Medication info

Gastrografin

Prescription medicationSolution
Ingredient · strength
Amidotrizoic Acid›59.73g / 1 bottleMeglumine›15.924g / 1 bottleSodium Hydroxide›0.629g / 1 bottle
Manufacturer / importer
바이엘코리아(주)
Appearance
A slightly yellowish, nearly colorless solution contained in a brown bottle with a faint star anise scent.
Packaging
1CTN: 100ML × 1
Approval status
Active

MFDS item code 200800685 · Notified 2008.01.17 · Insurance code 641100411

Summary

Main use
Effective in the diagnosis of gastrointestinal tract (partial obstruction, perforation, etc.) and improvement of diagnostic methods.
Who uses it
Adults · Children
Adult dosage
1) Oral administration - For imaging the stomach: 60 mL (for adults and children over 10 years) - For continuous imaging of the gastrointestinal tract: up to 100 mL - Early diagnosis of perforation or suture connection defects in esophagus or gastrointestinal tract: 100 mL 2) Rectal administration - Use this drug diluted with 3-4 times water - More than 500 mL of dilute solution is not necessary. 2. In combination with barium sulfate - The typical dosage of barium sulfate should be supplemented with 30 mL of this drug.
Children's dosage
1) Oral administration - Children under 10 years: 15-30 mL, may be diluted with 2 times water - Infants or young children: Dilution with 3 times water is recommended 2) Rectal administration - Children over 5 years: 4-5 times water dilute.

Ingredients

Importer
바이엘코리아(주)

Efficacy & effects

Effective in the diagnosis of gastrointestinal tract (partial obstruction, perforation, etc.) and improvement of diagnostic methods.

  • Partial obstruction
  • complete obstruction
  • acute bleeding
  • urgent perforation
  • gastric ulcer
  • diverticulitis
  • acute conditions
  • risk of defect after gastric and intestinal resections
  • colon syndrome
  • foreign bodies
  • tumors
  • gastrointestinal fistulas
View approved original text

This drug can be administered orally or by enema as a contrast agent for gastrointestinal examinations. It is primarily used in cases where barium sulfate is unsuitable or ineffective, particularly when partial or complete obstruction is suspected, acute bleeding occurs, urgent perforation, acute surgical conditions arise, post-operative complications in stomach and intestinal resections, colon syndrome, pre-endoscopic examination of foreign bodies and tumors, and particularly for imaging gastrointestinal fistulas. Moreover, it can enhance diagnostic efficacy in conjunction with barium sulfate but is not recommended for the diagnosis of enteritis. This medication is also used for the early diagnosis of perforations or suture defects in the esophagus or gastrointestinal tract that are difficult to identify radiologically. Overall, this drug is useful for improving the diagnosis of various gastrointestinal-related conditions.

Dosage and Administration

Adult dosage

1) Oral administration - For imaging the stomach: 60 mL (for adults and children over 10 years) - For continuous imaging of the gastrointestinal tract: up to 100 mL - Early diagnosis of perforation or suture connection defects in esophagus or gastrointestinal tract: 100 mL 2) Rectal administration - Use this drug diluted with 3-4 times water - More than 500 mL of dilute solution is not necessary. 2. In combination with barium sulfate - The typical dosage of barium sulfate should be supplemented with 30 mL of this drug.

Children's dosage

1) Oral administration - Children under 10 years: 15-30 mL, may be diluted with 2 times water - Infants or young children: Dilution with 3 times water is recommended 2) Rectal administration - Children over 5 years: 4-5 times water dilute.

