Yilian Ilaprazole Sodium for Injection

1. Indications and Usage
Peptic Ulcer Bleeding: Treatment of patients with endoscopically confirmed peptic ulcer bleeding (e.g., gastric or duodenal ulcer).
Prevention of Stress Ulcer Bleeding: Prevention of stress ulcer bleeding in critically ill patients.
Other Acid-Related Diseases: Treatment of duodenal ulcers and reflux esophagitis (based on clinical guidelines).
2. Dosage and Administration
Route of Administration: For Intravenous (IV) Infusion ONLY. Intramuscular or subcutaneous injection is strictly prohibited.
Recommended Dosage:
Peptic Ulcer Bleeding: Initial dose 20 mg, followed by 10 mg once daily for 3 days. Afterward, switch to oral formulation if clinically appropriate.
Stress Ulcer Prophylaxis: 10 mg once daily.
Critical Administration Instructions:
Preparation: Reconstitute with 0.9% Sodium Chloride Injection only. Do not mix with other infusion fluids or drugs.
Infusion Time: Administer within 3 hours after preparation. The infusion should be completed within 30 minutes.
3. Mechanism of Action
Proton Pump Inhibition: Ilaprazole is a specific inhibitor of gastric H+/K+-ATPase (the proton pump).
Acid Suppression: It accumulates in the acidic environment of parietal cells, where it is converted into a sulfenic acid derivative. This active form covalently binds to cysteine residues on the proton pump, irreversibly blocking both basal and stimulated gastric acid secretion.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with known hypersensitivity to ilaprazole or other benzimidazoles (e.g., omeprazole, lansoprazole).
Clopidogrel Interaction: Like other PPIs, ilaprazole may reduce the antiplatelet effect of clopidogrel. Caution is advised when co-administering with clopidogrel.
Long-Term Risks: Long-term use (≥3 months) may increase the risk of hypomagnesemia, fractures, and Clostridium difficile infection.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Elevated liver enzymes (ALT, AST), decreased white blood cell count, headache, diarrhea, and rash.
Clinical Research Highlights: Clinical trials have demonstrated that intravenous ilaprazole effectively maintains intragastric pH >4.0, providing rapid and sustained acid suppression with a favorable safety profile compared to other PPIs.
6. Drug Interactions
Clopidogrel: Ilaprazole is metabolized by CYP3A4 and may interfere with the activation of clopidogrel. Co-administration should be avoided or closely monitored.
Drugs Absorption-Dependent on pH: May reduce the absorption of drugs requiring an acidic environment (e.g., ketoconazole, itraconazole, iron salts).
Methotrexate: PPIs may decrease the clearance of methotrexate; monitor closely in high-dose methotrexate therapy.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Ilaprazole Sodium.
Appearance: White or off-white porous cake or powder.
Packaging: Single-use vial (10 mg or 20 mg calculated as ilaprazole).
Storage: Store in the original carton at controlled room temperature (20°C to 25°C). Protect from light and moisture.