Omnipaque 240mg/ml Inj, 20ml

Manufacturer GE HEALTHCARE Active Ingredient Iohexol(eye oh HEX ole) Pronunciation eye oh HEX ole
WARNING: Some products must not be given into the spine. Very bad and sometimes deadly health problems have happened when these products were given into the spine. This includes coma, heart attack, kidney failure, paralysis, seizures, high body temperature, a muscle problem called rhabdomyolysis, or brain problems like bleeding or swelling. Talk with the doctor. @ COMMON USES: It is used before a CT scan or other test.
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Drug Class
Diagnostic agent
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Pharmacologic Class
Non-ionic, low-osmolar iodinated contrast medium
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Pregnancy Category
Category B
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FDA Approved
Jun 1985
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Iohexol is a special liquid, called a contrast agent, that helps doctors see inside your body more clearly on X-ray pictures like CT scans. It contains iodine, which makes certain parts of your body, like blood vessels or organs, show up better on the images. It's given by injection, usually into a vein, or sometimes directly into the area being examined.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully.

Preparation and Administration

Before receiving this medication, ensure you are not dehydrated. Consult your doctor to determine if you need to drink extra fluids beforehand. After taking this medication, drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Administration Methods

Injection: Your doctor will administer this medication. You may receive other medications before this one to help prevent side effects.
Liquid: This medication can be taken orally or rectally.

Storage and Disposal

Liquid: If you need to store this medication at home, consult your doctor, nurse, or pharmacist for guidance on proper storage.
Injection: This medication will be administered in a healthcare setting, and you will not need to store it at home.

Missed Dose

Liquid: If you miss a dose, contact your doctor to determine the best course of action.
Injection: Since this medication is administered in a healthcare setting, you will not need to worry about missing a dose.
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Lifestyle & Tips

  • Stay well-hydrated before and after the procedure, especially if you have kidney problems, to help your body clear the contrast agent.
  • Inform your healthcare provider about all medications you are taking, especially for diabetes (like Metformin) or kidney conditions.
  • Report any allergies, especially to iodine, shellfish, or previous contrast agents.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on procedure, route of administration, and patient weight. Typical doses range from 20 mL to 200 mL (e.g., 50-150 mL for CT, 20-200 mL for angiography). Concentration (e.g., 240 mgI/mL) is chosen based on the study.
Dose Range: 20 - 200 mg

Condition-Specific Dosing:

CT Scan (Head/Body): 50-150 mL (240-350 mgI/mL)
Angiography: 20-200 mL (240-350 mgI/mL) depending on vessel and number of injections
Myelography: 6-15 mL (180-300 mgI/mL)
Arthrography: 5-15 mL (180-300 mgI/mL)
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Pediatric Dosing

Neonatal: Dosing is weight-based and procedure-specific. Generally 1-3 mL/kg (240-300 mgI/mL) for IV administration, not to exceed 4 mL/kg or 100 mL total.
Infant: Dosing is weight-based and procedure-specific. Generally 1-3 mL/kg (240-300 mgI/mL) for IV administration, not to exceed 4 mL/kg or 100 mL total.
Child: Dosing is weight-based and procedure-specific. Generally 1-3 mL/kg (240-300 mgI/mL) for IV administration, not to exceed 4 mL/kg or 100 mL total.
Adolescent: Dosing is weight-based and procedure-specific. Generally 1-3 mL/kg (240-300 mgI/mL) for IV administration, not to exceed 4 mL/kg or 100 mL total.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment for mild impairment, but ensure adequate hydration.
Moderate: Consider lower doses or extended intervals, especially for high-volume procedures. Ensure aggressive hydration. Monitor renal function closely.
Severe: Use with extreme caution. Dose reduction or extended intervals are often necessary. Consider alternative imaging if possible. Aggressive hydration is critical. Risk of contrast-induced acute kidney injury (CI-AKI) is significantly increased.
Dialysis: Iohexol is dialyzable. If patient is on dialysis, administer immediately prior to dialysis session to facilitate removal. For patients not on dialysis, use with extreme caution and consider alternative imaging. If administered, monitor renal function closely and ensure adequate hydration.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required.

