IOPAMIDOL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Slate Run Pharmaceuticals, LLC

Administration route:

INTRAVASCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Iopamidol Injection is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography (phlebography), and adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head and body imaging (see below). Iopamidol Injection may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized. Iopamidol Injection may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the inves

Product summary:

Iopamidol Injection, USP formulations are clear, colorless to pale yellow, stable, aqueous, sterile, and nonpyrogenic solutions for intravascular 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) 70436-211-37 50 mL in single-dose vial 1 vial per carton (70436-211-80) 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 10000333/01 Revised 10/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IOPAMIDOL- IOPAMIDOL INJECTION, SOLUTION
SLATE RUN PHARMACEUTICALS, LLC
----------
IOPAMIDOL INJECTION, USP, 41%
RX ONLY
NOT FOR INTRATHECAL USE
IOPAMIDOL INJECTION, USP, 41% IS 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 CARDIOVASCULAR SYSTEM, INCLUDING
CEREBRAL
AND PERIPHERAL ARTERIOGRAPHY, CORONARY ARTERIOGRAPHY AND
VENTRICULOGRAPHY,
PEDIATRIC ANGIOCARDIOGRAPHY, SELECTIVE VISCERAL ARTERIOGRAPHY AND
AORTOGRAPHY, PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY), AND ADULT AND
PEDIATRIC
INTRAVENOUS EXCRETORY UROGRAPHY AND INTRAVENOUS ADULT AND PEDIATRIC
CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC (CECT) HEAD AND BODY
IMAGING
DESCRIPTION
Iopamidol Injection, USP formulations are stable, aqueous, sterile,
and nonpyrogenic
solutions for intravascular 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.
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).
PARAMETER
IOPAMIDOL 41%
Concentration (mgI/mL)
200
Osmolality @37°C (mOsm/kg
water)
413
Viscosity (cP) @37°C
2.0
@20°C
3.3
Specific Gravity @37°C
1.227
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
Intravascular injection of a radiopaque diagnostic agent opacifies
those vessels in the
path of flow of the contrast medium, permitting radiographic
visualization of the internal
structures of