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(sildenafil citrate) Tablets
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.” Nitrates are used to treat chest pain (angina ). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke .
Do not take VIAGRA if you take medicines called guanylate cyclase stimulators which include:
- Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension.
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 does not protect you or your partner from getting sexually transmitted diseases, including HIV —the virus that causes AIDS .
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).
VIAGRA is not for use in women or children.
It is not known if VIAGRA is safe and effective in women or children under 18 years of age.
Who should not take VIAGRA?
Do not take VIAGRA if you:
- take medicines called nitrates (such as nitroglycerin)
- use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitrate
- take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)
- are allergic to sildenafil, as contained in VIAGRA and REVATIO, or any of the ingredients in VIAGRA. See the end of this leaflet for a complete list of ingredients in VIAGRA.
What should I tell my healthcare provider before taking VIAGRA?
Before you take VIAGRA, tell your healthcare provider if you:
- have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure
- have had heart surgery within the last 6 months
- have pulmonary hypertension
- have had a stroke
- have low blood pressure. or high blood pressure that is not controlled
- have a deformed penis shape
- have had an erection that lasted for more than 4 hours
- have problems with your blood cells such as sickle cell anemia. multiple myeloma. or leukemia
- have retinitis pigmentosa. a rare genetic (runs in families) eye disease
- have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)
- have bleeding problems
- have or have had stomach ulcers
- have liver problems
- have kidney problems or are having kidney dialysis
- have any other medical conditions
Tell your healthcare provider about all the medicines you take*, 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:
- medicines called nitrates (see “What is the most important information I should know about VIAGRA?” )
- medicines called guanylate cyclase stimulators, such as riociguat (Adempas)
- medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of VIAGRA with alpha-blockers can lead to a drop in blood pressure or to fainting .
- medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz)
- some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconazole (Sporanox)
- some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
- other medicines that treat high blood pressure
- other medicines or treatments for ED
- 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.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take VIAGRA?
- 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.
- Take VIAGRA about 1 hour before sexual activity. You may take VIAGRA between 30 minutes to 4 hours before sexual activity if needed.
- VIAGRA can be taken with or without food. 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
- Do not take VIAGRA more than 1 time a day.
- If you accidentally take too much VIAGRA, call your doctor or go to the nearest hospital emergency room right away.
What are the possible side effects of VIAGRA?
VIAGRA can cause serious side effects. Rarely reported side effects include:
- an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.
- sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking VIAGRA and call your healthcare provider right away if you have sudden vision loss in one or both eyes.
- sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus ) or dizziness. If you have these symptoms, stop taking VIAGRA and contact a doctor right away.
The most common side effects of VIAGRA are:
- upset stomach
- abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision
- stuffy or runny nose
- back pain
- muscle pain
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.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
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. You may report side effects to FDA at 1800-FDA-1088.
How should I store VIAGRA?
- Store VIAGRA at room temperature between 68°F to 77°F (20°C to 25°C).
Keep VIAGRA and all medicines out of the reach of children.
General information about the safe and effective use of VIAGRA.
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.
For more information, go to www.viagra.com, or call 1-888-4VIAGRA
What are the ingredients in VIAGRA?
Active ingredient: sildenafil citrate
Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 10/3/2015
This monograph has been modified to include the generic and brand name in many instances.
So, youвЂ™re on dialysis, and with that, and age, the combination has led to embarrasing difficulties. If you are in a relationship from before you started dialysis, then your partner has shared things with you and may well be more understanding, but what if you are single, not only do you have the big D to overcome as a conversation stopper, but if things turn out great, the time will come when you go to bed and another embarrassment could result!
The good news is, so long as your blood pressure is fine, and you are generally well in your treatment, consult your GP about Viagra. Amazingly itвЂ™s not a big deal to talk about with your GP, and they will be able, in most cases, to prescribe Viagra. You may be started on a lower dose to check you can cope with the changes this causes. Viagra does have the effect of lowering blood pressure, so if your pressure is low to start then not a good idea to take it.
Also note that you are likely to experience elevated heart rate, so if this causes you problems, donвЂ™t take it and consult your GP.
The weird and almost beneficial effect is that if you have no renal function at all, the effects last longer!
But! Always consult your GP. and if they are not certain on the answers for you, they must consult your nephrologist or consultant.
The main thing is, donвЂ™t hold back, every day solutions can work for many on dialysis.
Hi, I’m Steve and have been a dialysis patient on some form of self-care or other since 1990. I’ve dialysed at home, abroad, in hospital, oh and had a transplant for 7 years. I work in the insurance industry for a City based business, but am very fortunate to be able to work from home 4 days a week. I hope, with my experiences, I can help others on dialysis or those facing dialysis in the future! It ain’t so bad! Steve
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Timing of sildenafil therapy in dialysis patientsвЂ”lessons following an episode of hypotension
Sildenafil therapy, as the first effective oral treatment, has revolutionized erectile dysfunction treatment. It is a selective inhibitor of cyclic guanozine monophosphate (cGMP)вЂ”specific phosphodiesterase type 5 (PDE5) [1 ]. It exerts its inhibitory action on the corpus cavernosum via increasing cGMP. This enhances the relaxant effect of endogenous nitric oxide (NO) on the smooth muscles facilitating flow of blood in the penis [2 ]. Maximum plasma concentration is achieved within 30вЂ“120 min and the terminal phase halfвЂђlife is 3вЂ“5 h [3 ].
