产品特点
NAME OF MEDICINE
MD-Gastroview™ (Diatrizoate Meglumine and Diatrizoate Sodium
Solution)
solution for oral or rectal administration.
DESCRIPTION
MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium
Solution) is a palatable lemon-vanilla flavoured water-soluble
iodinated
radiopaque contrast medium for oral or rectal administration. Each
mL
contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium;
pH has been adjusted to 6.0 to 7.6. Each mL contains approximately
4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine.
MD-Gastroview does not contain the wetting agent polysorbate 80.
The inactive ingredients are: Edetate Disodium Dihydrate,
Lemon-Vanilla
Flavor, Sodium Citrate, Sodium Hydroxide, Sodium Saccharin, Water
for
Injection. Air in the container is displaced with nitrogen.
Diatrizoate meglumine is designated chemically as 1-deoxy-1-
(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodobenzoate
(salt); diatrizoate sodium is monosodium 3,5-diacetamido-2,4,6-
triiodobenzoate. The two salts have the following structural
formulae:
CLINICAL PHARMACOLOGY
G
ENERAL
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
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