VIAGRA® (sildenafil citrate) Tablets Warnings

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Prescribing Information

VIAGRA^® (sildenafil citrate) Tablets
Warnings


	Return to the VIAGRA Product Center

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including VIAGRA, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), (see CLINICAL PHARMACOLOGY: Pharmacodynamics). While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.

Patients with the following underlying conditions can be particularly sensitive to the actions of vasodilators including VIAGRA – those with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.

There is no controlled clinical data on the safety or efficacy of VIAGRA in the following groups; if prescribed, this should be done with caution.

Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;
Patients with resting hypotension (BP <90/50) or hypertension (BP >170/110);
Patients with cardiac failure or coronary artery disease causing unstable angina;
Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

The concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC). If VIAGRA is prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of sildenafil are limited. Visual disturbances occurred more commonly at higher levels of sildenafil exposure. Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). To decrease the chance of adverse events in patients taking ritonavir, a decrease in sildenafil dosage is recommended (see Drug Interactions, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).

PRINTER-FRIENDLY

VIAGRA Safety Information

VIAGRA^® (sildenafil citrate) Indication

VIAGRA is indicated for the treatment of erectile dysfunction (ED).

Important Safety Information

The use of VIAGRA and organic nitrates in any form, at any time, is contraindicated.

Before treating ED, physicians should consider the impact of resuming sexual activity and the mild and transient vasodilatory effects of VIAGRA on blood pressure. Physicians should carefully consider whether patients with underlying cardiovascular disease or other more unusual conditions could be adversely affected by vasodilatory effects, especially in combination with sexual activity.

As there have been infrequent reports of prolonged erections lasting more than 4 hours or priapism with all ED treatments in this drug class, patients should be advised to seek immediate medical attention should these occur. Erections lasting longer than 6 hours can result in penile tissue damage and long-term loss of potency.

Use a starting dose of 25 mg for a patient who may have increased plasma levels (age >65, hepatic impairment, severe renal impairment, and concomitant use of potent CYP450 3A4 inhibitors). Patients taking ritonavir should not exceed 25 mg in a 48-hour period.

Patients with the following characteristics (recent serious cardiovascular events, hypotension or uncontrolled hypertension, or retinitis pigmentosa) did not participate in pre-approval clinical trials. In these patients, physicians should prescribe VIAGRA with caution.

Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely post-marketing in temporal association with the use of PDE5 inhibitors, including VIAGRA. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including VIAGRA, and seek medical attention in the event of sudden loss of vision.

Sudden decrease or loss of hearing has been reported in temporal association with the intake of PDE5 inhibitors, including VIAGRA. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. Physicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

In a controlled interaction study of VIAGRA and amlodipine, the mean additional reduction in supine blood pressure was 8 mm Hg systolic and 7 mm Hg diastolic.

Physicians should advise patients of the potential for PDE5 inhibitors, including VIAGRA, to augment the blood pressure lowering effect of alpha blockers and anti-hypertensive medications. In some patients concomitant administration of a PDE5 inhibitor and alpha blocker may lead to symptomatic hypotension. Patients should be stable on alpha-blocker therapy prior to initiating VIAGRA treatment and VIAGRA should be initiated at the lowest dose (25 mg).

Physicians should inform patients not to take VIAGRA with other PDE5 inhibitors, including REVATIO, as the safety and efficacy in these combinations have not been studied.

Use of VIAGRA offers no protection against sexually transmitted diseases, including the human immunodeficiency virus (HIV); therefore, physicians should consider counseling their patients about protective measures.

The most common side effects of VIAGRA were headache (16%), flushing (10%), and dyspepsia (7%). Adverse events, including visual effects (3%), were generally transient and mild to moderate.

Please see full prescribing information.

VIAGRA^® (sildenafil citrate) tablets

viagra_safety_information.htm

Full Prescribing Information