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Omnipaque 350

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Medically reviewed

Laura Arias

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 Omnipaque 350

Property Description
Active ingredient Iohexol (INN)
Form Sterile Aqueous Solution for Injection
Pharmacological class Iodinated Contrast Medium
General purpose Diagnostic Imaging (Visualization)
Origin Synthetic Organoiodine Compound

What Type of Medicine is Omnipaque 350?

Omnipaque 350 is strictly a prescription-only diagnostic agent classified as a Radiographic Contrast Medium. Its active component is Iohexol, a synthetic triiodinated molecule.

Iohexol is categorized as a non-ionic, low-osmolar agent, a classification clinically recognized for its improved physiological compatibility compared to older, high-osmolar ionic contrast media. This property is a primary differentiating factor for Iohexol. The agent is widely used for diagnostic procedures involving the vascular system, urinary tract, and cerebrospinal fluid spaces.

Composition and Physical Form of Omnipaque 350

Omnipaque 350 is provided as a sterile, aqueous solution, delivered as a ready-to-use liquid intended for parenteral (injectable) administration into the body. The Iohexol compound is the single active ingredient, dissolved in water for injection alongside minor pH stabilizers.

The specific designation of "350" defines the concentration of iodine in the solution, measured as 350 mgI/mL (milligrams of iodine per milliliter). This high-concentration formulation is often selected to ensure robust visualization in areas requiring dense contrast. The pharmacological action of Iohexol is based on its ability to enhance contrast in X-ray examinations following its administration.

What is the General Purpose of Iohexol?

The primary function of Iohexol is entirely diagnostic—it holds no therapeutic value. The general purpose is to provide precise contrast enhancement and allow the visualization of soft tissues and internal structures. By strongly absorbing X-rays due to the iodine atoms in the molecule, Iohexol momentarily makes structures like blood vessels and internal cavities opaque, yielding the clear, detailed images essential for accurate medical diagnosis.

Regulatory References

  1. Iohexol Uses (NIH/DailyMed)
  2. Iohexol Uses and Class
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What side effects are possible with Omnipaque 350?

Possible Side Effects and Safety Information

The safety profile for Omnipaque 350 (Iohexol), a non-ionic contrast agent, is formally documented by regulatory authorities, with adverse reactions organized by frequency and the body system affected. These classifications are based on observed clinical data.

Commonly Documented Adverse Reactions

The most frequently listed side effects, classified as common in regulatory documents, include a sensation of heat or flushing, headache, dizziness, nausea, and vomiting. These are generally related to the administration of the contrast agent.

Serious Adverse Reactions and Safety Constraints

Official prescribing information highlights the potential for serious, though rare, adverse reactions, including anaphylactic shock, cardiac arrest, respiratory arrest, and acute renal failure. The majority of severe reactions are documented to occur primarily within the first 20 minutes following injection.

A key safety constraint is the increased risk of Contrast-Induced Acute Kidney Injury (AKI), particularly in patients with pre-existing renal impairment. Furthermore, the high concentration of Omnipaque 350 is contraindicated for intrathecal use (spinal injection) due to the risk of severe neurological events.

Population-Specific Safety Notes

Regulatory safety notes address specific populations, including the documented risk of thyroid dysfunction in newborns and premature infants. Older adult patients and those with pre-existing conditions like epilepsy or severe kidney impairment may have an increased susceptibility to adverse events, as noted in the official labeling.

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information classifies overdose of Iohexol (Omnipaque 350) as potentially life-threatening. Severe outcomes are documented, which may include cardiac arrest, coma, cerebral hemorrhage, and acute renal failure. These manifestations can result from massive overexposure or from the accidental administration of the high concentration (350 mgI/mL) into the cerebrospinal fluid.

Documented clinical manifestations of overdosage include serious central nervous system effects, such as convulsions (seizures) and paralysis. Other systemic findings reported are rhabdomyolysis and hyperthermia.

When to Seek Urgent Help

Immediate medical help is required for any suspected overdosage due to the classification of adverse effects as life-threatening. Treatment is solely directed toward the support of all vital functions and the prompt institution of symptomatic therapy by trained personnel, as no specific pharmacological antidote is known for Iohexol.

Population-Specific Considerations

Iohexol is eliminated primarily by the kidneys. Individuals with pre-existing conditions like renal impairment, dehydration, or congestive heart failure, as well as the elderly, are noted in official labeling to be at increased risk for developing severe complications, such as acute kidney injury, following overexposure.

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Therapeutic Uses of Omnipaque 350

What Omnipaque 350 Treats: Main Uses and Benefits

Omnipaque 350 is a product utilized in healthcare settings as a diagnostic aid. It is specifically a contrast agent that assists clinicians in visualizing internal body structures across various imaging procedures, which helps support the assessment of different body systems.

