Omnipaque 300mg/ml Inj, 150ml

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
Iodinated contrast media, non-ionic
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Pregnancy Category
Not available
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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 dye used to help doctors see inside your body more clearly during X-ray tests like CT scans or angiograms. It makes blood vessels and organs show up better on the images. You might feel a warm sensation or a metallic taste when it's given.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure safe and effective use of this medication, follow your doctor's instructions carefully. Read all accompanying information and adhere to the prescribed regimen.

Preparation and Administration

Before receiving this medication, it is essential to be properly hydrated. Consult your doctor to determine if you need to drink additional fluids before administration. After taking this medication, consume plenty of non-caffeinated liquids, unless your doctor advises you to limit fluid intake.

Administration Methods

Injection: This medication will be administered by your doctor. You may receive other medications beforehand to minimize potential side effects.
Liquid: This form can be taken orally or administered 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 Instructions

Liquid: If you miss a dose, contact your doctor for advice on what to do next.
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.
  • Inform your doctor about all medications you are taking, especially for diabetes (like metformin) or kidney conditions.
  • Report any allergies, especially to iodine or previous contrast dyes.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on the procedure, route of administration, and patient weight/renal function. Examples: Intravascular (e.g., CT angiography): 50-150 mL (300 mgI/mL); Intrathecal (e.g., myelography): 10-15 mL (180-300 mgI/mL); Arthrography: 5-15 mL (240-300 mgI/mL).
Dose Range: 5 - 200 mg

Condition-Specific Dosing:

CT Angiography: 50-150 mL (300 mgI/mL)
Myelography: 10-15 mL (180-300 mgI/mL)
Arthrography: 5-15 mL (240-300 mgI/mL)
Urography: 50-100 mL (300 mgI/mL)
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Pediatric Dosing

Neonatal: Dosing is weight-based and procedure-specific. E.g., Intravascular: 1-3 mL/kg (max 50 mL) for 300 mgI/mL.
Infant: Dosing is weight-based and procedure-specific. E.g., Intravascular: 1-3 mL/kg (max 50 mL) for 300 mgI/mL.
Child: Dosing is weight-based and procedure-specific. E.g., Intravascular: 1-3 mL/kg (max 50 mL) for 300 mgI/mL.
Adolescent: Dosing is weight-based and procedure-specific, often approaching adult doses. E.g., Intravascular: 1-3 mL/kg (max 50 mL) for 300 mgI/mL.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment for intravascular use, but monitor for contrast-induced nephropathy (CIN).
Moderate: Use with caution. Consider lower doses, increased hydration, and extended interval between repeat studies. Monitor renal function closely.
Severe: Use with extreme caution. Avoid if possible. If essential, use lowest effective dose, ensure aggressive hydration, and consider dialysis post-procedure if patient is on dialysis. High risk of CIN.
Dialysis: Iohexol is dialyzable. For patients on dialysis, the timing of dialysis post-contrast administration is often debated; some recommend dialysis shortly after, others state it's not strictly necessary as long as the patient is already on dialysis. Consult nephrology.

Hepatic Impairment:

Mild: No specific dose adjustment needed as iohexol is primarily renally excreted.
Moderate: No specific dose adjustment needed.
Severe: No specific dose adjustment needed.

Pharmacology

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Mechanism of Action

Iohexol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. When administered, the iodine atoms within the molecule absorb X-rays, creating a contrast between the structures containing the contrast medium and the surrounding tissues. This allows for visualization of blood vessels, organs, and other body cavities during diagnostic imaging procedures.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (intravascular administration); variable for other routes (e.g., oral, rectal, intrathecal, intra-articular) depending on site and integrity of barriers.
Tmax: Not applicable for direct intravascular administration (instantaneous distribution). For intrathecal, peak CSF concentration is typically 2-6 hours.
FoodEffect: Not applicable for parenteral administration.

Distribution:

Vd: Approximately 0.16-0.22 L/kg (similar to extracellular fluid volume).
ProteinBinding: < 2% (negligible).
CnssPenetration: Limited (does not cross intact blood-brain barrier significantly after intravascular administration). For intrathecal administration, it distributes throughout the CSF.

