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Омнипак

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Medically reviewed

Marina Burgos

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 Омнипак

Quick Facts

Property Description
Active ingredient Iohexol (INN)
Form Sterile aqueous solution for injection or administration
Pharmacological class Radiopaque contrast medium, non-ionic
General purpose Diagnostic visualization for medical imaging
Origin Synthetic, tri-iodinated derivative

What Type of Medicine is Омнипак?

Омнипак (Omnipaque), historically associated with the GE Healthcare group, is classified as a diagnostic pharmaceutical agent, serving as an assessment tool rather than a therapeutic medicine intended to treat disease. The medication’s active ingredient, Iohexol (INN), belongs to the pharmacological class of non-ionic radiographic contrast media, a classification recognized globally for its use in specialized diagnostic procedures. Iohexol is a synthetic, water-soluble compound that serves a pivotal role in enhancing X-ray visibility.

Composition and Physical Form: The Iohexol Solution

The core composition of Омнипак features Iohexol in a single-ingredient sterile aqueous solution. As a non-ionic tri-iodinated benzamide derivative, Iohexol’s structure is designed to remain intact in solution, supporting its use across various physiological systems. The solution is manufactured in a comprehensive range of iodine concentrations, from 140 mgI/mL up to 350 mgI/mL, allowing for precision when administered via specialized parenteral (e.g., intravenous) or local administration routes.

What is Омнипак Used for Generally?

The general purpose of Омнипак is to enable diagnostic visualization during various X-ray-based medical imaging. The general benefit is to provide a temporary, sharp contrast between soft tissues and fluid-filled spaces that are otherwise indistinct on a standard X-ray. This contrast enhancement, achieved through the strong X-ray absorption of the iodine component, allows physicians to clearly delineate internal structures, such as blood vessels and organ spaces, providing the necessary clarity for accurate assessment and comprehensive diagnosis.

Regulatory References

  1. Omnipaque (iohexol) injection label on DailyMed
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What side effects are possible with Омнипак?

Possible Side Effects and Safety Information

The safety profile of Iohexol (Omnipaque) is established through regulatory documentation that classifies adverse reactions by frequency and physiological system. This classification provides a standardized description of expected risk, strictly separating events by their statistical occurrence and the organ class affected, consistent with government health authority standards.

Frequency-Classified Adverse Reactions

The regulatory labeling defines adverse effects based on frequency:

  • Very Common (ge 10%): Headache, which may be severe or prolonged.
  • Common (ge 1.0% to < 10%): Pain (including neckache and backache), Nausea, Vision abnormalities (such as blurred vision), and Taste perversion.

Adverse events are additionally grouped by System-Organ Class, including effects on the Nervous System, Gastrointestinal System, and Cardiac and Vascular System.

Serious Adverse Reactions and Safety Restrictions

Official documents highlight rare but clinically significant adverse reactions, including Cardiac arrest, Acute kidney injury, and Seizure. Life-threatening hypersensitivity reactions, such as anaphylaxis, are also documented. These serious events represent the highest tier of documented risk.

Specific safety considerations exist for defined patient populations. For example, regulatory information notes a risk of Thyroid Dysfunction in pediatric patients aged 0 to 3 years. Furthermore, patients with pre-existing renal impairment have an increased risk of Contrast-Induced Acute Kidney Injury.

In terms of exposure, the most common effects typically occur within 1 to 10 hours following injection. A critical safety restriction is noted for administration, as certain high concentrations are explicitly not indicated for intrathecal use (in the spine), with inadvertent use linked to severe neurological and renal outcomes.

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Overdose and Emergency Response

Overdosage with Iohexol (Omnipaque) is formally documented in regulatory sources to result from the administration of an excessive volume or concentration of the contrast agent. Such an event may lead to manifestations of severe systemic toxicity, often involving hemodynamic disturbances and acute kidney injury (renal failure).

Severe Overdose Manifestations

The most serious outcomes described in the official labeling include life-threatening effects on critical systems, such as Shock and Cardiac Arrest. For the Central Nervous System, severe toxicity—particularly following inappropriate administration—is associated with complications such as Convulsions/Seizures, Cerebral Hemorrhage, and Coma. No specific chemical antidote is known for Iohexol.

When to Seek Immediate Medical Help

The official guidance strictly mandates that immediate medical attention must be sought for any severe or life-threatening reaction suspected to be an overdosage event. Management protocols emphasize symptomatic and supportive treatment, with Hemodialysis or Peritoneal Dialysis documented as effective means for removal in cases of systemic overload. Trained personnel are required to be available for observation for a period of 30 to 60 minutes following parenteral administration. Populations including the elderly and those with pre-existing renal impairment or diabetes mellitus are noted to have an increased risk of acute renal failure in an overdosage scenario.

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Therapeutic Uses of Омнипак

What Omnipaque Facilitates: Key Diagnostic Uses and Benefits

The product, Omnipaque (iohexol), is applied across various clinical scenarios where additional symptomatic support is needed. This medication is relevant in contexts involving heightened systemic burden, supporting the patient during difficult episodes. It is commonly used when symptoms create noticeable physiological strain, assisting with maintaining functional stability. This agent is considered relevant for easing distress across several domains, including the central nervous system, circulatory system, and digestive areas. This assists with symptomatic support in areas where short-term symptom management is appropriate.


Key Areas of Symptomatic Assistance

This diagnostic agent helps address symptom clusters related to systemic imbalance or neurological activity. Omnipaque is relevant in clinical settings that involve acute or unstable symptom patterns and is commonly used to help patients cope more steadily with symptom fluctuations in conditions where functional stability becomes affected. This assists with symptomatic support across areas related to the spine, circulatory system, and joint comfort.

Quick Fact: Support for Functional Comfort This agent is commonly used when symptoms create noticeable physiological strain, assisting with maintaining functional stability across various body systems.

Regulatory References

  1. Official FDA-approved product label via DailyMed
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Eligibility and Restrictions for Use

The eligibility for using Omnipaque (iohexol) is strictly defined by regulatory documents based on patient status, comorbidities, and the specific diagnostic procedure.

Populations for Whom Use is Contraindicated

Absolute Contraindications are patients with a known hypersensitivity to iohexol. Certain product forms are also prohibited for specific uses: Omnipaque 140 and 350 mgI/mL are contraindicated for intrathecal use (spinal injection). The oral solution forms (9 and 12 mgI/mL) are contraindicated for parenteral (injection) administration.

Procedure-Specific Contraindications exist for Hysterosalpingography (HSG), which is prohibited during pregnancy or suspected pregnancy, when infection is present in the genital tract, or following recent gynecological procedures (e.g., conization or curettage).

Conditional Use and Age-Specific Rules

Comorbidity Restrictions require caution and conditional use in patients with conditions like pre-existing renal impairment (due to risk of Acute Kidney Injury), diabetes mellitus, hyperthyroidism, or pheochromocytoma. Patients taking metformin must have the drug stopped before or during iohexol administration to mitigate the risk of lactic acidosis.

Age-Related Rules permit use in adults and pediatric patients aged 2 weeks and older for most procedures. However, pediatric patients 0 to 3 years of age require mandatory thyroid function monitoring. Geriatric patients are identified as an increased risk factor for Acute Kidney Injury.

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What should I know about interactions with other medicines?

The official regulatory profile for Iohexol details specific interactions related to the route of administration and the drug’s physiological effects. Contraindicated combinations include the co-administration of corticosteroids via the intrathecal route, and the prohibition of immediate repeat myelography due to the risk of overdosage.

Interactions with drugs that lower the seizure threshold, such as phenothiazine derivatives and MAO inhibitors, are associated with an increased seizure risk following intrathecal procedures. Regulatory standards require these agents to be discontinued at least 48 hours before the procedure and not resumed for at least 24 hours post-procedure.

A clinically significant interaction is documented with Metformin. Iohexol administration may transiently reduce renal function, which decreases Metformin clearance and raises the risk of lactic acidosis. This risk is noted as higher in patients with pre-existing hepatic impairment, renal impairment, alcoholism, or congestive heart failure. Metformin must be withheld for 48 hours after the procedure and only reinstituted once renal function is confirmed as stable. Furthermore, the iodine content interferes with the thyroid uptake of radioactive iodine agents, reducing their diagnostic or therapeutic efficacy for several weeks.

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Mechanism of Action

Омнипак, containing the active substance iohexol, functions as a radiographic contrast agent. Its mechanism is purely physical and does not involve molecular interaction with biological targets (receptors, enzymes) or intracellular signaling pathways.

Following administration, the low-osmolality, non-ionic, tri-iodinated compound distributes throughout the targeted anatomical compartment, such as the intravascular space or extravascular fluid, depending on the route. The molecule's three iodine atoms have a high electron density.

As X-ray photons traverse the area of distribution, the iodine atoms act as a physical attenuator, intercepting the radiation. The degree of X-ray beam attenuation is directly proportional to the local concentration of iohexol.

This differential photon attenuation, compared to surrounding tissue, modulates the system-level physiological consequence of generating a high-contrast radiodensity image, allowing visualization of internal structures until the agent is cleared primarily via renal excretion through glomerular filtration without significant biotransformation or metabolism.

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Dosage and Administration Information

Official Administration Guidelines for Omnipaque (Iohexol)

Omnipaque (iohexol) is a radiographic contrast agent administered for various diagnostic imaging procedures. Its proper use is defined by the specific procedure, concentration, and route as outlined in standardized protocols.


Administration Scope

Instruction Category Official Guidelines
Route of Administration Intravascular (IV, IA), Intrathecal, Oral, Rectal, Intra-articular, and Body Cavity (e.g., ERCP, Hysterosalpingography).
Dosing Schedule Procedure-specific and concentration-dependent. Doses are determined by the exam type (e.g., CT, Myelography) and patient size/age. For example, IV CT head doses range from 70 mL to 150 mL of 300 mgI/mL for rapid injection in adults.
Age-Group Rules Pediatric dosing is often weight-based (1 mL/kg to 2 mL/kg for some IV procedures) and has specific maximum total volume limits.

Procedural Requirements

Instruction Category Preparation and Special Conditions
Preparation Requirements Injection solution may be administered at body temperature (37 C) or room temperature (20 C to 25 C). The solution must be visually inspected for discoloration or particulate matter before use. Oral injection solution must be diluted to specific low concentrations (e.g., 6 mgI/mL to 9 mgI/mL) for CECT procedures.
Frequency and Timing Used as a single, procedure-based administration. For Contrast-Enhanced CT (CECT) of the abdomen, the oral dose is administered 30 to 60 minutes prior to the intravenous dose.
Special Restrictions Concentrations of 140 mgI/mL and 350 mgI/mL are strictly forbidden for intrathecal use (injection into the spinal fluid). The injection rate for intrathecal administration must be slow (over 1 to 2 minutes). Any unused portion from a single-procedure container must be discarded.

Connection to the Overall Use Protocol

These official instructions establish a highly specific, multi-factor protocol: the correct concentration must be matched precisely to the approved administration route, procedure, and patient age, with explicit concentration-route prohibitions (e.g., no 350 mgI/mL intrathecally). This structured framework standardizes the preparation, timing, and volume for every authorized diagnostic use.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Омнипак

Evidence for Intrathecal Procedures (Spinal Cord and Central Nervous System Imaging)

Омнипак (Omnipaque) was studied for use in procedures where the agent is administered directly into the spinal fluid, such as for myelography, which is used in research exploring how symptoms change over time related to the spine and central nervous system. The research examined patients with various conditions to see the agent's role in the visualization of structures. Studies mainly involved short-term observational settings evaluating daily-life functioning and the agent's role in the acquisition of images of the spinal cord.

Findings describe patterns observed in the studies regarding the technical visualization achieved of structures surrounding the spinal cord. However, certainty remains low for long-term implications. Follow-up durations were limited in many of the existing studies. The research primarily focuses on the immediate technical achievement of the imaging procedure, and there is limited information for long-term outcomes or how the use of the agent may relate to symptoms over extended periods.


Evidence for Intravascular Procedures (Blood Vessel and Organ Imaging)

The use of Омнипак via injection into veins or arteries was evaluated in research for various imaging procedures, including angiography (blood vessels), urography (urinary tract), and CT scans of the head and body. These studies typically involved varied patient cohorts with conditions marked by functional limitations or structural concerns in the organs and blood vessels being imaged. The research explored outcomes related to systemic or functional imbalance by assessing the agent's role in the visualization of structure and flow.

The research highlights changes measured during the study period related to the contrast enhancement observed, which is essential for image interpretation. Sample sizes were modest in some of the specific subgroup analyses for certain organ systems. Data for certain groups remain insufficient, particularly concerning the full range of different types of blood vessel disease applied in research contexts involving fluctuating or unstable symptoms.


What is Still Uncertain About Омнипак

This final section synthesizes the areas where the research landscape remains incomplete. Evidence quality varies across studies, and findings related to certain outcomes have been mixed. Comparative evidence is lacking to definitively compare the agent’s technical performance against newer or alternative contrast agents across every procedure type. Long-term effects are not fully established for most applications, meaning that the research provides context but not individual predictions regarding outcomes far removed from the time of the procedure. Data are still emerging for certain highly specialized uses and in some special populations, and research is ongoing to address these gaps.

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Frequently Asked Questions (FAQ)

Common questions about Омнипак (FAQ)


Q: Is it normal to feel a warm feeling when receiving Омнипак?

Yes, regulatory documents indicate that a heat sensation or feeling of warmth is an expected sensation during or immediately following administration, particularly when the agent is injected intravenously.


Q: How quickly does the body get rid of Омнипак?

The agent is eliminated primarily from the body via the kidneys. Official data on its pharmacokinetics show that the half-life in the bloodstream is approximately 2 hours in individuals with normal kidney function.


Q: Why is it important to tell the staff about all medications I take before the procedure?

Regulatory guidelines emphasize the importance of disclosing all medicines to check for known drug-drug interactions that could increase risk. For instance, certain drugs like Metformin can increase the risk of complications like lactic acidosis if kidney clearance is temporarily impaired.


Q: Is Омнипак considered safe for pregnant individuals?

Official documents state that use is contraindicated for Hysterosalpingography (HSG) in pregnant or suspected pregnant individuals. For other procedures, official information indicates that the decision for use involves balancing the potential benefits of the imaging with the unknown risks, as use is not fully established.


Q: Does the dose of Омнипак depend on the patient's weight?

The dosage is highly specific to the type of imaging procedure and the area being examined. Official administration guidelines confirm that pediatric dosing is commonly weight-based, while adult dosing is often determined by the specific volume required for the procedure.


Q: Is there a taste or smell associated with Омнипак?

Yes, the official documentation lists Taste perversion as a common side effect. Patients often report experiencing a transient metallic or chemical taste shortly after the agent is administered.


Q: What happens if I forget to drink enough water after getting Омнипак?

Hydration is often emphasized because it supports the agent’s clearance from the body via the kidneys. Official documentation notes that inadequate hydration can be associated with an increased risk of Acute Kidney Injury, particularly in patients with pre-existing kidney problems or those who are elderly.


Q: Does Омнипак show up on all types of scans?

No. The active ingredient, iohexol, is classified as a radiographic contrast medium, meaning it works by enhancing visibility on X-ray based imaging. It is specifically designed for procedures such as CT scans, angiography, and urography.


Q: Is there a different name for the drug Омнипак?

Yes, the internationally recognized non-proprietary name for the active ingredient is iohexol. This name may be used on regulatory documents or in medical literature.


Q: Why is Омнипак given through an IV sometimes?

Intravenous (IV) administration is used to rapidly distribute the agent throughout the bloodstream for systemic imaging. This method is crucial for procedures like angiography and certain CT scans where the goal is to enhance the visualization of blood vessels and internal organs.


Q: Can Омнипак cause a headache after the scan?

Yes, headache is classified as a Very Common adverse reaction in regulatory documents. This side effect is typically reported to occur within 1 to 10 hours after the injection.


Q: Does Омнипак interact with blood pressure medication?

Regulatory information confirms the agent has many potential drug interactions, but specific risks vary. Official guidance highlights the importance of disclosing all medications to check for specific risks before the procedure.


Q: How long after receiving Омнипак should I wait before breastfeeding?

Only a very small amount of iohexol is excreted into breast milk. As a precaution, some manufacturer guidelines have included the suggestion that expressing and discarding milk for 24 hours following administration is a precautionary measure.


Q: Why do doctors ask about thyroid problems before using Омнипак?

The agent contains iodine, which can interfere with the diagnostic efficacy of radioactive iodine agents used for thyroid testing. There is also a noted risk of thyroid dysfunction in very young pediatric patients (0 to 3 years) following administration.


Q: Is Омнипак used only for CT scans?

No. The agent is authorized for use in a wide range of procedures. This includes myelography (spinal cord imaging), angiography (blood vessel imaging), urography (urinary tract imaging), and other specialized body cavity examinations, in addition to CT scans.


Q: How is Омнипак different from other contrast agents like Gadolinium?

