Consumer medicine information

Gastrografin

Amidotrizoate meglumine; Sodium amidotrizoate

BRAND INFORMATION

Brand name

Gastrografin (Old Formulation)

Active ingredient

Amidotrizoate meglumine; Sodium amidotrizoate

Schedule

Unscheduled

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Gastrografin. It does not contain all the available information. It does not take the place of talking to your doctor or radiologist.

The doctors conducting your X-ray examination are able to weigh up all the relevant facts. You should consult them about all aspects of this medicine as it relates to you.

If you have any concerns about using this diagnostic agent, ask your doctor or radiologist.

Keep this leaflet. You may need to read it again.

WHAT GASTROGRAFIN IS USED FOR

Gastrografin is an X-ray contrast medium that acts like an X-ray dye when X-rays of the gastrointestinal tract are being taken. It is provided as a solution for drinking or diluted for use as an enema. Gastrografin has a sweet taste. All X-ray contrast mediums, including Gastrografin, contain iodine. X-rays are able to pass through bones in your body and thus produce a ‘picture’, but X-rays are unable to pass through the iodine in contrast agents. Gastrografin enables the radiologist to see the gastrointestinal tract more clearly.

Gastrografin is often used when a barium enema or meal cannot be used. It is sometimes added to barium to improve the X-ray picture.

Gastrografin is sometimes used to treat meconium ileus, a specific type of bowel blockage.

Gastrografin may also be used for CT scan (Computerised Tomography) in the abdominal region.

Gastrografin is only available in X-ray departments and X-ray practices for use in conjunction with taking X-rays.

The radiologist will advise the use of Gastrografin if he/she feels that it is likely to assist the X-ray examination in finding out more about your medical condition.

Ask your doctor if you have any questions about why Gastrografin is being used. Your doctor may be using it for another reason.

BEFORE YOU ARE GIVEN GASTROGRAFIN

When you must not use it

You must not be given Gastrografin if you have an allergy to:

Amidotrizoate meglumine and/or sodium amidotrizoate the active ingredients in Gastrografin
iodine containing contrast agent
any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.

You must not be given Gastrografin if:

you have an overactive thyroid gland which is not being adequately treated.

Gastrografin must not be used:

undiluted in newborns, infants, children or dehydrated patients
in patients where there may be a possibility of inhalation of contrast media.

If you are not sure whether you should be given Gastrografin, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any medicines, foods, preservatives or dyes.

Tell your doctor if you have, or have had, any medical conditions especially the following:

any allergies (e.g. seafood allergy, hay fever, hives)
bronchial asthma
severe heart or blood vessel disease
known or suspected overactive thyroid gland. You may require thyroid function testing before administration of Gastrografin
swelling of the neck caused by enlargement of the thyroid gland
very poor general health
dehydration, where your body does not have as much water and fluids as it should; you might feel thirsty, have a dry mouth or your urine might be darker than usual.

Tell your doctor if you are pregnant, or think you may be pregnant, or if you are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given Gastrografin.

Taking other medicines

Tell your doctor if you are taking any medicines, including any that you get without a prescription from your pharmacy, supermarket, or health food shop.

Some medicines and Gastrografin may interfere with each other. These include:

interleukin (used to treat some forms of cancer
beta blockers (medicines used to treat high blood pressure or other heart conditions)

This medicine may be affected by Gastrografin or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.Your doctor will advise you.

Your doctor has more information on medicines to be careful with or to avoid while receiving Gastrografin.

HOW GASTROGRAFIN IS GIVEN

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions given, ask your doctor.

How much is given

The actual dose of Gastrografin that is right for you will be worked out by the doctor and will depend on your age and the type of X-ray examination that is being done.

How it is given

You will receive Gastrografin for drinking or diluted as an enema.

You may also receive Gastrografin for drinking along with barium sulfate, which is another type of contrast.

A cleansing of the bowels before the use of Gastrografin is recommended. Your doctor will advise you on this.

Gastrografin must not be given as an injection.

If you take too much (overdose)

As Gastrografin is administered by a doctor, overdosage is unlikely. If it does happen the doctor will treat any symptoms that follow.

