Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg of Viagra, therefore the effects are not related to dose or plasma levels within this dosage range.
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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.
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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.
Drug Interactions Effects of Other Drugs on Viagra In vitro studies Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route).
There were two subjects who had a standing SBP of < 85 mmHg.
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Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity.
It is intended for use only by men who have a condition called erectile dysfunction.
Sildenafil is only about 10-fold as potent for PDE5 compared to PDE6, an enzyme found in the retina which is involved in the phototransduction pathway of the retina.
Do not take it in larger doses or for longer than recommended by your doctor.
This metabolite has a PDE selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% of the parent drug.
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®.
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Check the label on the medicine for exact dosing instructions.
Carcinogenesis, Mutagenesis, Impairment of Fertility Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 29- and 42-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg.
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It works by helping to increase blood flow into the penis during sexual stimulation.
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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.
Store away from heat, moisture, and light.
This has occurred in a small number of people taking Viagra, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.
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The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (Child Pugh class C) have not been studied.
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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).
Studies have produced relevant data on the effects of Viagra on cardiac output.
Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers").
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This is not a complete list of all side effects that may occur.
Viagra is not a hormone or an aphrodisiac.
Keep the medicine from freezing.
Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting.
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.
Therefore, the use of such combinations is not recommended.
This medicine can cause serious side effects in patients with heart problems.
This is called erectile dysfunction if it becomes a frequent problem.
Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.
When a single 100 mg dose of Viagra was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
It is not known if sildenafil passes into breast milk or if it could harm a nursing baby.
Contact your doctor right away if you have an erection that lasts more than 4 hours.
The inhibition of PDE5 in these tissues by sildenafil may be the basis for the enhanced platelet antiaggregatory activity of nitric oxide observed in vitro, an inhibition of platelet thrombus formation in vivo and peripheral arterial-venous dilatation in vivo.
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The following factors are associated with increased plasma levels of sildenafil: age >65 (40% increase in AUC), hepatic impairment (e.
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It can help many men who have erectile dysfunction get and keep an erection when they become sexually excited (stimulated).
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Patients with the following underlying conditions can be particularly sensitive to the actions of vasodilators including Viagra – those with left ventricular outflow obstruction (e.
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Viagra should not be used with any other medical treatments that cause erections.
If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control.
It is important that you tell all of your healthcare providers that you take sildenafil .
Do not take Viagra more than once per day.
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).
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During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away.
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5 mg/mL in water and a molecular weight of 666.
It is not possible to determine whether these reported events are related directly to the use of Viagra, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients).
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At 24 hours the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was dosed alone.
Viagra had no effect on ritonavir pharmacokinetics (see DOSAGE AND ADMINISTRATION).
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If you think you need a larger dose of Viagra, check with your doctor.
nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness; bone pain; breast enlargement; chest pain; chills; confusion; convulsions (seizures); coughing up blood; deafness; decrease in amount of urine or in frequency of urination; dizziness or lightheadedness, especially when getting up from a lying or sitting position; dry eyes; dry mouth; dryness, redness, scaling, or peeling of the skin; eye pain; fainting or faintness; fast, irregular, or pounding heartbeat; feeling of something in the eye; groups of skin lesions with swelling; headache (severe or continuing); heart failure; hives; increase in size of pupil; increased sweating; increased thirst; itching of skin; low blood pressure; lower back or side pain; migraine headache; nausea (severe or continuing); nervousness; numbness of hands; painful, swollen joints; redness, itching, or tearing of eyes; shortness of breath or troubled breathing; skin paleness; skin rash; skin ulcers; sore throat and fever or
You may also report side effects at http://www.
The decrease in sitting blood pressure was most notable approximately 1–2 hours after dosing, and was not different than placebo at 8 hours.
Sildenafil is used to treat men who have erectile dysfunction (also called sexual impotence).
Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of Viagra patients reported improvement in erections compared with 26% of placebo.
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Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted.
All medicines may cause side effects, but many people have no, or minor, side effects.
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
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Store at room temperature Side effects cannot be anticipated.
In a double-blind study, 144 patients with erectile dysfunction and chronic stable angina limited by exercise, not receiving chronic oral nitrates, were randomized to a single dose of placebo or Viagra 100 mg 1 hour prior to exercise testing.