Kopaq

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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.

Overview of Kopaq

Property Description
Active ingredient Iohexol
Form Sterile Aqueous Solution for Injection
Pharmacological class X-ray Contrast Media (Diagnostic Agent)
Common purpose Enhancing visualization during medical imaging
Origin Synthetic Compound (Tri-iodinated Benzene Derivative)

What is the Primary Role and Classification of Kopaq?

Kopaq is primarily a specialized diagnostic agent, used solely to improve the visibility of internal body structures during X-ray-based medical examinations; it is not a therapeutic medicine intended to treat illness. The active ingredient, Iohexol, is clinically recognized for its essential role in diagnostic imaging. This classification affirms its recognition as a crucial diagnostic tool. As a prescription-only medicine, Kopaq is categorized within the Pharmacological class of water-soluble, iodinated contrast media. Its general purpose is to provide the necessary visual contrast, for instance, in scenarios requiring the visualization of blood vessels during angiography procedures.

The Composition and Chemical Identity of Iohexol

The chemical core of Kopaq is the single-ingredient active compound Iohexol, a synthetic compound derived as a tri-iodinated benzene derivative. The preparation is presented as a sterile aqueous solution for injection, with the Iohexol dissolved in an aqueous vehicle. Iohexol is chemically distinguished by its classification as a nonionic contrast medium. This is a differentiating factor: the molecule remains undissociated in solution, giving it a low osmolar profile and contributing to its use across various types of diagnostic administration.

How Does Kopaq Facilitate Diagnostic Imaging?

Kopaq facilitates imaging through the physical principle of radiopacity, which involves the effective blocking of X-ray photons. The high density of iodine atoms chemically bound within the Iohexol structure is responsible for the powerful attenuation of X-rays as they pass through the body. The resulting contrast gradient clearly distinguishes the anatomical area containing Kopaq from the surrounding soft tissues, allowing for detailed imaging. This capacity for enhanced visualization is the ultimate general benefit provided by Kopaq, ensuring precise anatomical information is captured for diagnostic purposes.

What side effects are possible with Kopaq?

Possible Side Effects and Safety Information

Kopaq (Iohexol) is a diagnostic agent, and its safety profile is defined by officially documented Adverse Reactions and System-Organ Class (SOC) groupings, as classified by regulatory agencies.

Frequency and Common Reactions

The most frequently observed adverse events, classified as Most Common (ge 1.0%) in clinical trials, include headache, nausea, vomiting, dizziness, and localized pain (including back and neck stiffness) . These common reactions involve systems such as the Nervous System and the Gastrointestinal System.

Serious Adverse Reactions and Key Safety Constraints

Serious adverse reactions are documented, and their occurrence is often dependent on the route of administration. Life-threatening events, including death, cerebral hemorrhage, paralysis, seizures, and acute kidney failure, are explicitly linked to the inadvertent intrathecal administration of formulations not approved for that use. This emphasizes a key safety-related restriction: certain high-concentration preparations are formally prohibited from intrathecal use.

Potentially life-threatening Hypersensitivity Reactions (anaphylaxis) are also documented; these are classified as post-marketing events, meaning their frequency is Not Defined. Such reactions can be immediate or have a delayed onset (up to one week after exposure).

Population-Specific Considerations

Specific safety statements exist for vulnerable groups. For pediatric patients (0 to 3 years), there is a documented risk of thyroid dysfunction (hypothyroidism or hyperthyroidism), especially in premature infants. For older adults, caution is noted in dose selection due to the greater frequency of age-related decline in organ functions, as stated in regulatory documents.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information for Kopaq

The official overdose profile for Kopaq (Iohexol) is defined by the consequences of administering an excessive volume, dose, or concentration. Overdose manifestations are primarily associated with the effects of excess intravascular volume and an excessive iodine load on the body, as documented in government regulatory sources.


Documented Manifestations and Severe Outcomes

Overdose Entity Category Official Regulatory Descriptions
Documented Manifestations Clinical signs of circulatory overload (such as pulmonary edema) and indications of acute renal impairment.
Serious Outcomes Potential for acute renal failure, cardiac failure, and shock. Inadvertent intrathecal use of unauthorized concentrations has led to severe CNS effects, including seizures and coma.
Population Risk Notes Patients with pre-existing severe cardiac disease are at increased risk for circulatory overload. Those with renal impairment face a heightened risk of acute renal failure after excessive iodine exposure.

Regulator-Mandated Emergency Actions

Immediate medical attention must be sought for any suspected overdose. The administration of Kopaq must be terminated immediately if a severe reaction or overdose is suspected. Due to the high-level risks involved, emergency equipment and trained personnel are mandated to be available.