Elimination:

HalfLife: Approximately 2 hours (intravascular).
Clearance: Primarily renal glomerular filtration (approximately 100-120 mL/min).
ExcretionRoute: Renal (unchanged in urine).
Unchanged: Approximately 97% within 24 hours.
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Pharmacodynamics

OnsetOfAction: Immediate (intravascular).
PeakEffect: Immediate (intravascular); variable for other routes depending on flow and distribution.
DurationOfAction: Minutes to hours, depending on the vascularity of the tissue and renal function. For intrathecal, visualization can last up to 30-60 minutes for myelography, with contrast remaining in CSF for several hours.

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 while taking this medication. If you notice 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, rapid 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)
+ Other serious reactions that can affect body organs and be life-threatening.
+ Symptoms may include: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the 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 Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you are concerned about any of the following side effects or if they persist, 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, consult 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:

  • Severe itching or hives
  • Swelling of your face, lips, tongue, or throat
  • Difficulty breathing or wheezing
  • Feeling dizzy or lightheaded
  • Chest pain or discomfort
  • Sudden decrease in urine output
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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.
If you have had a skin reaction to this medication or a similar drug in the past.
If you are currently taking metformin.

Additional Considerations for Specific Administration Routes:

If you will be receiving this medication via spinal injection:
+ Inform your doctor if you have an active infection.
+ Disclose any medications that may increase the risk of seizures or if you have taken such a medication within the last 48 hours. Your doctor or pharmacist can help you identify these medications.
If you will be receiving this medication via arterial or venous injection:
+ Tell your doctor if you are experiencing urinary retention.
* If this medication will be used before an x-ray of the uterus and fallopian tubes:
+ Inform your doctor if you are menstruating, have a genital infection, or have a suspected or confirmed growth in the reproductive tract.
+ Share your medical history if you have had a curettage or conization procedure within the past 30 days.
+ If you have had a pregnancy terminated within the last 6 months.
+ If you are pregnant or suspect you may be pregnant. Do not take this medication if you are pregnant.

Interactions with Other Medications and Health Conditions:

This is not an exhaustive list of potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health conditions you have. This will help ensure your safety while taking this medication. Never start, 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 workers 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 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 benefits and risks of this medication 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 questions or concerns, discuss them with your doctor.

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

Additionally, health problems like blood clots have been reported 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 or concerns, discuss them with 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)
  • Electrolyte imbalance
  • Acute renal failure
  • Cardiovascular collapse

What to Do:

Treatment is symptomatic and supportive. Iohexol is dialyzable. In case of suspected overdose, immediately contact emergency services or poison control (Call 1-800-222-1222 in the US).

Drug Interactions

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Major Interactions

  • Metformin (in patients with acute kidney injury or severe chronic kidney disease): Risk of lactic acidosis. Metformin should be withheld at the time of or prior to the procedure and for 48 hours after, and reinstituted only after renal function is stable.
  • Interleukin-2 (IL-2): Increased risk of delayed adverse reactions (e.g., fever, flu-like symptoms, skin reactions, oliguria, hypotension) when contrast media is administered within weeks of IL-2 therapy.
  • Beta-blockers: May blunt the compensatory cardiovascular responses to anaphylaxis, making treatment of severe hypersensitivity reactions more difficult.
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Moderate Interactions

  • Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin, amphotericin B): Increased risk of contrast-induced nephropathy (CIN) when co-administered, especially in patients with pre-existing renal impairment.
  • Diuretics: May increase risk of CIN due to dehydration.

Monitoring

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Baseline Monitoring

Renal function (serum creatinine, eGFR)

Rationale: To assess baseline kidney function and risk of contrast-induced nephropathy (CIN).

Timing: Prior to administration, especially in patients with risk factors for CIN.

Allergy history (especially to iodine or previous contrast media)

Rationale: To identify patients at increased risk of hypersensitivity reactions.

Timing: Prior to administration.

Thyroid function (TSH, T3, T4)

Rationale: Iodinated contrast can induce hyperthyroidism or hypothyroidism, especially in susceptible individuals.

Timing: Consider in patients with pre-existing thyroid disease or risk factors.

Hydration status

Rationale: Adequate hydration is crucial to prevent CIN.

Timing: Prior to administration.

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Routine Monitoring

Vital signs (BP, HR, RR, O2 Sat)

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

Target: Within patient's normal limits.

Action Threshold: Significant deviations (e.g., hypotension, tachycardia, dyspnea) require immediate intervention.

