MD-Gastroview

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Meglumine diatrizoate; Sodium diatrizoate

Summary of Product characteristics

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