Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Hypersensitivity to iodine-containing contrast media. Manifest hyperthyroidism.
Gastrografin must not be administered undiluted in patients with low plasma volume, as for example in newborns, infants, children and in dehydrated patients, since hypovolaemic complications can be particularly serious in these patients.
Gastrografin must not be administered undiluted in patients with suspected possibility of aspiration or bronchooesophageal fistula, since hyperosmolarity may cause acute pulmonary oedema, chemical pneumonia, respiratory collapse and death.
The following risks are higher in the case of intravascular administration of iodinated contrast media but are also relevant for the enteral use of Gastrografin.
As with other contrast agents, Gastrografin can be associated with anaphylactoid/hypersensitivity or other idiosyncratic reactions, characterized by cardiovascular, respiratory or cutaneous manifestations, and ranging to severe reactions including shock.
Delayed reactions may occur (hours later or up to several days) (see section 4.8).
Medication for the treatment of hypersensitivity reactions as well as readiness for institution of emergency measures are necessary.
The risk of anaphylactoid/hypersensitivity reactions is higher in case of:
Patients with cardiovascular disorders are more susceptible to serious or even fatal outcomes of severe anaphylactoid/hypersensitivity reactions.
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 an exposure to excess iodine may cause hypothyroidism, possibly requiring treatment.
If Gastrografin is used together with barium sulfate preparations, attention must be drawn to the contraindications, warnings and possible side effects relevant to the preparation.
This medicinal product contains from 224.40 to 374.00 mg of sodium in each dose (60-100 ml), equivalent to 11.2-18.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This medicinal product contains 112.20 mg of sodium in each dose (30 ml), equivalent to 5.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
In case of prolonged retention of Gastrografin in the gastrointestinal tract (e.g. obstruction, stasis), tissue damage, bleeding, bowel necrosis and intestinal perforation may occur.
Adequate hydration and electrolyte balance should be established and maintained in the patients, since the hyperosmolarity of Gastrografin may cause dehydration and electrolyte imbalance.
Because of the additives (flavourings and a wetting agent), Gastrografin must not be used intravascularly.
Hypersensitivity reactions can be aggravated in patients on beta-blockers.
Interleukin-2: Previous treatment (up to several weeks) with Interleukin-2 is associated with an increased risk of delayed reactions to Gastrografin.
Radioisotopes: Diagnosis and treatment of thyroid disorders with thyrotropic radioisotopes may be impeded for up to several weeks after administration of iodinated contrast agents due to reduced radioisotope uptake.
Adequate and well-controlled studies in pregnant women have not been conducted.
Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development (see section 5.3).
Caution should be exercised when using Gastrografin in pregnant women.
It is unknown whether sodium amidotrizoate or meglumine amidotrizoate are excreted in human breast milk. Intravascular use has shown that salts of the diatrizoic acid are excreted in breast milk. A decision on whether to continue/discontinue breast-feeding or continue/discontinue therapy with Gastrografin should be made taking into account the benefit of breast-feeding to the child and the benefit of administering Gastrografin to the woman.
None known.
Undesirable effects in association with the use of iodinated contrast media are usually mild to moderate and transient in nature. However, severe and life-threatening reactions as well as deaths have been reported.
Vomiting, nausea and diarrhoea are the most frequently recorded reactions.
The following undesirable effects have been recorded in association with the use of Gastrografin. The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Anaphylactoid shock, anaphylactoid/hypersensitivity reaction.
Systemic hypersensitivity is mostly mild and occurs generally in the form of skin reactions. However, the possibility of a severe hypersensitivity reaction cannot be entirely excluded (see section 4.4).
Hyperthyroidism, hypothyroidism*
^*^Reported mostly in neonates, especially preterm neonates [see section 4.4].
Fluid and electrolyte imbalance
Disturbances in consciousness, headache, dizziness
Cardiac arrest, tachycardia
Shock, Hypotension
Bronchospasm, dyspnoea, medication aspiration, pulmonary oedema following aspiration, aspiration pneumonia
The hypertonic Gastrografin solution may give rise to diarrhoea, but this ceases as soon as the intestine has been emptied. Existing enteritis or colitis may be temporarily exacerbated. In case of obstruction, the prolonged contact with bowel mucosa can lead to erosions and to bowel necrosis. Other undesirable effects include vomiting, nausea, diarrhoea, intestinal perforation, abdominal pain and oral mucosal blistering.
Toxic epidermal necrolysis, urticaria, rash, pruritus, erythema, oedema face
Pyrexia, sweating
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.
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