Pharmacology

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Mechanism of Action

Iohexol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When administered, it increases the attenuation of X-rays in the areas where it distributes, allowing for visualization of anatomical structures (e.g., blood vessels, urinary tract, subarachnoid space) on radiographic images. The iodine atoms in the molecule are responsible for the X-ray attenuation.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (following intravenous administration)
Tmax: Not applicable (immediate distribution following IV injection)
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: Approximately 0.16-0.23 L/kg (distributes into extracellular fluid)
ProteinBinding: < 2%
CnssPenetration: Limited (does not cross intact blood-brain barrier; enters CSF when administered intrathecally)

Elimination:

HalfLife: Approximately 2 hours
Clearance: Primarily renal glomerular filtration (renal clearance approximates GFR)
ExcretionRoute: Renal (urine)
Unchanged: > 95% (excreted unchanged in urine within 24 hours)
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Pharmacodynamics

OnsetOfAction: Immediate (upon injection)
PeakEffect: Immediate (upon injection, then dependent on circulation time and distribution)
DurationOfAction: Dependent on procedure and clearance; typically minutes to hours for diagnostic visualization, but remains in body until renally cleared.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic reactions: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Thyroid problems: Changes in weight, feeling nervous, excitable, restless, or weak, hair thinning, depression, eye or neck swelling, difficulty focusing, trouble with heat or cold, menstrual changes, shakiness, or sweating.
Injection-related side effects:
+ Chest pain or pressure, fast heartbeat, or abnormal heartbeat.
+ Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
+ Severe dizziness or fainting.
+ Shortness of breath, significant weight gain, or swelling in the arms or legs.
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm.
+ Seizures.
+ Changes in vision.
Tissue damage: If the medication leaks from the vein, it can cause tissue damage. Inform your nurse if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
Severe skin reactions: These can occur anywhere from 1 hour to several weeks after receiving the medication and may include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, these reactions can affect internal organs and be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin.
+ Red or irritated eyes.
+ Sores in your mouth, throat, nose, eyes, genitals, or skin.
+ Fever, chills, body aches, shortness of breath, or swollen glands.
Spinal injection side effects: A burning, numbness, or tingling sensation that is not normal.
Liquid formulation side effects: Swelling.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Common side effects:
+ Upset stomach or vomiting.
+ Headache.
Injection-related side effects (if given in an artery or vein):
+ Dizziness.
+ Feeling of warmth.
+ Changes in taste.
Spinal injection side effects:
+ Dizziness.
+ Back pain.
+ Neck pain.
+ Stiff neck.
* Liquid formulation side effects:
+ Stomach pain or diarrhea.
+ Gas.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Hives, rash, or itching
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or wheezing
  • Dizziness or feeling faint
  • Nausea or vomiting
  • Unusual pain or swelling at the injection site
  • Any delayed reactions such as fever, joint pain, or skin rash that appear hours or days after the procedure.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Describe the allergic reaction and its symptoms.
If you are dehydrated, have been experiencing poor nutrition, or have recently used a laxative or diuretic (water pill).
A history of skin reactions to this medication or similar drugs.
Current use of metformin.

Additional Considerations for Specific Administration Routes:

If you will be receiving this medication via spinal injection:
+ Presence of an infection.
+ Use of medications that may increase the risk of seizures or have taken such a medication within the last 48 hours. Consult your doctor or pharmacist if you are unsure about the medications you are taking.
If you will be receiving this medication via arterial or venous injection:
+ Inability to urinate.
* If this medication will be used before an x-ray of the uterus and fallopian tubes:
+ If you are currently menstruating, have a genital infection, or have or may have a growth in the reproductive tract.
+ Recent procedures, such as a curettage (tissue removal) or conization (cervix biopsy), within the past 30 days.
+ Pregnancy termination within the past 6 months.
+ Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.

Interactions with Other Medications and Health Conditions:

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Ensure that it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may need to monitor your blood work, and this medication may affect certain lab tests. Be sure to notify all your healthcare providers and lab personnel that you are taking this drug.

