Visipaque 320mg/ml Inj, 100ml
WARNING: This drug is given as a shot into a vein or artery only.This drug must not be given into the spine.Very bad health problems, paralysis, and death have happened when contrast has been given into blood vessels in the spinal cord. Talk with the doctor. @ COMMON USES: It is used before a CT scan or other test.
Drug Class
Diagnostic Agent
Pharmacologic Class
Iodinated Contrast Media
Pregnancy Category
Category B
FDA Approved
Jan 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iodixanol is a special dye injected into your body, usually into a vein, to help doctors see your internal organs, blood vessels, or other body parts more clearly on X-ray, CT scans, or other imaging tests. It helps highlight certain areas so abnormalities can be detected.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all accompanying information and follow the instructions provided.
This medication is administered via injection into a vein or artery only. Before receiving the injection, it is essential to be properly hydrated. Consult your doctor to determine if you need to consume additional fluids before the procedure.
After receiving the injection, drink plenty of non-caffeinated liquids unless your doctor advises you to limit your fluid intake. In some cases, other medications may be administered before this medication to minimize potential side effects.
Storage and Disposal
This injection will be administered in a healthcare setting, and you will not need to store it at home.
Missed Dose
As this medication is given in a healthcare setting, missed dose situations do not apply. Your healthcare provider will manage the administration schedule.
To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all accompanying information and follow the instructions provided.
This medication is administered via injection into a vein or artery only. Before receiving the injection, it is essential to be properly hydrated. Consult your doctor to determine if you need to consume additional fluids before the procedure.
After receiving the injection, drink plenty of non-caffeinated liquids unless your doctor advises you to limit your fluid intake. In some cases, other medications may be administered before this medication to minimize potential side effects.
Storage and Disposal
This injection will be administered in a healthcare setting, and you will not need to store it at home.
Missed Dose
As this medication is given in a healthcare setting, missed dose situations do not apply. Your healthcare provider will manage the administration schedule.
Lifestyle & Tips
- Ensure adequate hydration before and after the procedure, especially if you have kidney problems or diabetes.
- Inform your healthcare provider about all medications you are taking, especially metformin, and any allergies.
- Follow all pre- and post-procedure instructions given by your healthcare team.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable, depends on procedure and patient weight. Typically 50-150 mL for angiography, 100-150 mL for CT.
Dose Range:
20 - 250 mg
Condition-Specific Dosing:
Coronary Angiography:
Typically 50-150 mL, maximum 250 mL
CT Angiography:
Typically 75-150 mL
Peripheral Angiography:
Typically 20-150 mL
Pediatric Dosing
Neonatal:
0.5-4 mL/kg, maximum 4 mL/kg or 150 mL total, depending on procedure and patient condition.
Infant:
0.5-4 mL/kg, maximum 4 mL/kg or 150 mL total, depending on procedure and patient condition.
Child:
0.5-4 mL/kg, maximum 4 mL/kg or 150 mL total, depending on procedure and patient condition.
Adolescent:
0.5-4 mL/kg, maximum 4 mL/kg or 150 mL total, depending on procedure and patient condition.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment, but hydration and careful monitoring are crucial.
Moderate:
No specific dose adjustment, but hydration and careful monitoring are crucial. Consider lower doses and extended intervals between studies.
Severe:
Use with extreme caution. Consider alternative imaging modalities. If necessary, use lowest possible dose and ensure adequate hydration. Risk of contrast-induced nephropathy (CIN) is significantly increased.
Dialysis:
Can be used in patients on dialysis; however, timing of dialysis post-contrast administration is debated. Some recommend dialysis shortly after contrast administration to remove contrast, but evidence for benefit in preventing CIN is limited. Risk of CIN is high in non-dialysis dependent severe renal impairment.
Hepatic Impairment:
Mild:
No specific dose adjustment.
Moderate:
No specific dose adjustment.
Severe:
No specific dose adjustment, as iodixanol is primarily renally excreted. However, overall patient condition and comorbidities should be considered.
Pharmacology
Mechanism of Action
Iodixanol is a non-ionic, iso-osmolar, dimeric iodinated contrast medium. It enhances visualization of structures or fluids within the body by absorbing X-rays. The iodine atoms in the molecule absorb X-rays, creating a temporary difference in density between the area containing the contrast medium and surrounding tissues, which is then detectable by imaging equipment.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intravascular administration)
Tmax:
Immediately after injection (intravascular)
FoodEffect:
Not applicable (intravascular administration)
Distribution:
Vd:
Approximately 0.26 L/kg (similar to extracellular fluid volume)
ProteinBinding:
< 2%
CnssPenetration:
Limited (does not cross intact blood-brain barrier)
Elimination:
HalfLife:
Approximately 2 hours
Clearance:
Approximately 110 mL/min (renal clearance)
ExcretionRoute:
Primarily renal (glomerular filtration)
Unchanged:
> 97% (within 24 hours)
Pharmacodynamics
OnsetOfAction:
Immediate (upon injection)
PeakEffect:
Varies by injection site and imaging target (e.g., arterial phase, venous phase)
DurationOfAction:
Transient, typically minutes to hours, depending on blood flow and renal function. Sufficient for diagnostic imaging procedure.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of thyroid problems, such as:
+ Weight changes
+ Feeling nervous, excitable, restless, or weak
+ Hair thinning
+ Depression
+ Eye or neck swelling
+ Difficulty focusing
+ Sensitivity to heat or cold
+ Menstrual changes
+ Shakiness
+ Sweating
Chest pain or pressure
Fast or abnormal heartbeat
Severe dizziness or fainting
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Tissue damage at the injection site, characterized by redness, burning, pain, swelling, blisters, skin sores, or fluid leakage
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can occur within 1 hour to several weeks after administration. These reactions may cause:
+ 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
+ Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you are concerned about any of the following side effects or if they persist, contact your doctor:
Feeling of warmth
Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of thyroid problems, such as:
+ Weight changes
+ Feeling nervous, excitable, restless, or weak
+ Hair thinning
+ Depression
+ Eye or neck swelling
+ Difficulty focusing
+ Sensitivity to heat or cold
+ Menstrual changes
+ Shakiness
+ Sweating
Chest pain or pressure
Fast or abnormal heartbeat
Severe dizziness or fainting
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Tissue damage at the injection site, characterized by redness, burning, pain, swelling, blisters, skin sores, or fluid leakage
Severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can occur within 1 hour to several weeks after administration. These reactions may cause:
+ 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
+ Swollen glands
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you are concerned about any of the following side effects or if they persist, contact your doctor:
Feeling of warmth
Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
Seek Immediate Medical Attention If You Experience:
- Sudden rash or hives
- Difficulty breathing or wheezing
- Swelling of the face, lips, or throat
- Severe dizziness or fainting
- Unusual weakness or fatigue
- Significant decrease in urine output after the procedure
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are dehydrated, have a poor diet, or have recently used laxatives or diuretics (water pills) before starting this medication.
If you have experienced a skin reaction to this medication or similar medications in the past.
If you are currently taking metformin or any other medications that may interact with this drug.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are dehydrated, have a poor diet, or have recently used laxatives or diuretics (water pills) before starting this medication.
If you have experienced a skin reaction to this medication or similar medications in the past.
If you are currently taking metformin or any other medications that may interact with this drug.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Your doctor may need to monitor your blood work regularly, so be sure to discuss this with them.
Although rare, this medication can cause life-threatening or fatal heart problems, including low blood pressure and heart attack. It is crucial to talk to your doctor about these potential risks. Additionally, when used in conjunction with certain procedures, this medication can increase the risk of blood clots, which may lead to heart attack and stroke, potentially resulting in death. If you have any questions or concerns, consult your doctor.
This medication may interfere with certain laboratory tests, so it is vital to notify all your child's healthcare providers and lab workers that they are taking this medication.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the benefits and risks of this medication with their doctor, as it may affect the baby.
Special Considerations for Children
When administering this medication to children, use caution, as the risk of side effects may be higher in some pediatric patients. In children under 3 years of age, the use of similar medications has been associated with low thyroid function, which can impact child development. Your child's doctor may recommend regular thyroid function checks for a period after the injection. If you have any questions or concerns, consult your child's doctor.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Your doctor may need to monitor your blood work regularly, so be sure to discuss this with them.
Although rare, this medication can cause life-threatening or fatal heart problems, including low blood pressure and heart attack. It is crucial to talk to your doctor about these potential risks. Additionally, when used in conjunction with certain procedures, this medication can increase the risk of blood clots, which may lead to heart attack and stroke, potentially resulting in death. If you have any questions or concerns, consult your doctor.
This medication may interfere with certain laboratory tests, so it is vital to notify all your child's healthcare providers and lab workers that they are taking this medication.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the benefits and risks of this medication with their doctor, as it may affect the baby.
Special Considerations for Children
When administering this medication to children, use caution, as the risk of side effects may be higher in some pediatric patients. In children under 3 years of age, the use of similar medications has been associated with low thyroid function, which can impact child development. Your child's doctor may recommend regular thyroid function checks for a period after the injection. If you have any questions or concerns, consult your child's doctor.
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. Monitor vital signs, fluid and electrolyte balance. Hemodialysis can be used to remove iodixanol 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 acute kidney injury or severe chronic kidney disease)
- Interleukin-2 (risk of delayed adverse 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)
- Oral cholecystographic agents (may interfere with imaging)
Monitoring
Baseline Monitoring
Renal function (e.g., eGFR, serum creatinine)
Rationale: To assess risk of contrast-induced nephropathy (CIN) and guide hydration strategies.
Timing: Prior to contrast administration, especially in patients with risk factors for renal impairment.
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: 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.
Routine Monitoring
Vital signs (BP, HR, RR, O2 Sat)
Frequency: During and immediately after injection, then as clinically indicated.
Target: Within patient's normal limits.
Action Threshold: Significant deviations (e.g., hypotension, bradycardia, respiratory distress) require immediate intervention.
Signs/symptoms of hypersensitivity reaction
Frequency: Continuously during and for a period after injection (e.g., 30-60 minutes).
Target: Absence of symptoms.
Action Threshold: Rash, urticaria, angioedema, bronchospasm, hypotension, or anaphylaxis require immediate treatment.
Renal function (serum creatinine)
Frequency: 24-72 hours post-contrast in high-risk patients (e.g., pre-existing CKD, diabetes, dehydration).
Target: Stable or returning to baseline.
Action Threshold: Increase in serum creatinine by ≥ 0.3 mg/dL or ≥ 50% from baseline within 48-72 hours indicates CIN.
Symptom Monitoring
- Rash
- Hives (urticaria)
- Itching (pruritus)
- Swelling of face, lips, tongue, or throat (angioedema)
- Difficulty breathing (dyspnea, bronchospasm)
- Wheezing
- Dizziness
- Lightheadedness
- Nausea
- Vomiting
- Flushing
- Headache
- Chest pain
- Changes in urine output (decreased)
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown fetal harm. Human data are limited, but systemic absorption is minimal. Use only if clearly needed and potential benefits outweigh risks.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data, but avoid elective procedures.
Second Trimester:
Low risk based on animal data, but avoid elective procedures.
Third Trimester:
Low risk based on animal data, but avoid elective procedures. Potential for transient hypothyroidism in the neonate, though rare with non-ionic agents.
Lactation
L2 (Safer). Minimal excretion into breast milk. Less than 0.01% of the administered dose is excreted into breast milk within 24 hours. Infant exposure is very low. Breastfeeding can generally be continued without interruption.
Infant Risk:
Very low risk. No adverse effects reported in breastfed infants. Consider discarding milk for 24 hours if extreme caution is desired, but generally not necessary.
Pediatric Use
Dosing is weight-based. Safety and efficacy are established. Special attention to hydration and renal function is important, especially in neonates and infants due to immature renal function and higher susceptibility to fluid shifts.
Geriatric Use
No specific dose adjustment based on age alone. However, elderly patients are more likely to have pre-existing renal impairment, diabetes, or cardiovascular disease, increasing the risk of CIN and other adverse reactions. Careful assessment of renal function and hydration status is crucial.
Clinical Information
Clinical Pearls
- Iodixanol is iso-osmolar to blood, which may lead to a lower incidence of pain and warmth upon injection compared to hyperosmolar contrast media.
- Adequate hydration is the most important prophylactic measure against contrast-induced nephropathy (CIN), especially in high-risk patients.
- Patients on metformin should have their renal function assessed. Metformin should be withheld in patients with eGFR <30 mL/min/1.73m² or acute kidney injury, and for 48 hours after contrast administration in patients at risk for CIN, resuming only after renal function is stable.
- Always have resuscitation equipment and trained personnel immediately available for managing potential severe hypersensitivity reactions.
- Consider pre-medication with corticosteroids and antihistamines for patients with a history of previous contrast reactions, though this does not guarantee prevention.
Alternative Therapies
- Iohexol (Omnipaque)
- Iopamidol (Isovue)
- Ioversol (Optiray)
- Ioxaglate (Hexabrix - ionic, low-osmolar)
- Gadolinium-based contrast agents (for MRI, different mechanism, used when iodinated contrast is contraindicated or for specific indications)
Cost & Coverage
Average Cost:
Varies significantly by volume and institutional contracts. Typically several hundred dollars per 100mL vial. per 100mL vial
Insurance Coverage:
Usually covered under medical benefit for diagnostic procedures.
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 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, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for advice. Additionally, you may want to inquire about potential drug take-back programs in your area. Some medications may come with a separate patient information leaflet, so be sure to check with your pharmacist. 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 information about the medication taken, the amount, and the time it occurred.