REVATIO oral suspension should only be given using sildenafil for women the oral syringe supplied with each pack.

What side effects can this medication cause?

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. Your heart has to work hard to pump blood into your lungs.

2.2 Recommended Dosage in Pediatric Patients

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. See "What is the most important information I should know about REVATIO?" are allergic to sildenafil or any other ingredient in REVATIO.

5.2 Worsening Pulmonary Vascular Occlusive Disease

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. Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. 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). Insert the tip of the oral syringe into the adaptor while the bottle is upright, on a flat surface.

Drug Class Potential Effect Clinical Note
Nitrates Severe hypotension Absolute contraindication
Alpha-blockers Increased risk of hypotension Use with caution
CYP3A4 inhibitors (e.g., ketoconazole) Increased sildenafil levels Dose adjustment needed
Other vasodilators Enhanced vasodilatory effects Monitor blood pressure

Fully push down (depress) the plunger of the syringe. Turn the bottle upside down while holding the oral syringe in place.

  • Patients should avoid heavy meals before taking sildenafil solution.
  • Use caution if combining with other blood pressure medications.
  • Regular medical check-ups are advised during treatment.

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.

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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. Remove the oral syringe from the bottle by pulling straight up on the barrel of the oral dosing syringe. Put the tip of the oral syringe into your mouth. Point the tip of the oral syringe towards the inside of the cheek.

In case of emergency/overdose

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.

Statistical Analysis

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. 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. Slowly push down the plunger of the oral syringe. Wash the oral syringe as instructed below. The syringe should be washed after each dose. Store the syringe with REVATIO oral suspension in a clean safe place. Administer REVATIO oral suspension using the oral syringe supplied with each pack. Refer to the patient instructions for use for more detailed instructions for use. Discard any unused suspension after the expiration date written on the bottle. Throw away (discard) REVATIO oral suspension after 60 days. This Instruction for Use has been approved by the U.S. Food and Drug Administration. For current full prescribing information, please visit Sildenafil is commonly used for the following conditions. Erectile dysfunction, a condition where you have trouble getting or keeping an erection Pulmonary arterial hypertension, a condition where you have high blood pressure in the blood vessels that carry blood from your heart to your lungs Sildenafil may also be used for other conditions as determined by your healthcare provider. Sildenafil works by blocking an enzyme in the body called PDE5, which helps relax certain blood vessels.

Vasodilator; Phosphodiesterase Type 5 Inhibitor compounded for dogs and cats.

Lie down if you feel faint or dizzy. Tell your doctor if you get more short of breath after you start REVATIO. More shortness of breath than usual may be due to your underlying medical condition. 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.

5.5 Hearing Loss

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. Most of these happened in men who already had heart problems. If you have an erection that lasts more than 4 hours, get medical help right away.

4.1. Manufacturing of ODTs

If it is not treated right away, priapism can permanently damage your penis. 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. For erectile dysfunction, it increases blood flow to the penis when aroused. This makes it easier to get and keep an erection. For pulmonary arterial hypertension, sildenafil relaxes the blood vessels in the lungs.

  • Sildenafil oral solution is prescribed by a healthcare provider.
  • It should be taken on an empty stomach for faster effects.
  • The liquid form provides flexibility in dosing.

This lowers blood pressure and reduces strain on the heart.

Proper Use

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.

8.2 Lactation

REVATIO oral suspension will be mixed for you by your pharmacist. Do not mix REVATIO oral suspension with other medicine or flavoring. Shake well for at least 10 seconds before each dose. If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.

Competing interests

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. 10 mg/mL powder for oral suspension 20 mg, 25 mg, 50 mg, 100 mg oral tablets Sildenafil is also available in an injectable form that is usually given by a healthcare provider in a hospital or clinic.

  • Sildenafil oral solution can interact with nitrates and certain medications.
  • Always inform your doctor of all medicines being taken.
  • Failure to do so can cause serious adverse effects.

Sildenafil oral tablets should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Sildenafil oral liquid should be stored at room temperature below 86 F (30 C) or in the refrigerator, between 36 F to 46 F (2 C to 8 C). Throw away any remaining liquid 60 days after it has been mixed for you by a pharmacist or healthcare professional. Sildenafil injection is usually given by a healthcare provider in a hospital or clinic. You will not store it at home. The most common side effects of sildenafil are listed below. These side effects may vary depending on the condition that is being treated.

Frequently asked questions

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. Tell your healthcare provider if you have any of these side effects that bother you. Pain in your muscles, back, arms, or legs There may be other side effects of sildenafil that are not listed here.