Indicated for:

Treatment of Heart Failure in Self-identified Black Patients:

• 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.

BiDil is contraindicated in patients who are allergic to organic nitrates.

Do not use BiDil in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil.

Concomitant use can cause severe hypotension, syncope, or myocardial ischemia.

Do not use BiDil in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension.

Symptomatic hypotension, particularly with upright posture, may occur with even small doses of BiDil. Hypotension is most likely to occur in patients who have been volume or salt depleted; correct prior to initiation of BiDil.

Isosorbide dinitrate concentrations increase in patients with cirrhosis.

Hydralazine hydrochloride has been reported to cause a drug-induced systemic lupus erythematosus (SLE) syndrome. Symptoms and signs usually regress when hydralazine hydrochloride is discontinued.

Hydralazine hydrochloride can cause tachycardia and hypotension potentially leading to myocardial ischemia and angina, particularly in patients with hypertrophic cardiomyopathy.

Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness, and tingling, which may be related to an antipyridoxine effect. Pyridoxine should be added to BiDil therapy if such symptoms develop.

BiDil is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), PDE5 inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. Do not use BiDil in patients who are taking the soluble guanylate cyclase (sGC) stimulator. riociguat. Concomitant use can cause hypotension.

There are no data on BiDil use in pregnant women, and insufficient data on its components (hydralazine and isosorbide dinitrate) to assess a drug-associated risk of major birth defects or miscarriage with first trimester use. Available published data on hydralazine use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy-related outcomes. Animal studies: embryo-toxicity.

There are no data on the presence of BIDIL in human or animal milk, the effects on the breastfed infant or on milk production.

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• Use in patients under 18 years of age. GoToSource

• Achalasia and diffuse esophageal spasms. GoToSource

⚠️  Patients with the HLA-DR4 gene are more prone to drug-induced liver injury.

Tachyphylaxis (rapidly decreasing response to a drug), tachycardia (rapid heart rate), flushing, hypotension (low blood pressure), palpitations (abnormal or irregular heart beat), dizziness, drug-induced lupus erythematosus, serum sickness (hypersensitivity reaction), hemolytic anemia (abnormal breakdown or destruction of red blood cells), vasculitis (inflammation of blood vessels), glomerulonephritis (a type of kidney disease), liver injury, toxic epidermal necrolysis (severe skin disorder), myocardial ischemia (blood flow to heart muscle is obstructed), myocardial infarction and peripheral neuritis (damage to the nerves outside of the brain and spinal cord). GoToSource

Monday disease (drug tolerance) and methemoglobinemia (blood disorder). GoToSource

Depression, mild anxiety, psychosis and delirium. GoToSource

No major injury lawsuits reported.