In a study of healthy male volunteers, sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
Heat or moisture may cause the medicine to break down.
The combination of heparin and Viagra had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.
Heat or moisture may cause the medicine to break down.
Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for Viagra and 29% for placebo.
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Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.
POST-MARKETING EXPERIENCE Cardiovascular and cerebrovascular Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of Viagra.
The AUC of the active metabolite, N-desmethyl sildenafil, was increased 62% by loop and potassium-sparing diuretics and 102% by nonspecific beta-blockers.
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Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil, so that the metabolite accounts for about 20% of sildenafil's pharmacologic effects.
Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
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It is a treatment for erectile dysfunction.
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Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicited to questions about (1) the ability to achieve erections sufficient for sexual intercourse and (2) the maintenance of erections after penetration.
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Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury.
Allow 24 hours to pass between doses.
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If any develop or change in intensity, inform your doctor as soon as possible.
Of the twenty subjects who were ultimately assigned to treatment, a total of 13 subjects successfully completed dose period 1, and seven had successfully completed the previous doxazosin study (using Viagra 50 mg).
To prevent them, sit up or stand slowly, especially in the morning.
Two of the questions from the IIEF served as primary study endpoints; categorical responses were elicited to questions about (1) the ability to achieve erections sufficient for sexual intercourse and (2) the maintenance of erections after penetration.
Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; memory loss; painful or prolonged erection; ringing in the ears; seizure; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of vision in one or both eyes; sudden hearing loss.
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When a man is sexually excited, Viagra helps the penis fill with enough blood to cause an erection.
For the 20 subjects who received Viagra 100 mg and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows: Blood pressure was measured after administration of Viagra at the same times as those specified for the previous doxazosin studies.
Do not take Viagra if you are taking any nitrate-based drug, including nitroglycerin patches (Nitro-Dur, Transderm-Nitro), nitroglycerin ointment (Nitro-Bid, Nitrol), nitroglycerin pills (Nitro-Bid, Nitrostat), and isosorbide pills (Dilatrate-SR, Isordil, Sorbitrate).
Across all trials, Viagra improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.
Viagra is not for regular use.
There were no episodes of syncope reported in this study.
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In the second study, a single oral dose of Viagra 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH.
Consideration should be given to the following: - Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.
During 3 to 6 months of double-blind treatment or longer-term (1 year), open-label studies, few patients withdrew from active treatment for any reason, including lack of effectiveness.
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In the nonpregnant rat the AUC at this dose was about 20 times human AUC.
Twenty-five subjects were screened.
Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered.
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The frequency of patients reporting improvement of erections in response to a global question in four of the randomized, double-blind, parallel, placebo-controlled fixed dose studies (1797 patients) of 12 to 24 weeks duration is shown in Figure 4.
PREGNANCY and BREAST-FEEDING: Viagra is not approved for use in women.
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In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 1 hour after administration of Viagra 50 mg and resolving after approximately 7.
If you have prostate problems or high blood pressure for which you take medicines called alpha blockers, your doctor may start you on a lower dose of Viagra.
In addition, in a study performed in healthy male volunteers, coadministration of the HIV protease inhibitor saquinavir, also a CYP3A4 inhibitor, at steady state (1200 mg tid) with Viagra (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
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Viagra is indicated for the treatment of erectile dysfunction.
How is Viagra Supplied Viagra (sildenafil citrate) is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:This summary contains important information about Viagra®.
Make sure you tell your doctor if you have any other medical problems, especially: Age greater than 50 years or Coronary artery disease or Diabetes or Hyperlipidemia (excess of lipids in the blood) or Hypertension (high blood pressure) or Low cup to disc ratio (“crowded disc”) or Smoking—These conditions may increase risk for a serious eye problem called NAION.
You will need to have a thorough medical exam to diagnose your erectile dysfunction and to find out if you can safely take Viagra alone or with your other medicines.
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The patient addressed both questions at the final visit for the last 4 weeks of the study.
