COMPOSITION
Gastrografin contains a mixture of sodium amidotrizoate and meglumine amidotrizoate in a proportion of 10:66 (amidotrizoic acid or diatrizoic acid: 3,5-bis-acetamido-2,4,6-triiodobenzoic acid).
1 mL Gastrografin contains sodium amidotrizoate 100,00 mg and meglumine amidotrizoate 660,00 mg (sodium diatrizoate and meglumine diatrizoate) in aqueous solution plus flavourings and a wetting agent.
Iodine concentration |
370 mg/mL |
Iodine content per bottle of 100 mL |
37 g |
Contrast medium concentration |
760 mg/mL |
Contrast medium content per bottle of 100 mL |
76 g |
Viscosity (mPa.s or cP) |
|
at 20°C |
18,5 |
at 37 C |
8,9 |
Osmotic pressure at 37 C |
|
(MPa) |
5,58 |
(atm) |
55,1 |
Osmolality at 37°C (osm/kg H2O) |
2,15 |
PHARMACOLOGICAL ACTION
Actions
The contrast-giving substances in Gastrografin are salts of amidotrizoic acid in which the X-ray absorbing iodine is present in stable chemical bond.
Pharmacokinetics
Following oral administration only about 3% of the amidotrizoic acid is absorbed from the stomach and intestines. This portion, and also any contrast medium that might have reached the abdominal cavity or surrounding tissue through perforations in the gastro-intestinal tract, are eliminated mainly via the kidneys.
INDICATIONS
Gastrografin is designed for investigation for the gastrointestinal tract. It can be used either orally or as an enema. Follow-through examinations with barium can often be improved by combining it with Gastrografin. Gastrografin may be of particular value in the following instances:
Suspected partial or complete stenosis.
Acute haemorrhage.
Threatening perforation (peptic ulcer, diverticulum).
Other acute conditions which are likely to require surgery.
After resection of the stomach or intestine (danger of perforation or leak).
Megacolon.
Visualisation of a foreign body or tumour before endoscopy.
Visualisation of a gastrointestinal fistula.
Before endoscopy.
Further indications:
Early diagnosis of a radiologically undetectable perforation or anastomotic defect in the oesophagus.
The treatment of uncomplicated meconium ileus.
Computerised tomography in the abdominal region.
CONTRA-INDICATIONS
Manifest hyperthyroidism.
Not to be administered to patients who are hypersensitive to iodine.
Pregnancy and lactation, as safety has not been established.
WARNINGS
Fatal reactions have been associated with the administration of water-soluble contrast media. It is therefore of the utmost importance that a course of action be carefully planned in advance for the treatment of serious reactions, and that adequate and appropriate facilities and personnel be readily available in case of a severe reaction. Patients should be observed for a possible severe reaction during and for at least 30-60 minutes after administration. |
Aspiration of Gastrografin is extremely dangerous and often fatal.They suggest that that barium sulfate, which provides better radiographic detail and is not so hazardous when aspirated, should be the contrast medium of choice.