Overview of Omnipaque 240

Property	Description
Active ingredient	Iohexol
Form	Sterile Aqueous Solution (Injection/Oral)
Pharmacological class	Non-Ionic Iodinated Contrast Media
General purpose	Diagnostic Imaging Enhancement
Origin	Synthetic

What Type of Medicine is Omnipaque 240 (Iohexol)?

Omnipaque 240 is a specialized radiographic contrast agent formulated to increase the visual clarity of internal structures during diagnostic procedures. This compound belongs to the high-level pharmacological class of non-ionic iodinated contrast media, a category clinically recognized for its utility in modern imaging. These agents are critical for providing contrast during various X-ray procedures.

The product's active ingredient is the synthetic substance Iohexol, which is delivered as a sterile aqueous solution through various routes of administration, including intravascular injection and as an oral solution. Its primary function is purely diagnostic, as it temporarily enhances the visibility of internal anatomy during examinations such as vascular mapping or Computed Tomography (CT scan) of the abdomen.

Composition and Form: What is Iohexol and the '240' Designation?

The medication's identity is chemically defined by its Iohexol composition, which is a non-ionic, low-osmolar molecule. The designation “240” specifically refers to the concentration: each milliliter of the solution contains 240 milligrams of organic iodine. This concentration is intended to provide the necessary X-ray attenuation.

Iohexol is distinguished by its non-ionic nature, meaning it remains chemically intact in bodily fluids, contributing to its status as a low-osmolar compound compared to older contrast agents. This characteristic is a key factor in providing effective X-Ray Contrast Activity across multiple anatomical regions.

Why is a Low-Osmolar Contrast Agent Used for Diagnostic Imaging?

A low-osmolar contrast agent is used because this specific property allows the solution to provide high-quality radiopacity while generally causing fewer physiological disturbances compared to high-osmolar alternatives. The core benefit of Omnipaque 240 is its ability to achieve temporary, high-resolution visualization of the body's internal structures without relying on a therapeutic effect. The highly dense Iodine component efficiently absorbs X-rays, making structures distinctly visible for accurate clinical assessment.

What side effects are possible with Omnipaque 240?

Possible side effects and safety information

Omnipaque 240 (Iohexol) has an official safety profile structured by frequency and the body's physiological systems, as documented in government regulatory sources. These classifications help define the potential risks associated with its use as a diagnostic contrast agent.

Frequency-Classified Adverse Reactions

The officially documented side effects are categorized by estimated likelihood, based on clinical data from regulatory submissions. Effects are classified using standard terminology:

Common (may affect up to 1 in 10 people): Headache, pain (including backache or neckache), nausea, vomiting, dizziness, and taste perversion.
Uncommon (may affect up to 1 in 100 people): Difficulties with breathing (dyspnea) and other upper respiratory symptoms.
Rare (may affect up to 1 in 1,000 people): Seizures and hypersensitivity reactions.

These effects are formally grouped by the System-Organ Class they affect, including Nervous System Disorders, Gastrointestinal Disorders, and Immune System Disorders.

Serious Adverse Reactions and Safety Constraints

Official labeling identifies adverse reactions that are rare but medically serious. These include life-threatening anaphylactic shock (severe allergic reaction), cardiac arrest, acute kidney injury (renal failure), and cerebral hemorrhage.

Safety constraints and patterns are also documented. For instance, adverse reactions following administration into the spinal fluid (intrathecal use) generally appear within the first 1 to 10 hours. Specific safety notes are mandated for certain groups, such as the risk of thyroid dysfunction in pediatric patients (infants and neonates), which may require monitoring. Additionally, the label strictly warns against the inadvertent intrathecal administration of certain high concentrations, which is associated with serious outcomes.

Overdose and Emergency Response

Overdose Scope and When to Seek Urgent Help

The official regulatory profile for Iohexol (Omnipaque) is focused on the high-risk consequences of systemic overexposure or inadvertent administration into non-indicated spaces. Immediate medical attention is required for all signs of severe overexposure, reflecting the life-threatening nature of documented complications.

