not recommended (has not been studied); If pulmonary edema occurs when treating pulmonary arterial hypertension, consider the possibility of PVOD.
Vision loss, including permanent loss of vision, may occur and be a sign of nonarteritic anterior ischemia 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. Patients suffering sudden vision loss should discontinue therapy and consult health care provider immediately.
May cause dose-related impairment of color discrimination.
Use caution in patients with retinitis pigmentosa; a minority have genetic disorders of retinal phosphodiesterase (no safety information available).
Sudden decrease or loss of hearing has been reported; hearing changes maybe accompanied by tinnitus and dizziness.
A direct relationship between therapy and vision or hearing loss has not been determined.
Use of sildenafil is contraindicated in patients currently taking nitrate preparations.
Avoid abrupt discontinuation, especially if used as monotherapy in pulmonary arterial hypertension as exacerbation may occur.
Use caution in patients with bleeding disorders or with active peptic ulcer disease; safety has not been established.
Efficacy has not been established for treatment of pulmonary hypertension associated with sickle cell disease.
Use with caution in the elderly, or patients with renal or hepatic dysfunction; dose adjustment may be needed.