Immediately tell your doctor or other medical staff or telephone the Poisons Information Centre (Australia: 13 11 26 or New Zealand: 0800 POISON or 0800 764 766) for advice if you think that you or anyone else may have taken too much Gastrografin. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

AFTER HAVING GASTROGRAFIN

Things you must do

Follow carefully the directions given to you by your doctor and other medical staff.

If you are going to have a test on your thyroid, tell your doctor and the medical staff that you have received Gastrografin. Gastrografin can affect thyroid tests for about 2-6 weeks after receiving it.

Things to be careful of

Delayed reactions may occur. In this case Gastrografin could prevent you from driving safely and the ability to operate tools or machines may be impaired.

SIDE EFFECTS

Tell your doctor or radiologist as soon as possible if you do not feel well whilst receiving or after being given Gastrografin.

All contrast agents can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor or radiologist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

diarrhoea
nausea
vomiting.

The above list includes the more common side effects of Gastrografin. They are usually mild and short-lived. If they persist or get worse, tell your doctor.

Allergic and allergy like reactions have been observed after use of X–ray contrast agents such as Gastrografin.

Tell the doctor immediately if you notice any of the following:

swelling of the face, eyelids, lips, tongue or other parts of the body
watering, sore, inflamed or infected eyessneezing, runny nose, coughing or throat irritation
itching or hives, redness of the skin
difficulty breathing, gasping
gagging, feeling of suffocation
changes of consciousness
flu-like symptoms, joint pain
headache
dizziness
fast heartbeat
low blood pressure
stomach pain
blisters in the mouth
fever
sweating.

This list includes side effects that can be mild and temporary or may be more serious.

Some of these side effects could be the first signs of an allergic reaction. You may need urgent medical attention or hospitalisation.

Allergic reactions occur more frequently in patients with an allergic disposition.

Severe reactions requiring emergency treatment can occur, causing low blood pressure, increase in heart rate, difficulty breathing, and swelling of the face, lips or tongue leading to severe breathing difficulties and shock may occur.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people. Rarely, delayed reactions can occur.

STORING GASTROGRAFIN

Storage

The X-ray department or X-ray practice will store Gastrografin under conditions advised by the manufacturer. Shelf life and storage conditions are printed on the bottle.

Disposal

Unused Gastrografin must be discarded within 72 hours after opening the bottle.

PRODUCT DESCRIPTION

What it looks like

Gastrografin is a clear colourless liquid supplied in bottles of 100 mL and 250 mL.

Not all pack sizes may be marketed.

Ingredients

Active ingredients:

Gastrografin – contains 100 mg sodium amidotrizoate and 660 mg amidotrizoate meglumine per mL

Inactive ingredients:

disodium edetate
saccharin sodium
polysorbate 80
star anise oil
purified water.

Supplier

Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

Bayer New Zealand Limited
3 Argus Place, Hillcrest,
North Shore
Auckland 0627

Australian registration number

Gastrografin - AUST R 10684

Date of preparation

February 2020

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

See MEDSAFE website (www.medsafe.govt.nz) for latest New Zealand Consumer Medicine Information.

® Registered Trademark of Bayer AG, Germany

Published by MIMS April 2020

BRAND INFORMATION

Brand name

Gastrografin (Old Formulation)

Active ingredient

Amidotrizoate meglumine; Sodium amidotrizoate

Schedule

Unscheduled

1 Name of Medicine

Sodium amidotrizoate/ amidotrizoate meglumine.

2 Qualitative and Quantitative Composition

100 mL gastroenteral solution contains 10 g sodium amidotrizoate and 66 g amidotrizoate meglumine (sodium diatrizoate and meglumine diatrizoate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Presentation.

Gastrografin is a clear, faintly yellowish, aqueous, ionic, hypertonic solution.

