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
- abdominal pain
- agranulocytosis
- amblyopia
- angina
- asthenia
- blurred vision
- bradycardia
- chest pain (unspecified)
- conjunctivitis
- constipation
- cyanosis
- dizziness
- dysgeusia
- dyspnea
- dysuria
- eosinophilia
- erythema
- fluid retention
- flushing
- headache
- hepatitis
- hyperhidrosis
- hypoesthesia
- hypotension
- ileus
- impaired cognition
- impotence (erectile dysfunction)
- lacrimation
- lupus-like symptoms
- methemoglobinemia
- migraine
- myalgia
- myocardial infarction
- nausea
- neuritis
- orthostatic hypotension
- palpitations
- paresthesias
- peripheral edema
- peripheral vasodilation
- pruritus
- purpura
- sinus tachycardia
- sinusitis
- splenomegaly
- syncope
- tinnitus
- ventricular tachycardia
- vertigo
- vomiting
- weakness
- 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
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
- Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
- Acetaminophen; Dextromethorphan; Phenylephrine
- Acetaminophen; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Dichloralphenazone; Isometheptene
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- Acetaminophen; Pseudoephedrine
- Acetazolamide
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- Ziprasidone