Domain	Official Regulatory Statements
Documented Manifestations	Severe overdose may present with neurological effects, including convulsions and seizures. Less severe systemic effects can include nausea, vomiting, headache, and dizziness.
Severe/Life-Threatening Outcomes	Official labeling notes the potential for Cardiac Arrest, Shock, Acute Renal Failure, Cerebral Hemorrhage, and Coma. These outcomes are particularly associated with inadvertent intrathecal administration.
Emergency Actions	Emergency resuscitation equipment and trained personnel must be available. Administration must be terminated immediately if an imminent state of shock occurs.
Management & Antidote	No specific antidote is known. Management is restricted to symptomatic and supportive treatment. Should a seizure occur, the use of intravenous diazepam or phenobarbital sodium is specifically recommended.
Monitoring	Patients must be held under close observation for at least 30 minutes post-injection, as the majority of severe reactions are noted to occur within this period.

The regulatory profile mandates strict response protocols due to the drug's potential for cardiorenal and neurotoxicity upon overexposure. Urgent medical help is required for any severe systemic reaction, and the patient must be monitored continuously post-procedure to address the documented complications.

Therapeutic Uses of Omnipaque 240

Omnipaque 240 is a radiographic contrast agent, meaning its core purpose is to enhance the clarity and detail of diagnostic images, which plays a role in managing conditions associated with varying symptomatic burdens.

Iohexol (Omnipaque) is commonly used across a wide range of diagnostic procedures spanning multiple therapeutic domains, assisting clinicians in the management of conditions characterized by episodic or fluctuating symptom patterns. The procedures it aids include those relevant for assessing the spinal cord, brain, body organs, and blood vessels.

Use Across Symptom Domains

This agent is applied across domains where additional symptomatic support is needed, addressing symptom groups related to systemic imbalance, neurological distress, and musculoskeletal discomfort. When symptoms intensify and short-term symptomatic assistance is appropriate, Omnipaque 240 may assist in obtaining the necessary information to inform the treatment of conditions.

“It contributes to a clearer view for clinical assessment and care planning, which supports symptomatic relief.”

In clinical settings marked by temporary physiological imbalance, its use is relevant for easing discomfort or tension and may assist with maintaining functional stability. The resulting diagnostic clarity supports general well-being during symptomatic phases by helping clinicians in the assessment of the underlying source of distress.

Quick Fact: Diagnostic Support for Neurological Distress The use of Omnipaque 240 in diagnostic procedures, such as those for the spine and brain, helps manage symptoms related to neurological stress by contributing to a clearer assessment.

Regulatory References

NIH DailyMed iohexol Prescribing Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Omnipaque 240?

Eligibility for Omnipaque (iohexol) is strictly defined by regulatory documents, focusing on patient condition, medical history, and age.

Absolute Non-Eligibility (Contraindications)

Omnipaque must not be used in patients with a known hypersensitivity to iohexol or any of its components. Additionally, for the procedure of hysterosalpingography, the agent is contraindicated in pregnancy (or suspected pregnancy) and in the presence of infection in the genital tract. For intrathecal procedures (myelography), use is contraindicated when bacteremia or significant local or systemic infection is present.

Restricted and Conditional Use

Use requires caution in several patient populations due to increased risk, including those with pre-existing conditions such as renal impairment, diabetes mellitus, and severe cardiovascular disease. Caution is also advised for patients with a history of epilepsy or seizure activity, and those with pheochromocytoma.

Age and Physiological Status

Most adult patients are eligible. Intrathecal procedures are approved for pediatric patients aged 2 weeks and older. Older adult patients may require cautious dose selection due to a higher frequency of decreased organ function. Lactating women are advised to pump and discard breast milk for 10 hours after administration to minimize infant exposure.

What should I know about interactions with other medicines?

Omnipaque 240 (Iohexol) interactions are documented by regulatory authorities and focus on mandatory timing separation, specific toxicological risks, and administration restrictions.

A contraindicated combination is the co-administration of corticosteroids via the intrathecal route.

For patients taking Metformin, use with Iohexol carries an increased regulatory concern for lactic acidosis, particularly in those with existing or worsening renal function. To mitigate this risk, Metformin administration must be stopped at the time of, or prior to, injection, with renal function reevaluated 48 hours after the procedure.

Pharmacodynamic interactions involve agents that lower the seizure threshold, such as certain tricyclic antidepressants, MAO inhibitors, and phenothiazine derivatives. for myelography procedures, these agents must be discontinued at least 48 hours before Omnipaque administration and not resumed for at least 24 hours afterward.