4 Clinical Particulars

4.1 Therapeutic Indications

This medicinal product is for use by oral or rectal administration only.
Gastrografin is a contrast medium for the 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:
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 the intestine (danger of perforation or leak);
megacolon;
visualisation of a foreign body or tumour before endoscopy;
visualisation of gastrointestinal fistula.
In addition to these conditions Gastrografin can generally be used for the same purposes as barium sulfate with the exception of the visualisation of mucosal diseases. Due to the insufficient coating properties of Gastrografin, barium sulfate should be used for single or double contrast techniques.
In combination with barium sulfate, Gastrografin has considerably improved routine investigation of the gastrointestinal tract both from a diagnostic and from an organisational point of view - in the latter case 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 or gastrointestinal tract.
b) Treatment of meconium ileus.
c) Computerised 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.

4.2 Dose and Method of Administration

General information.

Because of the additives (flavourings and a wetting agent), Gastrografin must not be used intravascularly. Contrast medium solution not used within 72 hours after opening the bottle must be discarded.

Dietary suggestions.

Prior cleansing of the bowels facilitates the diagnostic validity.

Hydration.

Adequate hydration must be assured before and after contrast medium administration. This applies especially to patients with multiple myeloma, diabetes mellitus and nephropathy, polyuria, oliguria, hyperuricaemia, as well as to newborns, infants, small children and elderly patients. Disturbances of water and electrolyte balance must be corrected before the examination.

Newborns (< 1 month), infants (1 month-2 years) and children (2-11 years).

Young infants (age < 1 year) and especially newborns are susceptible to electrolyte imbalance and haemodynamic alterations. Care should be taken regarding: the dose of contrast medium to be given, the technical performance of the radiological procedure and the patient status.
Because of its high osmotic pressure and tendency to absorption from the intestine, Gastrografin should not be administered to newborns, infants and young children in higher doses than those recommended.
In newborns and infants, low osmolar contrast media can often be used more safely than the high osmolar Gastrografin.

Dosage of Gastrografin.

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

Adults and children 10 years of age and over.

Visualisation of the stomach: 60 mL.
Follow-through examination of the gastrointestinal tract: a maximum of 100 mL.
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 or gastrointestinal tract, the patient should drink up to 100 mL Gastrografin. If the suspected lesion cannot be clearly identified on 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.

Babies and young children: 15-30 mL (diluted with 3 times its volume of water).
Children (up to 10 years of age): 15-30 mL (can be diluted with twice its volume of water).
Computerised tomography (CT). The examination can be made after the administration of 1.0-1.5 L of an approx. 3% Gastrografin solution (30 mL Gastrografin/1 L water).
Rectal administration.

Adults.

Up to 500 mL Gastrografin dilution (diluted with 3-4 times its volume of water).
In general, unlike a barium enema, not more than 500 mL of this dilute Gastrografin solution is required.

Children.

Children (up to 5 years of age): up to 500 mL Gastrografin dilution (diluted with 5 times its volume of water).
Children (over 5 years of age): up to 500 mL Gastrografin dilution (diluted with 4-5 times its volume of water).
Therapy of meconium ileus. It is possible to cure an uncomplicated meconium ileus by using Gastrografin. 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.

Note.

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 plasma 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 over distension of the bowel as a result of the high osmolarity of Gastrografin has not occurred.

Dosage of Gastrografin in combination with barium sulfate.

Adults.

In addition to the usual dose of barium sulfate: 30 mL Gastrografin.
In adult patients, addition of approximately 30 mL Gastrografin to the usual dose of barium sulfate has proved most satisfactory.

Children.

In addition to the usual dose of barium sulfate:
Children (up to 5 years of age): 2-5 mL Gastrografin to 100 mL barium sulfate suspension.
Children (from 5-10 years of age): 10 mL Gastrografin to 100 mL barium sulfate 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.
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 or longer in individual cases.
The most favourable time for taking exposures of the colon is indicated by the urge to defaecate, which all patients experience.

4.3 Contraindications

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 broncho-oesophageal fistula, since hyperosmolarity may cause acute pulmonary oedema, chemical pneumonia, respiratory collapse and death.

4.4 Special Warnings and Precautions for Use

The following risks are higher in intravascular administration of iodinated contrast media; however they are also relevant for the enteral use of Gastrografin.

Hypersensitivity.

