Omnipaque 300mg/ml Inj, 10ml

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
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Pregnancy Category
B
FDA Approved
Mar 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 or CT scans. It makes certain parts of your body, like blood vessels or organs, show up better on the images. It's usually given as an injection into a vein.
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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 the information provided to you and adhere to the guidelines.

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, 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 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

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 or diabetes.
  • Inform your doctor about all medications you are taking, especially metformin, and any allergies you have.
  • Follow all pre-procedure instructions regarding fasting or medication adjustments.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on procedure and patient weight. For example, for cerebral angiography: 20-60 mL (300 mgI/mL or 350 mgI/mL) per injection.

Condition-Specific Dosing:

CT Scan (Head): 50-150 mL (300 mgI/mL or 350 mgI/mL) IV
CT Scan (Body): 50-150 mL (300 mgI/mL or 350 mgI/mL) IV
Angiography (Cerebral): 20-60 mL (300 mgI/mL or 350 mgI/mL) per injection
Angiography (Peripheral): 20-100 mL (300 mgI/mL or 350 mgI/mL) per injection
Urography: 50-100 mL (300 mgI/mL) IV
Myelography (Lumbar): 10-15 mL (180-300 mgI/mL) intrathecal
Myelography (Cervical/Thoracic): 6-12 mL (240-300 mgI/mL) intrathecal
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Pediatric Dosing

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

Renal Impairment:

Mild: No specific dose adjustment generally required, but hydration is crucial.
Moderate: Use with caution. Consider lower doses, extended intervals, and aggressive hydration. Risk of contrast-induced nephropathy (CIN) increased.
Severe: Use with extreme caution. Avoid if possible. If necessary, use lowest effective dose and ensure adequate hydration. High risk of CIN.
Dialysis: Iohexol is dialyzable. If administered to patients on dialysis, consider administering just prior to dialysis session to facilitate removal. No specific dose adjustment for patients already on chronic dialysis, but volume overload should be avoided.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required, as Iohexol is primarily renally excreted.

Pharmacology

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Mechanism of Action

Iohexol is a non-ionic, water-soluble, tri-iodinated benzoic acid derivative. It increases the attenuation of X-rays in the body structures where it is distributed, allowing for visualization of internal structures during diagnostic imaging procedures. The iodine atoms in the molecule absorb X-rays, creating contrast.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (intravascular administration)
Tmax: Immediately after IV injection (distribution phase)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.26 L/kg (similar to extracellular fluid volume)
ProteinBinding: < 2% (negligible)
CnssPenetration: Limited (does not cross intact blood-brain barrier; intrathecal administration bypasses this barrier for CNS imaging)

Elimination:

HalfLife: Approximately 2 hours (in patients with normal renal function)
Clearance: Renal clearance is approximately 120 mL/min/1.73m² (similar to GFR)
ExcretionRoute: Primarily renal (glomerular filtration)
Unchanged: > 97% (excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Immediate (upon injection)
PeakEffect: Varies by site of injection and imaging modality (e.g., arterial phase immediately, venous phase minutes later)
DurationOfAction: Minutes to hours, depending on the procedure and clearance from the body compartment. For intravascular use, sufficient contrast for imaging typically lasts 5-15 minutes.

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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Thyroid problems: Weight changes, nervousness, excitability, restlessness, weakness, hair thinning, depression, eye or neck swelling, difficulty focusing, heat or cold intolerance, menstrual changes, shakiness, or sweating.
Injection-related side effects:
+ Chest pain or pressure, rapid heartbeat, or irregular heartbeat.
+ Weakness on one side of the body, difficulty speaking or thinking, balance problems, 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 Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you are concerned about any 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
Injection-related side effects (if given into the spine):
+ 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, 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:

  • Difficulty breathing or wheezing
  • Severe rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat
  • Dizziness or lightheadedness
  • Chest pain or discomfort
  • Unusual weakness or numbness
  • Seizures (rare, but possible with intrathecal use)
  • Significant changes in urination (less frequent or no urination)
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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 and situations to ensure safe treatment with this medication:

Allergies: If you are allergic to this drug, any of its components, or other medications, foods, or substances, notify your doctor. Describe the allergic reaction and its symptoms.
Dehydration and poor nutrition: If you are dehydrated, have been eating poorly, or have recently used a laxative or diuretic, inform your doctor.
Previous skin reactions: If you have experienced a skin reaction to this medication or a similar drug in the past, tell your doctor.
Metformin use: If you are taking metformin, notify your doctor.

Additional Considerations for Specific Administration Routes:

Spinal injection: If you have an active infection or are taking medications that may increase the risk of seizures, or have taken such a medication within the last 48 hours, inform your doctor. Many drugs can increase seizure risk, so ask your doctor or pharmacist if you are unsure.
Injection into an artery or vein: If you are unable to urinate, notify your doctor.
Use before an x-ray of the uterus and fallopian tubes: If you are menstruating, have a genital infection, or have a suspected growth in the reproductive tract, inform your doctor. Additionally, if you have had a curettage or conization procedure within the past 30 days, or if you have had a pregnancy terminated within the last 6 months, notify your doctor.

Pregnancy and This Medication:

Do not take this medication if you are pregnant or may be pregnant.

Interactions with Other Medications and Health Conditions:

This is not an exhaustive list of all 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. Verify that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose 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 (if 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.

Although rare, life-threatening or fatal heart problems, including low blood pressure and heart attack, have been reported with this medication. Discuss any concerns with your doctor.

Additionally, health problems like blood clots have occurred with this medication when used in conjunction with certain procedures, which can increase the risk of heart attack and stroke. If you have questions, consult your doctor.

Injection (if given into the spine)

This medication may increase the risk of seizures in some individuals, particularly 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
  • Seizures (especially with intrathecal overdose)
  • Cardiovascular collapse

What to Do:

Treatment is symptomatic and supportive. Iohexol is dialyzable. Monitor vital signs, fluid balance, and renal function. In case of severe reaction, call 911 or Poison Control (1-800-222-1222).

Drug Interactions

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Major Interactions

  • Metformin (in patients with renal impairment or acute kidney injury): Increased 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 has been re-evaluated and found to be normal.
  • Interleukin-2 (IL-2) therapy: Increased risk of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, renal dysfunction) due to contrast media.
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Moderate Interactions

  • Beta-blockers: Increased risk of severe hypersensitivity reactions and reduced efficacy of epinephrine in treating such reactions.
  • Diuretics: Increased risk of acute kidney injury, especially in dehydrated patients.
  • Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin): Concomitant use may increase the risk of contrast-induced nephropathy.
  • Oral cholecystographic agents: May interfere with visualization of the gallbladder and bile ducts.

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 nephropathy (CIN).

Timing: Prior to administration, especially in patients with pre-existing renal impairment, diabetes, or other risk factors.

Allergy history (especially to iodine or contrast media)

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

Timing: Prior to administration.

Thyroid function (TSH, T4)

Rationale: Iodinated contrast media can induce thyroid dysfunction, especially in patients with pre-existing thyroid disease or neonates.

Timing: Consider in patients with known or suspected thyroid disease, or in neonates.

Hydration status

Rationale: Dehydration increases the risk of 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 range

Action Threshold: Significant deviations (e.g., hypotension, bradycardia, respiratory distress) require immediate intervention.

Signs/Symptoms of Hypersensitivity Reaction (rash, urticaria, dyspnea, angioedema)

Frequency: During and for several hours after administration.

Target: Absence of symptoms

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

Renal function (Serum Creatinine, eGFR)

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

Target: Return to baseline or stable

Action Threshold: Increase in serum creatinine by ≥ 0.3 mg/dL or ≥ 50% from baseline indicates CIN.

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Symptom Monitoring

  • Nausea
  • Vomiting
  • Headache
  • Dizziness
  • Warm sensation
  • Flushing
  • Metallic taste
  • Itching
  • Rash
  • Hives (urticaria)
  • Difficulty breathing (dyspnea)
  • Swelling of face/throat (angioedema)
  • Chest pain
  • Seizures (especially with intrathecal use)
  • Neurological changes (with intrathecal use)

Special Patient Groups

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Pregnancy

Category B. Animal reproduction studies have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: No specific increased risk identified beyond general pregnancy considerations for diagnostic procedures.
Second Trimester: No specific increased risk identified.
Third Trimester: No specific increased risk identified. Consider potential for transient hypothyroidism in the neonate due to iodine load, especially with repeated exposure.
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Lactation

L2 (Safer). Iohexol is minimally excreted into breast milk. Limited data suggest that the amount absorbed by the infant is very small. Breastfeeding can generally be continued without interruption. If concerns exist, a temporary interruption (e.g., 24 hours) and discarding milk may be considered, but is often not necessary.

Infant Risk: Low risk. Minimal systemic absorption by the infant. Potential for transient thyroid suppression in the infant is theoretical but considered very low.
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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 electrolyte imbalances. Special care is needed to avoid dehydration and to monitor renal function. Risk of thyroid dysfunction in neonates/infants due to iodine load.

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Geriatric Use

Increased risk of contrast-induced nephropathy due to age-related decline in renal function. More susceptible to adverse reactions, including cardiovascular events. Careful assessment of renal function and hydration status is crucial. Use lowest effective dose.

Clinical Information

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Clinical Pearls

  • Always assess renal function (eGFR) before administering iodinated contrast, especially in patients with risk factors for CIN (diabetes, pre-existing renal disease, heart failure, advanced age).
  • Ensure adequate hydration before and after contrast administration to minimize the risk of CIN.
  • Patients on metformin should have it withheld before and for 48 hours after contrast administration, with renal function re-evaluated before restarting.
  • Be prepared for hypersensitivity reactions, ranging from mild to severe, including anaphylaxis. Have resuscitation equipment and medications readily available.
  • For intrathecal administration, ensure the correct concentration and volume are used, and avoid rapid injection, as this can increase the risk of neurological adverse events (e.g., seizures).
  • Iohexol is a non-ionic contrast agent, generally associated with a lower incidence of adverse reactions compared to older ionic agents.
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Alternative Therapies

  • Iopamidol (Isovue)
  • Ioversol (Optiray)
  • Iodixanol (Visipaque - iso-osmolar)
  • Ioxaglate (Hexabrix - ionic, low osmolar)
  • Gadolinium-based contrast agents (for MRI, not X-ray/CT)
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Cost & Coverage

Average Cost: Varies widely by concentration, volume, and supplier. per 10 mL vial
Generic Available: Yes
Insurance Coverage: Typically covered under medical benefit for diagnostic procedures. Coverage tier varies by insurance plan.
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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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.