Registered Tanzania · TMDA

Cardiolek-320

Iodixanol USP 320 mg

TAN 21 HM 0213 Injection 320. 0.04, 1.2, 1.11, 0.1 various INN generic

What it does

Iodixanol is a contrast agent used in medical imaging to help doctors see inside the body more clearly during procedures.

Commonly used for: imaging of blood vessels (angiography), imaging of the urinary tract, computed tomography (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.
TAN 21 HM 0213
Registration date
2026-06-03
Expiry date
2031-06-01
Status
Registered/Compliant
Active ingredient
Iodixanol USP 320 mg
Dosage form
Injection
Strength
320. 0.04, 1.2, 1.11, 0.1
Pack size
-
Therapeutic class
-
ATC class (WHO)
V08AB - Watersoluble, nephrotropic, low osmolar X-ray contrast media
Drug group
VARIOUS
RxNorm RxCUI
27729
Country of origin
INDIA
Manufacturer location
Survey No. 101/2 & 102/1 Daman Industrial Estate, Bhimpore, Daman, Marwad, Dadra and Nagar Haveli and Daman and Diu 396210, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:35:42 · updated 2026-10-29 03:00:48

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

About this medicine

Iodixanol is a contrast agent used in medical imaging to help doctors see inside the body more clearly during procedures.

What it treats

  • imaging of blood vessels (angiography)
  • imaging of the urinary tract
  • computed tomography (CT) scans

How it works

Iodixanol works by absorbing X-rays, which makes certain areas of the body show up more clearly on imaging scans.

Who it's for

Iodixanol is for adults and children who need imaging tests to diagnose or monitor medical conditions.

Cautions

  • • Inform your doctor if you have kidney problems or allergies to contrast agents.
  • • Stay hydrated before and after the procedure to help your kidneys.

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

Clinical monograph: iodixanol

BNF-referenced

Iodixanol is a non-ionic, iso-osmolar iodinated contrast agent used primarily in radiographic imaging procedures, such as coronary angiography. It is designed to improve the visibility of internal structures during imaging studies by attenuating x-rays, allowing clinicians to distinguish between tissues and blood vessels containing iodine and those that do not.

Indications

  • Coronary angiography
  • CT imaging
  • Angiographic procedures

Dosage

Children: Refer to the BNF for Children for appropriate dosing information in paediatric patients.

Adults: Refer to the BNF for detailed dosing guidance based on the specific procedure and patient condition.

Mechanism of action

Iodixanol, as an organic iodine compound, attenuates x-rays as they pass through the body. The opacity produced is directly proportional to the concentration and volume of the iodinated contrast agent within the x-ray path. This property allows for the visualization of internal structures until significant hemodilution and elimination occur after intravascular administration.

Pharmacodynamics

Iodixanol is particularly useful in patients with renal dysfunction due to its lower toxicity profile compared to other contrast agents. It has an osmolality similar to that of blood (290 mOsm/kg H2O), which reduces the risk of adverse renal effects during imaging procedures.

Pharmacokinetics

After intravascular injection, iodixanol distributes rapidly in the vascular system. The contrast agent is primarily eliminated through renal excretion. The pharmacokinetics of iodixanol are influenced by the patient's renal function, and it is important to consider this when dosing and administering the agent.

Pregnancy

Iodixanol should only be used in pregnancy if the benefits outweigh the risks, as safety has not been established.

Breast-feeding

Iodixanol is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, protected from light. Do not freeze.

Formulations

  • Iodixanol 270 mg/ml solution for injection
  • Iodixanol 320 mg/ml solution for 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: iodixanol

PubChem CID 3724

Molecular formula: C35H44I6N6O15

Mechanism of action

Organic iodine compounds attenuate x-rays as they pass through the body, thereby allowing the body structures containing iodine to be delineated in contrast to those structures that do not contain iodine. The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays. After intravascular administration, iodixanol makes opaque those internal structures in its path of flow, allowing their visualization until significant hemodilution and elimination occur. Intravascular injection of iodixanol opacifies those vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant dilution and elimination occurs.

Pharmacodynamics

Iodixanol is a contrast agent commonly used during coronary angiography, particularly in individuals with renal dysfunction, as it is believed to be less toxic to the kidneys than most other intravascular contrast agents. It is an imaging contrast agent with the same osmolality as blood (290mOsm/kg H20).

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.