Uses of Revatio Injection:

• It is used to treat high blood pressure in the lungs.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Revatio Injection?

• If you have an allergy to sildenafil or any other part of Revatio Injection (sildenafil injection (PAH)).
• If you are allergic to Revatio Injection (sildenafil injection (PAH)); any part of Revatio Injection (sildenafil injection (PAH)); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a health problem called pulmonary veno-occlusive disease (PVOD).
• If you use drugs called "poppers" like amyl nitrite and butyl nitrite.
• If you are taking any of these drugs: Isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, riociguat, or ritonavir.
• If you are taking any of these drugs: Itraconazole or ketoconazole.
• If you are taking another drug that has the same drug in it.
• If you are taking another drug like this one that is used to treat erectile dysfunction (ED) or high pressure in the lungs.

This is not a list of all drugs or health problems that interact with Revatio Injection (sildenafil injection (PAH)).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Revatio Injection (sildenafil injection (PAH)) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Revatio Injection?

• Tell all of your health care providers that you take Revatio Injection (sildenafil injection (PAH)). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Revatio Injection (sildenafil injection (PAH)) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Talk with your doctor before you drink alcohol.
• Rarely, certain side effects like abnormal heartbeat, heart attack, stroke, bleeding in the lungs, and very bad high blood pressure have happened with Revatio Injection (sildenafil injection (PAH)). Sometimes, this has been deadly. Most of the time, these problems happened in people who had heart problems before taking Revatio Injection (sildenafil injection (PAH)). It is not known if Revatio Injection (sildenafil injection (PAH)) caused these problems. If you have questions, talk with the doctor.
• A very bad eye problem has rarely happened with Revatio Injection (sildenafil injection (PAH)). This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.
• If you have sickle cell disease, talk with your doctor.
• If you are 65 or older, use Revatio Injection (sildenafil injection (PAH)) with care. You could have more side effects.
• This medicine is not approved for use in children. A higher rate of death has been seen in children as the dose of Revatio Injection (sildenafil injection (PAH)) gets higher. However, your child's doctor may decide the benefits of taking Revatio Injection (sildenafil injection (PAH)) may outweigh the risks. If your child has been given Revatio Injection (sildenafil injection (PAH)), talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving Revatio Injection (sildenafil injection (PAH)) to your child.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Revatio Injection) best taken?

Use Revatio Injection (sildenafil injection (PAH)) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Revatio Injection (sildenafil injection (PAH)) as you have been told by your doctor or other health care provider, even if you feel well.
• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Dizziness or passing out.
• Very bad headache.
• Very upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Change in eyesight.
• Loss of eyesight.
• Ringing in the ears, hearing loss, or any other changes in hearing.
• Trouble breathing that is new or worse.
• Swelling in the arms or legs.
• Fever.
• Any unexplained bruising or bleeding.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

What are some other side effects of Revatio Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Flushing.
• Headache.
• Heartburn.
• Upset stomach.
• Stuffy nose.
• Runny nose.
• Muscle pain.
• Diarrhea.
• Redness.
• Nosebleed.
• Trouble sleeping.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Revatio Injection?

• If you need to store Revatio Injection (sildenafil injection (PAH)) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Revatio Injection (sildenafil injection (PAH)), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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