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Two were discontinued after study period 1: one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 30 minutes after dosing with open-label Viagra 50 mg. 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.

The mean profiles of the change from baseline in standing systolic blood pressure in subjects treated with doxazosin in combination with mg Viagra or matching placebo are shown in Figure 4. Blood pressure was measured after administration of Viagra at the same times as those specified for the previous doxazosin studies.

All three were taking Viagra mg, and all three reported mild adverse events at the time of reductions in standing SBP, including vasodilation and lightheadedness. 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 mg. There were no episodes of syncope reported in this study.

Effect of Viagra on Blood Pressure When Co-administered with Anti-hypertensives: When Viagra mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic. Effect of Viagra on Blood Pressure When Co-administered with Alcohol: Viagra 50 mg did not potentiate the hypotensive effect of alcohol 0. The maximum observed decrease in systolic blood pressure was The maximum observed decrease in diastolic blood pressure was There were no reports of postural dizziness or orthostatic hypotension.

The maximum recommended dose of mg sildenafil was not evaluated in this study [ see Drug Interactions 7. Effects of Viagra on Cardiac Parameters: Single oral doses of sildenafil up to mg produced no clinically relevant changes in the ECGs of normal male volunteers.

Studies have produced relevant data on the effects of Viagra on cardiac output. In one small, open-label, uncontrolled, pilot study, eight patients with stable ischemic heart disease underwent Swan-Ganz catheterization. A total dose of 40 mg sildenafil was administered by four intravenous infusions.

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 mg in healthy male volunteers, the hemodynamic response to exercise was preserved in these patients.

In a double-blind study, 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 mg 1 hour prior to exercise testing. The primary endpoint was time to limiting angina in the evaluable cohort.

The mean times adjusted for baseline to onset of limiting angina were These results demonstrated that the effect of Viagra on the primary endpoint was statistically non-inferior to placebo. Effects of Viagra on Vision: At single oral doses of mg and mg, transient dose-related impairment of color discrimination was detected using the Farnsworth-Munsell hue test, with peak effects near the time of peak plasma levels.

This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of Viagra on visual acuity, intraocular pressure, or pupillometry. Effects of Viagra on Sperm : There was no effect on sperm motility or morphology after single mg oral doses of Viagra in healthy volunteers. The pharmacokinetics of sildenafil are dose-proportional over the recommended dose range.

It is eliminated predominantly by hepatic metabolism mainly CYP3A4 and is converted to an active metabolite with properties similar to the parent, sildenafil. Both sildenafil and the metabolite have terminal half lives of about 4 hours. Mean sildenafil plasma concentrations measured after the administration of a single oral dose of mg to healthy male volunteers is depicted below:.

Absorption and Distribution: Viagra is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. The mean steady state volume of distribution Vss for sildenafil is L, indicating distribution into the tissues. Protein binding is independent of total drug concentrations.

Based upon measurements of sildenafil in semen of healthy volunteers 90 minutes after dosing, less than 0. The major circulating metabolite results from N-desmethylation of sildenafil, and is itself further metabolized.

Similar values for pharmacokinetic parameters were seen in normal volunteers and in the patient population, using a population pharmacokinetic approach. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function Child-Pugh Class C have not been studied [ see Dosage and Administration 2. A starting oral dose of 25 mg should be considered in those patients [ see Dosage and Administration 2.

Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.

The concomitant use of erythromycin or strong CYP3A4 inhibitors e. Viagra had no effect on saquinavir pharmacokinetics. A stronger CYP3A4 inhibitor such as ketoconazole or itraconazole could be expected to have greater effect than that seen with saquinavir. Population pharmacokinetic data from patients in clinical trials also indicated a reduction in sildenafil clearance when it was co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, or cimetidine [ see Dosage and Administration 2.

