The package insert provides dosage, administration, contraindications, side effects, storage, and regulatory information for Isosorbide Dinitrate Injection.
This package insert describes the composition, appearance, and approved indications of Isosorbide Dinitrate Injection (brand name 异舒吉®). It includes detailed instructions for preparation, dosage, and infusion rates, as well as safety warnings and handling procedures.
Clinicians are guided on initial dosing (1‑2 mg/h, adjustable up to 8‑10 mg/h), dilution methods, monitoring parameters, and management of adverse reactions such as hypotension and headache. Regulatory details, storage conditions, and packaging specifications are also provided. This manual is written in Chinese.
| Concentration | 10 mg per 10 ml |
|---|---|
| Form | Clear, colorless solution |
| Molecular formula | C6H8N2O8 |
| Molecular weight | 236.14 g/mol |
| Excipients | Sodium chloride and water for injection |
| Storage temperature | Room temperature (10‑30 °C) |
| Packaging | Ampoules, 10 ml each, 10 ampoules per box |
The initial dose can start at 1‑2 mg per hour and be adjusted according to the patient’s response, with a usual maximum of 8‑10 mg per hour.
After opening, dilute the solution under sterile conditions to either 100 µg/ml (0.01 %) or 200 µg/ml (0.02 %) using the specified volumes of the 0.1 % solution and sterile water.