Generic Name: sildenafil (Oral route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antihypertensive, Peripheral Vasodilator
Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor
Sildenafil is used to treat men who have erectile dysfunction (also called sexual impotence). Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.
The penis is one of the areas in the body where the phosphodiesterase enzyme works. By controlling the enzyme, sildenafil helps to maintain an erection after the penis is stroked. Without physical action to the penis, such as that occurring during sexual intercourse, sildenafil will not work to cause an erection.
Sildenafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is a type of high blood pressure that occurs between the heart and the lungs. When hypertension occurs in the lungs, the heart must work harder to pump enough blood through the lungs. Sildenafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of sildenafil in children with pulmonary arterial hypertension. Safety and efficacy have not been established.
Sildenafil should never be used in children for erectile dysfunction.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sildenafil in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving sildenafil.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain sildenafil. It may not be specific to Revatio. Please read with care.
This medicine comes with patient instructions. Read and follow these instructions carefully each time you get a refill of your medicine. Ask your doctor if you have any questions.
Use sildenafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects is increased.
When using this medicine for pulmonary arterial hypertension, you may take it with or without food.
This medicine usually begins to work for erectile dysfunction within 30 minutes after taking it. It continues to work for up to 4 hours, although its action is usually less after 2 hours.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is important that you tell all of your doctors that you take sildenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took sildenafil.
If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
If you take sildenafil for pulmonary arterial hypertension, do not take Viagra® or other PDE5 inhibitors, such as tadalafil (Cialis®) or vardenafil (Levitra®). Viagra® also contains sildenafil. If you take too much sildenafil or take it together with these medicines, the chance for side effects will be higher.
Sildenafil should not be used with any other medicine or device that causes erections.
If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent tissue damage to the penis and possibly permanent impotence.
This medicine does not protect you against sexually transmitted diseases. Use protective measures and ask your doctor if you have any questions about this.
Do not use this medicine if you are also using a nitrate medicine for chest pain (angina). Some examples of nitrate medicines are: isosorbide, nitroglycerin, Imdur®, Nitro-Bid®, Nitro-Dur®, Nitrol® ointment, Nitrolingual® spray, Nitrostat®, and Transderm Nitro®. Some illegal ("street") drugs or "poppers" also contain nitrates, such as amyl nitrate, butyl nitrate, or nitrite.
It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.
If you experience a sudden loss of vision in one or both eyes, stop using sildenafil and contact your doctor right away. This could be a symptom of a very serious eye condition called non-arteritic anterior ischemic optic neuropathy (NAION).
Stop using this medicine and check with your doctor right away if you have a sudden decrease in hearing or loss of hearing. You might also have dizziness and ringing in the ears.
If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low. Call your doctor right away if you have more than one of these symptoms: blurred vision; confusion; dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Less common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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