Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
IOPAMIDOL (UNII: JR13W81H44) (IOPAMIDOL - UNII:JR13W81H44)
Slate Run Pharmaceuticals
INTRATHECAL
PRESCRIPTION DRUG
Iopamidol Injection is indicated for intrathecal administration in adult neuroradiology including myelography (lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. Iopamidol Injection, 41% 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.
Iopamidol Injection, USP formulations are clear, colorless to pale yellow, stable, aqueous, sterile, and nonpyrogenic solutions for intrathecal administration. It is supplied in the following strengths: Iopamidol Injection, USP, 41% contains 408 mg iopamidol per mL and is supplied in vials as follows: Vial NDC Volume per Vial Package Size (NDC) 70436-124-33 10 mL in single-dose vial 10 vials per carton (70436-124-82) 70436-124-35 20 mL in single-dose vial 10 vials per carton (70436-124-52) Iopamidol Injection, USP, 61% contains 612 mg iopamidol per mL and is supplied in vials as follows: Vial NDC Volume per Vial Package Size (NDC) 70436-126-34 15 mL in single-dose vial 10 vials per carton (70436-126-82) Discard unused portion. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Zone, Haikou, Hainan, China 571127 Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215 10000243/02 Revised 09/2023
Abbreviated New Drug Application
IOPAMIDOL- IOPAMIDOL INJECTION, SOLUTION SLATE RUN PHARMACEUTICALS ---------- IOPAMIDOL INJECTION, USP, 41% AND IOPAMIDOL INJECTION, USP, 61% RX ONLY 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 DESCRIPTION Iopamidol Injection, USP formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intrathecal administration. Each mL of Iopamidol Injection, USP, 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 Iopamidol Injection, USP, 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 Iopamidol Injection, USP contrast media has been adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. Iopamidol Injection, USP is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). IOPAMIDOL PARAMETER 41% 61% Concentration (mgI/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 Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]- 2,4,6-triiodo-5-lactamidoisophthalamide. Structural formula: MW 777.09 C H I N O CAS-60166-93-0 Organically Bound Iodine: 49% 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 elimi Soma hati kamili