Particularly careful risk-benefit assessment is required in patients with known hypersensitivity to Gastrografin or any of its ingredients due to an increased risk for anaphylaxis/hypersensitivity reactions.
As with other contrast agents, Gastrografin can be associated with anaphylaxis/hypersensitivity or other idiosyncratic reactions, characterised by cardiovascular (e.g. hypotension), respiratory (e.g. wheeze), gastrointestinal (nausea, vomiting), or cutaneous (urticaria, pruritus) manifestations, and ranging to severe reactions including shock.

Management of anaphylaxis and emergency measures.

Before any contrast medium is administered, the patient should be questioned for a history of allergy (e.g. seafood allergy, hay fever, hives), sensitivity to iodine or to radiographic media and bronchial asthma as the reported incidence of adverse reactions to contrast media is higher in patients with these conditions. Premedication with antihistamines and/or glucocorticoids may be considered.
If hypersensitivity reactions occur (see Section 4.8 Adverse Effects (Undesirable Effects)), administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via a venous access.
Medication for the treatment of hypersensitivity reactions as well as preparedness for institution of emergency measures is necessary, e.g. cardiopulmonary resuscitation (CPR). Prompt and early treatment of anaphylaxis may prevent the aggravation of symptoms and the involvement of other organ systems.

Allergy-like hypersensitivity events that have been observed after use of Gastrografin.

Nausea, vomiting, mild angioedema, conjunctivitis, coughing, pruritus, rhinitis, sneezing and urticaria have been reported. These reactions, which can occur irrespective of the amount administered and the mode of administration, may be the first signs of an incipient state of shock.
Delayed reactions may occur (hours later or up to several days) (see Section 4.8 Adverse Effects (Undesirable Effects)).
The need for examination merits particularly careful consideration in the case of hypersensitivity to iodinated contrast media, in dehydrated patients and in babies and young children.

Other high risk categories.

The risk of anaphylaxis/hypersensitivity reactions is higher in the case of: any history of allergic disorders;
history of bronchial asthma;
a previous anaphylaxis/hypersensitivity reaction to iodinated contrast media.
Particularly careful risk-benefit assessment is required in patients with a previous anaphylaxis/hypersensitivity reaction to any other iodinated contrast medium because of an increased risk of anaphylaxis/hypersensitivity reactions in these patients.
Patients with a hypersensitivity or previous reaction to iodinated contrast media are at increased risk of experiencing a severe reaction. However, such reactions are irregular and unpredictable in nature.
In patients with an allergic disposition, known hypersensitivity to iodinated contrast media or a history of asthma, are at particular risk of experiencing bronchospasms or hypersensitivity reactions.
Patients taking beta-blockers who experience such reactions may be resistant to treatment with beta-agonists.
Patients with cardiovascular disorders are more susceptible to serious or even fatal outcomes of severe anaphylaxis/hypersensitivity reactions.

Thyroid dysfunction.

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 thyrotoxic crisis.
Testing of thyroid function prior to Gastrografin administration and/or preventive thyreostatic medication may be considered in patients with known or suspected hyperthyroidism.
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.

Severe cardiovascular disease.

There is an increased risk of aggravation of severe hypersensitivity reactions in individuals with severe cardiac disease and particularly in those with heart failure and coronary artery disease.

Very poor state of health.

The need for examination merits particularly careful consideration in patients with a very poor general state of health.

Barium sulfate.

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.

Gastrointestinal.

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.

Hydration.

Adequate hydration and electrolyte balance should be established and maintained in patients, since the hyperosmolarity of Gastrografin may cause dehydration and electrolyte imbalance.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.6 Fertility, Pregnancy and Lactation, Use in paediatrics.

Effects on laboratory tests.

Interference with diagnostic tests.

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.
If iodine isotopes are to be administered for diagnosing thyroid disease, it should be borne in mind that after the administration of iodised contrast media which are excreted via the kidneys, the capacity of the thyroid tissue to take up iodine will be reduced for 2 weeks and sometimes up to 6 weeks.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Hypersensitivity reactions can be aggravated in patients on beta-blockers, particularly in people with bronchial asthma. Patients who experience such reactions while taking beta-blockers may be resistant to treatment of anaphylaxis/hypersensitivity reactions with beta-agonists.

