Prescription Required Why?
India
BiDil is a prescription combination medication used in the treatment of heart failure in self-identified Black patients. It contains two active ingredients: isosorbide dinitrate and hydralazine hydrochloride, which work synergistically to improve heart function, reduce symptoms, and enhance quality of life in individuals with heart failure. BiDil is particularly effective in patients with New York Heart Association (NYHA) Class III or IV heart failure who are already receiving standard therapy.
Vasodilator Combination
Therapeutic Class: Cardiovascular Agent
Isosorbide Dinitrate (20 mg)
Hydralazine Hydrochloride (37.5 mg)
BiDil combines two direct vasodilators with distinct mechanisms of action:
Isosorbide Dinitrate is a nitrate that relaxes venous smooth muscle, reducing preload (the amount of blood returning to the heart), and decreases myocardial oxygen demand.
Hydralazine Hydrochloride primarily dilates arterial smooth muscle, reducing afterload (the resistance the heart must overcome to eject blood), which enhances cardiac output.
Together, they reduce the workload of the heart, improve left ventricular function, and alleviate heart failure symptoms.
BiDil is indicated for:
The treatment of heart failure in self-identified Black patients as an adjunct to standard therapy (ACE inhibitors or ARBs, beta-blockers, and diuretics).
Patients who remain symptomatic despite optimal therapy with conventional medications.
BiDil is FDA-approved based on the landmark A-HeFT (African-American Heart Failure Trial), which demonstrated significant reductions in mortality and hospitalizations in Black patients with heart failure.
Initial Dose: One tablet three times daily.
Maintenance Dose: Can be increased to two tablets three times daily based on clinical response and tolerability.
Note: Dose adjustment may be required in patients with renal impairment, hypotension, or adverse reactions.
Take BiDil exactly as prescribed by your healthcare provider.
Swallow the tablets whole with a glass of water.
Take with or without food, but maintain consistency.
Do not stop taking the medication abruptly without medical supervision.
Hypotension Risk: Monitor blood pressure regularly.
Systemic Lupus Erythematosus (SLE): Hydralazine has been associated with drug-induced lupus-like syndrome.
Tachycardia and Fluid Retention: May occur, especially in high doses.
Known hypersensitivity to hydralazine, isosorbide dinitrate, or any nitrate.
Concomitant use with PDE-5 inhibitors (e.g., sildenafil) may cause severe hypotension.
Headache
Dizziness or lightheadedness
Nausea
Fast heartbeat (palpitations)
Nasal congestion
Serious Side Effects:
Lupus-like syndrome (fever, joint pain, rash)
Severe hypotension
Peripheral neuropathy
Chest pain
Seek immediate medical attention if serious side effects occur.
Avoid concurrent use with drugs like sildenafil, tadalafil, and vardenafil due to risk of profound hypotension.
May interact with other antihypertensive drugs, leading to enhanced blood pressure lowering.
Inform your doctor of all medications, supplements, or herbal products you are taking.
The A-HeFT Trial, a randomized, double-blind, placebo-controlled study, showed that the combination of isosorbide dinitrate and hydralazine significantly reduced mortality by 43%, decreased hospitalizations by 33%, and improved quality of life scores in Black patients with advanced heart failure.
BiDil should be part of a comprehensive heart failure management plan.
Monitor blood pressure, kidney function, and signs of fluid overload during therapy.
Lifestyle changes such as reduced sodium intake, regular physical activity, and weight monitoring should accompany medication use.
Q: What is BiDil used for?
A: BiDil is used to treat heart failure, specifically in self-identified Black patients, in addition to standard therapies.
Q: Is BiDil a cure for heart failure?
A: No, BiDil helps manage the symptoms and progression of heart failure, but it is not a cure.
Q: Can BiDil be used by non-Black patients?
A: While BiDil is specifically approved for Black patients based on clinical trial data, your doctor may consider it in other populations if deemed appropriate.
Q: Can I take BiDil with other heart medications?
A: Yes, but only under medical supervision. It is usually added to ACE inhibitors, beta-blockers, and diuretics.
Q: What if I miss a dose?
A: Take the missed dose as soon as possible. Skip it if it’s almost time for your next dose. Do not double up.
