Registered Botswana · BoMRA

UROGRAFIN 30 %

Amidotrizoic acid (Meglumine amidotrizoate 0,26 g

BOT2500118 Solution for Infusion 0,26 g

What it does

Amidotrizoate is a contrast agent used in medical imaging to help visualize internal organs and structures during X-ray and CT scans.

Commonly used for: diagnostic imaging, X-ray procedures, CT scans

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

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Registration & product details

Registration no.
BOT2500118
Registration date
2023-02-20
Expiry date
2030-02-19
Status
Registered/Compliant
Active ingredient
Amidotrizoic acid (Meglumine amidotrizoate 0,26 g
Dosage form
Solution for Infusion
Strength
0,26 g
Pack size
-
Therapeutic class
-
RxNorm RxCUI
3319
Manufacturer / MAH
BerliMed
Country of origin
Spain
Manufacturer location
C. Francisco Alonso, 7, 28806 Alcalá de Henares, Madrid, Spain

Source: Botswana Medicines Regulatory Authority · fetched 2026-04-15 20:42:56 · updated 2026-10-20 04:31:58

Disclaimer: This information is sourced from Botswana Medicines Regulatory Authority (Botswana). Always consult a qualified healthcare professional before using any medication.

About amidotrizoate

Amidotrizoate is a contrast agent used in medical imaging to help visualize internal organs and structures during X-ray and CT scans.

What it treats

  • diagnostic imaging
  • X-ray procedures
  • CT scans

How it works

Amidotrizoate works by absorbing X-rays, which helps to highlight specific areas in the body during imaging tests.

Who it's for

It is used for patients who need detailed images of their organs for diagnosis.

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

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.

Clinical monograph: amidotrizoate

BNF-referenced

Amidotrizoate, an iodine-containing X-ray contrast agent, is commonly used in medical imaging to enhance the visibility of internal structures during radiographic examinations. It is water-soluble and works by scattering or stopping X-rays due to its high electron density, primarily from the iodine content. This allows for improved contrast in imaging, aiding in the diagnosis of various medical conditions.

Indications

  • Diagnostic imaging in radiography
  • Angiography
  • Computed tomography (CT) scans
  • Urography
  • Visualizing vascular structures and abnormalities

Dosage

Children: Dosing in children should be determined based on age, weight, and the specific imaging requirement. Refer to the BNF for Children for appropriate pediatric dosing guidelines.

Adults: The dosage for adults varies depending on the specific imaging procedure and the concentration of the contrast agent used. Refer to the BNF for detailed dosing information.

Mechanism of action

Amidotrizoate functions as a radiopaque agent that contains iodine, which effectively blocks X-rays. The high density of electron-dense iodine atoms scatters X-rays, allowing for clear imaging of body structures where the contrast medium localizes. This enables the differentiation of organs and tissues on X-ray films, appearing white and providing necessary contrast for diagnosis.

Pharmacodynamics

As a water-soluble, iodinated contrast medium, amidotrizoate is utilized to facilitate diagnostic imaging by creating a distinction between different organs and tissues during X-ray examinations. The localization of this agent in specific areas enhances the visibility of anatomical structures, aiding in the detection of abnormalities.

Pharmacokinetics

Amidotrizoate is administered primarily via intravenous injection, although it can also be given intraarterially, intrathecally, or intraabdominally. It is rapidly distributed throughout the body, and its excretion occurs predominantly through the kidneys. The contrast medium's nephrotoxicity is a significant concern, as it may reduce renal blood flow and directly affect renal tubular cells, leading to acute renal failure in susceptible patients.

Adverse effects

  • Allergic reactions
  • Nausea
  • Vomiting
  • Headache
  • Nephrotoxicity
  • Injection site reactions

Precautions

  • Use with caution in patients with known allergies to iodine or previous reactions to contrast media
  • Consider renal function prior to administration, especially in patients with pre-existing renal impairment
  • Monitor for signs of nephrotoxicity

Pregnancy

Safety in pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Storage

Store in a cool, dry place away from direct sunlight. Do not freeze.

Formulations

  • Injection solution

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: 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.

Molecular reference: amidotrizoate

PubChem CID 2140

Molecular formula: C11H9I3N2O4

Mechanism of action

Diatrizoate is an iodine-containing X-ray contrast agent. Iodated contrast agents were among the first contrast agents developed. Iodine is known to be particular electron-dense and to effectively scatter or stop X-rays. A good contrast agent requires a high density of electron-dense atoms. Therefore, the more iodine, the more "dense" the x-ray effect. Iodine based contrast media are water soluble and harmless to the body. These contrast agents are sold as clear colorless water solutions, the concentration is usually expressed as mg I/ml. Modern iodinated contrast agents can be used almost anywhere in the body. Most often they are used intravenously, but for various purposes they can also be used intraarterially, intrathecally (the spine) and intraabdominally - just about any body cavity or potential space. Radiocontrast medium induced nephrotoxicity is a major clinical problem. There is considerable interest in reducing the incidence of acute renal failure due to the use of radiocontrast media (RCM). Reduction of renal blood flow and direct toxic effect on renal tubular epithelial cells have been postulated as major causes of RCM nephropathy. Understanding the molecular mechanisms by which RCM cause cell damage may allow the development of pharmacological therapy to prevent their nephrotoxicity. In this work we have investigated the signaling pathways that may be affected by RCM. The incubation of human renal tubular proximal cells with sodium diatrizoate, iopromide and iomeprol caused a marked dephosphorylation of the kinase Akt on Ser473 within 5min of incubation. RCM also caused a decrease in cell viability, which was substantially alleviated by transfecting the cells with a constitutively active form of Akt. Further downstream targets of Akt, including the Forkhead family of transcription factors FKHR and FKHRL1, were also dephosphorylated by RCM at Thr24 and Thr32, respectively. The P70S6 kinase was also dephosphorylated at Thr389 and Ser371 by RCM. However there was a more dramatic decrease in phosphorylation of the phosphorylated form of mammalian target of rapamycin (mTOR) and of the extracellular-signal regulated kinases (ERK) 1/2 caused by sodium diatrizoate than by iopromide. These results demonstrate the effect of RCM on some intracellular signaling pathways that may allow understanding of the mechanism of their toxicity and may allow the development of strategies to overcome their adverse effects.

Pharmacodynamics

Diatrizoate is the most commonly used water-soluble, iodinated, radiopaque x-ray contrast medium. Radiopaque agents are drugs used to help diagnose certain medical problems. They contain iodine, which blocks x-rays. Depending on how the radiopaque agent is given, it localizes or builds up in certain areas of the body. The resulting high level of iodine allows the x-rays to make a "picture" of the area. The areas of the body in which the radiopaque agent localizes will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.

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.