Interleukin-2.

Previous treatment (up to several weeks) with interleukin-2 is associated with an increased risk of delayed reactions to Gastrografin.
The prevalence of delayed reactions (e.g. fever, rash, flu-like symptoms, joint pain and pruritus) to contrast media is higher in patients who have received interleukin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
It has not yet been demonstrated that Gastrografin is safe for use in pregnant patients. Adequate and well controlled studies in pregnant women have not been conducted. Since, wherever possible, radiation exposure should be avoided during pregnancy, the benefits of any X-ray examination, whether with or without contrast material, should be carefully weighed against the possible risk.
Caution should be exercised when using Gastrografin in pregnant women. See Section 4.4 Special Warnings and Precautions for Use, Thyroid dysfunction; Section 4.6 Fertility, Pregnancy and Lactation, Use in paediatrics.
It is not known whether Gastrografin enters the breast milk. See Section 4.4 Special Warnings and Precautions for Use, Thyroid dysfunction; Section 4.6 Fertility, Pregnancy and Lactation, Use in paediatrics.

Use in paediatrics.

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. See Section 4.4 Special Warnings and Precautions for Use, Thyroid dysfunction.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Frequency of adverse reactions from spontaneous reports and literature:
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.
Table 1 reports adverse reactions by MedDRA system organ classes (MedDRA SOCs).

Immune system disorders, anaphylaxis reactions/hypersensitivity.

Systemic hypersensitivity is rare, mostly mild and occurs generally in the form of skin reactions. However, the possibility of a severe hypersensitivity reaction cannot be totally excluded (see Section 4.4 Special Warnings and Precautions for Use).

Gastrointestinal.

The hypertonic Gastrografin solution may give rise to diarrhoea but this ceases as soon as the intestine has been emptied. Diarrhoea, nausea and vomiting occur commonly and are the most frequently recorded reactions. Existing enteritis or colitis may be temporarily exacerbated. In case of obstruction the prolonged contact with bowel mucosa can lead to bowel necrosis.

Adverse drug reactions from post-marketing spontaneous reports.

Endocrine disorders.

Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been reported with unknown frequency following iodinated contrast media administration to adult and paediatric patients, including infants. Some patients were treated for hypothyroidism.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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:
In Australia: http://www.tga.gov.au/reporting-problems.
In New Zealand: https://nzphvc.otago.ac.nz/reporting/.

4.9 Overdose

Disorders of water and electrolyte balance caused by overdose should be corrected.
For information on the management of overdose, contact:
Australia: The Poison Information Centre on 131126.
New Zealand: The National Poisons Centre on 0800 POISON (0800 764766).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacotherapeutic group: X-ray contrast media, iodinated and water soluble.
ATC code: V08AA01.
Gastrografin does not exert a pharmacological effect. It is an iodine containing contrast medium, iodine being radio-opaque.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Gastrografin also contains disodium edetate, saccharin sodium, polysorbate 80, anise oil and purified water.

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned (see Section 4.2 Dose and Method of Administration).

6.3 Shelf Life

2 years.

6.4 Special Precautions for Storage

Store below 25 degrees Celsius.
Protect from light and X-rays.

Instructions for use/handling.

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.
Unused Gastrografin in opened containers must be discarded within 72 hours after first opening the container.

6.5 Nature and Contents of Container

Amber, type III glass bottles of 100 mL with HDPE screw cap.

6.6 Special Precautions for Disposal

In Australia and New Zealand, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

See Table 2.

Chemical structure.

CAS number.

Sodium amidotrizoate.

737-31-5.

Amidotrizoate meglumine.

131-49-7.

Physicochemical properties.

Iodine concentration: 370 mg/mL. Contrast medium concentration: 760 mg/mL. Osmotic pressure at 37°C: 55.1 atm. Osmolality at 37°C: 2.15 Osm/kg H₂O.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

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Gastrografin

Amidotrizoate meglumine; Sodium amidotrizoate

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