hydralazine hydrochloride 37.5 mg isosorbide dinitrate 20 mg oral tablet bidil

1 INDICATIONS AND USAGE BiDil is a combination of isosorbide dinitrate, a nitrate vasodilator, and hydralazine hydrochloride, an arteriolar vasodilator, indicated for: the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status ( 1.1 ) Limitations of use: There is little experience in patients with NYHA class IV heart failure ( 1.2 ) 1.1 Treatment of Heart Failure in Self-identified Black Patients 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. 1.2 Limitations of Use There is little experience in patients with NYHA class IV heart failure.

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FDA Reported Adverse Reactions
[1] toxicity to various agents    [2] completed suicide    [3] drug abuse    [4] drug ineffective    [5] acute kidney injury    [6] death    [7] off label use    [8] nausea    [9] chronic kidney disease    [10] renal failure