Precautions

This medication contains iodine, therefore it should not be used in patients with an allergy to iodine or those who have had hypersensitivity reactions to this drug or similar medications. It should also be avoided in patients with excessively activated thyroid function. Caution is necessary for patients with bronchial asthma or a tendency to easily develop skin allergy reactions. In patients with enteritis or colitis, caution is advised as symptoms may worsen. Children and dehydrated patients are at higher risk of complications due to decreased blood volume, so caution is needed. In patients suspected of having bronchial aspiration or tracheoesophageal leak, serious pulmonary complications may occur due to the hyperosmolar nature of this drug. Patients with intestinal obstruction should use this drug cautiously as prolonged contact with the intestinal mucosa can cause damage. Patients with asymptomatic hyperthyroidism or benign nodular goiter may also experience worsened symptoms due to this drug. Women who are pregnant or may become pregnant should discuss the use of this drug with their physician and should only be administered when the diagnostic necessity is substantial. This drug can rarely cause severe allergic reactions or shock, so careful monitoring of the patient's condition during administration is required and prompt treatment should be provided if any unusual symptoms arise. Gastrointestinal side effects may include nausea, vomiting, abdominal pain, diarrhea; delayed gastrointestinal elimination may lead to serious issues like tissue damage or bleeding. Cardiovascular side effects such as hypotension or tachycardia can occur rarely. The drug may affect thyroid function, leading to hyperthyroidism or hypothyroidism; thus, patients with thyroid disease should be cautious. In the central nervous system, side effects may include seizures, headache, and dizziness. Respiratory side effects may include bronchial dilation or breathing difficulties, pneumonia, and pulmonary edema occurring rarely. In terms of skin reactions, urticaria, rashes, itching, and in severe cases, toxic epidermal necrolysis (Stevens-Johnson syndrome) may occur. This drug must be used according to the instructions of an experienced professional, and thorough medical history and emergency measures should be prepared in anticipation of the possibility of hypersensitivity reactions. Post-administration, vital signs of the patient should continue to be monitored, and if any adverse reactions occur, administration should be stopped immediately and appropriate treatment should be initiated. Delayed adverse reactions may appear several hours to days after administration, requiring adequate explanation to the patient and guidance to consult medical personnel if symptoms arise. Patients with cardiovascular diseases should be particularly cautious as severe hypersensitivity reactions can lead to fatal outcomes. This drug may influence thyroid function, potentially triggering or worsening hyperthyroidism, so patients with thyroid diseases should consider thyroid function tests and preventive measures prior to administration. When administering to pregnant women or children, consultation with a physician is essential due to the presence of saccharin. Due to the hyperosmolar nature of this drug, dehydration or electrolyte imbalance may arise, so adequate hydration and electrolyte status should be assessed before administration, particularly for children, dehydrated patients, and the elderly. This drug is prohibited from intravenous injection; it must be diluted when administered rectally. Once opened, it must be used within 24 hours, and before use, ensure that there are no particulates in the solution. Additionally, this drug can affect certain clinical test results, so care should be taken before and after undergoing thyroid function tests or pancreatic function tests.

Side effects and when to seek care immediately

Serious side effects

Shock, anaphylactic reactions, syncope, loss of consciousness, breathing difficulties, respiratory arrest, cardiac arrest, oropharyngeal edema, facial edema, tissue damage, gastrointestinal bleeding, bowel necrosis, bowel perforation, seizures, toxic epidermal necrolysis (Lyell's syndrome), pneumonia, pulmonary edema, urticaria.

Mild side effects

  • Nausea
  • vomiting
  • abdominal pain
  • abdominal discomfort
  • oral mucosal blisters
  • diarrhea
  • hypotension
  • tachycardia
  • hypothyroidism
  • dizziness
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  • bronchial dilation
  • rash
  • itching
  • erythema
  • fever
  • sweating
  • fluid and electrolyte imbalance
  • headache
  • consciousness disturbance.

Not everyone experiences these, and they can vary from person to person.

Storage

This drug can deteriorate when exposed to light, so it should be stored in a light-protected, tightly sealed container. The storage temperature should ideally be maintained between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

A slightly yellowish, nearly colorless solution contained in a brown bottle with a faint star anise scent.

Package unit

1CTN: 100ML × 1

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.