Consumer medicine information

Gastrografin

Amidotrizoate meglumine; Sodium amidotrizoate

BRAND INFORMATION

Brand name

Gastrografin

Active ingredient

Amidotrizoate meglumine; Sodium amidotrizoate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Gastrografin.

SUMMARY CMI

GASTROGRAFIN®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I given GASTROGRAFIN?

GASTROGRAFIN contains the active ingredients sodium amidotrizoate and amidotrizoate meglumine. GASTROGRAFIN is a contrast agent used during an X-ray examination.

For more information, see Section 1. Why am I given GASTROGRAFIN? in the full CMI.

2. What should I know before I am given GASTROGRAFIN?

Do not use if you have ever had an allergic reaction to GASTROGRAFIN or any of the ingredients listed at the end of the CMI.

Talk to your doctor, radiographer or nurse if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

The X-ray picture is improved if your bowels are emptied. A cleansing of the bowels before you are given GASTROGRAFIN is recommended. Your doctor, radiographer or nurse will advise you on this. It is important that you still drink fluids as normal.

For more information, see Section 2. What should I know before I am given GASTROGRAFIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with GASTROGRAFIN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How am I given GASTROGRAFIN?

GASTROGRAFIN is given different ways depending on your examination. It will be given by either drinking the solution or as an enema by your doctor, radiographer or nurse.

More instructions can be found in Section 4. How am I given GASTROGRAFIN? in the full CMI.

5. What should I know while receiving GASTROGRAFIN?

Things you should doTell your doctor, radiographer or nurse if you:
  • experience any of the severe symptoms of loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock
  • experience any asthma symptoms e.g. chest tightening.
Driving or using machinesBe careful before you drive or use any machines or tools until you know how GASTROGRAFIN affects you.
Laboratory testsGASTROGRAFIN can affect the results of some thyroid tests up to several weeks after receiving it.
Looking after your medicineThe X-Ray unit will store GASTROGRAFIN as required by the manufacturer.

For more information, see Section 5. What should I know while receiving GASTROGRAFIN? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. If they do occur, they are usually minor and temporary. Do not be alarmed by this list. You may not experience any of them.

Serious side effects can include severe allergic reactions, difficulty breathing and heart attack. Common side effects can include vomiting, nausea and diarrhoea.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

GASTROGRAFIN® (Gas-tro-graf-in)

Active ingredients: sodium amidotrizoate and amidotrizoate meglumine


Consumer Medicine Information (CMI)

This leaflet provides important information about using GASTROGRAFIN. You should also speak to your doctor, radiographer, nurse or pharmacist if you would like further information or if you have any concerns or questions about using GASTROGRAFIN.

Where to find information in this leaflet:

1. Why am I given GASTROGRAFIN?
2. What should I know before I am given GASTROGRAFIN?
3. What if I am taking other medicines?
4. How am I given GASTROGRAFIN?
5. What should I know while receiving GASTROGRAFIN?
6. Are there any side effects?
7. Product details

1. Why am I given GASTROGRAFIN?

GASTROGRAFIN contains the active ingredients sodium amidotrizoate and amidotrizoate meglumine.

GASTROGRAFIN is a contrast medium (a dye) which contains iodine. It can be given orally (by mouth) by drinking the solution or given as an enema in the rectum. It is used to clearly show on X-rays or CT (computed tomography) scan areas of your gastrointestinal tract.

2. What should I know before I am given GASTROGRAFIN?

Warnings

Do not use GASTROGRAFIN if:

  • you are allergic to sodium amidotrizoate and/or amidotrizoate meglumine, or any of the ingredients listed at the end of this leaflet
  • have an overactive thyroid which isn't being treated
  • Always check the ingredients to make sure you can use this medicine.

Check with your doctor, radiographer or nurse if you have:

  • any allergies to other iodine -containing contrast or any other allergies (e.g. shellfish, hay fever, hives, anaphylaxis) or asthma
  • overactive thyroid gland or goitre (swelling in the neck)
  • heart or cardiovascular disease, including heart failure or coronary artery disease
  • a very poor state of general health
  • are dehydrated and your body needs more fluids
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

You may be asked to stay in the X-ray department for a period of time after your examination so that the medical staff can monitor you for side effects.

Pregnancy and breastfeeding

Advise your doctor, radiographer or nurse if you are pregnant or intend to become pregnant.

Talk to your doctor, radiographer or nurse if you are breastfeeding or intend to breastfeed.

Use in children

GASTROGRAFIN is approved for use in adults, adolescents and children including full-term newborns.

Food and drink before your procedure

The X-ray picture is improved if your bowels are emptied. A cleansing of the bowels before you are given GASTROGRAFIN is recommended. Your doctor, radiographer or nurse will advise you on this.

It is important that you still drink fluids as normal. You will be advised to take fluids before and after the examination to help protect your kidneys.

3. What if I am taking other medicines?

Tell your doctor, radiographer, nurse or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

  • are taking beta-blockers used for high blood pressure or heart conditions
  • are taking interleukin used to treat some cancers.

Some medicines may interfere with GASTROGRAFIN and affect how it works.

If you experience an allergy-like reaction to GASTROGRAFIN, any treatment given to you may be affected by these medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect GASTROGRAFIN.

