ISOVUE-M- iopamidol injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bracco Diagnostics Inc

INN (International Name):

IOPAMIDOL

Composition:

IOPAMIDOL 408 mg in 1 mL

Administration route:

INTRATHECAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

ISOVUE-M 200 (lopamidol Injection 41%) Ten 10 mL single dose vials (NDC 0270-1411-11) 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.

Authorization status:

New Drug Application

Summary of Product characteristics

ISOVUE-M- IOPAMIDOL INJECTION, SOLUTION
BRACCO DIAGNOSTICS INC
----------
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 approxi