Revatio(TM) sildenafil

Common Questions

Below are answers to some common questions about REVATIO (sildenafil) 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
  • Helped lessen symptoms
  • Slowed down worsening changes in your physical condition

REVATIO contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take REVATIO with VIAGRA or other PDE5 inhibitors.

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. REVATIO can be taken with or without food. The recommended dose of REVATIO is 20 mg three times a day.

To take REVATIO properly, you should:

  • Take all 3 doses each day — and try taking the doses at the same time each day so it’s easier to remember
  • Not stop taking REVATIO without first talking to your doctor
  • Be sure to follow your doctor’s advice — you will get the most from your treatment if you take REVATIO the way your doctor tells you
  • If you miss a dose, take it as soon as you remember, as long as it is not too close to your next dose

If you have any questions about how to take REVATIO, talk to 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.

REVATIO contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take REVATIO with VIAGRA or other PDE5 inhibitors.

Erections that last for more than four hours may occur. Call a doctor right away if this happens.

What should I tell my doctor before starting REVATIO?

Discuss your health status with your doctor to see if REVATIO is right for you.

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 any bleeding problem

Also tell your doctor if you are pregnant, could be pregnant, or are breast-feeding. The effects of REVATIO in these patients are not known.

REVATIO and other medicines

Tell your doctor about any medicines or health products you are now taking. If you take any of the medicines listed below, your doctor may need to adjust your dose.

  • Alpha-blockers for blood pressure or prostate problems
  • Seizure medication, such as phenytoin or Tegretol®* (carbamazepine)
  • Blood thinners, such as Coumadin® (warfarin sodium)
  • Medicine for tuberculosis like rifampin or rifabutin
  • Certain HIV medicines
  • Tracleer® (bosentan)

What are the possible side effects of REVATIO?

In studies, the side effects reported most were:

  • Nosebleeds
  • Headache
  • Upset stomach
  • Diarrhea
  • Flushing (feeling “red in the face” or a “head rush” feeling)
  • Trouble sleeping

Very few people had to stop taking REVATIO because of side effects. Sudden decrease or loss of hearing has been reported in people taking PDE5 inhibitors, including REVATIO. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. 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. Be sure to let your doctor know if you have any side effects while taking REVATIO.

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
  • Tracleer® (bosentan)

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
  • Keeping active (talk to your doctor about what exercises are right for you)

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.

*Tegretol® is a registered trademark of Novartis Pharmaceutical Inc.
Coumadin® is a registered trademark of Bristol-Myers Squibb.
Tracleer® is a registered trademark of Actelion Pharmaceuticals US.

Indication

REVATIO (sildenafil) is prescribed to treat pulmonary arterial hypertension (WHO Group I) to improve exercise ability and help lessen symptoms and slow down worsening changes in your physical condition. REVATIO has not been studied in patients taking bosentan.

Important Safety Information

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

REVATIO contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take REVATIO with VIAGRA or other PDE5 inhibitors.

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. 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.

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

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.

Sudden decrease or loss of hearing has been reported in people taking PDE5 inhibitors, including REVATIO. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you take a PDE5 inhibitor, including REVATIO, and experience a sudden decrease or loss of hearing, contact a doctor right away.

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.

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.

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 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

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