Signs/symptoms of hypersensitivity reaction

Frequency: Continuously during and for at least 30-60 minutes post-administration.

Target: Absence of symptoms.

Action Threshold: Rash, urticaria, pruritus, angioedema, bronchospasm, hypotension, laryngeal edema.

Renal function (serum creatinine)

Frequency: 48-72 hours post-administration in high-risk patients (e.g., pre-existing renal impairment, diabetes, heart failure, elderly).

Target: Stable or returning to baseline.

Action Threshold: Increase in serum creatinine by â‰Ĩ 0.3 mg/dL or â‰Ĩ 50% from baseline within 48-72 hours.

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Symptom Monitoring

  • Hives
  • Itching
  • Rash
  • Swelling of face, lips, tongue, or throat
  • Difficulty breathing or wheezing
  • Lightheadedness or dizziness
  • Nausea
  • Vomiting
  • Headache
  • Warm sensation or flushing
  • Pain or discomfort at injection site
  • Signs of extravasation (swelling, pain, redness at injection site)
  • Changes in urine output (decreased)

Special Patient Groups

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Pregnancy

Iohexol is generally considered safe for use in pregnancy when medically necessary, as systemic absorption by the fetus is minimal. However, caution is advised, and the decision should be based on a careful risk-benefit assessment. The American College of Radiology (ACR) recommends using contrast only when the diagnostic information cannot be obtained by other means.

Trimester-Specific Risks:

First Trimester: Low risk, but generally avoided if non-contrast alternatives exist due to organogenesis.
Second Trimester: Low risk, generally considered safer than first trimester.
Third Trimester: Low risk, but potential for transient neonatal hypothyroidism due to iodine load, especially with repeated doses. Monitor neonatal thyroid function if exposed.
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Lactation

Iohexol is minimally excreted into breast milk (less than 0.5% of the administered dose). The amount absorbed by the infant is negligible. Most guidelines suggest that breastfeeding can continue without interruption after administration of iohexol. If concerns exist, a temporary interruption (e.g., 12-24 hours) and discarding milk can be considered, but is generally not necessary.

Infant Risk: Very low risk (L2 - Safer).
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Pediatric Use

Dosing is weight-based and procedure-specific. Children, especially neonates and infants, are more susceptible to fluid shifts and temperature changes. Careful attention to hydration, dose calculation, and monitoring is essential. Risk of contrast-induced nephropathy is generally lower than in adults but still a concern in vulnerable populations.

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Geriatric Use

Elderly patients are at increased risk for contrast-induced nephropathy due to age-related decline in renal function, comorbidities (e.g., diabetes, heart failure), and polypharmacy. Careful assessment of renal function, hydration, and use of the lowest effective dose are crucial. Monitor for adverse reactions more closely.

Clinical Information

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Clinical Pearls

  • Always assess renal function (eGFR) before administering iohexol, especially for intravascular routes.
  • Ensure adequate hydration before and after contrast administration to minimize the risk of contrast-induced nephropathy (CIN).
  • Carefully review medication list for metformin; hold metformin in at-risk patients.
  • Be prepared for hypersensitivity reactions, ranging from mild to severe anaphylaxis. Have resuscitation equipment and medications readily available.
  • For intrathecal use, ensure the correct concentration is used and avoid exceeding recommended volumes to prevent neurological complications.
  • Patients with a history of asthma, allergies, or previous contrast reactions are at higher risk for hypersensitivity reactions.
  • Iohexol is a non-ionic contrast agent, which generally has a lower incidence of adverse reactions compared to older ionic agents.
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Alternative Therapies

  • Iopamidol (Isovue)
  • Iodixanol (Visipaque)
  • Ioversol (Optiray)
  • Gadolinium-based contrast agents (for MRI, different mechanism)
  • Non-contrast imaging modalities (e.g., ultrasound, non-contrast CT, non-contrast MRI)
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Cost & Coverage

Average Cost: Varies widely by concentration, volume, and supplier. E.g., Omnipaque 300mg/mL, 150mL can range from $150 - $300+ per vial. per 150mL vial
Generic Available: Yes
Insurance Coverage: Generally covered by medical insurance as part of a diagnostic 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 promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, 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 information about the medication taken, the amount, and the time of ingestion.