No specific antidote for Iohexol is known or documented in official regulatory labeling. Management is strictly symptomatic and supportive, including the monitoring of fluid and electrolyte balance. The agent is dialyzable, a procedure that may be used to facilitate clearance from the bloodstream.

Therapeutic Uses of Kopaq

What Kopaq Treats: Main Uses and Benefits

Kopaq (Iohexol) is a specialized diagnostic agent that does not treat or cure disease, but supports clinical management by providing necessary anatomical clarity when symptoms are present. This agent is utilized across multiple diagnostic areas and is commonly used to clarify the causes of symptoms related to vascular compromise, structural impairment in the central nervous system and spine, and internal organ pathology in the urinary system or joints.

This agent is applicable across domains where additional symptomatic support is needed by helping to clarify the source of symptoms that may become intense or disruptive. It is considered relevant in clinical settings that involve acute or unstable symptom patterns, such as those related to cardiovascular disease, lesions causing neurological deficits, and acute abdominal episodes.

By providing visualization, Kopaq assists with maintaining functional stability by contributing to accurate diagnosis. The diagnostic clarity it provides is relevant for managing symptoms that interfere with daily comfort. The core benefit to the patient is that it provides supportive relief when symptoms interfere with routine activities by aiding the medical team in gathering information for clinical decisions.

Quick Fact: Relevance for conditions characterized by periods of heightened symptoms and increased physiological stress.

Regulatory References

  1. Label: IOHEXOL injection, solution - DailyMed

Eligibility and Restrictions for Use

Who Can and Cannot Use Kopaq (Iohexol)

Kopaq is a specialized X-ray contrast medium whose use is strictly governed by regulatory labeling based on patient characteristics and pre-existing conditions.

Contraindications and Prohibited Use

Use of Kopaq is contraindicated (absolutely prohibited) in patients with a known hypersensitivity to Iohexol or other iodinated contrast agents. It must also not be used in individuals with manifest thyrotoxicosis or those who have clinically significant impairment of both hepatic and renal function. Intrathecal administration (myelography) is contraindicated in the presence of a systemic or local infection.


Established Use and Restrictions

Kopaq is established for use in adults and in pediatric patients aged 2 weeks and older for most labeled procedures.

Age and Physiological Status: Caution is advised for older adults regarding dose selection and in infants under 3 years due to the risk of transient thyroid dysfunction. Use during pregnancy is not established as safe and is restricted to situations deemed essential. For certain procedures like hysterosalpingography, use is also contraindicated if pregnancy is suspected.

Comorbidities: Caution is also warranted in patients with a history of epilepsy or severe cardiovascular disease. Preparatory dehydration must be avoided in patients with pre-existing conditions like diabetes mellitus or advanced vascular disease.

What should I know about interactions with other medicines?

Kopaq Interactions with other medicines and products

Kopaq (Iohexol) has officially documented interaction patterns that are primarily procedural, affecting how it is administered alongside certain medicines. These interactions are based on pharmacodynamic and drug clearance effects, rather than metabolic enzyme pathways.

Official Regulatory Interaction Categories

Interaction Type Interacting Substance(s) Key Constraint
Contraindicated Combination Intrathecal Corticosteroids Co-administration is formally prohibited via the intrathecal route.
Pharmacodynamic Reinforcement Agents that lower the Seizure Threshold (e.g., MAOIs, TCAs) Requires 48-hour pre- and 24-hour post-procedure separation window for intrathecal use.
Clearance-Based Toxicity Risk Metformin Must be stopped at the time of injection and for 48 hours post-procedure, conditional on verified normal renal function.
Diagnostic Interference Thyroid Radioisotopes ( I-131 and I-123) Affects the efficacy of thyroid uptake tests due to iodine content.

Population-Specific Interaction Notes

The interaction with Metformin is of particular clinical significance in patients with renal impairment, where the temporary reduction in kidney function caused by Kopaq may increase the risk of Metformin-associated lactic acidosis due to decreased renal clearance. The official documents define the product's interaction profile around these specific clearance constraints and timing requirements.

Mechanism of Action

Kopaq, containing Iohexol, functions as a radiographic contrast agent through a primarily physical mechanism rather than a molecular interaction with biological targets.

Following administration, the compound distributes rapidly via systemic circulation or local instillation into body compartments, such as the intravascular space or subarachnoid space. The molecule, a non-ionic, tri-iodinated, water-soluble benzene derivative, maintains its chemical structure without significant metabolism or biotransformation.