If you experience any signs of kidney problems, such as difficulty urinating, changes in urine output, bloody, brown, or foamy urine, shortness of breath, cough, or swelling in your face, feet, or hands, contact your doctor immediately.

Special Considerations

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Similarly, if the patient is a child, use this medication with caution, as the risk of side effects may be higher in some children.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

Injection (Given in an Artery or Vein)

In children under 3 years of age, the use of medications like this one has been associated with low thyroid function, which can impact child development. If the patient is a child, your doctor may need to monitor their thyroid function for an extended period after the injection. If you have concerns, discuss them with your doctor.

Rarely, life-threatening or fatal heart problems, including low blood pressure and heart attack, have been reported with this medication. Consult your doctor to discuss the potential risks.

Additionally, health problems like blood clots have occurred with this medication when used in conjunction with certain procedures. In some cases, blood clots can lead to heart attack and stroke, which can be fatal. If you have questions, consult your doctor.

Injection (Given into the Spine)

This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
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Overdose Information

Overdose Symptoms:

  • Fluid overload (pulmonary edema, heart failure)
  • Electrolyte disturbances
  • Acute renal failure
  • Severe hypersensitivity reactions

What to Do:

Treatment is symptomatic and supportive. Iohexol is dialyzable, so hemodialysis can be used to remove it from the body in cases of severe overdose or renal failure. Monitor vital signs, fluid and electrolyte balance, and renal function. Manage hypersensitivity reactions with antihistamines, corticosteroids, and epinephrine as needed. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Metformin (in patients with renal impairment or acute kidney injury): Risk of lactic acidosis. Metformin should be withheld at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR <30 mL/min/1.73 m2 or in patients with acute kidney injury. It should be withheld for 48 hours after the procedure and reinstituted only after renal function has been re-evaluated and found to be stable.
  • Interleukin-2: Increased incidence of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, arthralgia, pruritus, hypotension, oliguria, renal dysfunction) following contrast administration.
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Moderate Interactions

  • Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin, cyclosporine): Increased risk of contrast-induced acute kidney injury (CI-AKI) when co-administered, especially in patients with pre-existing renal impairment.
  • Beta-blockers: May blunt the compensatory cardiovascular responses to contrast-induced anaphylactoid reactions, making them more severe and difficult to treat.
  • Diuretics: May increase the risk of CI-AKI due to dehydration.

Monitoring

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Baseline Monitoring

Renal function (Serum Creatinine, eGFR)

Rationale: To assess baseline kidney function and identify patients at risk for contrast-induced acute kidney injury (CI-AKI), especially important for Metformin use.

Timing: Prior to administration, typically within 30 days, or immediately prior for high-risk patients.

Allergy history (especially to iodine, shellfish, or previous contrast media)

Rationale: To identify patients at increased risk for hypersensitivity reactions and determine need for pre-medication.

Timing: Prior to administration.

Hydration status

Rationale: Adequate hydration is crucial to prevent CI-AKI, especially in at-risk patients.

Timing: Prior to administration.

Thyroid function (TSH, T4)

Rationale: Iodinated contrast can induce hyperthyroidism in susceptible individuals (e.g., those with latent hyperthyroidism or autonomous thyroid nodules).

Timing: Consider in patients with known thyroid disease or risk factors.

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Routine Monitoring

Vital signs (Blood Pressure, Heart Rate, Respiratory Rate, Oxygen Saturation)

Frequency: Before, during, and immediately after administration, then as clinically indicated.

Target: Within patient's normal limits.

Action Threshold: Significant deviations (e.g., hypotension, tachycardia, dyspnea) warrant immediate intervention for potential adverse reactions.

Signs and symptoms of hypersensitivity reaction (e.g., rash, urticaria, pruritus, dyspnea, angioedema, hypotension)

Frequency: Continuously during and for at least 30 minutes post-administration, and instruct patient to report delayed reactions.

Target: Absence of symptoms.

Action Threshold: Any signs of allergic reaction require immediate medical attention.

