Isosorbide Dinitrate
Regulatory sources consulted
- AEMPS CIMA FT 49679: https://cima.aemps.es/cima/dochtml/ft/49679/FT_49679.html
- Clinical Pharmacology Knowledge
- AEMPS CIMA · nº registro 49679 ↗
- RxNorm rxcui 6058 ↗
Approved indications
- Treatment and prophylaxis of angina pectoris.
- Treatment of chronic congestive heart failure (in combination with other drugs, typically hydralazine).
- Treatment of diffuse esophageal spasm.
Contraindications
Absolute
- Concomitant use of phosphodiesterase-5 inhibitors (sildenafil, tadalafil, vardenafil) due to risk of severe hypotension.
- Severe hypotension (systolic blood pressure < 90 mmHg) or cardiogenic shock.
- Severe anemia.
- Hypersensitivity to nitrates.
Clinical warnings
- Major warning · Risk of orthostatic hypotension, especially in the elderly or volume-depleted patients. May cause syncope. — AEMPS CIMA
- Drug tolerance may develop, decreasing its effect. A daily nitrate-free interval is required. — AEMPS CIMA
Drug interactions
- HighSildenafilG04BE03
Mechanism: Synergistic increase in cGMP (NO donor + PDE5 inhibition), resulting in severe systemic vasodilation and life-threatening hypotension.
Recommendation: Concomitant use is contraindicated. Actively ask the patient about the use of these drugs.
AEMPS CIMA FT 49679
- HighRiociguatC02KX05
Mechanism: Potentiation of the hypotensive effect. Both drugs increase the cGMP pathway, one by NO donation and the other by stimulating soluble guanylate cyclase.
Recommendation: Concomitant use is contraindicated.
AEMPS CIMA FT 49679
Adverse events
Common (≥1%)
headache · dizziness · hypotension · reflex tachycardia · flushing
Rare but serious
methemoglobinemia · syncope · paradoxical angina · exfoliative dermatitis
Pregnancy and lactation
FDA category: C
Pregnancy: Use only if the benefit outweighs the potential risk to the fetus. Lactation: It is unknown if excreted in human milk; use with caution.