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Viagra contains sildenafil, which is the same medicine found in another drug called REVATIO. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). Viagra should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]). Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. Take Cialis exactly as your healthcare provider prescribes it.

Your healthcare provider will prescribe the dose that is right for you. Some men can only take a low dose of Cialis or may have to take it less often, because of medical conditions or medicines they take.

Do not change your dose or the way you take Cialis without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to Cialis and your health condition.

If you take too much Cialis, call your healthcare provider or emergency room right away. Take Viagra exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Viagra to take and when to take it. Your healthcare provider may change your dose if needed. You may take Viagra between 30 minutes to 4 hours before sexual activity if needed. If you take Viagra after a high fat meal (such as a cheeseburger and french fries), Viagra may take a little longer to start working.

If you accidentally take too much Viagra, call your doctor or go to the nearest hospital emergency room right away. Nitrates: Administration of VIAGRA to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form either regularly and/or intermittently, is contraindicated.

VIAGRA was shown to potentiate the hypotensive effect of nitrates. Concomitant Guanylate Cyclase (GC) Stimulators: Do not use VIAGRA in patients who are using a GC stimulator, such as riociguat.

PDE5 inhibitors, including VIAGRA, may potentiate the hypotensive effects of GC stimulators.

Hypersensitivity Reactions: VIAGRA is contraindicated in patients with a known hypersensitivity to sildenafil, as contained in VIAGRA and REVATIO, or any component of the tablet. Hypersensitivity reactions have been reported including rash and urticaria. Cardiovascular: Patients should not use VIAGRA if sexual activity is inadvisable due to cardiovascular status.

Physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by the vasodilatory effects of VIAGRA, especially in combination with sexual activity. There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with the following characteristics: recent serious cardiovascular events, hypotension, or uncontrolled hypertension; if prescribed, this should be done with caution. Prolonged Erection: Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Use VIAGRA with caution in patients predisposed to priapism. Effects on the Eye: Patients should stop VIAGRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).

VIAGRA should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.

Patients with a "crowded" optic disc may also be at an increased risk of NAION. There are no controlled clinical data on the safety or efficacy of VIAGRA in patients with retinitis pigmentosa; if prescribed, this should be done with caution.

Hearing Loss: Sudden decrease or loss of hearing has been reported in temporal association with the intake of PDE5 inhibitors, including VIAGRA.

(It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.) 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.

Potential Drug Interactions: VIAGRA can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.

Initiate VIAGRA at 25 mg with concomitant use of alpha-blockers. CYP3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole, erythromycin) increase VIAGRA plasma exposure. Do not exceed 25 mg of VIAGRA in a 48-hour period with ritonavir. Consider a starting dose of 25 mg of VIAGRA with erythromycin or strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, saquinavir).

Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

Specific Populations: Consider a starting dose of 25 mg of VIAGRA for patients age >65, patients with hepatic impairment, lady era tablet buy or severe renal impairment. Sexually Transmitted Diseases: Use of VIAGRA offers no protection

against

Total maximum savings for this Savings Offer are $4,200 You must be 18 years of age or older to redeem this Savings Offer Patients who are enrolled in Medicare, Medicaid, or another state or federal healthcare program may use this Savings Offer if paying for the prescription covered by this Savings Offer outside of their government insurance benefit, and no claim is submitted to Medicare, Medicaid, or any federal or state healthcare program.

Such patients must not apply any out-of-pocket expenses incurred using this Savings Offer toward any government insurance benefit out-of-pocket spending calculations, such as Medicare Part D true out-of-pocket (TrOOP) costs You are responsible for reporting use of this Savings Offer to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using this Savings Offer, as may be required. You should not use this Savings Offer if your insurer or health plan prohibits use of manufacturer Savings Offers This Savings Offer is not valid for Massachusetts or California residents whose prescriptions are covered, in whole or in part, by third-party insurance This Savings Offer is not valid where prohibited by law This Savings Offer cannot be combined with any other rebate/offer, free trial, or similar offer for the specified prescription This Savings Offer will be accepted only at participating pharmacies This Savings Offer is not health insurance This Savings Offer is good only in the U.S.

and Puerto Rico This Savings Offer is limited to 1 per person during this offering period and is not transferable No other purchase is necessary This Savings Offer may not be redeemed more than once per 30 days per patient Data related to your redemption of this Savings Offer may be collected, analyzed, and shared with Pfizer for market research and other purposes related to assessing Pfizer's programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Savings Offer redemptions and will not identify you Pfizer reserves the right to rescind, revoke, or amend this Savings Offer without notice No membership fees.