A number of shortвЂђterm studies, in clinical practice, proved safety, efficacy and tolerability of this medication by patients suffering erectile dysfunction due to various aetiological factors. Recognized sideвЂђeffects include headache, nausea, gastroвЂђoesophageal reflux, flushing, nasal congestion, colour vision disturbance, pupil sparing and third nerve palsy [4 ]. Most of these adverse effects were explained by the drug’s mode of action. Significant hypotension has been reported in patients with ischaemic heart disease and its use is contraвЂђindicated in patients receiving concurrent nitrate therapy.
Current guidelines allow the use of sildenafil in patients with chronic renal failure and erectile dysfunction, however, this agent has not been fully evaluated in this group of individuals, particularly those receiving renal replacement therapy (RRT) [5 ]. We report the case of a patient with erectile dysfunction on maintenance haemodialysis, with no known cardiac history, who developed symptomatic hypotension delaying haemodialysis (HD) following initiation of sildenafil therapy.
A 49вЂђyearвЂђold male patient with an underlying diagnosis of polycystic kidney disease had been on maintenance HD for 5 years with no known cardiovascular disease. The only drugs he was receiving were erythropoietin 2000 units thrice weekly (haemoglobin 11.7 g/dl), omeprazole, phosex, ascorbic acid, ferrous sulphate, quinine sulphate, senna and lactulose. His erectile dysfunction was of 6 years duration and started 1 year before commencing RRT.
A test dose of 50 mg was taken at 21. 30 h on a nonвЂђdialysis day at home. No therapeutic effect was achieved. One hour after ingestion he felt unwell with headache, nausea, epigastric pain and flushing, followed by lightвЂђheadedness and dizziness. The next day he reported for his dialysis still experiencing dizziness and lightвЂђheadedness, 12 h after the initial dose. He was hypotensive with a blood pressure of 80/50 mmHg. Mean preвЂђdialysis BP over the preceding 10 days was 120/75 mmHg. His preвЂђdialysis weight was 82.5 kg, 0.5 kg above target. Dialysis was not performed. His blood pressure rose spontaneously to 180/65 mmHg 17 h after the administration of sildenafil. There was no evidence of an acute cardiac event with normal ECG and enzymes. A subsequent echocardiography confirmed normal left ventricular function (ejection fraction 60вЂ“70%) with no evidence of any chamber enlargement or segmental contractility abnormality. There was no evidence of valvular dysfunction; however, the mitral valve annulus was calcified. Mild left ventricular hypertrophy was present. Dialysis was performed uneventfully 6 h after admission; postвЂђdialysis BP was 111/60 mmHg. No longвЂђterm sequalae have been identified and the patient has remained on HD without further incident.
No previous cases have been reported of significant hypotension secondary to sildenafil in HD patients. These patients are at high risk of occult cardiovascular disease. The use and safety of sildenafil has not been evaluated in patients on maintenance HD programmes. Our patient developed a significant adverse reaction following sildenafil therapy with no therapeutic benefit.
Hypotension occurred shortly after the administration of this agent for which no other cause was identified. The exclusion of hypovolaemia as a cause of hypotension in dialysis patients is difficult. In this case a number of factors argue against hypovolaemia. The patient was well and haemodynamically stable before the initiation of sildenafil. The onset of his symptomatology started 1 h after ingesting the tablet, within the predicted time of efficacy of sildenafil. Given that there is a shared pathway for mechanism of action and adverse effects it is highly probable that the administration of sildenafil was temporally implicated. He had also been stable on HD prior to exposure to this agent and has had no further episodes of hypotension since. In the absence of any other aetiological factors we have identified sildenafil as the most likely cause of his transient hypotension.
In patients on maintenance peritoneal dialysis this treatment was well tolerated [7 ]. An important question remains the timing of administration of sildenafil in relation to HD as sildenafil may potentiate hypotension during dialysis. After dialysis the patient may remain relatively hypovolaemic for some time and thus be vulnerable to the potential systemic effects of sildenafil. We recommend that sildenafil should be used on nonвЂђdialysis days. However, further work is required to evaluate the timing of sildenafil therapy in HD patients.
- В© European Renal Association-European Dialysis and Transplant Association
Boolell M, Allen MJ, Ballard SA et al. Sildenafil: an orally active type 5 cyclic GMPвЂђspecific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Int J Impot Res 1996 ; 8. 47 вЂ“52
Rajfer J, Aronson WJ, Bush PA, Dorey FJ, Ignarro LJ. Nitric Oxide as a mediator of relaxation of the corpus cavernosum in response to nonadrenergic, noncholinergic neurotransmission. N Engl J Med 1992 ; 326. 90 вЂ“94
Morales C, Gingell C, Collins M, Wicker PA, Osterloh IH. Clinical safety of oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction. Int J Impot Res 1998 ; 10. 69 вЂ“74
Donahue SP, Taylor RJ. Pupil sparing 3rd nerve palsy associated with Sildenafil Citrate (Viagra). Am J Ophthalmol 1998 ; 126. 476 вЂ“477
The National Health Service (General Medical Services) Ammendment (No. 2) regulations. HSC 1999 / 148
Webb DJ, Freestone F, Alden MJ, Murhead GJ. Sildenafil citrate and blood pressure lowering drugs, results of drug interaction studies with an organic nitrate and calcium antagonist. Am J Cardiol 1999 ; 83. 21 вЂ“28
Macdougall IC, Mahon A, Muir A, Sidhu P. Randomised placebo controlled study of sildenafil (Viagra) in peritoneal dialysis patients with erectile dysfunction. Renal Association Meeting, Royal College of Physicians, London, October 1999