IOPAMIDOL injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

IOPAMIDOL (UNII: JR13W81H44) (IOPAMIDOL - UNII:JR13W81H44)

제공처:

Slate Run Pharmaceuticals

관리 경로:

INTRATHECAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

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

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

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