"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Iopamidol Injection 41%
Iopamidol Injection 51%
Iopamidol Injection 61%
Iopamidol Injection 76%
NOT FOR INTRATHECAL USE
ISOVUE 200, 250, 300 and 370 are NOT FOR INTRATHECAL USE. See INDICATIONS, and DOSAGE AND ADMINISTRATION sections for further details on proper use
DIAGNOSTIC NONIONIC RADIOPAQUE CONTRAST MEDIA For Angiography Throughout the CardiovascularSystem, Including Cerebral and Peripheral Arteriography, Coronary Arteriography and Ventriculography,Pediatric Angiocardiography, Selective VisceralArteriography and Aortography, Peripheral Venography (Phlebography), andAdult and Pediatric Intravenous Excretory Urography and Intravenous Adult and PediatricContrast Enhancement of Computed Tomographic(CECT) Head and Body Imaging
ISOVUE (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration.
Each mL of ISOVUE-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-250 (lopamidol Injection 51%) provides 510 mg iopamidol with 1 mg tromethamine and 0. 33 mg edetate calcium disodium. The solution contains approximately 0.036 mg (0.002 mEq) sodium and 250 mg organically bound iodine per mL.
Each mL of ISOVUE-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.
Each mL of ISOVUE-370 (lopamidol Injection 76%) provides 755 mg iopamidol with 1 mg tromethamine and 0.48 mg edetate calcium disodium. The solution contains approximately 0.053 mg (0.002 mEq) sodium and 370 mg organically bound iodine per mL.
The pH of ISOVUE contrast media has been adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE (lopamidol Injection) is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively).
|Osmolality @ 37° C (mOsm/kg water)||413||524||616||796|
|Viscosity (cP) @ 37° C||2.0||3.0||4.7||9.4|
|@ 20° C||3.3||5.1||8.8||20.9|
|Specific Gravity @ 37° C||1.227||1.281||1.339||1.405|
lopamidol is designated chemically as (S)-N,N'-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]2,4,6-triiodo-5-lactamidoisophthalamide. Structural formula:
Last reviewed on RxList: 7/29/2015
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
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.