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