Nicorandil Ampoule Dosing
A standard 5 mL intravenous ampoule of nicorandil contains 12 mg of the drug, providing a concentration of 2.4 mg/mL. 1
Critical Context for U.S. Practitioners
Nicorandil is NOT FDA-approved in the United States and no standardized U.S. infusion protocol exists. 2 The drug is approved and widely used in Europe, Japan, and other countries but remains unavailable for routine clinical use in American practice. 2
Standard IV Dosing Protocols (International)
Acute Coronary Syndromes
- Initial IV bolus: 2–14 mg administered over 5 minutes 1
- Continuous infusion: Titrate to clinical response (angina relief or hemodynamic targets) 1
- In clinical trials, a 12 mg bolus followed by continuous infusion demonstrated significant benefit in ST-elevation MI patients undergoing PCI 3
Acute Decompensated Heart Failure
- Loading dose: 0.2 mg/kg IV bolus over 5 minutes 4
- Maintenance infusion: 0.05–0.20 mg/kg/hour for 6 hours, titrated to effect 4
- This regimen decreased pulmonary artery wedge pressure by 26.5% and increased cardiac index by 15.8% in a dose-dependent manner 4
Prevention of Slow Coronary Flow During PCI
- Single 6 mg IV bolus immediately before PCI 5
- This dose showed optimal vasodilatation efficacy without significant hemodynamic instability 5
Pharmacokinetic Properties
- Bioavailability: 75–100% with minimal first-pass metabolism 6, 7
- Peak plasma concentration: Achieved within 30 minutes after oral dosing; immediate with IV administration 6
- Elimination half-life: Approximately 1 hour for the rapid phase 6, 7
- Volume of distribution: 1.0–1.4 L/kg body weight 6, 7
- Protein binding: Weak (~25%), with >75% free fraction 6, 7
Critical Contraindications
Absolute contraindications include: 1
- Concomitant use with phosphodiesterase-5 inhibitors (sildenafil, tadalafil, vardenafil) due to severe hypotension risk (Class I, Level C) 1
- Cardiogenic shock or severe hypotension 1
Relative contraindications and cautions: 2, 8, 1
- Do NOT combine with other nitrates—no additional efficacy and increased hypotension risk 2, 8, 1
- Avoid combination with ivabradine or ranolazine due to unknown safety profile 2, 8
- Use cautiously with aspirin—increased risk of GI ulcers, perforations, and hemorrhage 2, 1
- Long-term safety in heart failure patients remains uncertain 2, 8, 1
Monitoring Requirements During IV Infusion
Continuous hemodynamic monitoring is essential: 1
- Blood pressure and heart rate monitoring throughout infusion 1
- Titrate dose until anginal symptoms resolve or adverse effects emerge 1
- Watch for hypotension, dizziness, syncope, or headache 1
- Promptly discontinue if signs of severe hypotension develop 1
Common Pitfalls to Avoid
Do NOT confuse nicorandil with nicardipine—these are entirely different drugs with different mechanisms (potassium channel opener/nitrate hybrid vs. calcium channel blocker) and indications. 2
Rare but serious adverse effects with chronic use include skin, mucosal, and eye ulceration. 2, 1