NOT FOR INTRATHECAL USE
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. [see CONTRAINDICATIONS.]
ULTRAVIST (iopromide) Injection is a nonionic, water soluble x-ray contrast agent for intravascular administration. The chemical name for iopromide is N,N'-Bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methyl- 1,3-benzenedicarboxamide. Iopromide has a molecular weight of 791.12 (iodine content 48.12%). Iopromide has the following structural formula:
ULTRAVIST Injection is a nonionic sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution of iopromide, containing 2.42 mg/mL tromethamine buffer and 0.1 mg/mL edetate calcium disodium stabilizer.
ULTRAVIST Injection is available in four strengths:
150 mg I/mL provides 311.7 mg/mL iopromide,
240 mg I/mL provides 498.72 mg/mL iopromide,
300 mg I/mL provides 623.4 mg/mL iopromide,
370 mg I/mL provides 768.86 mg/mL iopromide.
During the manufacture of ULTRAVIST Injection, sodium hydroxide or hydrochloric acid may be added for pH adjustment. ULTRAVIST Injection has a pH of 7.4 (6.5–8) at 25± 2°C, is sterilized by autoclaving and contains no preservatives.
The iodine concentrations (mg I/mL) available have the following physicochemical properties:
|ULTRAVIST INJECTION||ULTRAVIST INJECTION||ULTRAVIST INJECTION||ULTRAVIST INJECTION|
|Property||150 mg I/mL||240 mg I/mL||300 mg I/mL||370 mg I/mL|
|Osmolality*(mOsmol/kg water) @ 37°C||328||483||607||774|
|Osmolarity*(mOsmol/L) @ 37°C||278||368||428||496|
|Viscosity (cP) @ 20°C||2.3||4.9||9.2||22|
|Density (g/mL) @ 20°C||1.164||1.262||1.330||1.409|
|*Osmolality was measured by vapor-pressure osmometry. Osmolarity was calculated from the measured osmolal concentrations.|
Solutions of ULTRAVIST Injection 150 mg I/mL, 240 mg I/mL, 300 mg I/mL and 370 mg I/mL have osmolalities from approximately 1.1 to 2.7 times that of plasma (285 mOsmol/kg water).
Last reviewed on RxList: 5/24/2012
This monograph has been modified to include the generic and brand name in many instances.
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