Gastrografin Oral Liquid Bottle

What it is

Gastrografin is an oral liquid containing 10 g sodium amidotrizoate and 66 g amidotrizoate meglumine per 100 mL of gastroenteral solution. It is a clear, faintly yellowish, aqueous, ionic, hypertonic solution. Gastrografin is an iodine-containing contrast medium used as an X-ray contrast medium; iodine is radio-opaque and Gastrografin does not exert a pharmacological effect.

Approved indications

Gastrografin is a contrast medium for the examination of the gastrointestinal tract and can be administered orally and as an enema, primarily indicated in cases in which the use of barium sulfate is unsatisfactory, undesirable or contraindicated. — Suspected partial or complete stenosis. — Acute haemorrhage. — Threatening perforation such as peptic ulcer or diverticulum. — Other acute conditions likely to require surgery. — After resection of the stomach or the intestine due to danger of perforation or leak. — Megacolon. — Visualisation of a foreign body or tumour before endoscopy. — Visualisation of gastrointestinal fistula. — Early diagnosis of a radiologically undetectable perforation or anastomotic defect in the oesophagus or gastrointestinal tract. — Treatment of meconium ileus. — Computerised tomography in the abdominal region.

Dosing overview

The dosage is dependent on the type of examination and the age of the patient. For adults and children 10 years of age and over, visualisation of the stomach requires 60 mL, and follow-through examination of the gastrointestinal tract requires a maximum of 100 mL. For babies and young children, 15–30 mL diluted with three times its volume of water is used; for children up to 10 years of age, 15–30 mL can be diluted with twice its volume of water. For computerised tomography, the examination can be made after administration of 1.0–1.5 L of an approximately 3 per cent Gastrografin solution. For rectal administration in adults, up to 500 mL Gastrografin dilution diluted with 3–4 times its volume of water is used.

Key safety warnings

Patients with known hypersensitivity to Gastrografin or any of its ingredients have an increased risk for anaphylaxis and hypersensitivity reactions, which can be characterised by cardiovascular manifestations such as hypotension, respiratory manifestations such as wheeze, gastrointestinal manifestations including nausea and vomiting, and cutaneous manifestations such as urticaria and pruritus, ranging to severe reactions including shock. Patients taking beta blockers who experience such reactions may be resistant to treatment with beta agonists. Particularly careful risk-benefit assessment is required in patients with known or suspected hyperthyroidism or goitre, as iodinated contrast media may interfere with thyroid function, aggravate or induce hyperthyroidism and thyreotoxic crisis. In neonates, especially preterm infants, who have been exposed to Gastrografin either through the mother during pregnancy or in the neonatal period, it is recommended to monitor thyroid function, as exposure to excess iodine may cause hypothyroidism, possibly requiring treatment. In case of prolonged retention of Gastrografin in the gastrointestinal tract such as from obstruction or stasis, tissue damage, bleeding, bowel necrosis and intestinal perforation may occur. Adequate hydration and electrolyte balance should be established and maintained in patients, since the hyperosmolarity of Gastrografin may cause dehydration and electrolyte imbalance.

Contraindications

Manifest hyperthyroidism is a contraindication. Gastrografin must not be administered undiluted in patients with low plasma volume, such as 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-oesophageal fistula, since hyperosmolarity may cause acute pulmonary oedema, chemical pneumonia, respiratory collapse and death.

Regulatory history

Gastrografin Oral Liquid Bottle was first listed on the Australian Register of Therapeutic Goods on 19 August 1991. The product was first approved on 19 August 1991, with the most recent revision dated 20 December 2024.