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OMNISCAN™
(gadodiamide) Injection for Intravenous Use
WARNING
NOT FOR INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
NOT FOR INTRATHECAL USE: Inadvertent intrathecal use of OMNISCAN (gadodiamide) has caused convulsions, coma, sensory and motor neurologic deficits [see WARNINGS AND PRECAUTIONS].
NSF:
OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging.
OMNISCAN (gadodiamide) is administered by intravenous injection. OMNISCAN (gadodiamide) is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each 1 mL contains 287 mg gadodiamide and 12 mg caldiamide sodium in Water for Injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN (gadodiamide) contains no antimicrobial preservative. OMNISCAN (gadodiamide) is a 0.5 mol/L solution of aqua[5,8-bis(carboxymethyl)11-[2-(methylamino)-2-oxoethyl]-3-oxo-2,5,8,11-tetraazatridecan-13-oato (3-)-N5, N8, N11, O3, O5, O8, O11, O13] gadolinium hydrate, with a molecular weight of 573.66 (anhydrous), an empirical formula of C16H28GdN5O9•xH2O, and the following structural formula:
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Pertinent physicochemical data for OMNISCAN (gadodiamide) are noted below:
PARAMETER
| Osmolality (mOsmol/kg water) | @ 37°C | 789 |
| Viscosity (cP) | @ 20°C | 2 |
| @ 37°C | 1.4 | |
| Density (g/mL) | @ 25°C | 1.14 |
| Specific gravity | @ 25°C | 1.15 |
OMNISCAN (gadodiamide) has an osmolality approximately 2.8 times that of plasma at 37°C and is hypertonic under conditions of use.
Last reviewed on RxList: 2/11/2011
This monograph has been modified to include the generic and brand name in many instances.
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