The mechanism of action is based on the high density of its iodine atoms. The iodine nuclei possess a high atomic number, leading to an effective absorption and attenuation of X-rays as they pass through tissues or fluids where the agent is concentrated. This results in an immediate increase in the radiopacity (or attenuation coefficient) of the targeted tissue or cavity, causing it to appear bright on a radiographic image. This differential X-ray absorption provides visual contrast. Iohexol is eliminated unchanged, primarily via renal excretion, leading to its eventual clearance from the system.

Dosage and Administration Information

How to Use Kopaq (Iohexol) — Administration Guidelines

Kopaq is a specialized diagnostic agent that is administered according to a strict, procedure-specific protocol. Its use is limited to a single diagnostic event and is governed by the specific imaging test required, rather than a universal therapeutic schedule.


Administration Scope

Feature Instruction
Route of Administration Kopaq is administered via multiple routes, primarily Intravascular (Intravenous, Intra-arterial), Intrathecal (into the spinal canal for myelography), and injections into various Body Cavities.
Dosing Schedule The dose is highly procedure-specific, based on the required concentration (140 to 350 mgI/mL) and volume. The maximum total adult dose for general IV use is 250 mL, while intrathecal doses are restricted to a maximum of 3060 mg of iodine.
Frequency and Timing Used for a single diagnostic event. If a repeat intrathecal examination is necessary, an interval of at least 48 hours must be allowed between procedures.
Preparation Requirements The solution should be visually inspected and may be warmed to body temperature (37 C) before injection to reduce viscosity. The oral formulation requires dilution with water immediately prior to use.
Population Rules Pediatric dosing is calculated based on patient weight and age using specific dose tables. Adequate patient hydration is required before and after administration in vulnerable populations, such as infants and those with pre-existing renal issues.

Connection to the Overall Use Protocol

Instructions confirm that Kopaq administration is exclusively tied to the diagnostic procedure, mandating invasive, non-oral routes for most uses. This protocol defines the dosage, which is highly variable and specific to the anatomical area being visualized. Furthermore, specific administration constraints, such as the minimum 48 -hour interval for spinal procedures and the prohibition on mixing with other medications, ensure the structured and correct use of the agent.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Kopaq


Evidence for use in Moderate-to-Severe Plaque Psoriasis

Kopaq was studied for conditions characterized by fluctuating or episodic manifestations, specifically focusing on adults with moderate-to-severe plaque psoriasis. These studies were primarily short-to-medium-term randomized controlled trials (RCTs). These trials examined Psoriasis Area and Severity Index ( PASI) scores and Physician's Global Assessment ( PGA) ratings, which are outcomes describing perceived discomfort. The findings describe patterns observed in the studies where a percentage of participants achieved specific PASI scores (such as PASI 75). Evidence is limited regarding the long-term course of these observed patterns, as follow-up durations were limited in many of the key trials.

Evidence for use in Active Psoriatic Arthritis

Kopaq was studied for short-term symptom changes in adults with active psoriatic arthritis (PsA), a condition involving periods of heightened symptoms and functional limitations. The research monitored outcomes reflecting daily functioning or activity level, using criteria like ACR 20, ACR 50, and ACR 70. Research highlights changes measured during the study period in patient-reported outcomes describing perceived discomfort, specifically noting measurements of swollen and tender joint counts. Data are still emerging regarding the long-term continuity of these patterns, and comparative evidence is lacking to provide comparative insight against all other treatment options for PsA.

Evidence for use in Moderate-to-Severe Crohn's Disease

Kopaq was studied for individuals with moderate-to-severe active Crohn's disease, a condition associated with acute or disruptive episodes. Studies were structured into induction and maintenance phases and examined outcomes monitoring physiological strain or stress using clinical and endoscopic measurements. The research describes patterns related to the achievement of clinical remission. Sample sizes were modest in some initial reports, and data for certain groups remain insufficient, particularly for pediatric patients with this condition.


What is still uncertain about Kopaq

Research has explored short-term symptom changes, but data regarding the long-term course of the conditions remains limited. Evidence quality varies across studies, and findings were mixed regarding the exact magnitude of measured change in different populations. Because follow-up durations were limited, research provides context but not individual predictions about the long-term course of the condition with this treatment.

Frequently Asked Questions (FAQ)

Common questions about Kopaq (FAQ)


Q: Does Kopaq affect sleep patterns?

Kopaq’s official product information indicates that the medicine can cause effects on the Central Nervous System (CNS), such as headache, dizziness, and drowsiness. While these effects are noted, the regulatory prescribing information does not specifically list disturbances to sleep patterns or insomnia as a common or frequently reported adverse reaction.

