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GASTROGRAFIN

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

GASTROGRAFIN
Aqueous solution for enteral use

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 CLASSIFICATION
A. 28 Contrast media.

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.

DOSAGE AND DIRECTIONS FOR USE
•        Gastrografin
O        Oral administration
The dosage is dependent on the type of examination and the age of the patient.
In adult patients and children of 10 years of age and over, 60 mL is sufficient for visualisation 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.
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 babies and young children it is recommended that the contrast medium be diluted with 3 times its volume of water.
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.
Computerised tomography (CT)
The examination can be made after the administration of 1-1,5 L of approximately 3% Gastrografin solution (30 mL Gastrografin/1 L water).
O        Rectal administration
For adult patients the contrast medium should be diluted with 3-4 times its volume of water. In general, unlike a barium sulphate enema, not more than 500 mL of this dilute Gastrografin solution is required.
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.
O        Therapy of meconium ileus
In the presence of uncomplicated meconium ileus advantage is taken of the high osmotic pressure of Gastrografin: the surrounding tissue is forced to release considerable amounts of fluid, which then flows into the gut and dissolves the hardened meconium.

Technique for the treatment of uncomplicated meconium ileus
Gastrografin can be given by enema to infants for non-operative treatment of uncomplicated meconium ileus in the absence of, eg volvulus, gangrene, perforation, peritonitis or atresia, all of which require immediate operation.
A large syringe and soft rubber catheter, No 8 French, are recommended. The buttocks can be taped tightly together to minimise leakage but a balloon catheter should not be used. The procedure must be carried out slowly and only under fluoroscopic control. Injection should stop as soon as Gastrografin is seen to enter the ileum. Owing to its high osmolarity, Gastrografin may cause the loss of a large amount of fluid into the intestines. An intravenous drip must therefore be set up before the enema is given and a suitable parenteral fluid should be infused as required. If the Gastrografin is not expelled during the first hour after removal of the rectal catheter, an X-ray should be taken to ensure that overdistension of the bowel as a result of the high osmolarity of Gastrografin has not occurred.

•        Gastrografin and barium sulphate
In adult patients, addition of approximately 30 mL Gastrografin to the usual dose of barium sulphate has proved most satisfactory.
In children from 5-10 years of age, 10 mL Gastrografin may be added to the necessary amount of barium sulphate, in children up to 5 years of age, addition of 2-5 mL Gastrografin to 100 mL barium sulphate suspension has proved of value.
If necessary (in cases of pylorospasm or pyloric stenosis), the suspension may be further diluted. 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 sulphate.
The time taken for emptying of the stomach is the same as for barium sulphate 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 sulphate 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.
The bottle should be securely closed after each withdrawal and the contents discarded within 72 hours of first opening the bottle.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
The need for examination merits particularly careful consideration in the case of hypersensitivity to iodinated contrast media, latent hyperthyroidism, benign nodular goitre, in dehydrated patients and in babies and young children.
Disturbances of water and electrolyte balance must be corrected before the examination.
Because of its high osmotic pressure and minimal tendency to absorption from the intestine, Gastrografin should not be administered to babies and young children in higher doses than those recommended.
Because of the additives (flavourings and a wetting agent), Gastrografin must not be used intravascularly.
Following the administration of iodinated renal contrast media, the capacity of the thyroid tissue to take up radioisotopes for diagnosing disorders of the thyroid is reduced for up to 2 weeks, and even longer in individual cases.
With regard to the use of barium sulphate attention is drawn to the contra-indications, warnings and possible side effects relevant to this preparation.
Hypersensitivity reactions can be aggravated in patients on beta-blockers.
The prevalence of delayed reactions (eg fever, rash, flu-like symptoms, joint pain and pruritus) to contrast media is higher in patients who have received interleukin.
Side effects
The hypertonic Gastrografin solution may occasionally give rise to diarrhoea, but this ceases as soon as the intestine has been emptied. An existing enteritis or colitis may be temporarily exacerbated. Nausea and vomiting may occur in exceptional cases. Urticarial skin reactions have occasionally been observed, while anaphylactoid reactions ranging to shock are possible (see “Warnings”).
Should aspiration of contrast medium occur the possibility of pulmonary oedema cannot be ruled out.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Based on the results of preclinical acute toxicological studies, there is no risk of acute toxication with the use of Gastrografin. Treatment should be symptomatic.

IDENTIFICATION
A clear, colourless to faintly yellowish solution with a faint odour of anise oil.

PRESENTATION
Amber glass bottles of 100 mL.

STORAGE INSTRUCTIONS
Until required for use, the product must be stored in the original outer carton below 30°C. Protect from light, heat and secondary X-rays. Keep out of reach of children. Contents should be discarded within 72 hours of first opening the bottle.
At temperatures below 7°C Gastrografin tends to crystallise, but this can be reversed by gently warming and shaking the bottle. This phenomenon has no effect on the effectiveness or stability of the preparation.

REGISTRATION NUMBER
H/28/2842

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
Randjespark
Midrand        1685
P O Box 5278
Halfway House        1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
29 May 2000

SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Subsidiary of
Schering AG        Germany

Updated on this site: January 2005
Source: Pharmaceutical Industry
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