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Isosorbide Dinitrate

    DEA Class; Rx

    Common Brand Names; Dilatrate-SR, Isordil, Isordil Titradose, ISDN

    • Nitrates, Angina
    Moderate- to long-acting oral organic nitrate; used for relief and prophylaxis of angina pectoris; also used as an adjunctive agent for CHF (off-label use); in combination with hydralazine, it improves mortality in patients with CHF, but to a lesser degree than observed with the first-line ACE inhibitor therapy for CHF.

    Indicated for the prevention of angina pectoris due to coronary artery disease.

    For the treatment of heart failure.
    For the treatment of diffuse esophageal spasm without gastroesophageal reflux.
    For the treatment of achalasia.

    Hypersensitivity

    Recent use (within several days) of PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, or vardenafil) may cause dangerously low hypotension; the time course of the interaction appears to be related to the PDE-5 inhibitor half-life

    Severe anemia, shock, markedly low blood pressure (BP)

    Concomitant administration with guanylate stimulator riociguat

    Cardiovascular: Rebound hypertension (uncommon), syncope, unstable angina flushing, hypotension/orthostatic hypotension, lightheadedness, palpitations, tachyarrhythmia

    Central nervous system (CNS): Dizziness, headache, restlessness, weakness

    Gastrointestinal (GI): Nausea

    Hematologic: Methemoglobinemia (infrequent)

    Allergies to nitrates, head trauma/cerebral hemorrhage (potential contraindication), hypertrophic cardiomyopathy, increased intraocular pressure, postural hypotension, acute myocardial infarction (MI), congestive heart failure, hyperthyroidism

    Inability to relieve chest pain after 3 doses may signal acute MI necessitating emergency management

    Tolerance to extended-release formulation may develop, rendering formulation ineffective after a few weeks

    Do not change brands unintentionally; formulations are not all bioequivalent

    Severe hypotension, particularly with upright posture, may occur with even small doses; use with caution in patients who may be volume depleted or who are already hypotensive; hypotension induced by isosorbide dinitrate may be accompanied by paradoxical bradycardia and increased angina pectoris

    Nitrate therapy may aggravate angina caused by hypertrophic cardiomyopathy

    Treat drug-induced headache with aspirin or acetaminophen

    Provide nitrate-free interval (10-12 hours or overnight) to prevent development of tolerance

    Use supportive treatment in overdose

    Avoid use of extended release formulation in acute MI or acute heart failure; adverse events are not easily reversible if they develop

    Avoid use in patients with hypertrophic cardiomyopathy with outflow tract obstruction; nitrates may reduce preload, which may cause exacerbation of obstruction and cause hypotension or syncope and/or worsening of heart failure

    Pregnancy category: C

    Lactation: Unknown whether drug is distributed into breast milk

    Adults

    480 mg/day PO for immediate-release preparations; 160mg/day PO for sustained-release preparations; maximum dosage for SL route is not available.

    Elderly

    480 mg/day PO for immediate-release preparations; 160mg/day PO for sustained-release preparations; maximum dosage for SL route is not available.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Isosorbide Dinitrate

    capsule/tablet, extended release

    • 40mg

    tablet, sublingual

    • 2.5mg
    • 5mg

    tablet

    • 5mg
    • 10mg
    • 20mg
    • 30mg
    • 40mg