Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.
The mean times (adjusted for baseline) to onset of limiting angina were 423.
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Viagra was evaluated primarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover).
The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized.
Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200–800 mg).
Sildenafil has not been studied in pregnant women.
Renal Insufficiency In volunteers with mild (CLcr=50–80 mL/min) and moderate (CLcr=30–49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of Viagra (50 mg) were not altered.
The mean subject age in this study was 63.
Precautions While Using This Medicine Sildenafil has not been studied with other medicines used for treatment of erectile dysfunction.
If any develop or change in intensity, inform your doctor as soon as possible.
In addition, patients were asked a global efficacy question and an optional partner questionnaire was administered.
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Viagra is to be used only by the patient for whom it is prescribed.
The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.
As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to 100 mg or down to 25 mg of Viagra; all patients, however, were receiving 50 mg or 100 mg at the end of the study.
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eatments that cause erections (eg, medicines injected or inserted into the penis, implants or vacuum pumps) Some MEDICINES MAY INTERACT with Viagra .
Viagra Dosage and Administration For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.
Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.
Combining Viagra with these drugs can cause a severe drop in blood pressure.
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In another study in healthy male volunteers, coadministration with the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg bid) with Viagra (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1000% (11-fold) increase in sildenafil plasma AUC.
Therefore, when Viagra is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating Viagra treatment and Viagra should be initiated at the lowest dose.
If you notice any other effects, check with your doctor.
In dose period 1, subjects were administered open-label doxazosin and a single dose of Viagra 50 mg simultaneously, after at least 14 consecutive days of doxazosin.
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Do not let anyone else take your Viagra.
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Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD.
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It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.
Effects of Viagra on Blood Pressure Single oral doses of sildenafil (100 mg) administered to healthy volunteers produced decreases in sitting blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8.
In fixed-dose studies, the incidence of some adverse events increased with dose.
It works by dilating blood vessels in the penis, allowing the inflow of blood needed for an erection.
Over 550 patients were treated for longer than one year.
NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
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Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered.
Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively.
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Sildenafil is not indicated for use in women for erectile dysfunction.
Twenty-five subjects were screened.
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The AUC of the active metabolite, N-desmethyl sildenafil, was increased 62% by loop and potassium-sparing diuretics and 102% by nonspecific beta-blockers.
This medicine can cause serious side effects in patients with heart problems.
Renal Insufficiency In volunteers with mild (CLcr=50–80 mL/min) and moderate (CLcr=30–49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of Viagra (50 mg) were not altered.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc.
There are no adequate and well-controlled studies of sildenafil in pregnant women.
There were highly statistically significant improvements on the two principal IIEF questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) on Viagra compared to placebo.
Metabolism and Excretion Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Do not use more of it and do not use it more often than your doctor ordered.
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Be sure to tell your doctor if you: have ever had any heart problems (e.
Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.
Following at least 14 consecutive daily doses of doxazosin, Viagra 100 mg or matching placebo was administered simultaneously with doxazosin.
One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period.
Patients who experience symptoms (e.
The patients in studies had varying degrees of ED.
While there were no severe adverse events potentially related to blood pressure reported in this study, one subject reported moderate vasodilatation after both Viagra 50 mg and 100 mg.
You may report side effects to FDA at 1-800-FDA-1088.
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In one small, open-label, uncontrolled, pilot study, eight patients with stable ischemic heart disease underwent Swan-Ganz catheterization.
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The adverse events were generally transient and mild to moderate in nature.
If you have any questions about Viagra , please talk with your doctor, pharmacist, or other health care provider.
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Viagra is not a hormone or an aphrodisiac.
Viagra (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of 0.
Only your doctor can decide if it is right for you.
Overdosage In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but incidence rates and severities were increased.
The mean subject age was 66.
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Do not start using a new medication without telling your doctor.
One-third to one-half of the subjects in these studies reported successful intercourse at least once during a 4-week, treatment-free run-in period.
These doses represent, respectively, about 20 and 40 times the MRHD on a mg/m2 basis in a 50 kg subject.
Visual disturbances occurred more commonly at higher levels of sildenafil exposure.
Depending on how and when the drug works for you, an interval of one-half hour to as much as 4 hours may prove ideal.
Storage—To store this medicine: Keep out of the reach of children.
All three were taking Viagra 100 mg, and all three reported mild adverse events at the time of reductions in standing SBP, including vasodilation and lightheadedness.
If you experience sudden loss of vision in one or both eyes, stop using sildenafil and contact your doctor immediately.
There were four subjects with a decrease from baseline in standing systolic BP >30mmHg following Viagra 100 mg, one subject with a decrease from baseline in standing systolic BP > 30 mmHg following placebo and one subject with a decrease from baseline in standing systolic BP > 30 mmHg following both Viagra and placebo.
NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
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Twenty subjects received Viagra 50 mg, but only 19 subjects received matching placebo.
Subjects who had successfully completed the previous doxazosin interaction study (using Viagra 50 mg), including no significant hemodynamic adverse events, were allowed to skip dose period 1.
Some conditions and medicines interfere with this natural erection process.
Do not use Viagra without telling your doctor if you are pregnant or plan to become pregnant during treatment.
Sit or lie down at the first sign of any of these effects.
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It is especially important to check with your doctor before combining Viagra with the following: Viagra should not be used by women.
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It works by helping to increase blood flow into the penis during sexual stimulation.
If not treated right away, permanent damage to your penis could occur (see How Sex Affects the Body).
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Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole would be expected to have still greater effects, and population data from patients in clinical trials did indicate a reduction in sildenafil clearance when it was coadministered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine) (see DOSAGE AND ADMINISTRATION).
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®.
Across all trials, Viagra improved the erections of 43% of radical prostatectomy patients compared to 15% on placebo.
The mean subject age in this study was 63.
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This is consistent with ritonavir's marked effects on a broad range of P450 substrates.
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In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and Viagra, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted (see Drug Interactions).