Visipaque 270mg/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, Non-ionic, Dimeric, Iso-osmolar
Pregnancy Category
Category B
FDA Approved
May 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Iodixanol is a special dye used during X-ray tests like CT scans or angiograms. It helps doctors see your blood vessels and organs more clearly on the images, which helps them diagnose medical conditions. It's given as an injection into a vein.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines.
This medication is administered via injection into a vein or artery only. Before receiving the injection, it is essential to ensure you are not dehydrated. Consult your doctor to determine if you need to consume extra 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 given before this drug to help minimize side effects.
Storage and Disposal
This injection will be administered in a healthcare setting, and you will not need to store it at home.
Missing a Dose
Since this medication is given in a healthcare setting, you will not need to worry about missing a dose. The healthcare professionals will manage the administration of the medication.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines.
This medication is administered via injection into a vein or artery only. Before receiving the injection, it is essential to ensure you are not dehydrated. Consult your doctor to determine if you need to consume extra 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 given before this drug to help minimize side effects.
Storage and Disposal
This injection will be administered in a healthcare setting, and you will not need to store it at home.
Missing a Dose
Since this medication is given in a healthcare setting, you will not need to worry about missing a dose. The healthcare professionals will manage the administration of the medication.
Lifestyle & Tips
- Stay well-hydrated before and after the procedure, especially if you have kidney problems. Your doctor or nurse will give you specific instructions.
- Inform your healthcare provider about all your medications, especially metformin, and any allergies you have, particularly to iodine or previous contrast dyes.
- Follow any specific dietary restrictions (e.g., NPO for a certain period) given by your doctor before the procedure.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on procedure and patient weight. Common doses range from 50 mL to 200 mL for most diagnostic procedures. For example, CT head: 50-150 mL; CT abdomen/pelvis: 100-150 mL; Angiography: 50-250 mL depending on the study.
Dose Range:
50 - 250 mg
Condition-Specific Dosing:
CT Angiography:
100-150 mL (270 or 320 mgI/mL)
Peripheral Angiography:
50-250 mL (270 or 320 mgI/mL)
Urography:
50-100 mL (270 or 320 mgI/mL)
CT Head/Body:
50-150 mL (270 or 320 mgI/mL)
Pediatric Dosing
Neonatal:
0.5-4 mL/kg (270 or 320 mgI/mL) depending on procedure, not to exceed 4 mL/kg or 150 mL total volume.
Infant:
0.5-4 mL/kg (270 or 320 mgI/mL) depending on procedure, not to exceed 4 mL/kg or 150 mL total volume.
Child:
0.5-4 mL/kg (270 or 320 mgI/mL) depending on procedure, not to exceed 4 mL/kg or 150 mL total volume.
Adolescent:
0.5-4 mL/kg (270 or 320 mgI/mL) depending on procedure, not to exceed 4 mL/kg or 150 mL total volume. May use adult dosing if weight appropriate.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but careful hydration is recommended.
Moderate:
Use with caution. Adequate hydration is crucial. Consider alternative imaging or lower dose if clinically appropriate. Monitor renal function closely.
Severe:
Use with extreme caution. Increased risk of contrast-induced nephropathy (CIN). Consider alternative imaging. If necessary, ensure aggressive hydration and monitor renal function for 48-72 hours post-procedure. Dialysis may be considered if patient is already on dialysis.
Dialysis:
Iodixanol is dialyzable. For patients on hemodialysis, administer contrast immediately prior to dialysis session to facilitate removal. For peritoneal dialysis, no specific recommendation, but monitor for fluid overload.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary, as iodixanol is primarily renally eliminated.
Pharmacology
Mechanism of Action
Iodixanol is a non-ionic, dimeric, iso-osmolar iodinated contrast medium. It enhances the visibility of structures or fluids within the body during X-ray based imaging (e.g., CT, angiography) by attenuating X-rays. The iodine atoms within the molecule absorb X-rays, creating a temporary difference in density that is detectable by the imaging equipment, thus providing contrast between tissues and blood vessels.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.26 L/kg (distributes into extracellular fluid)
ProteinBinding:
<10%
CnssPenetration:
Limited (does not cross intact blood-brain barrier)
Elimination:
HalfLife:
Approximately 2 hours
Clearance:
Approximately 110 mL/min
ExcretionRoute:
Primarily renal (glomerular filtration)
Unchanged:
>97%
Pharmacodynamics
OnsetOfAction:
Immediate (upon injection)
PeakEffect:
Immediate (upon injection, depending on circulation time to target organ)
DurationOfAction:
Minutes to hours, depending on the vascularity of the tissue and renal elimination. Typically, sufficient for the duration of the imaging procedure.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 medical attention right away:
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
+ Excessive 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
In rare cases, this medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can 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
Swollen glands
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling of warmth
* Irritation at the injection site
Reporting 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.
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 medical attention right away:
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
+ Excessive 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
In rare cases, this medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can 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
Swollen glands
Other Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Feeling of warmth
* Irritation at the injection site
Reporting 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 shortness of breath
- Hives, rash, or severe itching
- Swelling of your face, lips, tongue, or throat
- Dizziness or feeling faint
- Chest pain or discomfort
- Severe pain, swelling, or redness at the injection site
- Unusual weakness or numbness
- Any new or worsening symptoms after the procedure, especially changes in urination or swelling.
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
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, 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 also affect the results of certain laboratory tests. Therefore, it is vital to inform all your child's healthcare providers and laboratory personnel 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, plan to become pregnant, or are breastfeeding should discuss the benefits and risks of this medication with their doctor, as it may affect both the mother and 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 medications like this one has been associated with low thyroid function, which can impact child development. Your child's doctor may recommend regular thyroid function checks after injection to monitor for potential effects. If you have any questions or concerns, consult your child's doctor.
