isosorbide dinitrate
Drug Details
- Generic Name
- isosorbide dinitrate
- Brand Names
- Isosorbide Dinitrate, ISOSORBIDE DINITRATE
- Application Number
- ANDA087537
- Sponsor
- Endo USA, Inc.
- NDC Codes
- 19
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- ISOSORBIDE DINITRATE
Indications and Usage
1 INDICATIONS AND USAGE Isosorbide dinitrate and hydralazine hydrochloride tablets are 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 Isosorbide dinitrate and hydralazine hydrochloride tablets are 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.