GASTROGRAFIN Gastroenteral solution Ref.[50791] Active ingredients: Diatrizoic acid Meglumine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

4.1. Therapeutic indications

This medicinal product is for diagnostic use by oral or rectal administration only.

Gastrografin is a contrast medium for the radiological examination of the gastrointestinal tract (also in combination with barium sulphate).

Gastrografin may be of particular value in the following instances:

  1. Suspected partial or complete stenosis.
  2. Acute haemorrhage.
  3. Threatening perforation (peptic ulcer, diverticulum).
  4. Other acute conditions which are likely to require surgery.
  5. After resection of the stomach or intestine (danger of perforation or leak).
  6. Megacolon.
  7. Visualisation of a foreign body or tumour before endoscopy.
  8. Visualisation of a gastrointestinal fistula.
  9. 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.

4.2. Posology and method of administration

Dosage for oral use

The dosage is dependent on the type of examination and the age of the patient.

Adults and children of 10 years of age or over

Visualisation of the stomach: 60 ml

Follow-through examination of the gastrointestinal tract: a maximum of 100 ml

Computerised tomography (CT)

0.5-1.5 litres of approximately 3% Gastrografin solution (30 ml Gastrografin/1 litre of water).

Older and cachectic patients

Dilution with an equal volume of water is recommended.

Children

Children (up to 10 years of age): 15-30 ml (can be diluted with twice its volume of water)

Infants and young children: 15-30 ml (diluted with 3 times its volume of water)

Dosage for rectal use (including therapy of uncomplicated meconium ileus)

Adults

Up to 500 ml Gastrografin dilution (diluted with 3-4 times its volume of water)

Children

Children (over 5 years of age): up to 500 ml Gastrografin dilution (diluted with 4-5 times its volume of water)

Children (up to 5 years of age): up to 500 ml Gastrografin dilution (diluted with 5 times its volume of water)

Therapy of uncomplicated meconium ileus

Gastrografin can be given by enema for non-operative treatment of 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 inspissated meconium.

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 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.

Dosage for Gastrografin in combination with barium sulphate: Oral and rectal administration

Adults

In adult patients, addition of approximately 30 ml Gastrografin to the usual dose of barium should be adequate.

Children

Children from 5-10 years of age: 10 ml Gastrografin to 100 ml barium sulphate suspension.

Children up to 5 years of age: 2-5 ml Gastrografin to 100 ml barium sulphate suspension.

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.

For the early diagnosis of a perforation or investigation of an anastomosis in the oesophagus or gastrointestinal tract, the patient should drink up to 100 ml Gastrografin. 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 two hours as a typical crystal formation in the precipitate.

4.9. Overdose

Disorders of water and electrolyte balance caused by overdose should be corrected.

6.3. Shelf life

Shelf life (unopened): 4 years
Shelf life (opened): 72 hours

6.4. Special precautions for storage

Protect from light and X-rays. Store below 25°C.

6.5. Nature and contents of container

Packs of 10 × 100 ml brown glass bottles with pilfer proof screw caps.

6.6. Special precautions for disposal and other handling

At temperatures below 7°C Gastrografin tends to crystallize, 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.

Contrast medium solution not used within 72 hours after opening the bottle must be discarded.

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