Procedural constraints also govern in-line administration, as Omnipaque injection must not be mixed with other medicinal products or total nutritional admixtures within the same intravenous line. Furthermore, iodinated contrast agents interfere with the thyroid uptake of Radioactive Iodine (I-131 and I-123), a process that decreases the efficacy of diagnostic and therapeutic thyroid procedures for a prolonged period.

Mechanism of Action

How Omnipaque 240 Works

Omnipaque 240 (iohexol) functions as a diagnostic agent through distinct physical and physiological mechanisms rather than receptor or enzyme modulation. The core mechanism involves the direct physical attenuation of X-ray photons. Iohexol molecules contain a high concentration of iodine, a heavy element that efficiently absorbs X-rays via photoelectric interaction within the imaging field. This action produces a transient, high-density contrast against surrounding low-density soft tissues.

Following administration, the agent operates via passive distribution into the bloodstream and extracellular spaces. Being water-soluble, it quickly diffuses through capillary walls but is generally restricted from crossing intact specialized biological barriers. This fluid-based mechanism leads to the establishment of uniform radiographic density across the target volume.

Furthermore, due to its molecular concentration, the agent causes localized, short-term modulation of osmotic dynamics upon injection. Its presence creates a transient concentration gradient, which momentarily influences fluid movement across nearby vascular structures. This engagement of local feedback mechanisms is associated with the rapid initial incorporation into physiological fluid pathways.

Dosage and Administration Information

How Omnipaque 240 is Used

Omnipaque 240 (Iohexol) is a diagnostic agent whose administration is governed by protocols that determine the specific procedure being performed. The product is approved for administration via multiple pathways, including intrathecal (into the spinal canal), intravenous (IV), intra-arterial, and oral intake, with the route matched to the required diagnostic study.

The medicine is strictly for single-procedure use only, and the administered dose volume is highly variable. For instance, the total dose for a single adult myelography procedure must not exceed 3,060 mg of iodine. Additionally, repeat intrathecal examinations require a minimum interval of at least 48 hours to be considered.

Procedural guidelines mandate that the solution may be administered at either room or body temperature and requires aseptic technique. For specific procedures like intrathecal injection, the dose must be administered slowly over 1 to 2 minutes. Crucially, the injection solution is not to be mixed with other drugs in the intravenous line, except for specific automated systems. For oral use, the required lower concentration must be achieved through proper dilution just prior to administration. For specific populations, dosing in pediatric patients is weight-based, and the agent is approved for use in patients 2 weeks and older.

Recent Clinical Evidence

Research evidence / Overview of studies for Omnipaque 240

Evidence for Use in Central Nervous System (CNS) Procedures

Research for Iohexol's use in imaging the brain and spinal cord, such as in myelography or CT scans of the CNS, was studied for the specific goal of visualizing these structures. These initial clinical evaluations often focused on historical comparisons against older contrast agents that were previously available. The trials evaluated outcomes related to diagnostic image quality for clinical assessment, including the clarity of the spinal cord and the spaces surrounding it.

Studies monitored the agent's behavior after injection, including how it was absorbed from the cerebrospinal fluid (CSF) and time to systemic clearance. The evidence data show patterns related to outcomes linked to inflammatory or irritative states that were observed in the studied populations. Long-term outcomes beyond the immediate diagnostic procedure are not the primary focus of the research and are not fully established.

Evidence for Use in Vascular and Organ Imaging

The research base for was studied for its use in diagnostic imaging of blood vessels (angiography) and organs via CT scans includes a variety of designs, such as randomized controlled trials (RCTs). Outcomes research examined included outcomes related to vessel opacification and outcomes related to diagnostic image quality across different anatomical regions.

Pharmacokinetic studies studies monitored the agent's absorption and elimination, reporting that the agent is rapidly cleared from the body primarily by the kidneys. Comparative evidence is lacking for certain specific procedures or against all contemporary alternatives, and the follow-up durations were limited to the acute period required for image acquisition and immediate post-procedure monitoring.

Evidence in Special Populations and Uncertainties

The agent was studied for its use in both adults and certain pediatric populations, including children as young as ge 2 weeks for CNS procedures. These studies were conducted to understand if diagnostic utility was observed in these younger groups. Sample sizes were modest in some of the subgroup analyses, meaning the results apply only to the populations studied and data for certain groups remain insufficient.

