Omnipaque 300mg/ml Inj, 100ml

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.
đŸˇī¸
Drug Class
Diagnostic Agent
đŸ§Ŧ
Pharmacologic Class
Iodinated Contrast Media
🤰
Pregnancy Category
Category B
✅
FDA Approved
Jun 1985
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Iohexol is a special dye, called a contrast agent, that helps doctors see inside your body more clearly during X-ray tests like CT scans or angiograms. It makes blood vessels, organs, or other body parts show up better on the images. It's usually given as an injection into a vein.
📋

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 instructions closely.

Preparation and Administration

Before receiving this medication, it is essential to be properly hydrated. Consult your doctor to determine if you need to drink extra 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.
💡

Lifestyle & Tips

  • Drink plenty of fluids before and after the procedure, especially if you have kidney problems, to help flush the dye out of your body.
  • Inform your doctor about all your medications, allergies (especially to iodine or previous contrast dyes), and medical conditions (especially kidney disease, diabetes, thyroid problems, or asthma) before the procedure.
  • Follow any specific instructions given by your healthcare provider regarding fasting or medication adjustments before the procedure.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Highly variable based on procedure and patient weight. Examples: CT scan (IV): 50-150 mL (300 mgI/mL); Angiography: 20-100 mL (300 mgI/mL) per injection site; Urography: 50-100 mL (300 mgI/mL).
Dose Range: 20 - 200 mg

Condition-Specific Dosing:

CT Scan (IV): 50-150 mL (300 mgI/mL)
Cerebral Angiography: 5-10 mL (300 mgI/mL) per injection
Peripheral Angiography: 20-100 mL (300 mgI/mL) per injection
Intravenous Urography: 50-100 mL (300 mgI/mL)
Myelography (lumbar): 10-15 mL (180-300 mgI/mL)
đŸ‘ļ

Pediatric Dosing

Neonatal: Dosing is weight-based and procedure-specific. E.g., IV Urography: 1-3 mL/kg (max 50 mL) of 300 mgI/mL.
Infant: Dosing is weight-based and procedure-specific. E.g., IV Urography: 1-3 mL/kg (max 50 mL) of 300 mgI/mL.
Child: Dosing is weight-based and procedure-specific. E.g., IV Urography: 1-3 mL/kg (max 50 mL) of 300 mgI/mL.
Adolescent: Dosing is weight-based and procedure-specific, often approaching adult doses for larger adolescents. E.g., IV Urography: 1-3 mL/kg (max 50 mL) of 300 mgI/mL.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required, but hydration is crucial.
Moderate: Use with caution. Adequate hydration before and after administration is critical. Consider lower doses or alternative imaging if possible. Monitor renal function closely.
Severe: Use with extreme caution. High risk of contrast-induced nephropathy (CIN). Consider alternative imaging. If necessary, ensure aggressive hydration and consider dialysis if patient is on chronic dialysis. Consult nephrology.
Dialysis: Can be used in patients on dialysis. Iohexol is dialyzable. Timing of dialysis post-contrast administration may be considered, but not strictly required for removal as it's primarily renally excreted. Hydration remains important.

Hepatic Impairment:

Mild: No dose adjustment required.
Moderate: No dose adjustment required as it is minimally metabolized by the liver.
Severe: No dose adjustment required as it is minimally metabolized by the liver.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Iohexol is a non-ionic, water-soluble, iodinated radiographic contrast medium. It enhances visualization of structures or fluids in the body by absorbing X-rays. When injected intravascularly, it distributes into the extracellular fluid space and provides contrast due to the iodine atoms, which attenuate X-rays. It does not bind to plasma proteins or undergo significant metabolism.
📊

Pharmacokinetics

Absorption:

Bioavailability: 100% (intravenous administration)
Tmax: Immediately after IV injection (peak plasma concentration)
FoodEffect: Not applicable for injectable forms.

Distribution:

Vd: Approximately 0.16-0.22 L/kg (similar to extracellular fluid volume)
ProteinBinding: < 2%
CnssPenetration: Limited (does not cross intact blood-brain barrier; used for myelography when administered intrathecally)

Elimination:

HalfLife: Approximately 1.5-2 hours (in patients with normal renal function)
Clearance: Primarily renal glomerular filtration (approximately 100-120 mL/min in healthy adults)
ExcretionRoute: Renal (unchanged in urine)
Unchanged: Approximately 97% within 24 hours
âąī¸

Pharmacodynamics

OnsetOfAction: Immediate (upon injection)
PeakEffect: Within minutes (depending on circulation time and site of injection)
DurationOfAction: Typically 5-15 minutes for vascular enhancement, longer for urinary tract visualization (up to 60 minutes or more).

Safety & Warnings

âš ī¸

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 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, 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. Seek medical help immediately if you experience any of these symptoms.
Injection into the Spine: A burning, numbness, or tingling sensation that is not normal.
Liquid Formulation: Swelling.

Other Possible 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:
+ Dizziness (if given in an artery or vein)
+ Feeling of warmth
+ Changes in taste
+ Dizziness (if given into the spine)
+ Back pain
+ Neck pain
+ Stiff neck
Liquid Formulation:
+ 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Difficulty breathing, wheezing, or tightness in the chest
  • Hives, rash, or severe itching
  • Swelling of the face, lips, tongue, or throat
  • Dizziness, lightheadedness, or fainting
  • Severe pain, swelling, or redness at the injection site
  • Unusual weakness or numbness
  • Changes in vision
  • Nausea or vomiting that is severe or persistent
📋

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 treatment:

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

Additional Considerations for Specific Administration Routes:

Spinal injection: Inform your doctor if you have an active infection or are taking medications that may increase the risk of seizures, or if you have taken such a medication within the last 48 hours. There are many drugs that can increase seizure risk, so consult your doctor or pharmacist if you are unsure.
Injection into an artery or vein: Tell your doctor if you are unable to urinate.
Use 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 growth in the reproductive tract. Also, notify your doctor 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.

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 problems you may have.
Before starting, stopping, or changing the dose of any medication, consult your doctor to ensure it is safe to do so in combination with this medication.
âš ī¸

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 regularly. Additionally, this medication may affect the results of certain laboratory tests, so 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, this medication should be used with caution, as the risk of side effects may be higher in some children.

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

Injection Administration

If this medication is administered via injection into an artery or vein, be aware of the following risks:

In children under 3 years of age, this medication has been associated with low thyroid function, which can impact child development. Your child's thyroid function may need to be monitored for an extended period after the injection.
Rarely, life-threatening or fatal heart problems, including low blood pressure and heart attack, have occurred with this medication. Discuss these risks with your doctor.
* When used in conjunction with certain procedures, this medication has been linked to health problems, such as blood clots, which can increase the risk of heart attack and stroke. If you have questions or concerns, consult your doctor.

If this medication is administered via injection into the spine, be aware that it may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
🆘

Overdose Information

Overdose Symptoms:

  • Fluid overload (pulmonary edema)
  • Electrolyte disturbances
  • Acute renal failure
  • Cardiovascular collapse
  • Seizures

What to Do:

Treatment is symptomatic and supportive. Monitor vital signs, fluid and electrolyte balance. Hemodialysis can be used to remove Iohexol from the body in cases of severe overdose or renal failure. Call 1-800-222-1222 (Poison Control).

Drug Interactions

🔴

Major Interactions

  • Metformin (in patients with renal impairment or acute kidney injury risk)
  • Interleukin-2 (increased risk of delayed reactions)
🟡

Moderate Interactions

  • Beta-blockers (increased risk of anaphylactoid reactions, blunted response to epinephrine)
  • Diuretics (increased risk of dehydration and CIN)
  • Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin) - increased risk of CIN

Monitoring

đŸ”Ŧ

Baseline Monitoring

Renal function (Serum Creatinine, eGFR)

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

Timing: Prior to contrast administration (within 48 hours for high-risk patients, or up to 30 days for low-risk patients).

Allergy history (especially to iodine or previous contrast media)

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

Timing: Prior to contrast administration.

Thyroid function (TSH, T4)

Rationale: Iodine can affect thyroid function, especially in patients with pre-existing thyroid disease.

Timing: Consider in patients with known or suspected thyroid dysfunction.

Hydration status

Rationale: Dehydration increases the risk of CIN.

Timing: Prior to contrast administration.

📊

Routine Monitoring

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

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

Target: Within patient's normal range

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

Signs of allergic/anaphylactoid reaction

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

Target: Absence of symptoms

Action Threshold: Rash, urticaria, dyspnea, angioedema, hypotension, bronchospasm.

Injection site for extravasation

Frequency: During and immediately after injection.

Target: Absence of swelling, pain, redness

Action Threshold: Pain, swelling, redness, or blistering at injection site.

Renal function (Serum Creatinine, eGFR)

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

Target: Stable or improving

Action Threshold: Increase in serum creatinine by â‰Ĩ0.3 mg/dL or â‰Ĩ50% from baseline within 48-72 hours.

đŸ‘ī¸

Symptom Monitoring

  • Hives
  • Itching
  • Rash
  • Swelling of face/lips/tongue/throat
  • Difficulty breathing or wheezing
  • Dizziness or lightheadedness
  • Nausea
  • Vomiting
  • Headache
  • Flushing
  • Metallic taste
  • Injection site pain or swelling
  • Chest pain
  • Seizures
  • Changes in vision

Special Patient Groups

🤰

Pregnancy

Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Animal studies have shown no evidence of harm, but human data are limited. Category B.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies show no teratogenicity.
Second Trimester: Limited human data; animal studies show no teratogenicity.
Third Trimester: Limited human data; animal studies show no teratogenicity. Potential for transient hypothyroidism in the neonate due to free iodide, though risk is considered low with non-ionic agents.
🤱

Lactation

Considered safe for use during breastfeeding. Iohexol is minimally excreted into breast milk and poorly absorbed by the infant's gastrointestinal tract. Infant exposure is very low. No need to interrupt breastfeeding.

Infant Risk: L1 (Lowest Risk) - Minimal to no risk to the breastfed infant.
đŸ‘ļ

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 and dose calculation is essential. Risk of contrast-induced nephropathy is generally lower than in adults but still a concern in vulnerable populations.

👴

Geriatric Use

Increased risk of contrast-induced nephropathy 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 crucial. Use the lowest effective dose.

Clinical Information

💎

Clinical Pearls

  • Always ensure adequate hydration before and after contrast administration, especially in patients at risk for CIN.
  • Carefully review patient history for allergies, renal impairment, diabetes, and thyroid disease prior to administration.
  • Have emergency equipment and medications (e.g., epinephrine, antihistamines, corticosteroids) readily available for immediate treatment of hypersensitivity reactions.
  • Non-ionic contrast agents like Iohexol have a lower incidence of adverse reactions compared to older ionic agents.
  • Extravasation can occur; monitor injection site closely. If extravasation occurs, elevate the limb, apply cold compresses, and monitor for skin integrity changes.
🔄

Alternative Therapies

  • Iopamidol (Isovue)
  • Iodixanol (Visipaque)
  • Ioversol (Optiray)
  • Gadolinium-based contrast agents (for MRI, different mechanism)
  • Barium sulfate (for GI tract imaging, different mechanism)
💰

Cost & Coverage

Average Cost: Varies significantly by concentration, volume, and supplier. Typically ranges from $50 - $200+ per 100mL vial. per 100mL vial
Generic Available: Yes
Insurance Coverage: Generally covered by medical insurance as part of diagnostic imaging procedures.
📚

General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which can be an alternative disposal option.

Some medications may come with an additional patient information leaflet. If you have questions or concerns about your medication, it is crucial 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 information about the medication taken, the quantity, and the time it was taken, as this will aid in prompt and effective treatment.