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Isosorbide Dinitrate/Hydralazine

    Brands

    DEA Class; Rx

    Common Brand Names; BiDil

    • Nitrates, Angina
    Oral fixed dose combination of a peripheral vasodilator (hydralazine) and a nitrate (isosorbide dinitrate); used as adjunctive therapy for heart failure in patients self-identified as black.

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

    Allergy to organic nitrates

    Concomitant use with PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, or vardenafil)

    Concomitant use with soluble guanylate cyclase (sGC) stimulators (eg, riociguat)

    Isosorbide Dinatrate

    • Flushing

    • Hypotension/orthostatic hypotension

    • Lightheadedness

    • Palpitations

    • Rebound hypertension (uncommon)

    • Syncope

    • Unstable angina tachyarrhythmia

    • Dizziness

    • Headache

    • Restlessness

    • Weakness

    • Nausea

    • Methemoglobinemia (infrequent)

    Hydralazine

    • Hypotension

    • Palpitations

    • Tachycardia

    • Headache

    • Neuropathy

    • Anorexia

    • Diarrhea

    • Nausea

    • Vomiting

    • Agranulocytosis

    • Leukopenia

    • Hepatotoxicity

    • Chest pain

    • Dyspnea

    • Nasal congestion

    Paradoxical bradycardia may occur

    Use caution in pulmonary hypertension

    Caution in patients with coronary artery disease or tachycardia

    Caution in suspected right ventricular infarction or acute MI

    Even small doses may cause symptomatic hypotension, particularly with upright posture; most likely to occur in patients who have been volume or salt depleted; correct prior to initiation of therapy

    Hydralazine may cause symptomatic lupus erythematosus syndromes; consider discontinuation if clinically appropriate

    May cause tachycardia and hypotension, potentially leading to myocardial ischemia and angina, particularly in patients with hypertrophic cardiomyopathy

    Associated with peripheral neuritis, which may cause paresthesia, numbness, and tingling that may result from an antipyridoxine effect; add pyridoxine to therapy if such symptoms develop

     

    There are no data on 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

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

    Adults

    225 mg/day PO hydralazine and 120 mg/day PO isosorbide dinitrate.

    Elderly

    225 mg/day PO hydralazine and 120 mg/day PO isosorbide dinitrate.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Isosorbide dinitrate/hydralazine

    tablet

    • 20mg/37.5mg