Country: United States
Language: English
Source: NLM (National Library of Medicine)
Iopamidol (UNII: JR13W81H44) (Iopamidol - UNII:JR13W81H44)
General Injectables & Vaccines, Inc.
Iopamidol
Iopamidol 408 mg in 1 mL
INTRATHECAL
PRESCRIPTION DRUG
ISOVUE-M (Iopamidol Injection) is indicated for intrathecal administration in adult neuroradiology inculding myelography(lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. ISOVUE-M 200 (lopamidol Injection) is indicated for thoraco-lumbar myelography in children over the age of two years. Intrathecal administration of corticosteroids with iopamidol is contraindicated. Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated (see interval recommendation under DOSAGE AND ADMINISTRATION). Myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely.
ISOVUE-M 200 (Iopamidol Injection 41%) Ten 10mL single dose vials (NDC 0270-1411-11) Ten 20mL single dose vials (NDC 0270-1411-25) ISOVUE-M 300 (Iopamidol Injection 61%) Ten 15mL single dose vials (NDC 270-1412-15) Storage Store at 20-25 degrees C (68-77 degrees F). [See USP]. Protect from Light RX ONLY Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Patheon Italia S.p.A. 03013 Ferentino (Italy) Revised October 2005 255032
New Drug Application
ISOVUE-M 200- IOPAMIDOL INJECTION, SOLUTION GENERAL INJECTABLES & VACCINES, INC. ---------- ISOVUE-M 200 DES CRIPTION 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 ISOVUE-M (Iopamidol Injection) formulations are stable, aqueous, sterile, and nonprrogenic solutions for intrathecal administration. Each mL of ISOVUE-M 200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1mg tromethamine and 0.26 mg edetate calcium disodium. The solution contains approximately 0.029 mg (0.001mEq) 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 cerbrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). Iopamidol Parameter 41% 61% Concentration 200 300 (mgl/mL) Osmolality @ 37 degrees C 413 616 (mOsm/kg water) Visosity (cP) @ 37 degrees C 2.0 4.7 @ 20 degrees C 3.3 8.8 Specific Gravity @37 degrees C 1.216 1.328 Iopamidol is designated chemically as (s)-N,N'-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2, 4, 6,- triiodo-5-lactamidoisophthalamide. Structural formula: CLINICAL PHARMACOLOGY The pharmacokinetics of intravenously administered iopamidol in normal subjects conform to an open two-compartment model with first order elimination (a rapid alpha phase for drug distribution and a slow beta phase for drug elimination). The elimination serum or plasma half-life is approximately two hours; the half-l Read the complete document