This is consistent with ritonavir's marked effects on a broad range of P substrates. Viagra had no effect on ritonavir pharmacokinetics [ see Dosage and Administration 2. Although the interaction between other protease inhibitors and sildenafil has not been studied, their concomitant use is expected to increase sildenafil levels. In a study of healthy male volunteers, co-administration of sildenafil at steady state 80 mg t. Concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma levels of sildenafil.

In healthy male volunteers, there was no evidence of a clinically significant effect of azithromycin mg daily for 3 days on the systemic exposure of sildenafil or its major circulating metabolite.

Pharmacokinetic data from patients in clinical trials showed no effect on sildenafil pharmacokinetics of CYP2C9 inhibitors such as tolbutamide, warfarin , CYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressants , thiazide and related diuretics, ACE inhibitors, and calcium channel blockers. These effects on the metabolite are not expected to be of clinical consequence. No significant interactions were shown with tolbutamide mg or warfarin 40 mg , both of which are metabolized by CYP2C9.

In a study of healthy male volunteers, sildenafil mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.

Sildenafil at steady state, at a dose not approved for the treatment of erectile dysfunction 80 mg t. 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 and times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose MRHD of mg.

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. In clinical studies, Viagra was assessed for its effect on the ability of men with erectile dysfunction ED to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. Viagra was evaluated primarily at doses of 25 mg, 50 mg and 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.

Viagra was administered to more than 3, patients aged 19 to 87 years, with ED of various etiologies organic, psychogenic, mixed with a mean duration of 5 years. Viagra demonstrated statistically significant improvement compared to placebo in all 21 studies.

The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo. Efficacy Endpoints in Controlled Clinical Studies. The effectiveness of Viagra was evaluated in most studies using several assessment instruments. The primary measure in the principal studies was a sexual function questionnaire the International Index of Erectile Function - IIEF administered during a 4-week treatment-free run-in period, at baseline, at follow-up visits, and at the end of double-blind, placebo-controlled, at-home treatment.

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. The patient addressed both questions at the final visit for the last 4 weeks of the study.

The possible categorical responses to these questions were 0 no attempted intercourse, 1 never or almost never, 2 a few times, 3 sometimes, 4 most times, and 5 almost always or always. 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.

Sexual function data were also recorded by patients in a daily diary. In addition, patients were asked a global efficacy question and an optional partner questionnaire was administered. Efficacy Results from Controlled Clinical Studies.

The effect on one of the major end points, maintenance of erections after penetration, is shown in Figure 6, for the pooled results of 5 fixed-dose, dose-response studies of greater than one month duration, showing response according to baseline function.

Results with all doses have been pooled, but scores showed greater improvement at the 50 and mg doses than at 25 mg. The pattern of responses was similar for the other principal question, the ability to achieve an erection sufficient for intercourse. The titration studies, in which most patients received mg, showed similar results. Figure 6 shows that regardless of the baseline levels of function, subsequent function in patients treated with Viagra was better than that seen in patients treated with placebo.

At the same time, on-treatment function was better in treated patients who were less impaired at baseline. 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 patients of 12 to 24 weeks duration is shown in Figure 7.

These patients had erectile dysfunction at baseline that was characterized by median categorical scores of 2 a few times on principal IIEF questions. The patients in studies had varying degrees of ED. 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.

In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients. In these studies, involving about patients, analyses of patient diaries showed no effect of Viagra on rates of attempted intercourse about 2 per week , but there was clear treatment-related improvement in sexual function: per patient weekly success rates averaged 1. 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.

Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured again using a 5-point scale in the IIEF. Viagra improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction.

As in the other titration studies, patients were started on 50 mg and allowed to adjust the dose up to mg or down to 25 mg of Viagra; all patients, however, were receiving 50 mg or mg at the end of the study. 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. The changes from baseline in scoring on the two end point questions frequency of successful penetration during sexual activity and maintenance of erections after penetration were highly statistically significantly in favor of Viagra.

A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age. Viagra sildenafil citrate is supplied as blue, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows:. Physicians should discuss with patients the contraindication of Viagra with use of guanylate cyclase stimulators such as riociguat [ see Contraindications 4.

