Oral Sildenafil Reduces Pulmonary Hypertension After Cardiac Surgery

Results: In the dose-response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001).

Medication Type	Potential Interaction	Effect	Notes
Nitrates	Severe hypotension	Dangerous drop in blood pressure	Absolute contraindication
Alpha-blockers	Enhanced hypotensive effect	Blood pressure may drop too low	Use with caution, monitor BP
CYP3A4 inhibitors	Increased sildenafil levels	Increased risk of side effects	Dose adjustment may be needed
Rifampin	Reduced sildenafil effectiveness	Lower plasma levels	May require dose increase

For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. 2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001).

Condition	Caution / Notes	Risk Factors
Cardiovascular disease	Use with caution	Heart failure, recent MI
Concomitant nitrate use	Absolute contraindication	Risk of severe hypotension
Severe hepatic impairment	May require dose adjustment	Reduced clearance
Retinitis Pigmentosa	Cautious use	Potential for vision disturbances

Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study. Conclusions: Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction. Sildenafil in the treatment of erectile dysfunction.N Engl J Med. 1998 Sep 3;339(10):699-700; author reply 701-2. 1998 Sep 3;339(10):700; author reply 701-2.

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Children younger than 1 year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets): If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children.

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Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store mixed oral liquid in the refrigerator. Throw away any unused mixed Revatio® oral liquid after 60 days. It is important that you tell all of your doctors that you take sildenafil.

Are you currently using Sildenafil (Viagra, Revatio)?

If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took sildenafil. Do not use this medicine if you are also using a nitrate medicine, often used to treat angina or high blood pressure. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite). Do not use this medicine if you also use riociguat (Adempas®). If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. 1998 Sep 3;339(10):700-1; author reply 701-2. 1998 Sep 3;339(10):701; author reply 701-2. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, or mixed causes.

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In a 24-week dose–response study, 532 men were treated with oral sildenafil (25, 50, or 100 mg) or placebo.

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Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings decrease in amount of urine or the frequency of urination dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position dryness, redness, scaling, or peeling of the skin increase in the size of the pupil redness, burning, or swelling of the eyes redness, itching, or tearing of the eyes seeing shades of colors differently than before swelling of the face, hands, feet, or lower legs unusual feeling of burning or stinging of the skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Erectile dysfunction

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: pain or tenderness around the eyes and cheekbones diarrhea or stomach cramps (severe or continuing) numbness or tingling of the hands, legs, or feet redness, soreness, swelling, or bleeding of the gums sensation of motion, usually whirling, either of one's self or of one's surroundings sexual problems in men (continuing), including failure to experience a sexual orgasm sores in the mouth and on the lips Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. N Engl J Med 1998 Jul 2;339(1):59 Background: Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] in the corpus cavernosum and therefore increases the penile response to sexual stimulation. In the dose–response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001).

Other Comments

We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, and mixed causes. Methods: In a 24-week dose-response study, 532 men were treated with oral sildenafil (25, 50, pfizer sildenafil 100 or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this dose-escalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question. Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction. Erectile dysfunction, the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is estimated to affect up to 30 million men in the United States.1 The disorder is age-associated,1–3 with estimated prevalence rates of 39 percent among men 40 years old and 67 percent among those 70 years old.2 The available treatments include vacuum-constriction devices; intracavernosal injections of vasoactive agents, including alprostadil (prostaglandin E1)4; transurethral delivery of alprostadil5; implantation of penile prostheses; and venous or arterial surgery. No effective oral therapy for erectile dysfunction is currently available.6 Normal penile erection depends on the relaxation of smooth muscles in the corpora cavernosa.

• Sildenafil is sometimes used off-label for other medical conditions.
• Continuous use without medical supervision is not recommended.
• Follow your provider's instructions for frequency of use.

In response to sexual stimuli, cavernous nerves and endothelial cells release nitric oxide, which stimulates the formation of cyclic guanosine monophosphate (GMP) by guanylate cyclase.7–9 The mechanism by which cyclic GMP stimulates relaxation of the smooth muscles remains to be elucidated.

• Some men may experience minor flushing after taking sildenafil.
• If an adverse reaction occurs, stop medication and contact your doctor.
• Be aware of possible symptoms like sudden vision loss.

Sildenafil is a selective inhibitor of cyclic-GMP–specific phosphodiesterase type 5, the predominant isozyme metabolizing cyclic GMP in the corpus cavernosum.10 By selectively inhibiting cyclic-GMP catabolism in cavernosal smooth-muscle cells,11 sildenafil would be expected to restore the natural erectile response to sexual stimulation but not cause erections in the absence of such stimulation.

• Sildenafil is used to treat erectile dysfunction and pulmonary hypertension.
• It belongs to the class of phosphodiesterase inhibitors.
• Oral sildenafil should be taken about 30-60 minutes before activity.

Sildenafil is rapidly absorbed, with maximal plasma concentrations occurring within one hour after oral administration and a mean terminal half-life of three to five hours.10 In a placebo-controlled pilot study of 12 men, sildenafil significantly improved the erectile response during visual sexual stimulation.10,12 We therefore undertook two studies to evaluate in a home setting the efficacy and safety of sildenafil in men with erectile dysfunction.

Before taking this medicine

This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If you take sildenafil for pulmonary arterial hypertension, do not take Viagra®, Vibrique™ or other PDE5 inhibitors, including tadalafil (Cialis®) or vardenafil (Levitra®). If you take too much sildenafil or take it together with these sildenafil citrate drug medicines, the chance for side effects will be higher. It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

Sildenafil, a novel effective oral therapy for male erectile dysfunction

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. If you experience a sudden loss of vision in one or both eyes, contact your doctor immediately. Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low.

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Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. In two sequential studies, we studied a total of 861 men 18 years of age or older with a clinical diagnosis of erectile dysfunction (as defined previously1) of six months' duration or longer at 37 centers in the United States.

• Common side effects include headache, flushing, and nasal congestion.
• Serious side effects are rare but can include vision changes and priapism.
• Report any severe reactions to your doctor immediately.