Please scroll to see Indication and Important Safety Information.
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 patients 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. 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.
Full Prescribing Information and Patient Package Insert.
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STUDY DESCRIPTIONS
*Data pooled from 5 double-blind, flexible-dose, placebo-controlled, parallel-group, phase 2 and 3 studies with 1370 patients with ED. Patients (n=1244) responded to the International Index of Erectile Function (IIEF) Q7: "When you attempted sexual intercourse, how often was it satisfactory for you?" Responses to this question were rated on a scale of 0 (no sexual activity) to 5 (almost always or always). Improvement was defined as shifting 1 or more categories from baseline. At the end of treatment, the mean score for men taking VIAGRA (n=635) was 3.59, compared with 2.05 for men taking placebo (n=609; P<.0001). For Q4, the mean baseline score was 1.55 for men taking VIAGRA (n=633), and 1.49 for men taking placebo (n=606). At the end of treatment, the mean score for men taking VIAGRA was 3.42, compared with 1.69 for men taking placebo
(P<.0001).
†Results from a double-blind phase of a placebo-controlled, fixed-dose study (VIAGRA 100 mg) of 228 patients with ED of various etiologies and degrees of severity. The study assessed time of onset (median time to erection hard enough for penetration and to erection that resulted in successful intercourse) and included previous VIAGRA 100-mg responders. The median time to onset for an erection hard enough for penetration was 31 minutes with VIAGRA and 61 minutes with placebo. The median time to onset for an erection that resulted in successful intercourse was 36 minutes with VIAGRA and 141 minutes with placebo. In this study, 67.8% of patients taking VIAGRA 100 mg had an erection that resulted in successful intercourse in 30 minutes vs 36.3% for those taking placebo (P=.0001) and 34.8% of patients taking VIAGRA 100 mg (n=115) had an erection that resulted in successful intercourse in 14 minutes vs 22.1% for those taking placebo (n=113; P=.0343).
‡Results based on 21 randomized, double‐blind, placebo‐controlled trials of more than 3000 men aged 19 to 87 years, with ED of various etiologies with a mean duration of 5 years. Studies had a duration of up to 6 months, and used a variety of study designs (fixed dose, titration, parallel, crossover). In most studies, the effectiveness of VIAGRA was evaluated using several assessment instruments. The primary measure in the principal studies was Q3 and Q4 of the IIEF. VIAGRA demonstrated statistically significant improvement compared to placebo in all 21 studies.
References
- Data on file. Pfizer Inc, New York, NY.
- Padma-Nathan H, Stecher VJ, Sweeney M, Orazem J, Tseng L-J, DeRiesthal H. Minimal time to successful intercourse after sildenafil citrate: results of a randomized, double-blind, placebo-controlled trial. Urology. 2003;62(3):400-403.
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