ISOVUE-M 200- iopamidol injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Iopamidol (UNII: JR13W81H44) (Iopamidol - UNII:JR13W81H44)

Available from:

General Injectables & Vaccines, Inc.

INN (International Name):

Iopamidol

Composition:

Iopamidol 408 mg in 1 mL

Administration route:

INTRATHECAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ISOVUE-M (Iopamidol Injection) is indicated for intrathecal administration in adult neuroradiology inculding 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 (Iopamidol Injection 41%)    Ten 10mL single dose vials (NDC 0270-1411-11)    Ten 20mL single dose vials (NDC 0270-1411-25) ISOVUE-M 300 (Iopamidol Injection 61%)    Ten 15mL single dose vials (NDC 270-1412-15) Storage Store at 20-25 degrees C (68-77 degrees F). [See USP]. Protect from Light RX ONLY Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Patheon Italia S.p.A. 03013 Ferentino (Italy) Revised October 2005 255032

Authorization status:

New Drug Application

Summary of Product characteristics

ISOVUE-M 200- IOPAMIDOL INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
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ISOVUE-M 200
DES CRIPTION
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
ISOVUE-M (Iopamidol Injection) formulations are stable, aqueous,
sterile, and nonprrogenic solutions
for intrathecal administration. Each mL of ISOVUE-M 200 (lopamidol
Injection 41%) provides 408 mg
iopamidol with 1mg tromethamine and 0.26 mg edetate calcium disodium.
The solution contains
approximately 0.029 mg (0.001mEq) 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 been 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 cerbrospinal fluid
(approximately 285 and 301 mOsm/kg water, respectively).
Iopamidol
Parameter
41%
61%
Concentration
200
300
(mgl/mL)
Osmolality @ 37 degrees C
413
616
(mOsm/kg water)
Visosity (cP) @ 37 degrees C
2.0
4.7
@ 20 degrees C
3.3
8.8
Specific Gravity @37 degrees 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:
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 hours;
the half-l