Cialis - Warnings & Precautions

WARNINGS

Cardiovascular

General —

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status.

Left Ventricular Outflow Obstruction —

Patients with left ventricular outflow obstruction, (e. g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.

Patients Not Studied in Clinical Trials

The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for CIALIS, and, therefore, the use of CIALIS is not recommended in these groups until further information is available:

-patients with a myocardial infarction within the last 90 days

-patients with unstable angina or angina occurring during sexual intercourse

-patients with New York Heart Association Class 2 or greater heart failure in the last 6 months

-patients with uncontrolled arrhythmias, hypotension (< 90/ 50 mm Hg), or uncontrolled hypertension (> 170/ 100 mm Hg)

-patients with a stroke within the last 6 months

In addition, patients with known hereditary degenerative retinal disorders, including retinitis

pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Prolonged Erection

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

PRECAUTIONS

Evaluation of erectile dysfunction should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing CIALIS, it is important to note the following: