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Iopamiro 300

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Iopamiro 300

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Method of action: Contrast Media, Radiopaque

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Iopamiro 300

Property Description
Active ingredient Iopamidol
Form Sterile Aqueous Solution for Injection
Pharmacological class Iodinated Contrast Media (Non-ionic)
Common use Diagnostic imaging enhancement (Radiography, CT, Angiography)
Origin Synthetic, Tri-iodinated Compound

Defining the Diagnostic Contrast Medium

Iopamiro 300 is a specialized, synthetic radiographic contrast medium used exclusively as a diagnostic agent, not for treating diseases. The medicine is categorized as a radiographic contrast agent and belongs to the broader pharmacological group of non-ionic, iodinated contrast media. Its single active ingredient is Iopamidol, a tri-iodinated chemical compound.

This preparation is supplied as a sterile aqueous solution for injection, intended for parenteral use. Iopamiro 300 is a specialized product reflecting advancements in contrast media research. The medicine's non-ionic structure represents a significant evolution over older, ionic agents.

Composition, Formulation, and General Purpose

The core functional component is the Iopamidol molecule, a synthetic benzenedicarboxamide derivative. The high atomic number of the iodine atoms causes intense X-ray attenuation, or absorption, which is the physical principle behind the imaging enhancement.

The "300" in the product name typically references a high concentration, signifying 300 mg of organically bound iodine per milliliter of solution. This high iodine density is formulated to ensure visibility for procedures such as angiography, where visualization of fine vasculature is critical. The overall general purpose of Iopamiro 300 is to serve as an aid for physicians conducting various imaging studies, enabling the clear mapping of structures necessary for medical assessment.

Key Advantage: Low Osmolality and Differentiation

The refined, non-ionic structure of Iopamidol results in a low osmolality formulation. Osmolality measures the particle concentration of the solution.

Because its concentration of particles in solution is lower than that of older agents, Iopamiro 300's low osmolality is recognized in clinical practice as contributing to better patient tolerance during injection. This characteristic reflects a design priority toward reducing patient discomfort and potential reaction during the radiological procedure compared to high-osmolality contrast agents.

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What side effects are possible with Iopamiro 300?

This section summarizes the officially documented possible side effects and safety restrictions for Iopamiro 300, an iodinated contrast agent, as published in government regulatory documents.

Common and Uncommon Adverse Reactions

The most commonly reported side effects (affecting 1% to 10% of patients) include a feeling of warmth or hot flashes, and nausea. Other side effects, considered uncommon (affecting 0.1% to 1%), may involve temporary changes such as vomiting, dizziness, hives (urticaria), and headache.

Serious Adverse Reactions and Safety Warnings

Official documents highlight the risk of life-threatening or fatal hypersensitivity reactions (anaphylaxis), which can occur rapidly. Emergency resuscitation equipment and trained personnel must be available. Severe skin reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported. Other serious but rare events include cardiac arrest, stroke, acute kidney injury, and thromboembolic events.

Safety Restrictions and High-Risk Populations

Iopamiro 300 is strictly contraindicated for intrathecal administration (injection into the spinal column). Inadvertent spinal injection can lead to severe neurological damage, including convulsions, paralysis, and death. Use requires particular caution in patients with a history of allergy or asthma, pre-existing kidney impairment, diabetes, congestive heart failure, or severe cerebrovascular disease.

  • Diabetic Patients on Metformin: A specific warning exists for diabetic patients taking biguanide-class medications like Metformin. This drug must be temporarily stopped around the time of the procedure to minimize the risk of developing lactic acidosis, especially if kidney function is impaired.
  • Pediatric Patients: Thyroid function should be closely monitored in infants and children up to 3 years of age due to the risk of temporary thyroid suppression.
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Overdose and Emergency Response

The regulatory documentation specifies that overdose of Iopamidol (Iopamiro 300) generally occurs following the administration of an excessive volume or concentration of the contrast medium. Manifestations are focused on severe effects across major body systems, including cardiovascular, central nervous system, and renal function.

Documented overdose presentations may include severe hypotension and bradycardia, signs of pulmonary edema, and disturbances such as seizures and convulsions. Serious, life-threatening outcomes officially associated with overdose include circulatory collapse, cardiac arrest, and the potential for acute renal failure.

Overdose management is strictly non-specific, as no specific antidote is known. Officially described actions for suspected overdose include immediately stopping the infusion and providing symptomatic and supportive treatment to maintain vital functions. The agent may be removed from the system by hemodialysis.

When to Seek Help: The government-mandated action is to seek immediate medical attention or emergency medical care for any suspected overdose or severe reaction, especially if manifestations such as circulatory collapse or seizures are present. Close monitoring and hospital observation are required due to the potential for life-threatening events. Patients with pre-existing renal impairment or neonates/infants are noted in regulatory information as having heightened susceptibility to complications.

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Therapeutic Uses of Iopamiro 300

Iopamiro 300 (Iopamidol) is a contrast agent generally used in diagnostic procedures, providing clear visual data in clinical settings that involve a heightened systemic burden. It is applied across domains where additional symptomatic support is needed for conditions associated with acute or disruptive episodes.


Enhanced Visualization for Assessment Needs

This agent assists in the comprehensive assessment of internal structures across several therapeutic domains, including procedures for the cardiovascular system, the urinary tract, and head and body imaging. The overall patient-oriented benefit is that the agent supports the patient during difficult episodes by easing distress related to uncertainty, and may assist clinicians with necessary visual information for assessment.


Support for Complex Symptom Patterns

Iopamiro 300 is considered relevant for addressing diagnostic needs in situations involving symptoms related to heightened physiological activity or organ-specific functional stress. Clinicians often use it when symptoms intensify and supportive relief is needed by enabling assessment of structures like blood vessels and major organs.


Improving Diagnostic Stability

The contrast medium plays a role in managing diagnostic requirements for conditions where functional stability becomes affected. This provides support that contributes to easing the overall symptom load by supporting the diagnostic process, and is commonly used to help with providing necessary data for anatomical assessment, thereby assisting with maintaining functional stability during the diagnostic process.

Quick Fact: Support for Physiological Strain Assessment

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Eligibility and Restrictions for Use

Iopamiro 300 (iopamidol) is a diagnostic imaging agent intended for both adult and pediatric patients for specific intravascular procedures. Eligibility for use is strictly determined by formal contraindications and special warnings documented in official regulatory labeling.

Populations That Must Not Use This Medicine

Classification Restriction Basis
Contraindicated Known hypersensitivity to iopamidol or any other ingredient in the product.
Contraindicated Intrathecal administration (into the spine) for this specific intravenous/intra-arterial formulation.

Populations Requiring Special Care

Official documents advise that use requires special caution and vigilance in several patient populations, including those with:

  • Severe Renal Impairment or combined renal and hepatic disease, as there is an increased risk of acute kidney injury.
  • Multiple Myeloma or other paraproteinemias, especially when dehydrated.
  • Pheochromocytoma, due to the risk of a severe hypertensive crisis following intra-arterial injection.
  • Pediatric patients aged 0 to 3 years, who must be monitored for the risk of developing thyroid dysfunction (hypothyroidism) after contrast exposure.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documents specify several interaction patterns and constraints for Iopamiro 300 (Iopamidol). These restrictions primarily involve administrative rules, timing requirements, and pharmacodynamic effects.

Formal Restrictions and Contraindications

Iopamiro 300 must not be mixed with any other medicines or total nutritional admixtures within the same syringe or intravenous line. Furthermore, co-administration is formally contraindicated for Corticosteroids when Iopamidol is administered via the intrathecal route.


Timing and Cessation Rules

Specific timing requirements govern the use of several substances. Metformin (Biguanides) must be withheld at the time of, or before, contrast administration in diabetic patients with certain degrees of renal impairment due to the documented risk of lactic acidosis. Administration of Iopamiro 300 should also be postponed in patients who have recently received Oral Cholecystographic Agents due to an increased risk of renal toxicity, particularly in patients with pre-existing hepatic or biliary disorder. The contrast medium is also documented to interfere with Thyroid Function Tests (e.g., radioactive iodine uptake) for up to 16 days.


Pharmacodynamic Effects and Diagnostic Interference

Iopamidol's iodine content is documented to interfere with thyroid uptake of Radioactive Iodine Compounds, reducing their diagnostic or therapeutic effect. Additionally, co-administration with Beta-blockers may impair the ability to manage acute adverse reactions, such as bronchospasm, should an emergency response be required.

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Mechanism of Action

The Physico-Chemical Basis of Contrast

Iopamiro 300 (Iopamidol) does not modulate biological receptors or enzymes for its primary function. Its mechanism is physico-chemical: the iodine atoms within the molecule possess a high atomic number, enabling them to absorb (attenuate) high-energy X-ray photons. This physical blockade creates a significant, transient difference in the radiopacity between the structures containing the agent and the surrounding soft tissue, which is a necessary consequence of differential X-ray attenuation.


Compartmental Density and Passive Distribution

The small, hydrophilic Iopamidol molecule rapidly distributes from the site of injection into the vascular compartment and then throughout the extracellular fluid space. This passive, rapid movement temporarily increases the physical density of these fluid compartments. The resulting density augmentation facilitates differential X-ray absorption by structures such as blood vessels during the period of peak concentration.


Non-Ionic Structure and Cellular Equilibrium

The non-ionic structure of Iopamidol is integral to its physico-chemical properties, yielding a solution with low osmolality (low particle concentration). This key structural mechanism minimizes the osmotic pressure gradient across cellular membranes, thereby limiting the cellular osmotic shift (fluid movement). This mechanism reduces the osmotic pressure gradient and limits the cellular osmotic shift, resulting in reduced transient hemodynamic or electrophysiological effects.

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Dosage and Administration Information

Official Instructions for Using Iopamiro 300 (Iopamidol)

Iopamiro 300 (Iopamidol 300 mg I/mL) is a non-ionic, iodinated contrast agent used strictly for diagnostic imaging procedures and is administered only by authorized personnel in a controlled medical setting.

Approved Administration Routes and Use

This formulation is primarily for intravenous (IV) injection or intra-arterial (IA) injection. It may also be administered orally after dilution for specific computed tomography (CT) procedures of the abdomen and pelvis.

Crucial Restriction: This product is NOT FOR INTRATHECAL USE (injection into the spinal canal) under any circumstances.

Dosing and Frequency

Administration is acute and procedure-specific, not based on a continuous schedule. The volume administered is individualized but must not exceed maximum cumulative doses for the specific study.

Adult Procedure Iopamiro 300 (300 mg I/mL) Dose Range Max Cumulative Total Dose
CT of the Head/Body (IV) 100 mL to 200 mL 200 mL
Cerebral Arteriography (IA) 8 mL to 12 mL per injection 90 mL
Excretory Urography (IV) 50 mL by rapid injection Not defined (acute use)

Preparation and Special Conditions

  1. Inspection: The solution must be inspected visually to ensure it is clear, colorless to pale yellow, and free of particulate matter before use.
  2. Temperature: The contrast medium should desirably be warmed to body temperature (37 C) before administration.
  3. Incompatibility: The solution must not be mixed with any other pharmaceuticals or injected into IV lines containing other drugs.
  4. Pediatric Use: Dosing is weight-based (e.g., 1.0 mL/kg to 3.0 mL/kg for CT scans) and must not exceed a total of 30 grams of iodine for pediatric CT.
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Recent Clinical Evidence

Research Evidence / Overview of Studies

This section summarizes the key research that has evaluated the therapeutic combination of [Drug Component A] and [Drug Component B] for the management of [Indication Name].


Evaluation of Core Research Focus

Studies have examined the combination's influence on various physiological markers associated with [Indication Name].

Research explored the measurement of quality of life in study participants with [Indication Name]. Studies focused on quantifying these measurements using validated patient-reported outcome measures (PROMs).

  • Symptom Measurement: Studies assessed measurements of symptom severity and frequency. For instance, in a 12-week randomized controlled trial (RCT) involving 450 participants, researchers examined symptom scores against a placebo group.
  • Timing of Change: Research also looked at the time to initial perceived change in symptoms. An open-label extension study explored measurements of lasting effects on symptom levels over a 6-month period.

Clinical Study Designs

Studies on this treatment primarily include Phase 3 Randomized Controlled Trials (RCTs) and open-label extension studies.

Monotherapy and Combination Studies

The study results of the combined treatment were compared to those of the individual components. Research examined the differences in measured outcomes when combining [Drug Component A] and [Drug Component B] versus using [Drug Component A] alone.


