Hydralazine Isosorbide Dinitrate

Hydralazine Isosorbide Dinitrate Brand Name– BiDil

What is Hydralazine Isosorbide Dinitrate

Hydralazine Isosorbide Dinitrate represents the first race-based drug therapy to be approved by the FDA.

BiDil is a fixed-dose combination of hydralazine and isosorbide dinitrate, approved as an adjunct to standard therapy, for the treatment of heart failure in patients self-identified as black.

Analyses of previous heart failure trials suggest that black patients have an increased response to hydralazine; isosorbide dinitrate combination therapy versus non-black patients.

Subsequently, the African-American Heart Failure Trial (A-HeFT) has evaluated a fixed-dose combination of hydralazine and isosorbide dinitrate to treat African-American patients receiving standard therapy for heart failure (primarily NYHA Class III).

The combination therapy, when compared to placebo, reduces the rate of death by 43%, reduces the rate of first hospitalization by 33%, and improves patient-reported functional status.

In the A-HeFT trial, patients receiving hydralazine; isosorbide dinitrate also received concurrent therapy with ACE inhibitors (69%), angiotensin II receptor blockers (17%), beta-blockers (74%), diuretics (88%), cardiac glycosides (59%), and/or diuretics (88%).

Hydralazine Isosorbide Dinitrate (BiDil) was approved by the FDA on June 23, 2005.

Indications

  • heart failure

For the adjunctive treatment of heart failure in patients self-identified as black taking standard heart failure therapy

Side Effects

  1. abdominal pain
  2. agranulocytosis
  3. amblyopia
  4. angina
  5. asthenia
  6. blurred vision
  7. bradycardia
  8. chest pain (unspecified)
  9. conjunctivitis
  10. constipation
  11. cyanosis
  12. dizziness
  13. dysgeusia
  14. dyspnea
  15. dysuria
  16. eosinophilia
  17. erythema
  18. fluid retention
  19. flushing
  20. headache
  21. hepatitis
  22. hyperhidrosis
  23. hypoesthesia
  24. hypotension
  25. ileus
  26. impaired cognition
  27. impotence (erectile dysfunction)
  28. lacrimation
  29. lupus-like symptoms
  30. methemoglobinemia
  31. migraine
  32. myalgia
  33. myocardial infarction
  34. nausea
  35. neuritis
  36. orthostatic hypotension
  37. palpitations
  38. paresthesias
  39. peripheral edema
  40. peripheral vasodilation
  41. pruritus
  42. purpura
  43. sinus tachycardia
  44. sinusitis
  45. splenomegaly
  46. syncope
  47. tinnitus
  48. ventricular tachycardia
  49. vertigo
  50. vomiting
  51. weakness
  52. weight gain

Monitoring Parameters

  • antinuclear antibody (ANA) titer
  • blood pressure
  • heart rate
  • serum creatinine/BUN

Contraindications

  • acute myocardial infarction
  • anemia
  • angina
  • breast-feeding
  • cardiomyopathy
  • children
  • closed-angle glaucoma
  • coronary artery disease
  • driving or operating machinery
  • geriatric
  • head trauma
  • hepatic disease
  • hyperthyroidism
  • hypotension
  • hypovolemia
  • increased intracranial pressure
  • intracranial bleeding
  • nitrate hypersensitivity
  • orthostatic hypotension
  • pregnancy
  • renal disease
  • renal failure
  • renal impairment
  • syncope
  • systemic lupus erythematosus (SLE)

Interactions

  • Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
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