The Savings Offer and Program expire on 12/31/2021 For further information, call 1-855-842-4722, visit VIAGRA.com , or write: Pfizer Inc., 235 E 42nd Street, New York, NY lady era tablet price 10017.

If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this Savings Offer. Pay for your VIAGRA prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: VIAGRA Savings Offer, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560.

Be sure to include a copy of the front of your VIAGRA Savings Card, your name, and mailing address.

Please expect up to 4 to 6 weeks for reimbursement. Long-term safety and effectiveness of sildenafil citrate in men with erectile dysfunction. 1 Medical Affiliated Research Center, Huntsville, AL, USA. 2 Connecticut Clinical Research Center, Waterbury, CT, USA.

3 California Professional Research, Newport Beach, CA, USA. 5 Formerly Pfizer Global Research and Development, Sandwich, UK, currently PPD Inc, Cambridge, UK. 6 Members of the multicenter study group are listed in the appendix. Because sildenafil citrate is a treatment, not a cure, for erectile dysfunction (ED), many men may choose to use it for an extended period.

Men with ED who had previously completed 1 of 4 double-blind trials with short-term open-label extension (combined duration, 0.9–1.2 years) were eligible for this 4-year, open-label, extension study, which assessed the safety and effectiveness of flexible doses (25, 50, and 100 mg sildenafil) used as needed.

Adverse events that were serious or led to dosing changes or discontinuation (temporary or permanent) were recorded. Many of the 979 participants (mean age, 58 [range, 27–82] years; mean ED duration, 4.5 years) had concomitant hypertension (28%), diabetes (22%), or hyperlipidemia (14%).

Overall, 37 (3.8%) had treatment-related adverse events (none serious) requiring dosage change or discontinuation and 62 (6.3%) discontinued because of insufficient response. At each yearly assessment, more than 94% of participants responded affirmatively to the questions: “Are you satisfied with the effect of treatment on your erections?” and “If yes, has treatment improved your ability to engage in sexual activity?” These results argue against the loss of tolerability or the development of tachyphylaxis over a prolonged period of as needed, flexible-dose sildenafil treatment of men with ED.

In March 1998, the US Food and Drug Administration (FDA) approved sildenafil citrate (Viagra ® , Pfizer Inc, New York, NY, USA) for the treatment of erectile dysfunction (ED) (FDA 1998).

As of December 2005, more than 27 million men worldwide had received sildenafil for treatment of ED, including an estimated 17 million men in the US (Data on file, Pfizer Inc, New York, NY).

Thus, the long-term safety and effectiveness of sildenafil can now be evaluated in men who have been taking the drug for several years.

The efficacy, safety, and tolerability of sildenafil in the treatment of men with ED have been demonstrated in numerous studies of 1-year duration or less. For example, 1,358 men with ED completed 1 of 4 double-blind trials and continued with open-label sildenafil treatment in extension studies for a total treatment duration of approximately 1 year (Morales et al 1998; Steers et al 2001). In the current study, 979 of these men subsequently received up to 4 more years of open-label, flexible-dose (25, 50, and 100 mg) sildenafil. Preliminary (3-year) results were reported previously (Carson et al 2002; Padma-Nathan et al 2002), and we now present the final data.

The population included patients with ED of organic and psychogenic etiology and typical concomitant medical conditions for this population (ie, hypertension, diabetes, hyperlipidemia, and a history of ischemic heart disease). Our objective was to assess the long-term safety and effectiveness of sildenafil treatment in men with ED.

This was a 4-year, open-label, flexible-dose (25, 50, and 100 mg) study of sildenafil.

Men who previously completed and were compliant with sildenafil or placebo treatment in 1 of 4 double-blind, placebo-controlled trials, and subsequently completed and were compliant with sildenafil treatment in initial open-label extension, were eligible for inclusion in this long-term extension study.

Compliance was assessed by medication diaries and by continued study participation.