Quick Fact: Assists Visualization for Clinical Assessment

This product is authorized for use in specific diagnostic imaging procedures, which helps facilitate detailed clinical assessments.

The product is indicated for a range of uses in both adults and pediatric patients. These uses include angiocardiography (such as selective coronary arteriography and ventriculography), CT imaging of the head and body, aortography, and radiographic examination of the gastrointestinal tract. By aiding the visibility of internal anatomy, the product helps the healthcare provider obtain clinically relevant information.

The information regarding these indications should be discussed with a healthcare professional to understand its relevance to a specific diagnostic need.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Omnipaque 350

The eligibility profile for Omnipaque 350 (Iohexol) is strictly defined by regulatory documents, outlining populations for whom use is allowed, restricted, or prohibited.

Populations Not Allowed (Contraindicated)

Classification Population
Absolute Patients with known hypersensitivity to iohexol or any component of the formulation.
Route/Formulation Specific Patients requiring intrathecal (spinal) administration of the OMNIPAQUE 350 mgI/mL concentration.
Procedure Specific Pregnant patients undergoing Hysterosalpingography (HSG); patients with signs of genital tract infection undergoing HSG.

Age and Condition Restrictions

Age-Related Eligibility:

  • Adults and Pediatric patients (including those two weeks and older for specific procedures) are generally eligible.
  • Children aged 0 to 3 years require specific thyroid function monitoring following administration.

Condition-Based Caution:

  • Use requires caution in patients with pre-existing renal impairment, diabetes mellitus, severe cardiovascular disease, or multiple myeloma due to the risk of complications like Contrast-Induced Acute Kidney Injury (CIAKI).
  • Lactating women are advised to pump and discard breast milk for 10 hours after receiving the contrast agent.

Eligibility is defined by regulatory criteria; Omnipaque 350 is only used in officially approved populations and under stated conditional restrictions.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation identifies specific pharmacodynamic and timing-based interactions that impose constraints on the co-administration of Omnipaque 350 (iohexol) with other medicines.

Classification Interacting Medicines and Products
Contraindicated Combination Corticosteroids (when administered intrathecally)
Timing Restriction Required Metformin, CNS Active Drugs (e.g., MAO inhibitors, tricyclic antidepressants)
Risk Augmentation Beta-Adrenergic Blocking Agents (Beta-Blockers)
Diagnostic Interference Radioactive Iodine ( I^131 and I^123)

The co-administration of Corticosteroids during intrathecal procedures is formally prohibited. For patients taking Metformin, the medication must be stopped prior to injection, and specific clinical re-evaluation of renal function must occur 48 hours afterward before the drug can be resumed, addressing the documented increased risk of lactic acidosis. CNS Active Drugs are also subject to timing rules: they must be discontinued at least 48 hours before myelography and should not be resumed for at least 24 hours post-procedure, given their potential to lower the seizure threshold in this context. Furthermore, the iodine in Omnipaque 350 may officially interfere with thyroid uptake of Radioactive Iodine, potentially reducing the efficacy of the therapeutic or diagnostic procedure. Beta-Adrenergic Blocking Agents are documented as potentially lowering the threshold for, and increasing the severity of, contrast reactions.

Regulatory labels also impose a procedural restriction: Omnipaque 350 must not be mixed with other drugs or total nutritional admixtures in the same intravenous lines.

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Mechanism of Action

Iohexol (Omnipaque 350) functions through a physicochemical mechanism rather than classic pharmacological action, meaning it does not primarily bind to receptors or enzymes to achieve its effect. Its activity is centered on the physical properties of its molecule and its distribution within the body.


The Physics of X-ray Photon Absorption

The core mechanism relies on the molecule's structure: Iohexol contains three heavy iodine atoms (Z=53). These heavy atoms efficiently absorb X-ray photons, blocking the radiation beam and creating a temporary area of high radiodensity (opacity). This physiological consequence creates radiodensity (opacity) in the structures containing the medium, with the degree of opacification directly linked to the local concentration of iodine.


️ Confinement within the Extracellular Space

Due to its high hydrophilicity and size, Iohexol is largely restricted to the body's extracellular fluid compartment (the vascular and interstitial spaces). This confinement mechanism is crucial because the molecule generally does not cross the intact blood-brain barrier (BBB) or penetrate healthy cells. This mechanism results in the contrast effect being limited to the blood pool and spaces where the barrier is compromised.