4. How am I given GASTROGRAFIN?

How much to be given

The dosage of GASTROGRAFIN is based on the type of examination and your age. It may also be given diluted or mixed with another contrast called barium sulfate. The doctor, radiographer or nurse will calculate the right dose for you.

When GASTROGRAFIN is given

  • GASTROGRAFIN will be given before your examination.

How GASTROGRAFIN is given

GASTROGRAFIN is given different ways depending on the examination:

  1. Given orally by drinking the solution
  2. Given rectally as an enema by your doctor, radiographer or nurse.

GASTROGRAFIN has a sweet taste.

If you are given too much GASTROGRAFIN

If you think that you have been given too much GASTROGRAFIN, ask the doctor, radiographer or nurse. As GASTROGRAFIN is given by the doctor, radiographer or nurse, overdose is unlikely. If it does happen, a doctor will treat any symptoms that follow.

You should immediately:

  • phone the Poisons Information Centre
    (by calling Australia: 13 11 26 or New Zealand 0800 POISON or 0800 764 766), or
  • contact your doctor, or
  • go to the Emergency Depar tment at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while receiving GASTROGRAFIN?

Things you should do

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

Call your doctor, radiographer or nurse straight away if you:

  • experience any of the severe symptoms of loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock
  • experience any asthma symptoms e.g. chest tightening.

Remind any doctor, dentist or pharmacist you visit that you have been given GASTROGRAFIN.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how GASTROGRAFIN affects you.

It is not known if GASTROGRAFIN may cause delayed reactions that could impair the ability to drive and use machines.

Laboratory tests

  • GASTROGRAFIN can affect the results of some thyroid tests up to several weeks after receiving it
  • Remind your doctor or medical staff after you have received GASTROGRAFIN.

Looking after your medicine

  • The X-ray unit will store GASTROGRAFIN under the conditions advised by the manufacturer.
  • Shelf life and storage conditions are printed on the bottle.
  • Unused GASTROGRAFIN must be discarded within 72 hours after opening the bottle.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

A high level of excitement, anxiety and pain may increase the risk of side effects or make contrast agent related reactions more intense.

Allergic reaction

Some people may experience symptoms of an allergic reaction such as loss of consciousness or heart attack, increase in heart rate, difficulty breathing, low blood pressure and swelling of the face, lips or tongue leading to severe breathing difficulties and shock.

Allergic reactions occur more frequently in people with a history of allergies to other contrast agents, to foods (e.g. seafood) or those who suffer from anaphylaxis, hay fever or bronchial asthma.

Most of these reactions occur within several hours of receiving GASTROGRAFIN. Rarely, some of these reactions may be delayed (up to several days after receiving GASTROGRAFIN).

Less serious side effects

Less serious side effectsWhat to do
Gastrointestinal disorders
  • Nausea
  • Vomiting
  • Diarrhoea
  • Stomach pain
Nervous system disorders
  • Headache
  • Dizziness
General disorders
  • Feeling hot
  • Sweating
  • Fever
  • Flushing
  • Skin redness
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Immune system disorders
  • Experience swelling of the face, eyelids, lips, tongue or other parts of the body
  • Coughing or throat irritation
  • Sneezing, running nose
  • Itching or hives
  • Conjunctivitis
  • Wheezing, shortness of breath, difficulty breathing, gasping
  • Gagging, feeling of suffocation
  • Low blood pressure
  • Shock
Nervous system disorders
  • Loss of consciousness
Cardiac disorders
  • Abnormal heartbeat (maybe faster)
  • Heart attack
Respiratory disorders
  • Difficulty breathing
  • Change in breathing rate
  • Fluid on the lungs
Gastrointestinal disorders
  • Severe stomach pain
  • Blistering of the mouth
Skin disorders
  • Painful blistering or peeling of skin
General disorders
  • Rash
  • Severe dehydration
  • Flu-like symptoms, joint pain
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor, radiographer, nurse or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration in Australia online at www.tga.gov.au/reporting-problems or in New Zealand nzphvc.otago.ac.nz/reporting. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is only available in an X-ray unit.

What GASTROGRAFIN contains

Active ingredient
(main ingredient)
Sodium amidotrizoate and
Amidotrizoate meglumine
(contains iodine)
Other ingredients
(inactive ingredients)
Disodium edetate
Saccharin sodium
Polysorbate 80
Star anise oil
Purified water

Do not take this medicine if you are allergic to any of these ingredients.

What GASTROGRAFIN looks like

GASTROGRAFIN is a clear, faintly yellow solution for oral administration and is supplied in amber glass bottles of 100 or 250 mL.

100 mL or 250 mL glass bottles – AUST R 10684

Not all presentations may be marketed in Australia or New Zealand.

Who distributes GASTROGRAFIN

Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
www.bayer.com.au

Bayer New Zealand Limited
PO Box 2825
Shortland Street
Auckland 1140
Free phone 0800 229 376

This leaflet was prepared in December 2020.

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information or on the Medsafe website (www.medsafe.govt.nz) for New Zealand.

® Registered trademark

Published by MIMS February 2021

BRAND INFORMATION

Brand name

Gastrografin

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.

Summary Table of Changes