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
©Copyright 2007-2009
Pfizer Inc.
All rights reserved.
RVU00115A. December 2009.
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This product information is intended only for residents of the United States.
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.