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 in addition to routine heart medicines to treat heart failure in black patients, to extend life, 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 received routine 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 (Sorbitrate® or Isordil®). BiDil has a nitrate component, so you need to let your doctor know.

Tell your doctor if you're taking any erectile dysfunction or pulmonary hypertension drugs, like Viagra®/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.

Drinking alcohol when taking BiDil could make you feel very lightheaded. We recommend that you try to avoid drinking alcohol while taking BiDil.

It is possible you'll get headaches, especially at first. 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.

Sorbitrate is a registered trademark of AstraZeneca LP; Isordil is a registered trademark of Bioavail Corporation; Viagra is a registered trademark and Revatio is a trademark of Pfizer Inc.; Levitra is a registered trademark of Bayer Healthcare, GlaxoSmithKline, and Schering-Plough; Cialis is a registered trademark of Lilly ICOS LLC. Tylenol is a registered trademark of McNeil Pharmaceuticals, a Division of McNeil PPC, Inc.

Please see full Prescribing Information for BiDil.