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Generic Name: Sildenafil Tablets (PAH) (sil-DEN-ah-fill)
Brand Name: Revatio

Revatio is used for:

Treating high blood pressure of the lungs (pulmonary arterial hypertension [PAH]). It may also be used for other conditions as determined by your doctor.

Revatio is a phosphodiesterase inhibitor. It works by relaxing the smooth muscle lining in the arteries of the lungs. This causes the arteries to widen and decreases lung arterial blood pressure.

Do NOT use Revatio if:

  • you are allergic to any ingredient in Revatio
  • you are taking or using azole antifungals (eg, itraconazole), nitroglycerin (eg, tablet, patch, ointment), nitrates (eg, isosorbide), nitroprusside, or ritonavir
  • you have a history of severe low blood pressure, certain blood vessel problems (eg, pulmonary veno-occlusive disease [PVOD]), or severe liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Revatio :

Some medical conditions may interact with Revatio . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have cancer of the blood (eg, leukemia, myeloma), bleeding disorders, uncontrolled high blood pressure, or active stomach ulcers
  • if you have had a heart attack, stroke, or life-threatening irregular heartbeat within the last 6 months
  • if you have a history of heart disease, angina pectoris, kidney or liver problems, nervous system problems, certain eye problems (eg, retinitis pigmentosa), or if you have ever had severe vision loss
  • if you have a deformed penis (eg, Peyronie disease) or conditions that may cause a prolonged erection (eg, sickle cell anemia)

Some MEDICINES MAY INTERACT with Revatio . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Alpha-blockers (eg, prazosin), azole antifungals (eg, itraconazole), barbiturates (eg, phenobarbital), carbamazepine, delavirdine, H2 antagonists (eg, famotidine), HIV protease inhibitors (eg, indinavir), hydantoins (eg, phenytoin), ketolides (eg, telithromycin), macrolides (eg, erythromycin), mibefradil, non-nucleoside reverse transcriptase inhibitors (eg, efavirenz), rifabutin, rifampin, or ritonavir because side effects of Revatio may be increased
  • Anticoagulants (eg, warfarin), nitrates (eg, isosorbide), or nitroglycerin (eg, tablet, patch, ointment), or nitroprusside because the risk of side effects such as bleeding or severe low blood pressure may be increased
  • Bosentan because side effects may be increased by Revatio

This may not be a complete list of all interactions that may occur. Ask your health care provider if Revatio may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Revatio :

Use Revatio as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Taking Revatio with a high-fat meal may delay the time of onset of Revatio .
  • Revatio comes with an additional patient leaflet. Read it carefully.
  • Take Revatio by mouth as needed between 4 hours and 30 minutes before sexual activity (about 1 hour before is most effective).
  • Do not take Revatio more often than once daily as needed.
  • If you are taking Revatio in doses greater than 25 mg, do not take an alpha-blocker (eg, doxazosin) within 4 hours of taking Revatio . Taking these medicines at the same time may cause very serious side effects such as severe low blood pressure.

Ask your health care provider any questions you may have about how to use Revatio .

Important safety information:

  • Revatio may cause dizziness, blurred vision, fainting, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Revatio . Using this medicine alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • To minimize dizziness or lightheadedness, sit up or stand slowly when rising from a seated or lying position.
  • Revatio may rarely cause a painful penile erection, which can last for long periods of time and is not related to sexual activity. If not treated immediately, this may lead to permanent erectile dysfunction or impotence (not being able to have or maintain an erection for sexual purposes).
  • Do not use Revatio if your doctor has advised you to avoid sexual activity because of heart problems.
  • Revatio does not protect against sexually transmitted diseases, including HIV infection. Use "safe sex" practices such as latex condoms.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Revatio .
  • Use Revatio with caution in the ELDERLY because they may be more sensitive to its effects.
  • Use Revatio with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is unknown if Revatio can cause harm to the fetus. If you become pregnant while taking Revatio , discuss with your doctor the benefits and risks of using Revatio during pregnancy. It is unknown if Revatio is excreted in breast milk. If you are or will be breast-feeding while you are using Revatio , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Revatio :

All medicines may cause side effects, but many people have no, or minor, side effects. If any of the following most COMMON side effects continue or become bothersome, check with your doctor: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; dizziness; flushing; headache; indigestion; joint pain; lightheadedness; nasal stuffiness; nosebleed; trouble sleeping; vision changes (eg, blurred vision, sensitivity to light, impaired blue/green color discrimination).

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in heartbeat; chest pain; fainting; nausea; painful or prolonged erection (lasting more than 4 hours); severe dizziness; sudden decrease or loss of vision in one or both eyes; urinary tract infection.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (, or emergency room immediately. Symptoms may include fainting; prolonged erection; severe dizziness.

Proper storage of Revatio :

Store Revatio at room temperature at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Revatio out of the reach of children and away from pets.

General information:

  • If you have any questions about Revatio , please talk with your doctor, pharmacist, or other health care provider.
  • Revatio is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Revatio . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

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