Sildenafil 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.

Sildenafil 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 sildenafil 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 sildenafil 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. Percentage of Patients Reporting an Improvement in Erections. 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 sildenafil on rates of attempted intercourse about 2 per week , but there was clear treatment-related improvement in sexual function: 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. Sildenafil improved these aspects of sexual function: 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 sildenafil; 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 sildenafil 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 sildenafil. Efficacy Results in Subpopulations in Controlled Clinical Studies A review of population subgroups demonstrated efficacy regardless of baseline severity, etiology, race and age.

They are available as follows: NDC Bottles of Guanylate Cyclase GC Stimulators Physicians should discuss with patients the contraindication of sildenafil with use of guanylate cyclase stimulators such as riociguat [see Contraindications 4. Concomitant Use with Drugs Which Lower Blood Pressure Physicians should advise patients of the potential for sildenafil to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.

Concomitant administration of sildenafil and an alpha- blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment and sildenafil should be initiated at the lowest dose [see Warnings and Precautions 5. Cardiovascular Considerations Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors.

Patients who experience symptoms e. Sudden Loss of Vision Physicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil, 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.

Sudden Hearing Loss Physicians should advise patients to stop taking PDE5 inhibitors, including sildenafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil.

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. Priapism 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 sildenafil.

In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. Numerous sites on the Internet offer Viagra for sale after an "online consultation", often a simple web questionnaire.

Viagra is also informally known as "vitamin V", "the blue pill", or "blue diamond", as well as various other nicknames. Men between the ages of 30 and 65 would be eligible to buy four tablets after a consultation with a pharmacist. In , the Medicines and Healthcare products Regulatory Agency enacted legislation that expanded this nationwide [54] , allowing a particular branded formulation of Sildenafil, Viagra Connect 50mg , to be sold over the counter and without a prescription throughout the UK from early While the sale remains subject to a consultation with a pharmacist, the other restrictions from the trial have been removed, allowing customers over the age of 18 to purchase an unlimited number of pills [55].

The decision was made, in part, to reduce online sales of counterfeit and potentially dangerous erectile dysfunction treatments. On 6 May , Pfizer , which manufactures Viagra, told the Associated Press they will begin selling the drug directly to patients on its website. Counterfeit medications Counterfeit Viagra, despite generally being cheaper, [61] can contain harmful substances or substances that affect how Viagra works, such as blue printer ink, amphetamines , metronidazole , boric acid , and rat poison.

United States Sildenafil is available as a generic drug in the United States, labelled for pulmonary arterial hypertension.

The substance is the same under both trade names. The patent was published in and expired in

User Reviews & Ratings - sildenafil oral

This, in my view, is the key issue in this appeal. On 6 Maysildenafil 40 mg, Pfizerwhich manufactures Viagra, told the Associated Press they will begin selling the drug directly to patients on its website. Generic versions of this low-dose form of sildenafil have been available in the U. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil. Effects of Sildenafil on Sperm: It is eliminated predominantly by hepatic metabolism mainly CYP3A4 and is converted to an active metabolite with properties similar to the parent, sildenafil. The patent was published in and expired in The something works like viagra of patients reporting improvement of erections in response to a sildenafil 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. Sildenafil improved these aspects of sexual function: The pharmacokinetics of sildenafil in patients with severely impaired hepatic function Child-Pugh Class C have not been studied [see Dosage and Administration 2. Sildenafil at steady state, at a dose not approved for the treatment of erectile dysfunction 80 mg t. Therefore, when sildenafil is co-administered with alpha-blockers, patients should be stable on alpha-blocker sildenafil prior to initiating sildenafil treatment and sildenafil should be initiated at the lowest dose [see Warnings and Precautions 5. Pharmacokinetic data from patients in clinical trials showed no effect on sildenafil pharmacokinetics of CYP2C9 inhibitors such as tolbutamide, warfarinCYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressantsthiazide and related diuretics, ACE inhibitors, and calcium channel blockers. An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of sildenafil on visual acuity, intraocular pressure, or pupillometry.

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