While research has explored its use over decades of regulatory evaluation, the primary focus remains on the acute diagnostic utility. Long-term effects are not fully established because the research was not designed to monitor outcomes over extended periods.

Key Studies & References

Frequently Asked Questions (FAQ)

Common questions about Omnipaque 240 (FAQ)

Q: Is it normal to feel a warm sensation when Omnipaque 240 is injected?

A: Yes, feeling a sensation of warmth or a mild, burning pain at the site of the injection is a known and commonly reported reaction during or after the administration of Omnipaque 240. The official safety information classifies this as a typical response.

Q: How long does Omnipaque 240 stay in your system after the procedure?

A: According to official pharmacokinetic data, most of the injected contrast agent is eliminated from the body relatively quickly. Approximately 90% or more of the dose is removed primarily by the kidneys within the first 24 hours following the procedure.

Q: Do I need to do anything specific to prepare for a scan involving Omnipaque 240?

A: Regulatory documents emphasize the importance of maintaining adequate hydration to minimize any potential risk to the kidneys. Specific pre-scan preparation instructions, such as diet and medication management, are provided by your healthcare provider or imaging facility based on the procedure.

Q: What should I avoid eating or drinking before getting Omnipaque 240?

A: While the product label does not mandate fasting for all procedures, specific dietary or fluid restrictions may be required by your healthcare provider. Your care team will provide precise instructions, especially concerning hydration or changes to your medication schedule.

Q: How quickly does Omnipaque 240 start working once it's injected?

A: Omnipaque 240 works very rapidly. Following a fast intravenous injection, the agent achieves its peak concentration in the blood almost immediately. Optimal contrast and image enhancement for the scan often occur within 30 to 90 seconds.

Q: Do they use Omnipaque 240 for both CT scans and X-rays?

A: Yes, Omnipaque 240 is officially indicated for a wide variety of X-ray imaging procedures. This includes the use in modern diagnostic techniques such as Computed Tomography (CT) scans of the head and body, as well as several other general radiographic examinations.

Q: Does drinking extra water after the procedure help flush out the Omnipaque 240 faster?

A: Official labeling strongly recommends maintaining adequate hydration to help your body's natural processes remove the contrast agent. Maintaining good hydration is generally recommended to support the body’s natural excretion process.

Q: Can Omnipaque 240 cause a metallic taste in the mouth?

A: Yes, a change in taste, or taste perversion, is listed in the official documentation as a common side effect reported after the intravascular administration of Omnipaque. This experience is usually temporary.

Q: Why is Omnipaque 240 sometimes given orally or rectally instead of intravenously?

A: The route is determined by the diagnostic area. Oral or rectal administration is used specifically to provide contrast and enhance the visibility of the gastrointestinal (GI) tract during imaging, such as CT scans of the abdomen and pelvis.

Q: Can Omnipaque 240 interfere with the results of other lab tests?

A: Yes, official labeling notes that iodinated contrast agents can interfere with the results of certain laboratory procedures. Specifically, tests used to measure the thyroid uptake of radioactive iodine (I-131 and I-123) may be affected.

Q: Can I drive immediately after a procedure that used Omnipaque 240?

A: It depends on the procedure. For certain studies, particularly those involving the spinal canal (myelography), official guidelines advise patients not to drive a vehicle or operate machinery for a specific period, typically at least 24 hours. The healthcare provider overseeing your procedure will confirm any post-procedure restrictions that apply.

Q: Does Omnipaque 240 show up in urine or feces?

A: When administered intravenously, the drug is eliminated primarily by the kidneys and is therefore present in the urine. When taken orally, very little is absorbed into the bloodstream, and most of the agent is eliminated via the feces.

Q: Is Omnipaque 240 used in procedures other than simple diagnostic scans?

A: The agent is approved for a wide variety of diagnostic procedures beyond general screening. This includes imaging for the evaluation of certain malignancies (cancers), complex blood vessel mapping (angiography), and other structural assessments.

Q: Does my age affect how my body handles Omnipaque 240?

A: Yes, age is a factor in its use. Special considerations are necessary for different age groups, including special monitoring for thyroid function in infants and cautious dose selection for older adult patients who may have decreased organ function.

Q: Can I drink alcohol after getting Omnipaque 240?

