Sildenafil Oral Suspension: Package Insert / Prescribing Info

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.

• The medication works by relaxing blood vessels in the penis.
• It increases blood flow, resulting in an erection during sexual activity.
• It requires sexual stimulation to be effective.

Put the tip of the oral syringe into your mouth.

More about sildenafil

Low blood pressure may cause you to feel faint or dizzy. 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).

Who should not take sildenafil?

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. Most of these happened in men who already had heart problems. Point the tip of the oral syringe towards the inside of the cheek.

• The solution is usually flavored for better taste.
• Dosing involves measuring with a provided syringe or dropper.
• It offers rapid absorption into the bloodstream.

Slowly push down the plunger of the oral syringe. Wash the oral syringe as instructed below.

• 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.

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 sildenafil citrates date written on the bottle.

Key takeawaysAI

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). Throw away (discard) REVATIO oral suspension after 60 days. This Instruction for Use has been approved by the U.S.

Food and Drug Administration.

• The cost of sildenafil oral solution varies depending on brand and pharmacy.
• Generic versions are typically less expensive.
• Availability might be limited in some regions or countries.

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.

This formulation may be used in cases where the risk-benefit profile for a specific pediatric patient is acceptable.

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. 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.

8.1 Pregnancy

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? For erectile dysfunction, it increases blood flow to the penis when aroused. This makes it easier to get and keep an erection.

Full Prescribing Information

If you have an erection that lasts more than 4 hours, get medical help right away. 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.

Before taking sildenafil,

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. For pulmonary arterial hypertension, sildenafil relaxes the blood vessels in the lungs.

This lowers blood pressure and reduces strain on the heart. 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 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).

Aetos Pharma Private Limited is a leading WHO-GMP EU-GMP Pharmaceuticals Manufacturer exports products to the following continents

Medicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not use REVATIO blue sildenafil 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.

Prior authorization

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. 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. Tell your healthcare provider if you have any of these side effects that bother you.

What happens if you miss a dose of 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. Pain in your muscles, back, arms, or legs There may be other side effects of sildenafil that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at or by calling 866-234-2345. While less common, the most serious side effects of sildenafil are described below, along with what to do if they happen. Sildenafil may cause allergic reactions, which can be serious.

Warnings & Precautions

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.

Physicochemical Properties of Various Sildenafil-Loaded Drug Delivery Sytems

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. Stop taking sildenafil and get help right away if you have any of the following symptoms of a serious allergic reaction. Swelling of the face, lips, mouth, tongue, or throat Itching, skin rash, or pale red bumps on the skin called hives Sildenafil may cause an unwanted erection that is persistent, painful, and that may occur without sexual arousal. Permanent damage to the penis may occur if priapism is not treated quickly. Stop taking sildenafil and get emergency help if you have any of the following symptoms of priapism.