ISOVUE-M- iopamidol injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

BIPSO GmbH

प्रशासन का मार्ग:

INTRATHECAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

ISOVUE-M (lopamidol 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. 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.

उत्पाद समीक्षा:

ISOVUE-M 200 (lopamidol Injection 41%)    Ten 10 mL single dose vials (NDC 0270-1411-11)    Ten 20 mL single dose vials (NDC 0270-1411-25) ISOVUE-M 300 (lopamidol Injection 61%)    Ten 15 mL single dose vials (NDC 0270-1412-15) Store at 20-25° C (68-77° F). [See USP]. Protect from light.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

ISOVUE-M- IOPAMIDOL INJECTION, SOLUTION
BIPSO GMBH
----------
ISOVUE-M 200
IOPAMIDOL INJECTION 41%
ISOVUE-M 300
IOPAMIDOL INJECTION 61%
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
ISOVUE-M (lopamidol Injection) formulations are stable, aqueous,
sterile, and nonpyrogenic solutions
for intrathecal administration.
Each mL of ISOVUE-M 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-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 bean 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 cerebrospinal fluid
(approximately 285 and 301 mOsm/kg water,
respectively).
IOPAMIDOL
PARAMETER
41%
61%
Concentration
(mgl/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
lopamidol 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