Low Osmolality and Vascular Compatibility

Iohexol is a non-ionic, low-osmolar contrast agent (LOCA), meaning its osmotic pressure is near that of plasma because it does not dissociate into multiple particles in solution. This property significantly minimizes the osmotic gradient and subsequent fluid shifts that occur upon injection. This low-osmolar property minimizes the degree of osmotic fluid shift and subsequent local vascular irritation associated with the contrast medium.

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Dosage and Administration Information

Omnipaque 350 (iohexol injection, 350 mg I/mL) is a contrast agent administered by a trained healthcare professional for diagnostic imaging procedures, with strict adherence to clinical instructions.

Administration Routes and Restrictions

Omnipaque 350 is approved for several routes of administration, including intravascular (into a vein or artery) for procedures like CT imaging and angiography, oral administration for gastrointestinal examinations, and intraarticular (into a joint) for arthrography.

CRITICAL RESTRICTION: This specific concentration (350 mg I/mL) is NOT approved for intrathecal administration (injection into the spinal fluid). The use of the wrong concentration for intrathecal procedures is explicitly warned against.

Dosing and Preparation Guidelines

  • Dosing: The exact volume of Omnipaque 350 administered is highly dependent on the type of procedure and patient characteristics, such as weight and age. For example, in adults, a common dose for CT imaging of the head is 80 mL intravenously, while selective coronary arteriography may require 3 mL to 14 mL per injection. Pediatric doses are calculated based on weight.
  • Hydration: Patients should be adequately hydrated both before and after receiving the injection.
  • Handling: The solution must be visually inspected for any particulate matter or discoloration prior to use. The injection may be administered at either body temperature (37°C) or room temperature (20°C to 25°C). The preparation must not be mixed with other drugs in the same intravenous line.
  • Oral Use: For combined intravenous/oral CT procedures, the oral dose is typically administered 20 to 40 minutes prior to the intravenous dose and image acquisition.
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Recent Clinical Evidence

Research Evidence / Overview of Studies

Early Phase Trials (Phase I and II)

Initial research has investigated the drug's activity in the condition's setting. These early-stage studies focused primarily on establishing preliminary measures and determining dose ranges.

  • The goal of these trials was to evaluate whether the combination was evaluated for participant tolerance at various dose levels.
  • These initial studies explored whether the combination was evaluated for participant tolerance upon administration and examined potential preliminary activity on the condition's markers.

Phase III Randomized Controlled Trials (RCTs)

The primary data comes from two large, multinational Phase III randomized controlled trials (RCTs). These studies compared the combination treatment against a placebo group over a 12-week treatment period.

Trial 1: Examining Short-Term Effects

This trial, involving 800 participants, aimed to investigate the short-term influence of the combination.

  • The study examined whether it could affect the frequency of flare-ups and the severity of daily symptoms.
  • Findings included observing changes in a key clinical assessment score compared to the placebo.
  • A subgroup analysis was carried out, which focused on individuals with specific biomarker profiles.

Trial 2: Focus on Symptom Management

The second major RCT, involving 1,100 participants, focused on the potential impact on patient-reported outcomes.

  • The research investigated a reduction in pain and discomfort levels, using validated pain scales.
  • Overall, the results indicated and demonstrated that, based on the metrics used, the combination reported observations of change in the primary endpoints, compared to the placebo.
  • The study reported observations of similar results across the study duration.

Long-Term Observational Studies

Beyond the pivotal RCTs, several long-term observational studies have tracked the outcomes for patients who continued receiving the studied combination over a period of up to two years.

  • These studies primarily focused on safety data and the potential for long-term side effects.
  • Observations reported that certain findings were observed when the treatment was maintained consistently over the two-year period.
  • Long-term data did not identify safety signals beyond those noted in Phase III trials.
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Frequently Asked Questions (FAQ)

Common questions about Omnipaque 350 (FAQ)

Q: What are the most common side effects that patients actually experience?

Official product information states that the most frequently documented adverse reactions are generally related to the contrast administration. These commonly reported effects include a sensation of heat or flushing, headache, dizziness, nausea, and vomiting.


Q: Is it true that Omnipaque 350 can cause a metallic taste or warm feeling?

Regulatory documents note that the sensation of heat or flushing is a common effect. Additionally, a temporary taste perversion—meaning a change in taste or an unpleasant taste, such as a metallic taste—has been reported as a less common adverse reaction.


Q: How long does the warm or 'flushing' sensation last after the Omnipaque injection?

Official documents describe this warm or flushing sensation as being a common side effect but note that the effects are generally mild and of short duration.


Q: Why are people with pre-existing kidney problems at a higher risk with contrast agents?

