Patient Information l Common Questions l Important Safety Information
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Common Questions

Below are answers to some common questions about REVATIO and pulmonary arterial hypertension (PAH). Always talk to your doctor when you have questions about symptoms, medicine, or anything else about PAH. This is the best way to get the most from your treatment.

What is REVATIO?

REVATIO is a medicine called a phosphodiesterase type 5 (PDE5) inhibitor. It is used to treat PAH (WHO Group I).

In studies, REVATIO

  • Increased the distance people walked
  • Decreased pressure in the pulmonary artery

REVATIO contains the same ingredient as Viagra® (sildenafil citrate). Before taking REVATIO, talk to your doctor about medicines you need to avoid.

REVATIO was not studied in patients taking bosentan (a medicine used in patients with PAH).

How does REVATIO work?

There are chemicals in the cells lining the blood vessels of the lungs. These help control how narrow or wide the vessels can be.

REVATIO works by increasing one of these chemicals. This helps the blood vessels relax. Blood and oxygen can then flow more freely.

How is REVATIO taken?

REVATIO is a 20-mg pill that you take 3 times a day. You should take REVATIO at the same times every day. You can take REVATIO with or without food.

Do not stop taking REVATIO without first talking with your doctor. Always take REVATIO as directed by your doctor.

What do REVATIO tablets look like?

Pfizer RVT 20
(not actual size)
REVATIO comes in round, white 20-mg tablets that are taken three times a day.

Who should not take REVATIO?

Only your doctor can decide if REVATIO is right for you. REVATIO is not right for everyone.

You should NEVER take REVATIO if you take medicines with nitrates in them. This includes nitroglycerin for chest pain.

REVATIO should not be taken with the medicine ritonavir (used in patients with HIV). Do not take REVATIO with antifungals such as ketoconazole and itraconazole.

If you have ever had blockage of veins in your lungs, which is called pulmonary veno-occlusive disease (PVOD), REVATIO is not recommended for you.

What should I tell my doctor before starting REVATIO?

Discuss your health status with your doctor. This will help ensure you are healthy enough to take REVATIO.

Tell your doctor if you have or ever had

  • Heart problems such as heart attack, stroke, irregular heartbeat, or chest pain (angina)
  • Problems with high or low blood pressure or blood circulation
  • An eye problem called retinitis pigmentosa
  • Severe liver or kidney disease
  • Any disease or problem with the shape of the penis
  • Any blood problems such as sickle cell anemia or cancer of blood cells or bone marrow
  • A stomach ulcer or bleeding problem

REVATIO and other medicines

Before you start REVATIO, tell your doctor about all medicines or other health products you are now taking. You should not take REVATIO with certain medicines.

Also tell your doctor if you take any of the medicines listed below. Your doctor may need to adjust your dose.

  • Alpha-blockers
  • Barbiturates
  • Bosentan
  • Carbamazepine
  • Rifabutin
  • Rifampin
  • Phenytoin
  • Vitamin K antagonists
  • Certain HIV medicines

What are the possible side effects of REVATIO?

As with any medicine, REVATIO may have side effects. Common ones found in studies were

  • Nosebleeds
  • Upset stomach
  • Trouble sleeping
  • Headache
  • Flushing

Very few patients have to stop taking REVATIO due to side effects. Be sure to tell your doctor if you have any side effects while taking REVATIO.

In rare cases, men taking PDE5 inhibitors for erectile dysfunction had a sudden decrease or loss of sight in one or both eyes. It is not possible to know if these cases are directly caused by these medicines or other factors. If you take a PDE5 inhibitor, including REVATIO, and have a sudden decrease or loss of sight, call your doctor right away.

Do I have to have monthly liver tests if I take REVATIO?

No monthly liver testing is required with REVATIO.

Where can I get REVATIO?

You can only get REVATIO with a doctor’s prescription. In many cases, your local pharmacy can fill your prescription.

What causes PAH?

No one knows for sure. But doctors are learning more each day.

In some people PAH can happen for no reason at all. Sometimes it runs in families, although just because someone in your family has PAH does not mean you will.

PAH can also be caused by other things, such as

  • Heart disease
  • Scleroderma (skler-o-der-ma)
  • Liver disease
  • Certain diet medicines
  • HIV
  • Illegal drugs like cocaine

What more can I do?

The good news is that you have options to help the way you feel. Some involve medicine your doctor prescribes. Others you can do yourself:

  • Following a healthy, low-salt diet
  • Quitting smoking
  • Getting enough sleep
  • Walking for exercise (if your doctor approves)

Talk with your doctor about how you are feeling. Always follow directions for all medicines you take. Ask questions about REVATIO or other treatments you receive. Take an active role in your own health care. Get support and help from friends, family, and your doctor.

Important Safety Information

REVATIO is prescribed to treat pulmonary arterial hypertension (WHO Group I) to improve exercise ability. REVATIO has not been studied in patients taking bosentan.

If you take any medicines that contain nitrates (like nitroglycerin for chest pain) — daily or just once in a while — you should NOT take REVATIO.

REVATIO is not recommended for patients taking ritonavir or antifungal medicines, such as ketoconazole and itraconazole. If you are taking REVATIO with bosentan or medicines like barbiturates, carbamazepine, phenytoin, efavirenz, nevirapine, rifampin or rifabutin, your doctor may adjust your dose. Also, tell your doctor if you are taking alpha-blockers for prostate or blood pressure problems.

If you have ever had blockage of veins in your lungs, which is called pulmonary veno-occlusive disease, REVATIO is not recommended for you. If you feel dizzy, have chest pain, or discomfort while taking REVATIO, tell a doctor right away. Also, discuss your general health with your doctor, including if you ever had problems with low blood pressure or blood circulation.

Patients who did not take part in the clinical trial were those who have had: a heart attack, stroke, or life-threatening irregular heartbeat within the last 6 months; chest pain; blood pressure greater than 170/110; eye discoloration; or patients on bosentan.

The safety of REVATIO is not known in patients with bleeding problems and those with stomach ulcers. If you have a condition like these, tell your doctor.

Taking vitamin K antagonists (like coumadin or warfarin) with REVATIO may increase risk of nosebleeds. Tell your doctor if you take such medicines.

In rare cases, men who took PDE5 inhibitors for erectile dysfunction had a sudden decrease or loss of sight in one or both eyes. It is not possible to know if these cases are related directly to these medicines or something else. If you take a PDE5 inhibitor, including REVATIO, and have a sudden decrease or loss of vision, call your doctor right away.

Although rare, erections that last for more than four hours may occur with all drugs in this class. Call a doctor right away if this happens to you. Erections that last more than six hours may lead to long-term loss of potency.

The most common side effects of REVATIO are nosebleeds, headache, upset stomach, flushing, and trouble sleeping.

At doses more than the approved 20 milligrams 3 times a day, some side effects increased. These included flushing, loose stools, muscle pain, and visual disturbances.

Please See Full Prescribing Information for REVATIO

RVU00031. August 2007.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

This product information is intended only for residents of the United States.