Iodixanol is available as an injection solution in 2 concentrations: 270 mg/mL of organically bound iodine (270 mg I/mL, as 550 mg/mL [55%] of iodixanol) with calcium chloride dihydrate 0.074 mg/mL and sodium chloride 1.87 mg/mL and 320 mg/mL of organically bound iodine (320 mg I/mL, as 652 mg/mL [65.2%] of iodixanol) with calcium chloride dihydrate 0.044 mg/mL and sodium chloride 1.11 mg/mL.2195 Each mL of the solutions also contains tromethamine 1.2 mg, edetate calcium disodium 0.1 mg, and hydrochloric acid and/or sodium hydroxide to adjust pH.2195 Both concentrations are available in 50-, 100-, 150-, or 200-mL single-dose vials.2195 The 320-mg I/mL concentration also is available in a 500-mL pharmacy bulk package.2374 Table 1 presents the characteristics of iodixanol products.
Table 1. Iodixanol Product Characteristics2195
| Iodixanol Concentration (%) | Iodine Concentration (mg/mL) | Osmolality (mOsm/kg) | Viscosity at 20°C (cP) | Viscosity at 37°C (cP) | Density at 20°C (g/mL) | Density at 37°C (g/mL) |
|---|---|---|---|---|---|---|
| 55 | 270 | 290 | 12.7 | 6.3 | 1.314 | 1.303 |
| 65.2 | 320 | 290 | 26.6 | 11.8 | 1.369 | 1.356 |
pH
Adjusted during manufacturing to pH 7.4 with a range from 6.8 to 7.7 at 22°C.2195
Trade Name(s)
Visipaque
Iodixanol is administered intravenously and intra-arterially.2195 It is contraindicated for intrathecal use.2195 Extravasation should be avoided.2195 Iodixanol injection may be administered at either body or room temperature.2195
Iodixanol may be used with an automated contrast injection system or contrast media management system cleared for use with the product.2195 Consult specific device labeling for additional information.2195
Iodixanol is a clear, colorless to pale yellow solution.2195 Intact containers should be stored at controlled room temperature and protected from exposure to direct sunlight and from freezing.2195; 2374 Discard the product if inadvertently frozen because of possible damage to closure integrity.2195 Intact containers may be stored in a contrast media warmer at 37°C for up to 1 month.2195
If used with an automated contrast management system, the maximum use time is 4 hours after initial puncture.2195
Withdrawal of contents from pharmacy bulk packages should be completed within of 8 hours of initial closure entry.2374 After closure entry, the temperature of the container should not exceed 37°C.2374
For a list of references cited in the text of this monograph, search the monograph titled References.