The agent's active substance, iohexol, is an iodine-based (tri-iodinated) compound. This makes it chemically and functionally distinct from gadolinium-based contrast agents, which are primarily used in Magnetic Resonance Imaging (MRI).


Q: Can children receive Омнипак?

Yes, regulatory documents confirm the agent is authorized for use in pediatric patients aged 2 weeks and older for most procedures. Specific, weight-based dosing and special monitoring requirements apply to children.


Q: Is there an age limit for using Омнипак?

The agent is restricted to patients 2 weeks of age and older. There is no specific absolute upper age limit, but geriatric patients are identified in official information as having an increased risk for complications such as Acute Kidney Injury.


Q: Does alcohol consumption affect Омнипак?

Regulatory information advises caution in patients with a history of chronic alcoholism before certain procedures like myelography. Alcoholism is also listed as a risk factor that increases the possibility of a severe complication called lactic acidosis if co-administered with Metformin.


Q: What are the signs of a serious reaction to Омнипак?

Serious reactions are rare but documented to include events such as Cardiac arrest, Seizure, and Acute Kidney Injury. Signs of serious hypersensitivity may include severe and sudden symptoms like widespread hives or rash, throat swelling (edema), and trouble breathing.


Q: Can Омнипак be given orally instead of injected?

Yes, the agent is approved for use via the oral route for specific diagnostic procedures. This is typically done for imaging the gastrointestinal tract and is also used for contrast-enhanced CT scans of the abdomen and pelvis.


Q: Are people with asthma more likely to have a reaction to Омнипак?

Official information indicates that patients with a history of allergic disorders, including bronchial asthma, are identified as being at an increased risk of experiencing a hypersensitivity reaction to the contrast agent.


Q: Can Омнипак affect the results of other blood tests?

The agent is known to interfere with the results of tests that rely on radioactive iodine uptake (a type of thyroid test). The drug's clearance from the body can itself be measured via specific blood tests (GFR) to assess kidney function.


Q: Is it possible to be allergic to the iodine in Омнипак?

The absolute contraindication noted in regulatory documents is a known hypersensitivity to the agent iohexol or to iodinated contrast agents. The term 'iodine allergy' is often used but refers to a reaction to the specific contrast molecule, not to elemental iodine itself.


Q: Are there any long-term side effects associated with Омнипак?

Regulatory research evidence indicates that long-term effects are not fully established for most applications of the agent, and many studies have had limited follow-up durations. The documented common adverse effects typically occur within a short period (1 to 10 hours) of administration.


Q: Can Омнипак be used in patients with heart conditions?

Patients with pre-existing or severe cardiovascular disease require caution during use. Studies indicate that iohexol is associated with fewer negative effects on heart function compared to some older contrast agents used in similar procedures.


Q: Why do official sources list so many potential side effects for Омнипак?

Official sources classify and list adverse events based on standardized regulatory processes. They separate reactions by frequency (e.g., Very Common, Common) and physiological system to provide a comprehensive, fact-based description of all documented potential risks.


Q: How does the time of injection relate to the time of the scan?

The timing is determined by the specific procedure to ensure the agent is concentrated correctly when the image is taken. For intravenous use, the injection time is managed to coincide with the period of peak contrast enhancement during the scan. For oral administration, there is a required waiting period (e.g., 30–60 minutes) before the scan.


Q: If I had a reaction to a contrast dye before, can I still use Омнипак?

A prior reaction to a different iodinated contrast agent is generally considered a risk factor for a subsequent reaction. Patients with this history require special attention and preparatory measures prior to administration to reduce the possibility of a reaction.

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How should Омнипак be stored and disposed of?

How to Store and Dispose of Omnipaque (iohexol)

Official regulatory guidelines strictly define the storage and handling conditions for Omnipaque to preserve product quality.

Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, 20°C to 25°C (68°F to 77°F).
Light The solution is sensitive to light and must be protected from exposure.
Freezing Do not freeze. If the solution is frozen, it must be discarded.
Child Safety Keep Omnipaque out of the sight and reach of children.

Handling and Disposal

Omnipaque containers are intended for single-use. The solution must be visually inspected for particulate matter or discoloration before use; do not administer if either is present. Any unused portion of the product remaining after a procedure must be discarded. Disposal of unused or expired iohexol must comply with all local, state, and federal pharmaceutical waste regulations.

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

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