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See "What is the most important information I should know about REVATIO?" are allergic to sildenafil or any other ingredient in REVATIO. See "What are the ingredients in REVATIO?" What should I tell my doctor before taking REVATIO? Tell your doctor about all of your medical conditions, including if you have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack have a disease called pulmonary veno-occlusive disease (PVOD) have high or low blood pressure or blood circulation problems have an eye problem called retinitis pigmentosa have or had loss of sight in one or both eyes have any problem with the shape of your penis or Peyronie's disease have any blood cell problems such as sickle cell anemia have a stomach ulcer or any bleeding problems are pregnant or planning to become pregnant. It is not known if REVATIO could harm your unborn baby. REVATIO passes into your breast milk, it is not known if it could harm your baby.

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Your heart has to work hard to pump blood into your lungs. REVATIO improves the ability to exercise and can slow down worsening changes in your physical condition. REVATIO is not for use in children Adding REVATIO to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise. REVATIO contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take REVATIO with VIAGRA or other PDE-5 inhibitors. Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. REVATIO and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take REVATIO. Especially tell your doctor if you take See "What is the most important information I should know about REVATIO?" Ritonavir (Norvir®) or other medicines used to treat HIV infection Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. Take REVATIO exactly as your doctor tells you. REVATIO may be prescribed to you as Take REVATIO tablet or oral suspension 3 times a day about 4 to 6 hours apart Take REVATIO tablets or oral suspension at the same times every day.

Advice To Patients

Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking REVATIO not to take VIAGRA or other PDE-5 inhibitors. Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking REVATIO. Such an event may be a sign of NAION. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking REVATIO. REVATIO oral suspension will be mixed for you by your pharmacist.

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These increases were significantly better than those observed in the 1 mg dose group (Figure 12). Study 4 (REVATIO added to bosentan therapy – lack of effect on exercise capacity) A randomized, double-blind, placebo controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of three months. The PAH patients included those with primary PAH, and PAH associated with CTD. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5–125 mg twice a day). The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. Do not mix REVATIO oral suspension with other medicine or flavoring. Shake well for at least 10 seconds before each dose. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time. Do not take more than one dose of REVATIO at a time. Do not change your dose or stop taking REVATIO on your own. If you take too much REVATIO, call your doctor or go to the nearest hospital emergency room. What are the possible side effects of REVATIO? Low blood pressure may cause you to feel faint or dizzy. Tell your doctor if you get more short of breath after you start REVATIO.

Absorption and metabolism

Never take REVATIO with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level. Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called "poppers" (amyl nitrate or nitrite) Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine. REVATIO is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away. If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including REVATIO, or to other diseases or medicines, to other factors, or to a combination of factors. heart attack, stroke, irregular heartbeats, and death.

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The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone. REVATIO tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage for REVATIO Tablets: Store at controlled room temperature 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature]. REVATIO injection is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg sildenafil/12.5 mL presented in a single-use glass vial. Recommended Storage for REVATIO Injection: Store at controlled room temperature 20°C – 25°C (68°F – 77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature]. REVATIO powder for oral suspension is supplied in amber glass bottles. Most of these happened in men who already had heart problems. The most common side effects with REVATIO include: Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children. Tell your doctor if you have any side effect that bothers you or doesn't go away. These are not all the possible side effects of REVATIO. For more information, ask your doctor or pharmacist. Store REVATIO tablets at controlled room temperature, between 20°C – 25°C (68°F to 77°F). Store REVATIO 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 REVATIO oral suspension after 60 days. Keep REVATIO and all medicines away from children. Medicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not use REVATIO for a condition for which it was not prescribed. Do not give REVATIO to other people, even if they have the same symptoms you have.

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Each bottle contains white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following reconstitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided. See FDA-approved patient labeling (Patient Information). Inform patients of contraindication of REVATIO with regular and/or intermittent use of organic nitrates. This patient leaflet summarizes the most important information about REVATIO. If you would like more information about REVATIO talk with your doctor. You can ask your doctor or pharmacist for information about REVATIO that is written for health professionals. For more information go to or call 1-800-879-3477. For current full prescribing information, please visit This Patient Information has been approved by the U.S. Food and Drug Administration Read this Instructions for Use for REVATIO oral suspension before you start taking and each time you get a refill. This information does not take the place of talking to your doctor about your medical condition or your treatment. Your pharmacist should tell you how to measure REVATIO oral suspension by using the oral syringe provided in the pack. REVATIO oral suspension should only be given using the oral syringe supplied with each pack. REVATIO for oral suspension should not be mixed with any other medicine or flavoring. Supplies you will need to take REVATIO oral suspension: Bottle of REVATIO oral suspension with syringe adaptor fitted in neck of bottle Shake the bottle of REVATIO oral suspension for 10 seconds before each use. Open the bottle by pushing downward on the cap and twisting it in the direction of the arrow (counter-clockwise).

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These events may be accompanied by tinnitus and dizziness. For current full prescribing information, please visit Read this Patient Information before you start taking REVATIO and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about REVATIO, ask your doctor or pharmacist. What is the most important information I should know about REVATIO? Insert the tip of the oral syringe into the adaptor while the bottle is upright, on a flat surface. Fully push down (depress) the plunger of the syringe. Turn the bottle upside down while holding the oral syringe in place. Slowly pull back the plunger of the oral syringe until the bottom of the plunger is even with the graduation markings on the syringe for the prescribed dose for you. Take your dose of REVATIO oral suspension exactly as prescribed by your doctor. If air bubbles can be seen, slowly push the oral suspension in the syringe back into the bottle. Turn the bottle back upright with the oral syringe still in place.