Zaoning Moracizine Hydrochloride Tablets

1. Indications and Usage
Ventricular Arrhythmias: Mainly indicated for ventricular arrhythmias, including ventricular premature beats and ventricular tachycardia.
2. Dosage and Administration
Standard Dose: The usual adult dosage is 150–300 mg every 8 hours. The maximum daily dose is 900 mg.
Individualization: Dosage should be individualized. Other antiarrhythmic drugs should be discontinued for 1–2 half-lives before initiating Moracizine therapy.
3. Mechanism of Action
Sodium Channel Blockade: Belonging to Class I antiarrhythmic drugs, it inhibits fast Na+ influx.
Membrane Stabilization: It stabilizes the membrane, shortens phases 2 and 3 repolarization and action potential time, and shortens the effective refractory period.
4. Safety and Warnings
Proarrhythmic Risk: CAST trials confirmed that its use in patients with silent non-fatal ventricular arrhythmias post-myocardial infarction increases mortality within two weeks.
Black Box Warning: The drug carries a risk of increasing mortality in patients with non-lethal ventricular arrhythmias after a myocardial infarction.
Contraindications: Contraindicated in patients with 2nd or 3rd-degree atrioventricular block, bundle branch block (without a pacemaker), cardiogenic shock, or known hypersensitivity.
Monitoring: Use with caution in patients with severe heart failure, liver or kidney dysfunction. Early monitoring of ECG and blood pressure is recommended.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Dizziness, nausea, headache, fatigue, somnolence, abdominal pain, dyspepsia, vomiting, sweating, paresthesia, dry mouth, and diplopia.
Arrhythmogenic Effects: The incidence of proarrhythmic effects (worsening of existing arrhythmias or new arrhythmias) is approximately 3.7%.
6. Drug Interactions
Cimetidine: Can increase Moracizine blood concentration by 1.4 times; dose reduction of Moracizine may be necessary.
Theophylline: May increase the clearance of Theophylline and shorten its half-life.
Warfarin: May alter Warfarin’s effect on prothrombin time; monitoring is required when starting or stopping Moracizine in patients on stable anticoagulation.
7. Pharmaceutical Information
Active Ingredient: Moracizine Hydrochloride.
Strengths: Typically available as 50 mg tablets (or sugar-coated tablets).
Appearance: White tablets or sugar-coated tablets (decoated tablets appear white).
Storage: Keep protected from light and in a tight container.