Injection site for extravasation

Frequency: During and immediately after injection.

Target: Absence of swelling, pain, redness.

Action Threshold: Signs of extravasation require immediate cessation of injection and appropriate management.

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Symptom Monitoring

  • Rash
  • Hives (urticaria)
  • Itching (pruritus)
  • Difficulty breathing (dyspnea)
  • Wheezing
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Dizziness or lightheadedness
  • Nausea
  • Vomiting
  • Headache
  • Fever
  • Chills
  • Flu-like symptoms (delayed reactions)
  • Pain or swelling at injection site
  • Decreased urine output (sign of CI-AKI)

Special Patient Groups

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Pregnancy

Iohexol is classified as Pregnancy Category B. Animal studies have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Consider non-ionizing imaging modalities (e.g., ultrasound, MRI without gadolinium) if appropriate.

Trimester-Specific Risks:

First Trimester: No specific increased risk identified, but general caution with any drug exposure during organogenesis.
Second Trimester: No specific increased risk identified.
Third Trimester: No specific increased risk identified. Potential for transient hypothyroidism in the neonate due to iodine load, though rare with non-ionic agents.
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Lactation

Iohexol is minimally excreted into breast milk (less than 0.5% of the administered dose). It is considered compatible with breastfeeding. The American College of Radiology (ACR) and European Society of Urogenital Radiology (ESUR) recommend that breastfeeding can continue without interruption after administration of iodinated contrast media. If there is concern, the mother may pump and discard breast milk for 12-24 hours after administration, but this is generally not necessary.

Infant Risk: Low risk. Minimal absorption by the infant from breast milk. No known adverse effects reported.
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Pediatric Use

Dosing is weight-based and procedure-specific. Pediatric patients, especially neonates and infants, may be more susceptible to fluid shifts and electrolyte imbalances. Careful attention to hydration status and renal function is crucial. Higher risk of extravasation due to smaller, more fragile veins.

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Geriatric Use

Elderly patients are at increased risk for contrast-induced acute kidney injury (CI-AKI) due to age-related decline in renal function, comorbidities (e.g., diabetes, heart failure), and polypharmacy. Careful assessment of renal function and hydration status is essential. Use the lowest effective dose and ensure adequate hydration.

Clinical Information

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Clinical Pearls

  • Always assess renal function (eGFR) before administering iodinated contrast, especially in patients with risk factors for CI-AKI (e.g., pre-existing renal impairment, diabetes, heart failure, dehydration).
  • Ensure adequate hydration before and after contrast administration, particularly in high-risk patients, to minimize the risk of CI-AKI.
  • Strictly adhere to guidelines for Metformin discontinuation in patients receiving iodinated contrast to prevent lactic acidosis.
  • Pre-medication with corticosteroids and antihistamines may be considered for patients with a history of moderate to severe allergic reactions to contrast media, or other significant allergic history (e.g., asthma, multiple allergies).
  • Monitor patients closely for immediate and delayed hypersensitivity reactions. Have emergency equipment and medications readily available.
  • Avoid extravasation; ensure proper venous access. If extravasation occurs, stop injection immediately, elevate the limb, apply cold compresses, and monitor for signs of tissue damage.
  • Iohexol is a non-ionic, low-osmolar contrast agent, which generally has a lower incidence of adverse reactions compared to high-osmolar ionic agents.
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Alternative Therapies

  • Other iodinated contrast media (e.g., Ioversol, Iopamidol, Iodixanol)
  • Gadolinium-based contrast agents (for MRI, different mechanism of action)
  • Ultrasound (non-ionizing imaging)
  • Non-contrast CT or MRI (if diagnostic information can be obtained without contrast)
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Cost & Coverage

Average Cost: Varies widely by concentration, volume, and institutional purchasing agreements. Typically ranges from $50 to $500+ per vial/bottle. per 20 mL vial (240 mgI/mL)
Generic Available: Yes
Insurance Coverage: Generally covered by medical insurance as part of a diagnostic imaging procedure. Coverage tier depends on specific insurance plan and formulary.
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.