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5 mmHg), (see CLINICAL PHARMACOLOGY: Pharmacodynamics).
To avoid low blood pressure, do not take the 50-milligram or 100-milligram dose of Viagra within 4 hours of taking an alpha-blocking drug such as Cardura.
Follow your doctor's orders or the directions on the label .
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If you are taking medicines called alpha-blockers for the treatment of high blood pressure or prostate problems, your blood pressure could suddenly drop.
Both sildenafil and the metabolite have terminal half lives of about 4 hours.
Treating erectile dysfunction (ED).
This is called an erection.
There was no effect on sperm motility or morphology after single 100 mg oral doses of Viagra in healthy volunteers.
If you have prostate problems or high blood pressure for which you take medicines called alpha blockers, your doctor may start you on a lower dose of Viagra.
Physicians should advise patients to stop use of all PDE5 inhibitors, including Viagra, and seek medical attention in the event of a sudden loss of vision in one or both eyes.
Be sure to tell your doctor if you: have ever had any heart problems (e.
Do not take Viagra if you are also using a nitrate drug for chest pain or heart problems.
In addition, N-desmethyl metabolite AUC and Cmax values significantly increased 200% and 79% respectively in subjects with severe renal impairment compared to subjects with normal renal function.
If you are over 65, have liver or kidney problems, or are taking erythromycin, ketoconazole, itraconazole, ritonavir, or saquinavir a dose of 25 milligrams may be sufficient.
Viagra is not a hormone or an aphrodisiac.
This helps you to achieve and maintain an erection.
If too much is used, the chance of side effects is increased.
Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
Although the interaction between other protease inhibitors and sildenafil has not been studied, their concomitant use is expected to increase sildenafil levels.
Tell your doctor about any medicines you are taking.
Follow the directions on your prescription label.
Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; memory loss; painful or prolonged erection; ringing in the ears; seizure; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of vision in one or both eyes; sudden hearing loss.
Twenty subjects received Viagra 50 mg, but only 19 subjects received matching placebo.
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You may report side effects to FDA at 1-800-FDA-1088.
You will not get an erection just by taking this medicine.
Also collected as part of the IIEF was information about other aspects of sexual function, including information on erectile function, orgasm, desire, satisfaction with intercourse, and overall sexual satisfaction.
If you have a bleeding disorder, a stomach ulcer, or the inherited eye condition known as retinitis pigmentosa, use Viagra with caution.
For example: If you are older than age 65, or have serious liver or kidney problems, your doctor may start you at the lowest dose (25 mg) of Viagra.
Precautions General The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.
The concomitant use of potent cytochrome P450 3A4 inhibitors (e.
The penis then expands and hardens.
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Viagra may cause other side effects besides those listed on this sheet.
You could get dizzy, faint, or even have a heart attack or stroke.
Even though this total dosage produced plasma sildenafil concentrations which were approximately 2 to 5 times higher than the mean maximum plasma concentrations following a single oral dose of 100 mg in healthy male volunteers, the hemodynamic response to exercise was preserved in these patients.
The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (Child Pugh class C) have not been studied.
Viagra does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS.
If you miss a dose of Revatio, take the missed dose as soon as you remember.
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In fixed-dose studies, dyspepsia (17%) and abnormal vision (11%) were more common at 100 mg than at lower doses.
On a global improvement question, 83% of patients reported improved erections on Viagra versus 12% on placebo.
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Check with your doctor if any of these most COMMON side effects persist or become bothersome: Diarrhea; dizziness; flushing; headache; heartburn; mild, temporary vision changes (eg, blue/green color tint to vision, blurred vision, sensitivity to light); stuffy nose; upset stomach.
If too much is used, the chance of side effects is increased.
Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200–800 mg).
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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.
For the 20 subjects who received Viagra 100 mg and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows: Blood pressure was measured after administration of Viagra at the same times as those specified for the previous doxazosin studies.
Nitrates, such as nitroglycerin (e.