Classes
DEA Class; Rx
Common Brand Names; Dilatrate-SR, Isordil, Isordil Titradose, ISDN
- Nitrates, Angina
Description
Indications
Indicated for the prevention of angina pectoris due to coronary artery disease.
Contraindications
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
Adverse Effects
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)
Warnings
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 and Lactation
Pregnancy category: C
Lactation: Unknown whether drug is distributed into breast milk
Maximum Dosage
480 mg/day PO for immediate-release preparations; 160mg/day PO for sustained-release preparations; maximum dosage for SL route is not available.
480 mg/day PO for immediate-release preparations; 160mg/day PO for sustained-release preparations; maximum dosage for SL route is not available.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Isosorbide Dinitrate
capsule/tablet, extended release
- 40mg
tablet, sublingual
- 2.5mg
- 5mg
tablet
- 5mg
- 10mg
- 20mg
- 30mg
- 40mg