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Isovue-M
ISOVUE-M® 200
(iopamidol) Injection 41%
ISOVUE-M® 300
(iopamidol) Injection 61%
DIAGNOSTIC NONIONIC RADIOPAQUE CONTRAST MEDIA
For Intrathecal Administration in Neuroradiology Including Myelography (Lumbar, Thoracic, Cervical, Total Columnar) Pediatric Myelography (Lumbar, Thoracic), and for Contrast Enhancement of Computed Tomographic (CECT) Cisternography and Ventriculography
DRUG DESCRIPTION
ISOVUE-M (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intrathecal administration.
Each mL of ISOVUE-M 200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1 mg tromethamine and 0.26 mg edetate calcium disodium. The solution contains approximately 0.029 mg (0.001 mEq) sodium and 200 mg organically bound iodine per mL.
Each mL of ISOVUE-M 300 (lopamidol Injection 61%) provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL.
The pH of ISOVUE-M contrast media has been adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE-M (lopamidol Injection) is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively).
| Iopamidol | ||
| Parameter | 41% | 61% |
| Concentration(mgl/mL) | 200 | 300 |
| Osmolality @ 37° C (mOsm/kg water) | 413 | 616 |
| Viscosity (cP) @ 37° C 2.0 | 4.7 | |
| @ 20° C | 3.3 | 8.8 |
| Specific Gravity @ 37° C | 1.216 | 1.328 |
lopamidol is designated chemically as (S)-N,N'-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]- 2,4,6-triiodo-5lactamidoisophthalamide. Structural formula:
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Last reviewed on RxList: 8/28/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Isovue-M Information
Report Problems to the Food and Drug Administration
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