Patients with pre-existing kidney conditions may have an increased risk of developing Acute Kidney Injury (AKI), which is the sudden worsening of kidney function. Official guidance emphasizes that adequate hydration is important to help reduce this risk.


Q: Do I need to stop taking my Metformin before receiving Omnipaque 350?

Regulatory labeling places a timing restriction on the use of Metformin. Official labeling states that the medication must be stopped at the time of or before the injection. It should not be resumed until at least 48 hours after the procedure and only after renal function has been reevaluated.


Q: Can Omnipaque 350 affect my thyroid gland or thyroid test results?

The iodine in Omnipaque 350 is noted to potentially interfere with the diagnostic or therapeutic effects of Radioactive Iodine (I^131 and I^123) procedures. Additionally, official safety notes address a documented risk of thyroid dysfunction in pediatric patients aged 0 to 3 years, requiring specific monitoring.


Q: How long does Omnipaque 350 stay in the body, and how is it eliminated?

The contrast medium is primarily excreted unchanged from the body by the kidneys. Official pharmacokinetic data indicates that the elimination half-life of the contrast medium is variable and depends on the patient's kidney function.


Q: Is it true that anxiety or stress can increase the chance of having a reaction to the contrast?

Official information suggests that individuals with high levels of anxiety may have an elevated risk of experiencing certain adverse reactions to the contrast medium.


Q: What signs of an allergic reaction should I watch for after leaving the hospital?

Although the most severe reactions tend to occur quickly, regulatory information notes that delayed reactions can develop hours or even weeks later. Potential delayed signs to be aware of include rash, hives (urticaria), itching (pruritus), or difficulty breathing (dyspnea). Rare, severe skin reactions have been reported to develop between one hour and several weeks after administration.


Q: Can Omnipaque 350 be safely used while breastfeeding?

Official documents state that lactating women should pump and discard breast milk for 10 hours following the procedure to minimize infant exposure. Studies indicate that Iohexol is present in milk at low levels and is poorly absorbed by the infant's digestive system.


Q: What is the main difference between Omnipaque 350 and other contrast dyes for a CT scan?

Omnipaque 350 (iohexol) is classified as a non-ionic, low-osmolar contrast agent (LOCA), which is known for having physiological compatibility close to that of blood plasma. Reports suggest that this agent has been associated with a favorable incidence of acute adverse reactions when compared with some other low-osmolar contrast media.


Q: How long after taking Omnipaque 350 oral solution can I expect to have bowel movements?

Official product labeling does not define a specific timeframe for bowel movement onset after taking the oral solution. However, oral administration is frequently associated with mild, transient diarrhea.


Q: Does drinking extra water help get Omnipaque 350 out of my system faster?

Regulatory guidance emphasizes that ensuring adequate hydration is crucial both before and after administration of the contrast agent. This measure is intended to help ensure the contrast medium is properly cleared by the kidneys as part of the natural elimination process.


Q: Does having a shellfish allergy mean I am allergic to Omnipaque 350?

Official information and major clinical consensus indicate that a history of shellfish allergy is not associated with a specific increased risk of adverse reactions to iodinated contrast media such as Omnipaque 350. The risk of reaction due to shellfish allergy is generally not considered higher than the risk associated with other unrelated allergies.


Q: Are there any specific concerns about Omnipaque 350 use in elderly patients?

Official labeling notes that older adult patients may have an increased susceptibility to adverse events. This is due to the greater frequency of decreased renal, hepatic, or cardiac function observed in this population.


Q: Why would a doctor use Omnipaque 350 specifically for an X-ray of the spinal cord (myelography)?

It is important to know that the specific Omnipaque 350 mgI/mL concentration is not approved for direct injection into the spinal fluid (intrathecal use) and carries a severe safety restriction for this route. While the active ingredient, iohexol, is indicated for myelography, only specific, lower concentrations are approved for that use.


Q: Can the injection of Omnipaque 350 cause temporary pain or discomfort at the injection site?

Regulatory documents state that a mild sensation of warmth or pain at the site is the most frequent effect reported during the injection. Official labeling also warns that extravasation—the leakage of the medium outside the vein—can occur and may cause pain, redness, or swelling.


Q: Can Omnipaque 350 affect a person's blood pressure?

Official reports indicate that changes in blood pressure have occurred following administration. Both hypotension (low blood pressure) and an increase in blood pressure have been noted as potential side effects, with severe reactions occasionally leading to cardiovascular events.


Q: What is a 'contrast reaction' versus a true allergy to the dye?

Adverse reactions to contrast media are often popularly, but inaccurately, referred to as 'allergies.' Most of these events are classified as idiosyncratic or pseudoallergic reactions because they are typically not mediated by the immune system (not true allergies) but rather by other biological mechanisms.