A total of 1,545 men were originally enrolled in the double-blind trials, with 1,358 of these men continuing in the initial

open-label

The current study includes 979 of the original patients, who agreed to participate in the long-term extension ( Figure 1 ). The procedures were in accordance with the ethical standards of the responsible committee on human experimentation (institutional or regional). Number of patients and treatment duration in the original double-blind trials and the initial open-label extensions and disposition throughout 4 years of open-label, flexible-dose (25, 50, and 100 mg) sildenafil long-term extension study.

Of the 979 participants who entered the sildenafil long-term extension study, 584 (60%) completed all 4 years. Reasons for discontinuation, other than insufficient clinical response and treatment-related adverse event (AE), included AE unrelated to treatment, protocol violation, loss to follow-up, and other (eg, loss of interest in participation in a clinical study, loss of sexual partner, and ability to afford sildenafil after approval [thus, no longer needing to participate in a clinical study to obtain the medication]).

N for the satisfaction question (“Are you satisfied with the effect of treatment on your erections?”) is equal to the number of men who answered. *Some of the discontinued subjects supplied satisfaction data. At the time the study started, the FDA stated that there were sufficient routine safety data on sildenafil to make collection of standard adverse event data unnecessary. Therefore, only serious adverse events and adverse events leading to changes in dosing or to temporary or permanent discontinuation were recorded and evaluated by the investigators for relatedness to sildenafil treatment. Because the major focus of this study was safety, and it was designed before the development and validation of patient-reported outcomes to assess satisfaction with the quality of erection (eg, Quality of Erection Questionnaire (Porst et al 2007)) or satisfaction with ED treatment (eg, the Erectile Dysfunction Inventory of Treatment Satisfaction (Althof et al 1999)), effectiveness was assessed by asking, at yearly intervals or at discontinuation, simple, unvalidated general efficacy questions, “Are you satisfied with the effect of treatment on your erections?” and “If yes, has treatment improved your ability to engage in sexual activity?” The second question was based on the ED definition of the National Institutes of Health Consensus Conference: “…inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.” (NIH Consensus Conference.

NIH Consensus Development Panel on Impotence 1993).

Overall, 979 men initially agreed to participate in the study, most of whom were white (89%) and whose mean age was 58 years ( Table 1 ).

The duration of the double-blind trials plus initial open-label extension was 0.9 to 1.2 years (48–60 weeks).

Median duration of participation in the open-label, long-term extension study was 4 years, the median number of doses taken was 420 (range, 1–1469) ( Figure 2 ), and the preferred dose was 100 mg in more than 88% of the men. The retention rate was 84% (818/979) the first year, 75% (731/979) the second year, and 66% (648/979) the third year; the entire 4-year extension study was completed by 584 of the initial 979 men (60%) ( Figure 1 ).

Reasons for discontinuation included loss of interest in participation in a clinical study, loss of sexual partner, loss to follow-up, ability to afford sildenafil after approval (thus, no longer needing to participate in a clinical study to obtain the medication), insufficient clinical response, and adverse events. Usage of flexible-dose (25, 50, and 100 mg) sildenafil over 2–1561 days by the 979 participants who entered the study.

Age, mean (range) years 58.2 (27–82) Weight, mean (range) kg 89.2 (53.5–158.8) Race, n (%) White 873 (89.2) Black 68 (6.9) Asian 8 (0.8) Other 30 (3.1) ED duration, mean (range) years 4.5 (0.1–35.8) ED etiology, % organic/mixed/psychogenic 72/17/11 Common

concomitant

Of the few cardiovascular events determined by the investigator to be treatment related (4 cases of mild flushing and 1 each of moderate flushing, mild palpitations, and moderate tachycardia), only 1 led to permanent discontinuation.

In this case the man experienced mild flushing with the first dose of sildenafil 100 mg but continued therapy after a dose reduction.

After 629 days of therapy, at which time his dosage was once again 100 mg, he permanently discontinued sildenafil because of the flushing.

Two other cardiovascular events led to temporary discontinuation (mild flushing and moderate tachycardia), and the remainder were addressed with a change in dosing. Of the 149 serious adverse events that occurred during the 4 years of the study, including 18 acute myocardial infarctions, none were considered by the investigator to be treatment related.

Adverse events that led to changes in dosing or to temporary or permanent discontinuation.

