Revatio

Revatio is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH).

Revatio belongs to a group of drugs called PDE inhibitors. Revatio treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily.

Revatio comes in tablet and oral suspension (liquid) form and is taken taken 3 times a day, 4-6 hours apart.

This medication also comes in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include nosebleeds, headache, indigestion, and flushing. 

Revatio is a prescription medication used to treat adults with pulmonary arterial hypertension (PAH).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Pfizer Laboratories Div Pfizer Inc.

The most common side effects of Revatio are:

• nosebleeds
• indigestion
• headache
• flushing of the face
• difficulty falling or staying asleep
• runny nose

Revatio may cause other side effects besides those listed.

If you want more information or develop any side effects or symptoms you are concerned about, talk to your doctor or pharmacist.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take any of the following:

• medicines called alpha blockers. These include Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl) or Uroxatral (alfuzosin HCl). Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If sildenafil is taken with certain alpha blockers, your blood pressure could suddenly drop and you could get dizzy or faint.
• other medicines to treat high blood pressure (hypertension)
• medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• medicines or treatments for Erectile dysfunction.

Do not take Revatio if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.

• Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite.
• Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates.

This is not a complete list of Revatio drug interactions. Ask your doctor or pharmacist for more information.

• Revatio is not for newborns, children, or women.
• Do not let anyone else take your Revatio.

Less common side effects that may occur are temporary changes in color vision (such as trouble telling the difference between blue and green objects or having a blue color tinge to them), eyes being more sensitive to light, or blurred vision.

In rare instances, men taking PDE5 inhibitors reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including Revatio, and call a doctor right away.

In rare instances, men have reported an erection that lasts many hours. You should call a doctor immediately if you ever have an erection that lasts more than 4 hours. If not treated right away, permanent damage to your penis could occur.

Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including Revatio. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking Revatio and contact a doctor right away.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Revatio, there are no specific foods that you must exclude from your diet when receiving this medication.

Be sure to tell your doctor if you:

• have ever had any heart problems (e.g., angina, chest pain, heart failure, irregular heart beats, heart attack or narrowing of the aortic valve)
• have ever had a stroke
• have low or high blood pressure
• have ever had severe vision loss
• have a rare inherited eye disease called retinitis pigmentosa
• have ever had any kidney problems
• have ever had any liver problems
• have ever had any blood problems, including sickle cell anemia or leukemia
• are allergic to Revatio or any of its ingredients
• have a deformed penis, Peyronie's disease, or ever had an erection that lasted more than 4 hours
• have stomach ulcers or any types of bleeding problems
• are taking any other medicines
• have sickle cell disease; Revatio may cause serious complications if PAH is secondary to sickle cell disease

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are no adequate and well-controlled studies of Revatio in pregnant women.

Revatio is not indicated for use in newborns, children, or women.

It is not known if Revatio or its metabolites are excreted in human breast milk. Because many drugs pass into human milk, caution should be used when Revatio is administered to a nursing woman.

Revatio comes in tablet and oral suspension (liquid) form and is taken taken 3 times a day, 4-6 hours apart.To prepare the oral solution:

1. Tap the bottle to release the powder.
2. Remove the cap.
3. Accurately measure out 60 mL of water and pour the water into the bottle.
4. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds.
5. Remove the cap.
6. Accurately measure out another 30 mL of water and add this to the bottle. You should always add a total of 90 mL of water irrespective of the dose prescribed.
7. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds.
8. Remove the cap.
9. Press the bottle adaptor into the neck of the bottle. The adaptor is provided so that you can fill the oral syringe with medicine from the bottle. Replace the cap on the bottle.
10. Write the expiration date of the constituted oral suspension on the bottle label (the expiration date of the constituted oral suspension is 30 days from the date of constitution).

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

For the treatment of pulmonary arterial hypertension (PAH):

Revatio tablets and oral solution: The recommended dose of Revatio (sildenafil) is 20 mg three times a day. Take Revatio doses 4–6 hours apart. Doses higher than 20 mg three times a day is not recommended.

Injectable: The recommended dose is 10 mg (12.5 mL) given as an injection into the vein (IV) three times a day.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep Revatio out of the reach of children. Keep Revatio in its original container. Store at room temperature away from excessive heat or moisture.