Registered Tanzania · TMDA

Gastrografin Aq

Amidotrizoic Acid 59.73 ml/5ml,Meglumine 15.92 ml/5ml

TAN 00,572 V04A SCH Solution INN generic

What it does

Amidotrizoic is a contrast agent used during medical imaging procedures to help visualize internal structures in the body.

Commonly used for: medical imaging procedures, diagnostic tests

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
TAN 00,572 V04A SCH
Registration date
2024-03-01
Expiry date
2029-02-28
Status
Registered/Compliant
Active ingredient
Amidotrizoic Acid 59.73 ml/5ml,Meglumine 15.92 ml/5ml
Dosage form
Solution
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
3319
Manufacturer / MAH
Berlimed
Applicant / LTR
Bayer East Africa Ltd
Country of origin
SPAIN
Manufacturer location
C. Francisco Alonso, 7, 28806 Alcalá de Henares, Madrid, Spain

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:49:28 · updated 2026-10-19 03:00:45

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About amidotrizoic

Amidotrizoic is a contrast agent used during medical imaging procedures to help visualize internal structures in the body.

What it treats

  • medical imaging procedures
  • diagnostic tests

How it works

It helps to highlight certain areas in the body on imaging scans, making it easier for doctors to see and diagnose conditions.

Who it's for

This is used for patients undergoing certain imaging tests to help diagnose various health issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About meglumine

Meglumine is a compound often used in medical imaging and diagnostic procedures.

What it treats

  • medical imaging
  • diagnostic procedures

How it works

Meglumine helps to enhance the visibility of certain areas in the body during imaging tests, making it easier for healthcare providers to see and diagnose conditions.

Who it's for

Meglumine is used for patients undergoing specific imaging tests, such as X-rays or CT scans.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: amidotrizoic

Amidotrizoic acid is a non-ionic iodinated contrast agent used primarily in medical imaging to enhance the visibility of internal structures during radiographic examinations. It is commonly employed in procedures such as computed tomography (CT) scans and angiography. Due to its low osmolality, amidotrizoic acid is associated with fewer adverse reactions compared to older contrast agents.

Indications

  • Computed Tomography (CT) imaging
  • Angiography
  • Intravenous urography
  • Cholangiography

Dosage

Children: Refer to specific guidelines for the appropriate dose, as it depends on the procedure being performed and the patient's clinical condition.

Adults: Refer to specific guidelines for the appropriate dose, as it depends on the procedure being performed and the patient's clinical condition.

Mechanism of action

Amidotrizoic acid increases the contrast of the images obtained during radiological procedures by attenuating X-rays. The iodine atoms within the compound absorb X-rays more effectively than surrounding tissues, allowing for clearer delineation of vascular structures and organs.

Pharmacodynamics

The pharmacodynamics of amidotrizoic acid involve its role as a radiopaque agent. It functions by altering the density of tissues relative to surrounding structures, which enhances the contrast in imaging. Additionally, due to its non-ionic nature, amidotrizoic acid has a lower incidence of adverse effects such as allergic reactions and nephrotoxicity.

Pharmacokinetics

Amidotrizoic acid is administered intravenously and is rapidly distributed in the vascular system. It is primarily excreted unchanged by the kidneys. The peak plasma concentration is typically achieved within minutes of administration, and the elimination half-life is generally around 1 to 2 hours, although this can vary based on renal function.

Contra-indications

  • Hypersensitivity to amidotrizoic acid or any of its components
  • Severe renal impairment
  • Hyperthyroidism

Adverse effects

  • Nausea
  • Vomiting
  • Abdominal pain
  • Headache
  • Allergic reactions
  • Hypotension
  • Renal toxicity
  • Thyroid dysfunction

Interactions

  • Caution with other nephrotoxic agents
  • May interfere with laboratory tests of thyroid function

Precautions

  • Use with caution in patients with pre-existing renal impairment
  • Ensure adequate hydration before administration
  • Monitor renal function post-administration

Pregnancy

Amidotrizoic acid should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether amidotrizoic acid is excreted in human milk. Caution should be exercised when administering to breastfeeding women.

Storage

Store in a cool, dry place, protected from light. Follow specific storage instructions on the product label.

Formulations

  • Injection

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: meglumine

BNF-referenced

Meglumine is a compound used primarily as a pharmaceutical excipient and as a solubilizing agent in various medical preparations. It is a derivative of glucuronic acid and functions as a stabilizer for certain drug formulations, particularly in radiologic contrast media. Meglumine enhances the solubility of active ingredients, thereby improving their bioavailability.

Indications

  • Used as a solubilizing agent in pharmaceutical preparations
  • Used in radiographic contrast media formulations

Dosage

Children: Refer to specific formulations for paediatric dosing instructions as it varies depending on the application.

Adults: Refer to specific formulations for adult dosing instructions as it varies depending on the application.

Mechanism of action

Meglumine acts by enhancing the solubility and stability of drugs in solution, particularly in radiographic contrast agents. It is involved in purinergic signaling pathways, which are essential for various physiological processes, including neurotransmission and inflammation.

Pharmacodynamics

The pharmacodynamic profile of meglumine is largely influenced by its role as a solubilizing agent. It does not exhibit direct pharmacological effects on its own but rather facilitates the action of other active ingredients in formulations. Its impact on purinergic signaling may contribute to modulating physiological responses in the body.

Pharmacokinetics

Meglumine is rapidly absorbed when administered, with its pharmacokinetics closely tied to the properties of the drugs it accompanies. The distribution, metabolism, and excretion of meglumine are not well-defined as it typically functions as an excipient rather than an active therapeutic agent. Its elimination from the body is primarily via renal pathways.

Pregnancy

There is insufficient data on the use of meglumine in pregnancy, therefore it should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised when administering meglumine to breastfeeding women, as its effects on infants are not well studied.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: meglumine

PubChem CID 8567

Molecular formula: C7H17NO5

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.