Oral sildenafil in the treatment of erectile dysfunction in diabetic men: A randomized double-blind and placebo-controlled study

The overall clinical safety of oral sildenafil, a potent inhibitor of phosphodiesterase type 5, in the treatment of erectile dysfunction was evaluated in more than 3700 patients (with a total of 1631 years of exposure worldwide). Safety and tolerability data were analysed from a series of double-blind, placebo-controlled studies and from 10 open-label extension studies of sildenafil in the treatment of erectile dysfunction. A total of 4274 patients (2722 sildenafil, 1552 placebo; age range 19–87 y) received double-blind treatment over a period of up to six months’ duration, and 2199 received long-term, open-label sildenafil for up to 1 y. The most commonly reported adverse events (all causes) were headache (16% sildenafil, 4% placebo), flushing (10% sildenafil, 1% placebo), and dyspepsia (7% sildenafil, 2% placebo) and they were predominantly transient and mild or moderate in nature. These adverse events reflect the pharmacology of sildenafil as a phosphodiesterase type 5 inhibitor. The rate of discontinuation due to adverse events (all causes) was comparable for patients treated with sildenafil (2.5%) and placebo (2.3%). In open-label extension studies, 90% of patients completed long-term sildenafil treatment, with only 2% withdrawing due to adverse events. Sildenafil is a well-tolerated oral treatment for erectile dysfunction. This is a preview of subscription content, access via your institution Receive 12 print issues and online access Instant access to the full article PDF. Prices may be subject to local taxes which are calculated during checkout Morales, A., Gingell, C., Collins, M. et al. Clinical safety of oral sildenafil citrate (VIAGRATM) in the treatment of erectile dysfunction. Sildenafil (Revatio, Viagra) is a generic prescription medication used to treat erectile dysfunction and pulmonary arterial sildenafil 50 mg india hypertension in adults. Sildenafil, which is also called sildenafil citrate, comes as an oral tablet. The drug also comes as an oral liquid suspension and IV infusion. However, this article does not cover these forms.

Pregnancy & Lactation

Do not take two doses at one time. If you take too much sildenafil, call your doctor or go to the nearest hospital emergency room. Drinking alcohol with sildenafil can cause side effects. Grapefruit juice and products may interact with sildenafil, leading to unwanted side effects. Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor.

Common Side Effects

Tell your healthcare provider about all the medicines you take, including prescription and over-the-countermedicines, vitamins, and herbal supplements. Sildenafil may affect the way other medicines work, and other medicines may affect the way sildenafil works, causing side effects. Especially tell your healthcare provider if you take: Nitrates for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). It only covers the side effects of sildenafil oral tablets. If you’d like to learn more about these forms, talk with your doctor. As with other drugs, sildenafil can cause side effects (adverse effects).

It’s typically taken as a long-term treatment. Read on to learn about potential common, mild, and serious side effects. For a general overview of sildenafil, including details about its uses, refer to this article. Your doctor can also tell you more about sildenafil. Sildenafil can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist. These are just a few of the more common side effects reported by people who took sildenafil in clinical trials:* * To learn more about the clinical trials of sildenafil, refer to the drug’s prescribing information for erectile dysfunction and pulmonary arterial hypertension. † For more information about this side effect, see “Sildenafil: Side effect specifics” below. Optum Perks is owned by RVO Health. By clicking on this link, we may receive a commission.

Methods of synthesis

Follow all directions on your prescription label and read all medication guides or instruction sheets. Do not change your dose or stop taking this medicine on your own. Take sildenafil tablet or oral suspension 3 times a day, about 4 to 6 hours apart. Take at approximately the same times every day. Sildenafil oral suspension will be mixed for you by your pharmacist.

Study designs of evaluations included in the review

Do not mix with other medicines or flavorings. Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). When sildenafil is used for ED, it is used as needed, so you are not likely to miss a dose. If you are taking sildenafil for PAH and you miss a dose, take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Mild side effects can occur with sildenafil use. This list doesn’t include all possible mild side effects sildenafil citrate tablets 200mg of the drug.