A: The official label does not provide a general timeline for resuming alcohol consumption. Specific restrictions following your procedure should be discussed with the healthcare provider.

Q: Is Omnipaque 240 safe for children or teenagers?

A: Omnipaque is indicated and approved for use in pediatric patients, including children and teenagers, for many procedures. For example, it is approved for intrathecal procedures starting at 2 weeks of age, with weight-based dosing and specific monitoring protocols.

Q: Can the concentration of Omnipaque 240 be adjusted?

A: The Omnipaque 240 solution, as an injection, has a fixed concentration of 240 mg of iodine/mL. However, for procedures requiring oral use, the required lower concentration is achieved through proper dilution of the product just before administration.

Q: Is Omnipaque 240 the same as other contrast dyes I've heard of?

A: Omnipaque 240 is not the same as all other dyes. Its active ingredient, Iohexol, belongs to the class of non-ionic, iodinated contrast media. This molecular structure gives it a low-osmolar property, which distinguishes it from older, higher-osmolar agents.

Q: What is the difference between Omnipaque 240 and Omnipaque 300 or 350?

A: The number in the name refers to the concentration of the active ingredient. Omnipaque 240 contains 240 mg of iodine per milliliter. The 300 and 350 strengths contain 300 mg/mL and 350 mg/mL of iodine, respectively, offering different levels of image enhancement.

Q: What if I'm currently taking metformin? Does that affect using Omnipaque 240?

A: Yes, there is an important safety consideration if you take Metformin. To help mitigate the risk of lactic acidosis, the official instructions require Metformin to be discontinued at the time of, or prior to, the injection, and kidney function must be reevaluated 48 hours afterward.

Q: Can Omnipaque 240 be used if I have a shellfish allergy?

A: Omnipaque 240 is only strictly contraindicated (should not be used) in patients with a known hypersensitivity to iohexol or any of its components. The official label does not specifically list shellfish allergy as a contraindication; however, any severe allergy history should always be reviewed with the prescribing physician.

Q: Why do some people need to be pre-medicated before getting this contrast?

A: Pre-medication is not standard for all patients. However, because life-threatening hypersensitivity reactions are a possibility, a healthcare provider may decide to pre-medicate certain individuals based on their medical history or pre-existing conditions that increase their risk.

Q: What kind of research supports the effectiveness of Omnipaque 240?

A: The effectiveness is supported by clinical studies that focused primarily on the quality of the diagnostic image. These evaluations examined outcomes related to vessel opacification and the clarity of the spinal cord to confirm the agent’s utility in clinical assessment.

Q: How does Omnipaque 240 differ from gadolinium-based contrast agents?

A: Omnipaque 240 is an iodinated contrast agent used in X-ray and CT imaging procedures. Gadolinium-based agents, on the other hand, are a chemically distinct class of contrast media used specifically for Magnetic Resonance Imaging (MRI) procedures.

Q: Does Omnipaque 240 interact with blood thinners?

A: While official prescribing information does not list blood thinners (anticoagulants) as a contraindication, the label does include a general warning about thromboembolic events that may occur during angiographic procedures, emphasizing the need for proper procedural technique.

Q: Do I need to stop taking any of my regular medications before the procedure?

A: Yes, certain medications may need to be temporarily stopped. This is specifically required for Metformin and for certain drugs that are known to lower the seizure threshold, such as some tricyclic antidepressants or MAO inhibitors, as instructed by the healthcare provider.

How should Omnipaque 240 be stored and disposed of?

Storage and Disposal of Omnipaque 240

The official labeling for Omnipaque 240 (iohexol) injection details specific requirements for environmental control, handling, and disposal of the solution.

Storage Conditions

Condition	Requirement (Based on Official Labeling)
Temperature	Store at controlled room temperature (20 C to 25 C / 68 F to 77 F); do not freeze.
Protection	Protect from light and keep out of the reach of children.
Warmer Storage	May be stored in a contrast media warmer at 37 C (98.6 F) for a maximum of one month.
Pre-Use Check	Visually inspect for particulate matter or discoloration; do not administer if defects are present.

Disposal Instructions

Omnipaque 240 is supplied in single-dose containers and is intended for one procedure only. Any unused portion must be discarded immediately after the procedure. Disposal of the unused product and all related waste must be performed in accordance with local, state, and federal regulations for pharmaceutical waste.

Omnipaque 240