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BiDil (isosorbide dinitrate and hydralazine hcl) 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 con-verting enzyme inhibitor or an angiotensin II receptor blocker,and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.
DOSAGE AND ADMINISTRATION
Treatment with BiDil (isosorbide dinitrate and hydralazine hcl) should be initiated at a dose of one BiDil (isosorbide dinitrate and hydralazine hcl) Tablet,3 times a day.BiDil (isosorbide dinitrate and hydralazine hcl) may be titrated to a maximum tolerated dose,not to exceed two BiDil (isosorbide dinitrate and hydralazine hcl) Tablets, 3 times a day.
There is no adequate experience in heart failure with doses of BiDil (isosorbide dinitrate and hydralazine hcl) other than those recommended and no experience with use of individual components.
Although titration of BiDil (isosorbide dinitrate and hydralazine hcl) can be rapid (3-5 days),some patients may experience side effects and may take longer to reach their maximum tolerated dose. The dosage may be decreased to as little as one-half BiDil (isosorbide dinitrate and hydralazine hcl) Tablet 3 times a day if intolerable side effects occur. Efforts should be made to titrate up as soon as side effects subside.
BiDil (isosorbide dinitrate and hydralazine hcl) Tablets contain 20 mg of isosorbide dinitrate plus 37.5 mg of hydralazine hydrochloride.They are biconvex,approximately 8 mm in diameter,scored,film-coated,orange tablets debossed "20"on one side over the score and "N"on the other side.
NDC 12948-001-01 bottle of 12.
NDC 12948-001-12 bottle of 180.
Keep bottles tightly closed.
Store at 25°C (77°F),excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.]
Protect from light. Dispense in a light-resistant,tight container.
Manufactured for: NitroMed, Inc. Lexington,MA 02421, USA. By Schwarz Pharma Mfg.,Inc. Seymour, IN 47274, USA. FDA Rev date: 6/23/2005
Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.
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