For more information, you can refer to sildenafil’s prescribing information for erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). Mild side effects that have been reported with sildenafil include: These side effects may be temporary, lasting a few days to weeks. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking sildenafil and want to tell the FDA about it, visit MedWatch.

• Sildenafil is sometimes used off-label for other medical conditions.
• Continuous use without medical supervision is not recommended.
• Follow your provider's instructions for frequency of use.

* For more information about this side effect, see “Sildenafil: Side effect specifics” below. † An allergic reaction is possible after taking sildenafil.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Active ingredient: sildenafil citrateInactive ingredients: dextrose and water for injection. Contains no ingredients made from gluten-containing grain (eg, wheat, barley, or rye). Revatio is distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017. Viagra is distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017. It is distributed by: IBSA Pharma Inc, Parsippany, NJ 07054 USA.

How does sildenafil work (mechanism of action)?

Cialis vs Viagra - What's the difference between them? Do you know these 11 amazing facts about Viagra? Is generic Viagra available in the U.S.? Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Sildenafil citrate has been shown to be effective in a wide range of patients with erectile dysfunction and has been approved in the United States for this indication. However, this side effect was rarely reported in clinical trials of sildenafil for ED and PAH. To learn more, see the “Sildenafil: Side effect specifics” section below. The list below may not include all possible serious side effects of the drug.

What should I know about storage and disposal of this medication?

Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure Alpha-blockers are sometimes prescribed for prostate problems orhigh blood pressure. In some patients, the use of sildenafil with alpha-blockers can lead to a drop in blood pressure or fainting Other drugs to treat high blood pressure or a prostate disorder Medicines to treat HIV, such as protease inhibitors, such as ritonavir and saquinavir Some types of oral antifungal sildenafil chewable tablets medicines, such as ketoconazole and itraconazole Some types of antibiotics, such as erythromycin Other medicines that treat high blood pressure Medicines or treatments for ED, such as avanafil (Stendra), tadalafil (Cialis), or vardenafil (Levitra). Tell your doctor about all other medications you use for erectile dysfunction. 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.

Impotence in diabetic men

Other drugs may interact with sildenafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Store sildenafil tablets and oral film at room temperature, between 20°C and 25°C (68°F and 77°F). Store sildenafil reconstituted oral suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to 46°F). Throw away the reconstituted oral suspension after 60 days. If you develop serious side effects while taking sildenafil, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number. Serious side effects that have been reported and their symptoms include: Symptoms can include:tinnitus (ringing in your ear)dizzinessdecrease in hearing Symptoms can include:trouble seeing in either eyeblurry visionseeing eye floaters * To learn more about this side effect, see the “Sildenafil: Side effect specifics” section below. Sildenafil is not approved by the Food and Drug Administration (FDA) for use in children. In clinical trials, children who were given sildenafil long term to treat pulmonary arterial hypertension had an increased risk of fatality. However, your child’s doctor may recommend taking sildenafil off-label in some cases. (With off-label use, a doctor prescribes an FDA-approved drug for a purpose other than what it’s approved for.) Talk with your child’s doctor to determine if sildenafil is right for your child. They can help compare the risks and benefits of the drug.

Sildenafil oral tablets come in different strengths: 20 milligrams (mg), 25 mg, 50 mg, and 100 mg. The dosage you’re prescribed will depend on what condition you’re taking sildenafil for. It also depends on how the dosage is working for you. You can experience mild or severe side effects from sildenafil with any dosage. However, you may have an increased risk of side effects with higher dosages. If you start to experience side effects that become bothersome or severe while taking sildenafil, talk with your doctor.

• Patients with heart conditions should consult a cardiologist before use.
• Sildenafil may cause a temporary drop in blood pressure.
• Do not use sildenafil if you have a history of stroke or heart attack.