GASTROGRAFIN diatrizoate meglumine and sodium liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

diatrizoate meglumine (UNII: 3X9MR4N98U) (DIATRIZOIC ACID - UNII:5UVC90J1LK)

Available from:

E-Z-EM Canada Inc

INN (International Name):

diatrizoate meglumine

Composition:

diatrizoate meglumine 660 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

GASTROGRAFIN- DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM LIQUID
E-Z-EM CANADA INC
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GASTROGRAFIN
DIATRIZOATE MEGLUMINE
AND DIATRIZOATE SODIUM
SOLUTION USP
DESCRIPTION
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution)
is a palatable lemon-flavored
water-soluble iodinated radiopaque contrast medium for oral or rectal
administration only. Each mL
contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium;
pH has been adjusted to 6.0 to
7.6 with sodium hydroxide. _Each mL contains approximately 4.8 mg
(0.21 mEq) sodium_ and 367 mg
organically bound iodine. Inactive ingredients: edetate disodium,
flavor, polysorbate 80, purified water,
saccharin sodium, simethicone, and sodium citrate.
Diatrizoate meglumine is designated chemically as
1-deoxy-1-(methylamino)-D-glucitol 3,5-
diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is
monosodium 3, 5-diacetamido-2,4,6-
triiodobenzoate. Structural formulas:
CLINICAL PHARMACOLOGY
The most important characteristic of contrast media is the iodine
content. The relatively high atomic
weight of iodine contributes sufficient radiodensity for radiographic
contrast with surrounding tissues.
Diagnostic enteral radiopaque agents have few known pharmacological
effects. Diatrizoate meglumine
and diatrizoate sodium exert a mild laxative effect attributable to
their high osmolarity.
®
Diatrizoate meglumine and diatrizoate sodium are sparingly absorbed
from the intact gastrointestinal
tract, and therefore permit gastrointestinal opacification and
delineation after oral or rectal
administration. Oral administration is used for radiographic
evaluation of the esophagus, stomach and
proximal small intestine. Rectal administration is used for
examination of the colon; however,
visualization of the distal small bowel is generally unsatisfactory,
since the hypertonicity of the medium
causes intraluminal diffusion of water with subsequent dilution of the
medium. Enough absorption from
the gastrointestinal tract to permit incidental visualization of t