1. BiDil Prescribing Information
2. Isosorbide dinitrate Prescribing Information. Par Pharmaceuticals; February 2002.
3. Hydralazine hydrochloride Prescribing Information. Par Pharmaceuticals; June 2003.
4. Taylor AL, Ziesche S, Yancy C, et al, for the African-American Heart Failure Trial Investigators. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004;351:2049-2057.
5. Yancy CW. Heart failure in African Americans: a cardiovascular enigma. J Card Fail. 2000;6(3):183-186.
6. Dries DL, Exner DV, Gersh BJ, et al. Racial differences in the outcome of left ventricular dysfunction. N Engl J Med. 1999; 22:791-794.
7. Bourassa MG, Gurné O, Bangdiwala SI, et al, for the SOLVD Investigators. Natural history and patterns of current practice in heart failure. J Am Coll Cardiol. 1993;22(suppl A):14A-19A.
8. Thom T, Haase N, Rosamond W, et al. Heart disease and stroke statistics—2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2006:113;e85-e151.
9. U.S. Census Bureau. Statistical Abstract of the United States: 2000. 119th ed. Washington, DC: US Census Bureau; 2000.
10. Yancy CW. Heart failure in African Americans: pathophysiology and treatment. J Card Fail. 2003;9(suppl 3):S210-S215.
11. Rector TS, Cohn JN. Minnesota Living With Heart Failure® Questionnaire. Available at www.mlhfq.org.
12. Drexler H, Hasenfuss G. Physiology of the normal and failing heart. In: Crawford MH, DiMarco JP, Paulus WJ, eds. Cardiology. 2nd ed. Edinburgh: Mosby; 2004.
13. Pierpont GL, Cohn JN, Franciosa JA. Combined oral hydralazine-nitrate therapy in left ventricular failure. Chest. 1978;73:8-13.
14. Massie B, Chatterjee K, Werner J, Greenberg B, Hart R, Parmley WW. Hemodynamic advantage of combined administration of hydralazine orally and nitrates nonparenterally in the vasodilator therapy of chronic heart failure. Am J Cardiol. 1977;40:794-801.
15. Food and Drug Administration. Orange Book. http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm. Accessed March 9, 2007
16. NDA 20-727: FDA Clinical Pharmacology/Biopharmaceutics Review: Submission Date: July 3, 1996
17. Münzel T, et al. Hydralazine prevents nitroglycerin tolerance by inhibiting activation of a membrane-bound NADH oxidase: A new action for an old drug. J Clin Invest. 1996;98(6):1465-1470
18. Hare JM. Nitroso-redox balance in the cardiovascular system. N Engl J Med. 2004;351:2112-2114
Information for Patients about BiDil®
BiDil is approved for use with other heart medicines to treat heart failure in black patients to improve survival, improve heart failure symptoms, and help patients stay out of the hospital longer. There is little experience in patients with heart failure who experience significant symptoms while at rest. Most patients in the clinical study of BiDil also received other heart failure medicines.
IMPORTANT SAFETY INFORMATION
Tell your doctor about any allergies you have, especially if you're sensitive to nitrates, such as nitroglycerin tablets or isosorbide dinitrate (Isordil®). BiDil has a nitrate component, so you need to let your doctor know.
WARNINGS AND PRECAUTIONS
Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs like Viagra® or Revatio™ (sildenafil), Levitra® (vardenafil) or Cialis® (tadalafil). Mixing these with BiDil may cause a sudden drop in blood pressure, fainting, chest pain, or heart attack.
Also tell your doctor if you are taking any medication to decrease blood pressure because when taken with BiDil, blood pressure may become too low.
It is possible you'll get headaches, especially at first, but they often lessen over time. For some patients, Tylenol® (acetaminophen) helps ease the discomfort. Keep your doctor posted on your headache progress and Tylenol use; he or she may want to adjust your dosage.
If you experience dizziness, call your doctor. Please make sure to tell your doctor about any of the signs or symptoms mentioned below or about any unusual events that worry you.
Drinking less fluids than your doctor recommends or losing fluid due to diarrhea, sweating, or vomiting may cause low blood pressure, lightheadedness, or fainting. If fainting occurs, stop taking BiDil and contact your doctor immediately.
Lightheadedness may occur when standing, especially after sitting or lying down.
If you experience any achy and/or swollen joints, unexplained fever for more than a few days, skin rashes, chest pain, prolonged weakness or fatigue (even after a good night's sleep), or any other unexplained signs or symptoms, make sure to tell your doctor as they may be signs of a serious medical condition.
You may also experience rapid heartbeat that could lead to chest pain or aggravate chest pain, or numbness or tingling in the hands or feet.
COMMON SIDE EFFECTS
Headache and dizziness were the most frequent side effects experienced in studies with BiDil. Other side effects included chest pain, weakness, nausea, chest infection, low blood pressure, sinusitis, palpitations, high blood sugar, runny nose, tingling, vomiting, impaired vision, high cholesterol, and rapid heart rate.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here to see full Prescribing Information for BiDil. This information does not take the place of talking with your healthcare provider about your condition or your treatment. Ask your doctor if BiDil may be right for you.
Isordil is a registered trademark of Biovail Laboratories International SRL; Viagra is a registered trademark and Revatio is a trademark of Pfizer Inc.; Levitra is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline; Cialis is a registered trademark of Eli Lilly and Company; Tylenol is a registered trademark of McNEIL-PPC, Inc.