CONRAY- iothalamate meglumine injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IOTHALAMATE MEGLUMINE (UNII: XUW72GOP7W) (IOTHALAMIC ACID - UNII:16CHD79MIX)

Available from:

Liebel-Flarsheim Company LLC

INN (International Name):

IOTHALAMATE MEGLUMINE

Composition:

IOTHALAMATE MEGLUMINE 600 mg in 1 mL

Administration route:

INTRAVASCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Conray is indicated for use in excretory urography, cerebral angiography, peripheral arteriography, venography, arthrography, direct cholangiography, endoscopic retrograde cholangiopancreatography, contrast enhancement of computed tomographic brain images, cranial computerized angiotomography, intravenous digital subtraction angiography and arterial digital subtraction angiography. Conray may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space. Continuous or multiple scans separated by intervals of 1 to 3 seconds during the first 30 to 90 seconds post-injection of the contrast medium (dynamic CT scanning) may provide enhancement of diagnostic significance, and may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions. In oth

Product summary:

Storage Store below 30°C (86°F). Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs, the container should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved, and that the container and closure have not been damaged. This preparation is sensitive to light and must be protected from strong daylight or direct exposure to the sun. As with all contrast media, glass containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used. Reference 1 Young, S. W., Turner, R.J., Castellino, R. A.: “A strategy for the contrast enhancement of malignant tumors using dynamic computed tomography and intravascular pharmacokinetics,” Radiology, 137 :137-147, October 1980. Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA GBT 0953A223 Revised 02/2023                                                                            

Authorization status:

New Drug Application

Summary of Product characteristics

CONRAY- IOTHALAMATE MEGLUMINE INJECTION
LIEBEL-FLARSHEIM COMPANY LLC
----------
2/2023
CONRAY (IOTHALAMATE MEGLUMINE INJECTION USP 60%)
NOT FOR INTRATHECAL USE
DESCRIPTION
Conray is a sterile aqueous solution intended for use as a diagnostic
radiopaque
medium. Conray contains 60% w/v iothalamate meglumine, which is
1-deoxy-1-
(methylamino)-D-glucitol 5-acetamido-2,4,6
triiodo-N-methylisophthalamate (salt), and
has the following structural formula:
Each milliliter contains 600 mg of iothalamate meglumine, 0.09 mg
edetate calcium
disodium as a stabilizer and 0.125 mg of monobasic sodium phosphate as
a buffer. The
solution provides 28.2% (282 mg/mL) organically bound iodine. Conray
has an
osmolarity of approximately 1000 mOsmol per liter, an osmolality of
approximately 1400
mOsmol per kilogram and is, therefore, hypertonic under conditions of
use. The
viscosity (cps) is approximately 6 at 25°C and 4 at 37°C. The pH is
6.5 to 7.7.
Conray is a clear solution containing no undissolved solids.
Crystallization does not
occur at normal room temperatures. It is supplied in containers from
which the air has
been displaced by nitrogen.
CLINICAL PHARMACOLOGY
Following intravascular injection, Conray is rapidly transported
through the circulatory
system to the kidneys and is excreted unchanged in the urine by
glomerular filtration.
The pharmacokinetics of intravascularly administered radiopaque
contrast media are
usually best described by a two compartment model with a rapid alpha
phase for drug
®
distribution and a slower beta phase for drug elimination. In patients
with normal renal
function, the alpha and beta half-lives of Conray were approximately
10 and 90 minutes,
respectively.
Angiography may be performed following intravascular injection which
will permit
visualization until significant hemodilution occurs.
Renal accumulation is sufficiently rapid that maximum radiographic
density in the calyces
and pelves occurs, in most instances, about 3 to 8 minutes after
injection. In patients
with impaired renal function, dia