Adverse events (AEs) in 979 men Treatment-related a All causality Patients with AEs, n (%) 37 (3.8) 210 (21.5) Discontinued because of AEs, n (%) 11 (1.1) 55 (5.6) Most frequent (?0.5%) AEs, n (%) Headache 10 (1.0) 10 (1.0) Dyspepsia 10 (1.0) 12 (1.2) Rhinitis 6 (0.6) 6 (0.6) Flushing 5 (0.5) 5 (0.5) Coronary artery disorder 0 24 (2.5) Prostatic disorder 0 16 (1.6) Carcinoma 0 14 (1.4) Myocardial infarction 0 11 (1.1) b Arthritis 0 9 (0.9) Bone fracture accidental 0 9 (0.9) Accidental injury 0 7 (0.7) Cerebrovascular disorder 0 7 (0.7) Atrial fibrillation 0 6 (0.6) Cholecystitis 0 6 (0.6) Sepsis lady era tablet price 0 5 (0.5) Heart failure 0 5 (0.5) Gastrointestinal carcinoma 0 5 (0.5) Bone disorder 0 5 (0.5) Each treatment year, less than 1% of the men who started the year discontinued sildenafil because of treatment-related adverse events, for a total of only 11 (1.1%) of the original 979 participants over the 4 years of the study ( Table 3 ).

Discontinuations were caused by dyspepsia (n = 4), rhinitis (n = 2), abnormal vision plus headache (n = 1), dyspepsia plus rhinitis (n = 1), and flushing, dizziness, and myalgia (n = 1 each). Percentage of participants who discontinued, (n/N) a Study year Treatment-related adverse event Insufficient response Other reasons (not treatment related) 1 0.5 (5/979) 2.2 (22/979) 13.7 (134/979) 2 0.2 (2/818) 2.3 (19/818) 8.1 (66/818) 3 0.1 (1/731) 1.9 (14/731) 9.3 (68/731) 4 0.5 (3/648) 1.1 (7/648) 8.3 (54/648) Effectiveness.

Of the 979 men who participated in the study, 932 (95%) were analyzed for efficacy. At the completion of each year, at least 94% of the annually decreasing number of participants reported satisfaction with the effect of sildenafil treatment on their erections, with only a 3.3 percentage point variation across the 4 yearly assessments ( Table 4 ).

Almost all of these men reported improved ability to engage in sexual activity. Percentage of participants (n/N) a Study year Satisfied with treatment effect on erections Improved ability to have sexual activity End of year End of year 1 98.1 (806/822) 99.6 (803/806) 2 96.6 (672/696) 99.9 (671/672) 3 94.8 (551/581) 99.6 (549/551) 4 96.3 (550/571) 100 (550/550) Each treatment year, less than 3% of the men who started the year discontinued sildenafil treatment because of insufficient clinical response.

Over the 4 years of the study, only 62 (6.3%) of the original 979 participants discontinued because of insufficient response ( Table 3 ).

There are numerous data published on the efficacy and safety of sildenafil treatment for ED.

Before approval, sildenafil was evaluated in 18 phase II/III double-blind, placebo-controlled trials, in which men with ED were randomized to receive treatment with sildenafil (n = 2722) or placebo (n = 1552) for up to 6 months (Morales et al 1998).

Pooled data from these trials demonstrated that sildenafil is a well-tolerated oral therapy for ED (Morales et al 1998). Adverse events were mostly transient and mild to moderate in severity and included most commonly headache, lady era tablet price flushing, dyspepsia, and rhinitis. The rate of discontinuation because of adverse events was low and comparable between patients who received sildenafil and those who received placebo.

A more recent retrospective analysis, in which data were pooled from 35 Pfizer-sponsored double-blind trials involving 4819 patients who received sildenafil and 3296 patients who received placebo, supports the conclusions of the earlier pooled data but also found that sildenafil is well tolerated among patients taking antihypertensive medications, including lady era tablet price those on multidrug regimens (Padma-Nathan et al 2002). Pooled data also support the efficacy of sildenafil; results from 11 double-blind, flexible-dose, placebo-controlled trials that included a total of 2,667 men ages 23 to 89 years with ED of broad-spectrum etiology show significantly improved erectile function for sildenafil compared with placebo as measured by the International Index of Erectile Function, a global efficacy question, and a patient-recorded event log of sexual activity (Carson et al 2002).