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, 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 also affect the results of certain laboratory tests. Therefore, it is vital to inform all your child's healthcare providers and laboratory personnel 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, plan to become pregnant, or are breastfeeding should discuss the benefits and risks of this medication with their doctor, as it may affect both the mother and 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 medications like this one has been associated with low thyroid function, which can impact child development. Your child's doctor may recommend regular thyroid function checks after injection to monitor for potential effects. 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
- Cardiovascular collapse
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. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
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 has been re-evaluated and found to be normal.
- Interleukin-2 (IL-2): Increased risk of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, arthralgia, myalgia, pruritus, hypotension, oliguria, renal dysfunction).
Moderate Interactions
- Beta-adrenergic blocking agents: May blunt the compensatory cardiovascular responses to contrast media-induced hypotension and may increase the risk and severity of anaphylactoid reactions.
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin): Concomitant use may increase the risk of contrast-induced nephropathy (CIN), especially in patients with pre-existing renal impairment.
- Diuretics: May increase the risk of CIN due to dehydration.
Monitoring
Baseline Monitoring
Renal Function (Serum Creatinine, eGFR)
Rationale: To assess baseline kidney function and risk of contrast-induced nephropathy (CIN).
Timing: Within 7 days prior to contrast administration, especially for patients at risk.
Allergy History
Rationale: To identify prior reactions to contrast media or other allergens, guiding pre-medication decisions.
Timing: Prior to contrast administration.
Hydration Status
Rationale: Adequate hydration is crucial for preventing CIN.
Timing: Prior to contrast administration.
Thyroid Function (TSH, T4)
Rationale: Iodinated contrast can affect thyroid function, especially in patients with pre-existing thyroid disease.
Timing: Consider in patients with known or suspected thyroid dysfunction.
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, tachycardia, desaturation) require immediate intervention.
Signs of Hypersensitivity Reaction
Frequency: Continuously during and for at least 30 minutes post-injection.
Target: Absence of symptoms.
Action Threshold: Rash, urticaria, dyspnea, bronchospasm, angioedema, hypotension, or anaphylaxis require immediate medical attention.
Injection Site Assessment
Frequency: During and immediately after injection.
Target: Absence of pain, swelling, redness.
Action Threshold: Signs of extravasation (pain, swelling, erythema) require immediate management.
Symptom Monitoring
- Hives or rash
- Itching
- Swelling of face, lips, tongue, or throat
- Difficulty breathing or wheezing
- Dizziness or lightheadedness
- Nausea or vomiting
- Headache
- Pain or discomfort at injection site
- Signs of delayed reaction (e.g., fever, rash, flu-like symptoms, arthralgia, myalgia, pruritus, hypotension, oliguria, renal dysfunction) in the days following administration.
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified in animal studies, but general caution for drug exposure during organogenesis.
Second Trimester:
No specific increased risk identified.
Third Trimester:
No specific increased risk identified. However, transient hypothyroidism has been reported in neonates exposed to iodinated contrast media in utero; monitoring of thyroid function in the neonate may be considered.
Lactation
L3 (Moderately safe). Iodixanol is minimally excreted into breast milk. Limited data suggest low infant exposure. Caution is advised. The American College of Radiology (ACR) recommends that breastfeeding can continue without interruption after administration of iodinated contrast media.
Infant Risk:
Low risk. Minimal amount excreted into breast milk, poorly absorbed orally by the infant. Potential for transient diarrhea or rash in the infant, but rare.
Pediatric Use
Dosing is weight-based. Pediatric patients, especially neonates and infants, may be more susceptible to fluid shifts and electrolyte imbalances. Careful monitoring of hydration status and renal function is essential. Risk of thyroid dysfunction in neonates and infants should be considered.
Geriatric Use
Elderly patients (âĨ65 years) are at increased risk for adverse reactions, particularly contrast-induced nephropathy (CIN), due to age-related decline in renal function, comorbidities (e.g., diabetes, hypertension), and concomitant nephrotoxic medications. Careful assessment of renal function and hydration status is crucial. Use the lowest effective dose.
Clinical Information
Clinical Pearls
- Iodixanol (Visipaque) is an iso-osmolar contrast medium, meaning its osmolality is similar to that of blood. This property may lead to less discomfort and a lower incidence of adverse events (e.g., pain, warmth, nausea) compared to hyperosmolar or low-osmolar contrast agents, particularly in sensitive patients or for intra-arterial injections.
- Adequate hydration before and after the procedure is the most effective strategy to prevent contrast-induced nephropathy (CIN), especially in high-risk patients.
- Patients with a history of severe allergic reactions to contrast media may require pre-medication with corticosteroids and antihistamines, although this does not guarantee prevention of a reaction.
- Always confirm patient allergies, current medications (especially metformin), and renal function prior to administration.
- Monitor for delayed hypersensitivity reactions, which can occur hours to days after administration.
Alternative Therapies
- Iohexol (Omnipaque)
- Iopamidol (Isovue)
- Iopromide (Ultravist)
- Ioversol (Optiray)
- Gadolinium-based contrast agents (for MRI, different mechanism)
Cost & Coverage
Average Cost:
Highly variable, typically hospital-administered per 100ml vial
Insurance Coverage:
Typically covered under medical benefit for diagnostic procedures when medically necessary.
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. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call 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 was taken to ensure prompt and effective treatment.