Revatio

INDICATIONS

Revatio is indicated for the treatment of pulmonary arterial hypertension. Revatio is a phosphodiesterase type 5 (PDE5) inhibitor. It works by relaxing and dilating the blood vessels in the lungs. This lowers the blood pressure in the lungs and helps to improve your ability to exercise.

INSTRUCTIONS

Use Revatio as directed by your doctor.

• Take Revatio by mouth with or without food. Take your doses 4 to 6 hours apart unless your doctor tells you otherwise.
• Take Revatio on a regular schedule to get the most benefit from it. Take it at the same times each day.
• Continue to take Revatio even if you feel well. Do not miss any doses.
• Do not suddenly stop taking Revatio or change your dose without talking to your doctor.
• If you miss a dose of Revatio, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

DOSAGE

The recommended dose of Revatio is 20 mg three times a day (TID). Treatment with doses higher than 20 mg TID is not recommended. Dosages lower than 20 mg TID were not tested. Whether dosages lower than 20 mg TID are effective is not known.

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

STORAGE

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.

MORE INFO:

Active Ingredient: Sildenafil citrate.

Do NOT use Revatio if:

• you are allergic to any ingredient in Revatio
• you have pulmonary veno-occlusive disease (PVOD)
• you are taking nitrates (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, spray, patch, ointment), or nitroprusside
• you take another medicine that contains sildenafil, another PDE5 inhibitor (eg, tadalafil, vardenafil), or ritonavir
• you use certain recreational drugs called "poppers" (eg, amyl nitrate or nitrite, butyl nitrate or nitrite).

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

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 a history of a prolonged (more than 4 hours) or painful erection (priapism)
• if you have a deformed penis (eg, cavernosal fibrosis, Peyronie disease), certain blood cell problems (eg, leukemia, multiple myeloma, sickle cell anemia), or any other condition that may increase the risk of a prolonged or painful erection (priapism)
• if you have a history of certain eye problems (eg, macular degeneration, optic neuropathy, retinitis pigmentosa, sudden vision loss in one or both eyes) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
• if you are dehydrated or have a history of liver or kidney problems, high or low blood pressure, ulcers, bleeding problems, heart problems (eg, aortic stenosis, angina, irregular heartbeat, heart failure), blood vessel problems, or nervous system problems
• if you have a history of heart attack, stroke, or life-threatening irregular heartbeat, especially within the past 6 months
• if you are taking bosentan or medicine for erectile dysfunction (ED).

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, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
• Azole antifungals (eg, itraconazole, ketoconazole), H₂ antagonists (eg, cimetidine), HIV protease inhibitors (eg, ritonavir, saquinavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Revatio's side effects
• Barbiturates (eg, phenobarbital), bosentan, carbamazepine, efavirenz, nevirapine, phenytoin, rifabutin, or rifampin because they may decrease Revatio's effectiveness.

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.

Important safety information:

• Revatio may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Revatio with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
• Revatio may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Patients with heart problems who take Revatio may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck, or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain, or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms.
• Revatio may rarely cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if you have an erection that lasts more than 4 hours.
• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
• Revatio may uncommonly cause mild, temporary vision changes (eg, blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe.
• Rarely, an eye problem called nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Revatio. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away.
• Sudden decreases in hearing and loss of hearing have been reported in some patients who have taken Revatio. Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
• Do not use medicines or treatments for ED while you are taking Revatio without first checking with your doctor.
• Use Revatio with caution in the elderly; they may be more sensitive to its effects.
• Revatio should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.
• Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Revatio while you are pregnant. It is not known if Revatio is found in breast milk. If you are or will be breast-feeding while you use Revatio, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Diarrhea; dizziness; flushing; headache; muscle aches; nosebleed; numb or tingling skin; stuffy nose; trouble sleeping; upset stomach.

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); chest pain; confusion; fainting; fast or irregular heartbeat; fever; memory loss; numbness of an arm or leg; one-sided weakness; painful or prolonged erection; ringing in the ears; seizure; severe or persistent dizziness or nosebleed; severe or persistent vision changes; shortness of breath; speech problems; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.