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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.
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The population of the current 4-year open-label study of sildenafil differed from those of the pooled double-blind studies in that it was self-selected. Consequently, it is likely that men with poor tolerability or inadequate effectiveness did not opt to participate and that the population included mostly men who had previously experienced a good response to sildenafil. Also, men who could afford to purchase sildenafil may have lost incentive to participate in the long-term study when sildenafil became commercially available. This phenomenon necessitated discontinuation of a European long-term OL study when sildenafil became commercially availabile in Europe (Padma-Nathan et al 2001). Another limitation was the use of unvalidated general efficacy questions, explained by the fact that the major focus of the study was safety and by the absence at the time of the study design of appropriate validated questionnaires to assess satisfaction with ED treatment. Regardless, the results add to the previously published reports by showing continued safety and effectiveness during prolonged treatment. During 4 years of open-label, flexible-dose administration, there were few discontinuations because of either intolerable adverse events or insufficient clinical response. The majority of men were satisfied with sildenafil treatment for their ED and reported improved ability to engage in sexual activity. Throughout the 4-year study period, the consistently low incidence of adverse events of sufficient severity to negatively impact treatment argues against the loss of tolerability with time, and the low rate of discontinuation because of insufficient clinical response (
Despite a preferred sildenafil dose of 100 mg (the highest recommended dose) in more than 88% of the men, treatment-related cardiovascular adverse events necessitating changes in dosing or temporary or permanent discontinuation were limited to one case each of mild palpitations and tachycardia and 5 cases of flushing. There were no treatment-related acute myocardial infarctions or other serious adverse events. Only 1.1% of participants discontinued treatment over 4 years because of treatment-related adverse events, which were most frequently dyspepsia, rhinitis, and headache. In comparison, treatment-related adverse events were responsible for discontinuation by 1.2% of men treated with sildenafil 100 mg in 6-month, double-blind, placebo-controlled trials (Morales et al 1998) and by 2% of 1008 men enrolled in 36-week or 52-week, open-label extension studies (Steers et al 2001). Adverse events were responsible for similarly low rates of discontinuation in clinical practice studies of varying duration conducted worldwide; in California 2.7% of 74 men discontinued (Marks et al 1999), in Brazil none of 256 men discontinued (Moreira et al 2000), and in China none of 1,290 men discontinued (Jiann et al 2003). Among 22,471 men treated with sildenafil in general practice in the UK, headache was the most frequently reported treatment-related adverse event and was cited as the reason for discontinuation in 0.3% of men (Boshier et al 2004).
Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Sildenafil (Revatio) is used to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Children should not usually take sildenafil, but in some cases, a doctor may decide that sildenafil (Revatio) is the best medication to treat a child's condition. Sildenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Sildenafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily.
If you are taking sildenafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Sildenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).
If you are taking sildenafil to treat erectile dysfunction, follow your doctor's directions and the guidelines in this paragraph. Take sildenafil as needed before sexual activity. The best time to take sildenafil is about 1 hour before sexual activity, but you can take the medication any time from 4 hours to 30 minutes before sexual activity. Sildenafil usually should not be taken more than once every 24 hours. If you have certain health conditions or are taking certain medications, your doctor may tell you to take sildenafil less often. You can take sildenafil with or without food. However, if you take sildenafil with a high-fat meal, it will take longer for the medication to start to work.
If you are taking sildenafil to treat PAH, follow your doctor's directions and the guidelines in this paragraph. You will probably take sildenafil three times a day with or without food. Take sildenafil at around the same times every day, and space your doses about 4 to 6 hours apart.
Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sildenafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
If you are taking sildenafil for erectile dysfunction, your doctor will probably start you on an average dose of sildenafil and increase or decrease your dose depending on your response to the medication. Tell your doctor if sildenafil is not working well or if you are experiencing side effects.
If you are taking sildenafil for PAH, you should know that sildenafil controls PAH but does not cure it. Continue to take sildenafil even if you feel well. Do not stop taking sildenafil without talking to your doctor.
If you are taking sildenafil for PAH, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Some patients experienced a sudden loss of some or all of their vision after they took sildenafil or other medications that are similar to sildenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking sildenafil, call your doctor immediately. Do not take any more doses of sildenafil or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor.
There have been reports of heart attack, stroke, irregular heartbeat, bleeding in the brain or lungs, high blood pressure, and sudden death in men who took sildenafil for erectile dysfunction. Most, but not all, of these people had heart problems before taking sildenafil. It is not known whether these events were caused by sildenafil, sexual activity, heart disease, or a combination of these and other causes.Talk to your doctor about the risks of taking sildenafil.
Some patients experienced a sudden decrease or loss of hearing after they took sildenafil or other medications that are similar to sildenafil. The hearing loss usually involved only one ear and did not always improve when the medication was stopped. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking sildenafil, call your doctor immediately. If you are taking sildenafil (Viagra) for erectile dysfunction, do not take any more doses of sildenafil (Viagra) or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. If you are taking sildenafil (Revatio) for PAH, do not stop taking your medication until you talk to your doctor.
Methods: In this double-blind, placebo-controlled study, we randomly assigned 278 patients with symptomatic pulmonary arterial hypertension (either idiopathic or associated with connective-tissue disease or with repaired congenital systemic-to-pulmonary shunts) to placebo or sildenafil (20, 40, or 80 mg) orally three times daily for 12 weeks. The primary end point was the change from baseline to week 12 in the distance walked in six minutes. The change in mean pulmonary-artery pressure and World Health Organization (WHO) functional class and the incidence of clinical worsening were also assessed, but the study was not powered to assess mortality. Patients completing the 12-week randomized study could enter a long-term extension study.
A person should avoid consuming large amounts of grapefruit when taking sildenafil. Consuming grapefruits or grapefruit juice can increase the levels of sildenafil in the body, causing the medication to be less effective.
Individuals should not exceed the prescribed dosage, which generally means not taking more than one pill daily. However, if a doctor has advised a person to microdose their prescription, they may take smaller doses of sildenafil more frequently.
Sildenafil should not cause an erection without sexual arousal. However, if a person takes this medication as a healthcare professional directs, the sildenafil should help a person to develop an erection.
Pfizer originally discovered the medication in 1989 while looking for a treatment for heart-related chest pain. It was approved for medical use in the United States and in the European Union in 1998. In 2020, it was the 183rd most commonly prescribed medication in the United States, with more than 2 million prescriptions. It is available as a generic medication. In the United Kingdom, it is available over the counter. Most of the Active Pharmaceutical Ingredient (API) in Sildenafil, Sildenafil citrate, is produced in Pfizer's Ringaskiddy complex in County Cork, Ireland, which is Pfizer's largest production facility outside of the United States. 041b061a72