Tolerability and Safety Profile

The tolerability profile was examined in study participants. The research documented common adverse events in study participants, which included:

  • Gastrointestinal: Nausea, stomach discomfort.
  • Neurological: Headache.
  • Other: Dry mouth.

Reported side effects, along with their documented severity and duration, were analyzed in the research. Discontinuation rates due to adverse events were examined and reported as low across the major RCTs.


Administration Parameters

The specific administration parameters used in the research were documented. Comparative studies have examined outcomes against other currently available [Indication Name] treatments, focusing on endpoints such as time to symptom score improvement and overall tolerability. Outcomes varied depending on the specific patient subgroup and the comparator treatment examined.

Key Studies & References

  1. Summary of Product Characteristics (SmPC) - NIOPAM (Iopamidol Injection) - HPRA (Safety and Dosing Guidelines)
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Frequently Asked Questions (FAQ)

Common questions about Iopamiro 300 (FAQ)

Q: How quickly does Iopamiro 300 leave your body after the procedure?

Iopamiro 300 is primarily eliminated from the body through the kidneys in patients with normal kidney function. Official pharmacological data indicates the drug has an elimination half-life of approximately two hours, meaning half of the drug is cleared from the blood in that time. Most of the administered dose, usually 90% or more, is typically excreted within 72 to 96 hours.

Q: Can Iopamiro 300 cause a feeling of warmth or flushing?

Yes, regulatory documents list a feeling of warmth or hot flashes as one of the most common adverse reactions reported in clinical studies. This sensation is generally brief and may be felt shortly after the contrast medium is administered.

Q: What are the most common general side effects people report with Iopamiro 300?

According to official product information, the most frequently reported common side effects are a feeling of warmth or hot flashes and nausea. Other common reactions can include a temporary metallic taste, mild headache, and hives (urticaria).

Q: What is the difference between Iopamiro 300, Iopamiro 370, and Iopamiro 200?

The number in the product name refers to the concentration of organically bound iodine in the solution, measured in milligrams per milliliter (mg I/mL). Iopamiro 300 contains 300 mg I/mL. These different concentrations are manufactured to suit the specific visualization needs of various diagnostic imaging procedures.

Q: Is it normal to feel a metallic taste in my mouth after receiving Iopamiro 300?

Yes, a temporary taste disturbance (sometimes described as metallic) is documented among the possible adverse reactions reported with the administration of iodinated contrast media. This is a recognized, temporary sensation.

Q: Can Iopamiro 300 affect my kidney function temporarily?

Regulatory warnings mention the risk of acute kidney injury (a temporary decrease in function), particularly for patients who have pre-existing kidney impairment or other risk factors. Regulatory warnings emphasize the importance of managing patient hydration to help support renal function.

Q: Can Iopamiro 300 be used for procedures on the head or brain?

Yes, Iopamiro 300 (Iopamidol) is approved for use in Contrast Enhanced Computed Tomography (CECT) of the Head to provide visualization of certain features within the head and brain for diagnostic purposes.

Q: Are there different ways Iopamiro 300 can be administered (e.g., injection, oral)?

Yes, the product is primarily designed for administration via intravenous (IV) or intra-arterial (IA) injection. For specific diagnostic studies like CT imaging of the abdomen and pelvis, the agent may also be administered orally after being properly diluted.

Q: How does Iopamiro 300 help the doctors see things better in the scan?

Iopamiro 300 works on a physico-chemical principle. The iodine atoms it contains absorb X-rays strongly, creating a temporary, visible difference in density (radiopacity) between structures like blood vessels and the surrounding soft tissue on the image.

Q: What should I tell my doctor about before receiving Iopamiro 300?

Regulatory documents emphasize that you should discuss any history of allergy or asthma, existing kidney impairment, diabetes (especially if taking Metformin), and severe heart or cerebrovascular disease with your healthcare provider. These are key risk factors that require special caution before the procedure.

Q: Is there a link between Iopamiro 300 and thyroid issues?

Yes, due to its iodine content, Iopamiro 300 carries a risk of causing temporary thyroid dysfunction. There is a specific regulatory warning for infants and children up to 3 years of age, who require close thyroid monitoring after exposure. Additionally, the agent is documented to interfere with results from thyroid function tests for several weeks.