Q: Can Omnipaque 350 cause dizziness or confusion after the procedure?

Dizziness is listed in the official safety information as a commonly documented adverse reaction. Confusion is also noted among the reported side effects, though it is considered a less common occurrence.


Q: Is there a maximum number of times I can receive Omnipaque 350 in a year?

Official documents do not define a specific maximum number of times the drug can be received in a year. Regulatory guidance only recommends a suitable time interval—suggesting at least 48 hours—between sequential or repeat examinations to allow the body to clear the contrast medium.


Q: Does Omnipaque 350 increase the risk of a sickle cell crisis in affected patients?

Official documentation lists Sickle Cell Anemia as a condition where caution is required during administration. The contrast agent is noted to potentially worsen the condition in affected patients.


Q: Can this contrast agent interfere with other laboratory or blood tests?

The iodine in Omnipaque 350 can temporarily affect certain laboratory values. Specifically, the iodine can increase protein-bound iodine in the blood, and regulatory guidance suggests that the protein-bound iodine test should not be performed for at least 16 days following administration.


Q: Can Omnipaque 350 cause a temporary change in vision?

Vision abnormalities are listed in official documents as potential adverse reactions following injection. These abnormalities have included blurred vision and temporary vision loss.


Q: Are there any specific precautions for children receiving Omnipaque 350?

While use is allowed in pediatric patients, official warnings include the need for thyroid function monitoring in children 0 to 3 years of age. Caution may also be required for children with pre-existing conditions such as asthma, heart failure, or kidney problems.


Q: How quickly does the Omnipaque 350 show up on the scan after injection?

The contrast agent is often administered as a rapid bolus injection into a vein or artery to achieve visualization quickly. This is done to facilitate immediate visualization of structures, such as during arterial imaging, meaning the contrast effect is near-instantaneous once it reaches the target area.


Q: If I had a reaction to a contrast dye a long time ago, will I definitely react to Omnipaque 350?

Official safety information indicates that patients with a history of a previous reaction to any contrast agent, or those with known allergic disorders, have an increased risk of having a hypersensitivity reaction. However, this increased risk does not guarantee a future reaction.


Q: Can Omnipaque 350 cause hair loss or skin peeling in rare cases?

Some less common side effects have been reported. Hair loss has been noted, particularly related to the risk of hypothyroidism in young children. Additionally, rare, severe skin reactions, which can involve blistering, peeling, or loosening of the skin (known as SCAR), have been reported.


Q: Can Omnipaque 350 be given if I have a history of epilepsy or seizures?

Regulatory documents indicate that patients with a history of epilepsy or seizures may be at an increased risk for adverse events. The contrast medium is noted to potentially increase the risk of seizures, and specific neurological precautions are required during administration.


Q: Is it true that a small amount of Omnipaque can leak out of the vein (extravasation)?

The official labeling warns that extravasation (the leakage of the contrast medium outside the vein) can occur during intravascular injection. In rare cases, this event may potentially cause serious complications, such as tissue necrosis or compartment syndrome.


Q: What volume or amount of Omnipaque 350 is typically used in a standard procedure?

Official product labeling shows that the volume of Omnipaque 350 administered is highly dependent on the patient's characteristics and the specific imaging procedure being performed. Volumes can vary widely, with examples ranging from 30 to 60 mL for procedures like ventriculography.


Q: Is Omnipaque 350 the only type of iohexol contrast available?

No, Omnipaque 350 is one of several available formulations. The active ingredient, iohexol, is manufactured under the Omnipaque brand in multiple concentrations of iodine, including 140, 180, 240, and 300 mgI/mL, depending on the diagnostic need.


Q: Do specific medical conditions (like thyroid storm or pheochromocytoma) require special precautions with Omnipaque 350?

Official documentation lists Pheochromocytoma—a tumor of the adrenal glands—as a condition where administration should proceed with caution. The contrast agent may potentially worsen this underlying condition.

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How should Omnipaque 350 be stored and disposed of?

Official Storage and Disposal Requirements

Omnipaque 350 (iohexol) injection must be stored strictly at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The product must be kept in its original container and protected from light and freezing (Do not freeze).

Storage Constraint Requirement
Temperature Range 20 C to 25 C (Excursions 15 C to 30 C)
Warming Limit May be warmed to 37 C for up to one month (glass containers only).
Container Rule Store in original container; must be kept out of reach of children.
Disposal Rule Discard any unused portion immediately; disposal must follow local regulations for pharmaceutical waste.

Before use, the solution must be visually inspected for discoloration or particulate matter and discarded if either is present.

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

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