Physicians should advise patients of the potential for Viagra to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.

Concomitant administration of Viagra and an alpha-blocker may lead to symptomatic hypotension in some patients. 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 [ see Warnings and Precautions 5. Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors.

Patients who experience symptoms e. 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.

Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy NAION , a cause of decreased vision including possible permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a "crowded" optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including Viagra, for this uncommon condition [ see Warnings and Precautions 5.

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Warnings and Precautions 5. Physicians should warn patients that prolonged erections greater than 4 hours and priapism painful erections greater than 6 hours in duration have been reported infrequently since market approval of Viagra.

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions 5. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus HIV , may be considered [ see Warnings and Precautions 5.

What is the most important information I should know about Viagra? Viagra can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take Viagra if you take any other medicines called "nitrates.

A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Tell all your healthcare providers that you take Viagra.

If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Viagra. Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.

Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

Ask your doctor if your heart is healthy enough to handle the extra strain of having sex. Viagra is a prescription medicine used to treat erectile dysfunction ED. You will not get an erection just by taking this medicine.

Viagra helps a man with erectile dysfunction get and keep an erection only when he is sexually excited stimulated. Tell your healthcare provider about all the medicines you take 1 , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Viagra may affect the way other medicines work, and other medicines may affect the way Viagra works causing side effects.

Especially tell your healthcare provider if you take any of the following:. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. Viagra can cause serious side effects. Rarely reported side effects include:. In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking Viagra.

Most, but not all, of these men had heart problems before taking Viagra. It is not known if Viagra caused these problems. These are not all the possible side effects of Viagra. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use Viagra for a condition for which it was not prescribed. Do not give Viagra to other people, even if they have the same symptoms that you have.

It may harm them. This Patient Information leaflet summarizes the most important information about Viagra. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Viagra that is written for health professionals.

This product's label may have been updated. For current full prescribing information, please visit www. Viagra sildenafil citrate , Revatio sildenafil , Cardura doxazosin mesylate , and Minipress prazosin HCl are registered trademarks of Pfizer Inc. Other brands: Revatio. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Subscribe to Drugs. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.

We comply with the HONcode standard for trustworthy health information - verify here. Skip to Content. View All. Table 2. In these studies, only one patient discontinued due to abnormal vision. Placebo-subtracted mean maximum decrease in systolic blood pressure mm Hg Viagra 25 mg Supine 7. Placebo-subtracted mean maximum decrease in systolic blood pressure mm Hg Viagra mg Supine 7. Table 3. Figure 6. Percentage of Patients Reporting an Improvement in Erections.

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As common as endometriosis or "endo" is—affecting an estimated one in 10 women of reproductive age—its diagnosis is often delayed, sometimes by as much as six to 10 years.

To help deepen our endo understanding, we asked gynecologist Mary Jane Minkin, MD to give us the latest update on research targeting this often-painful disorder. Take charge of your health.

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The Vaginal Infection Many Women Ignore If you think you may have a vaginal infection, take note of these signs of bacterial vaginosis share. Smart Steps for Healthy Feet Simple steps can protect your feet from common problems, some of which are hard to get rid of.

How to Show Yourself Some Love Self-compassion leads to contentment and offers a kind of immunity against negative influences like fear. Upbeat Attitude May Be a Pain Fighter Optimism may be key to coping with chronic pain, claims a new study of soldiers who served in Iraq and Afghanistan.

Dangerous Bacteria May Lurk in Hospital Sinks Hospital germ detectives say the sinks next to toilets in patient rooms may harbor potentially dangerous bacteria. BeHealthiHER Make self-care a priority in your everyday life, so you can ultimately become a "healthier her"—for yourself and your family. Common Blood-Thinning Medication Questions People With AFib Ask Here are some frequently asked questions that may help you better understand how blood-thinning medication works and some risks.

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