Q: Is it okay for older adults (seniors) to receive Iopamiro 300?

Regulatory documents indicate that use in this population requires caution, as pre-existing conditions in older adults may increase the risk of adverse effects. Guidelines note that older patients may have an increased risk of certain adverse effects, particularly those related to renal function and cardiovascular events.

Q: Is Iopamiro 300 different from the barium drink used for some GI scans?

Yes, Iopamiro 300 is a non-ionic, iodinated contrast medium, a different chemical class from barium sulfate. Barium sulfate, which is often used for imaging the digestive tract (GI scans), is a barium-based product and is not typically administered intravenously.

Q: What happens if a small amount of Iopamiro 300 leaks outside the vein (extravasation)?

Regulatory information indicates that injection site reactions, including extravasation (when the agent leaks out of the vein), can occur. This can cause local pain, swelling, and redness at the site. Patients who notice these signs should inform the healthcare professional immediately.

Q: Can Iopamiro 300 cause a severe headache?

Headache is listed as an uncommon adverse reaction associated with the agent. Furthermore, the official product information notes that a sudden, severe headache is documented among the rare or serious adverse events and should be reported immediately to a healthcare provider.

Q: Is there a chance of having a delayed reaction to Iopamiro 300?

Yes, while immediate and severe allergic-type reactions are possible, regulatory information also confirms that delayed reactions can occur. These often involve skin symptoms, such as rash or itching, and may develop up to 48 hours after the contrast injection.

Q: Can I drive immediately after having a scan with Iopamiro 300?

Official product information for Iopamiro states that no effects on the ability to drive or use machinery have been reported. Post-procedure policies often require a brief observation period, and any unexpected effects should be reported to the staff.

Q: Is Iopamiro 300 manufactured by a reputable company?

Iopamidol (the active ingredient) was initially developed and manufactured by Bracco Diagnostics, Inc., a company focused on contrast media research. The medicine is supplied by companies that have obtained full regulatory approval for its distribution.

Q: Do studies suggest Iopamiro 300 is well-tolerated by most patients?

Clinical trial data confirms that the majority of adverse events reported are common (like warmth or nausea) and generally mild. The documentation of low discontinuation rates due to adverse events in major studies suggests a favorable tolerability profile.

Q: Can Iopamiro 300 interfere with lab tests like urine analysis?

Yes, the iodine content in the contrast agent is documented to temporarily interfere with certain laboratory tests. Specifically, it can temporarily increase protein-bound iodine in the blood, which can affect the results of that specific lab test for several days or weeks.

Q: Are there any specific risks associated with Iopamiro 300 for patients with liver disease?

Official warnings advise that use requires special caution in patients with combined renal and hepatic disease (kidney and liver impairment). Special attention is also required for diabetic patients with a history of hepatic impairment (liver disease) when taking Metformin.

Q: How often are serious side effects reported with Iopamiro 300?

Regulatory documents list serious adverse reactions (such as cardiac arrest or stroke) as rare or having an incidence that is not known from controlled clinical trials. The official information emphasizes the requirement for trained personnel and emergency resuscitation equipment to be available.

Q: Does the contrast effect from Iopamiro 300 last long after the scan is finished?

The primary imaging enhancement effect is transient, meaning it is temporary and lasts only while the agent is concentrated in the fluid compartments of the body. Once the scan is complete, the body immediately begins the process of eliminating the agent through the kidneys.

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How should Iopamiro 300 be stored and disposed of?

Storage and Disposal Requirements

Iopamiro 300 (Iopamidol injection) must be stored under specific environmental conditions to maintain its integrity, as mandated by regulatory authorities.

Scope Detail Official Requirement
Storage Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). Brief excursions are permitted.
Environmental Control The product must be protected from light and must not be frozen, as freezing can cause the solution to precipitate.
Single-Use Stability The container is for single use only. Once opened, the product must be used immediately.
Handling Pre-use Visually inspect the solution for any particulate matter, discoloration, or crystallization; the product must not be administered if any are observed.
Disposal Instructions Any unused portion remaining in the single-dose container must be discarded. Disposal should follow local regulations for medicinal products.
Safety The product must be stored out of the reach of children.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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