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The FDA has confirmed there are no generic substitutes for BiDil.15

TERMS AND CONDITIONS OF USE:

Access to and use of this web site is subject to these Terms and Conditions of use and all applicable laws and regulations. Please read these Terms and Conditions of use carefully. Your use of this web site constitutes your acceptance of these Terms and Conditions. If you do not agree to abide by all of the provisions contained in these Terms and Conditions, you must not use or access the web site. These Terms and Conditions may also be changed, such changes which will be posted to this page and will become effective immediately upon posting. For this reason, you are urged to read Terms and Conditions each time you visit this web site. These Terms and Conditions were last updated August, 2007.

Copyright and Trademark Information

This web site, and the content which it contains, is the property of NitroMed, Inc. ("NitroMed") and its affiliates and licensors, and is protected from unauthorized copying and dissemination by United States copyright law, trademark law, international conventions and other intellectual property laws. NitroMed®, BiDil®, More Life to Live™, NitroMed Cares™, and the "N" design are registered trademarks or trademarks of NitroMed, Inc. in the United States and other countries.

All other product names are trademarks or registered trademarks of their respective owners.

Use of BiDil.com Web Site and Its Content

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The information contained throughout this web site is provided by NitroMed for informational purposes only. The information on this web site is not intended to take the place of professional medical care, or professional medical advice or to constitute a treatment recommendation. If you have, or suspect you have, a medical condition, you should consult with your physician or another qualified health care provider. Although NitroMed will use reasonable efforts to include accurate and up-to-date information on this site, it makes no warranties or representations as to its accuracy.

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All disputes arising out of or relating to these Terms and Conditions shall be finally resolved by arbitration conducted in the English language in Boston, Massachusetts, U.S.A. under the commercial arbitration rules of the American Arbitration Association. The parties shall appoint as sole arbitrator a retired judge who presided in the Commonwealth of Massachusetts. The parties shall bear equally the cost of the arbitration (except that the prevailing party shall be entitled to an award of reasonable attorneys' fees incurred in connection with the arbitration in such an amount as may be determined by the arbitrator). All decisions of the arbitrator shall be final and binding on both parties and enforceable in any court of competent jurisdiction. Notwithstanding this, application may be made to any court for a judicial acceptance of the award or order of enforcement. Notwithstanding the foregoing, NitroMed shall be entitled to seek injunctive relief, security, or other equitable remedies from the United States District Court for the District of Massachusetts or any other court of competent jurisdiction.

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Important information about BiDil®
(isosorbide dinitrate/hydralazine hydrochloride):

INDICATIONS AND USAGE
BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient reported functional status. There is little experience in patients with NYHA class IV heart failure. Most patients in the clinical trial supporting effectiveness (A-HeFT) received a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.

CONTRAINDICATIONS
BiDil is contraindicated in patients who are allergic to organic nitrates.

WARNINGS
Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors such as sildenafil, vardenafil, or tadalafil could result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Reasonable supportive care should consist of those measures used to treat a nitrate overdose with elevation of the extremities and central volume expansion.

ADVERSE REACTIONS
Adverse events reported in A-HeFT and seen more frequently in the group given BiDil included headache (50% in BiDil patients vs. 21% in placebo patients) and dizziness (32% in BiDil patients vs. 14% in placebo patients).

The full Prescribing Information for BiDil is available here.


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