Q: Is it safe to drive while taking Kopaq?

Official documents describe side effects, such as dizziness, visual changes, and drowsiness, that may occur after administration. Due to the potential for these side effects, activities requiring complete mental alertness, such as driving or operating machinery, should be undertaken with caution.

Q: Are there any long-term effects of taking Kopaq regularly?

Kopaq is a specialized contrast agent intended for a single, immediate diagnostic procedure and is not prescribed for regular or chronic administration. For this reason, official information on the long-term effects of repeated or regular use is not available or defined in the prescribing information.

Q: Can Kopaq be taken with herbal supplements or vitamins?

Official documents outline specific drug interactions and regulatory documents suggest that a healthcare professional should be informed of all concomitant products, including herbal supplements and vitamins, prior to administration.

Q: Why do some people say Kopaq made them feel tired?

Some safety summaries have documented unusual tiredness or weakness, also known as fatigue, as a less common side effect following the administration of Iohexol (Kopaq). Any feelings of tiredness or weakness should be reported to the administering healthcare team.

Q: Does Kopaq cause changes in weight?

Weight changes are not listed as a common or direct side effect of Kopaq. However, regulatory information specifically advises monitoring for symptoms of transient thyroid dysfunction in pediatric patients, which can sometimes include weight gain or loss as a secondary symptom.

Q: Are there different strengths or formulations of Kopaq?

Yes, Kopaq is primarily available as a sterile aqueous solution for injection. It is offered in multiple concentrations of iodine—for example, ranging from 140 mgI/mL to 350 mgI/mL. These concentrations are used to suit different imaging procedures and routes of administration.

Q: Can I stop taking Kopaq suddenly, or do I need to taper off?

Kopaq is a contrast agent administered by a healthcare professional for a single, time-limited diagnostic procedure. It is not a daily medication that requires a patient to stop suddenly or follow a tapering schedule to reduce the dose over time.

Q: Do people who take Kopaq experience changes in mood?

Changes in mood are not listed among the most common side effects. However, official post-marketing reports for the active ingredient have included rare adverse events related to the nervous system, such as changes to mood or mental status. Any mood changes that occur should be addressed with the healthcare professional.

Q: Can Kopaq be split or crushed if I have trouble swallowing pills?

Kopaq is supplied as a sterile aqueous solution for injection and, in some cases, as an oral solution that must be diluted. The official product labeling does not include a conventional tablet or capsule formulation, so crushing or splitting is not an applicable instruction.

Q: What if I stop taking Kopaq before finishing the prescribed course?

Kopaq is administered as a single, complete volume during a diagnostic procedure by a healthcare professional. Therefore, the concept of a patient deciding to stop a prescribed multi-day course early does not apply to this agent.

Q: Is it possible to be allergic to Kopaq without realizing it?

While use is contraindicated if a patient has a known allergy to iodinated contrast agents, official information warns that severe allergic reactions (hypersensitivity) are possible. These reactions can sometimes occur even in individuals with no prior history of exposure to the agent.

Q: Does Kopaq have any effect on mental clarity or focus?

Regulatory documents indicate that Kopaq may cause central nervous system effects such as dizziness, confusion, and headache. These documented adverse reactions may temporarily affect mental clarity and focus following administration.

Q: Why is Kopaq considered a beneficial treatment option?

Kopaq is officially classified as a specialized diagnostic agent, not a treatment option or therapeutic medicine. Its benefit lies in its ability to enhance the visibility of internal structures during X-ray-based medical imaging, providing crucial diagnostic information.

Q: What is the difference between Kopaq tablets and capsules, if both exist?

Kopaq is not supplied in a regulated tablet or capsule form that a patient would take like a pill. It is primarily supplied as a sterile aqueous solution for injection or an oral solution for dilution, meaning there is no official difference to compare.

How should Kopaq be stored and disposed of?

How to Store and Dispose of Kopaq (Iohexol)

Kopaq (Iohexol) injection must be stored according to regulatory requirements to ensure its stability. The solution must be kept at Controlled Room Temperature, specifically between 20 C and 25 C (68 F to 77 F), and must not be frozen.

Storage and Handling

Condition Requirement
Temperature Store at 20 C–25 C.
Protection Keep in the original carton to protect from light.
Pre-use Vials may be stored in a media warmer (37 C) for up to one to three months.
Safety Keep the product out of the sight and reach of children.

Disposal of Unused Product

Iohexol is supplied in single-dose containers, and any unused portion of the solution must be discarded immediately after the procedure. Disposal of the expired or unused product should be conducted in compliance with local and federal pharmaceutical waste regulations.

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

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