BiDil has been approved by the US Food and Drug Administration for use by African American patients in addition to routine heart failure (HF) medicines. Only BiDil has been shown to improve survival, improve quality of life, and help reduce the rate of first hospitalization for HF vs standard therapy alone.1,2
The starting dosage for BiDil should be 1 tablet taken 3 times a day, but this may be increased up to a maximum of 2 tablets taken 3 times daily. The dosage may also be decreased to a minimum of a ½ tablet, 3 times a day if the patient has intolerable side effects.1
Daily dosing for BiDil1
ISDN=isosorbide dinitrate; TID=3 times daily.
Other important dosing information
- Although titration of BiDil can be rapid (3 to 5 days), some patients may experience side effects and take longer to reach their maximum tolerated dose
- Dosing selection for the elderly should be cautious, usually starting at the low end of the dosing range
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INDICATIONS AND USAGE
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. There is little experience in patients with NYHA class IV heart failure. Most patients in the clinical trial supporting effectiveness (A-HeFT) received a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.
IMPORTANT SAFETY INFORMATION
BiDil is contraindicated in patients who are allergic to organic nitrates, or who take phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). Concomitant use can cause hypotension.
WARNINGS AND PRECAUTIONS
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.
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. 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.
Most common adverse reactions (> 5% more on BiDil than on placebo) were headache and dizziness.
References: 1. BiDil [package insert]. Atlanta, GA: Arbor Pharmaceuticals, Inc; 2015. 2. Taylor AL, Ziesche S, Yancy C, et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004;351(20):2049-2057.