GASTROGRAFIN SOLUTION [SIN05846P]

Product Info

GASTROGRAFIN SOLUTION

[SIN05846P]

Indication

Indications
Gastrografin is a contrast medium for the radiological examination of the gastrointestinal tract. It can be administered orally and as an enema and is primarily indicated in cases in which the use of barium sulfate is unsatisfactory, undesirable or contraindicated.

Among these are:
Threatening perforation (peptic ulcer, diverticulum), after resection of the stomach or the intestine (danger of perforation or leak), suspected partial or complete stenosis, acute haemorrhage, other acute conditions which are likely to require surgery, megacolon, visualization of a foreign body or tumour before endoscopy, visualization of a gastrointestinal fistula.

In addition to these conditions Gastrografin can generally be used for the same purposes as barium sulfate.

In combination with barium sulfate, Gastrografin has considerably improved routine investigation of the gastrointestinal tract both from a diagnostic and from an organizational point of view – the latter by speeding up the examination. It is unsuitable only for the diagnosis of enteritis.

Further indications:
a) Early diagnosis of a radiologically undetectable perforation or anastomotic defect in the oesophagus and/or gastrointestinal tract
b) Treatment of meconium ileus
c) Computerized tomography in the abdominal region. The danger of false diagnoses is significantly reduced if the intestine is opacified with Gastrografin, especially for differential diagnoses in the minor pelvis. Gastrografin facilitates delimitation of the intestine from neighbouring organs and permits an assessment of changes in the shape of the pancreas

Dosing

Dosage and method of administration

General information
Because of the additives (flavorings and a wetting agent), Gastrografin must not be used intravascularly.

Because of its high osmotic pressure and the tendency to absorption from the intestine, Gastrografin should not be administered to newborns, infants and young children in doses higher than those recommended. In newborns and infants low osmolar contrast media can often be used more safely than the high osmolar Gastrografin.

Dosage for oral use
The dosage is dependent on the type of examination and the age of the patient.

Adults
In adult patients and children of 10 years of age and over, 60 ml is sufficient for visualization of the stomach; for a follow-through examination of the gastrointestinal tract a maximum of 100 ml may be required. For elderly and cachectic patients a dilution with an equal volume of water is recommended.

For the early diagnosis of a perforation or anastomosis in the oesophagus and/or gastrointestinal tract, the patient should drink 100 ml Gastrografin. If the suspected lesion cannot be clearly identified in the X-ray film, a chemical reaction can be employed for further clarification. After 30 – 60 minutes (later, if the defect is suspected of being in the distal gut), a urine specimen should be taken and 5 ml mixed with 5 drops of concentrated hydrochloric acid.

The contrast medium which has undergone renal excretion will appear within 2 hours as a typical crystal formation in the precipitate.

Children
In children up to 10 years of age, 15 – 30 ml is generally sufficient. This dose can be diluted with twice its volume of water. For infants and young children it is recommended that the contrast medium be diluted with 3 times its volume of water.

Computerized tomography (CT)
The examination can be made after the administration of 1 – 1.5 l of an approx. 3 % Gastrografin solution (30 ml Gastrografin/1 l water).

Dosage for rectal use

Adults
For adult patients the contrast medium should be diluted with 3 – 4 times its volume of water. In general, unlike a barium-sulfate enema, not more than 500 ml of this Gastrografin dilution is required.

Children
For children over 5 years of age, the contrast medium should be diluted with 4 – 5 times its volume of water; for children up to 5 years of age a dilution with 5 times its volume of water is recommended.

Therapy of meconium ileus
Gastrografin can be given by enema for non-operative treatment of an uncomplicated meconium ileus. Advantage is taken of the high osmotic pressure of the contrast medium: the surrounding tissue is forced to release considerable amounts of fluid, which then flows into the gut and dissolves the hardened meconium.

Dosage for Gastrografin in combination with barium sulfate

Adults
In adult patients, addition of approximately 30 ml Gastrografin to the usual dose of barium sulfate has been shown to be most satisfactory.

Children
In children from 5 – 10 years of age, 10 ml Gastrografin may be added to the necessary amount of barium sulfate, in patients up to 5 years of age, addition of 2 – 5 ml Gastrografin to 100 ml barium sulfate suspension has proved of value.

If necessary (in cases of pylorospasm or pyloric stenosis), the portion of Gastrografin in the suspension may be further increased. This does not affect the contrast.

Exposures
Exposures of the stomach are taken in the usual way whether Gastrografin is used alone or in combination with barium sulfate.

The time taken for emptying of the stomach is the same as for barium sulfate whereas that for filling of the intestine is shorter. When Gastrografin alone is used, the contrast medium has generally reached the rectum after 2 hours, while the Gastrografin/barium sulfate mixture may take up to 3 hours and, in individual cases, longer.

The most favourable time for taking exposures of the colon is indicated by the urge to defaecate which all patients experience.

Contraindications

Contraindications
Gastrografin must not be administered undiluted in patients with low plasma volume, as for example in newborns, infants, children and in dehydrated patients, since hypovolemic complications can be particularly serious in these patients.

Gastrografin must not be administered undiluted in patients with suspected possibility of aspiration or broncho-esophageal fistula, since hyperosmolarity may cause acute pulmonary edema, chemical pneumonia, respiratory collapse and death.

Manifest hyperthyroidism.