Visipaque 320mg/ml Inj, 150ml
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, iso-osmolar
Pregnancy Category
Category B
FDA Approved
Jan 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Visipaque is a special liquid called a 'contrast agent' that contains iodine. When it's injected into your body, it helps doctors see your blood vessels and organs more clearly on X-ray, CT scans, or other imaging tests. This helps them diagnose medical conditions.
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.
This medication is administered via injection into a vein or artery. Before receiving the injection, it is essential to be properly hydrated. Consult your doctor to determine if you need to consume extra fluids beforehand.
After receiving the medication, 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 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.
Missing a Dose
Since this medication is given in a healthcare setting, you will not be responsible for administering it yourself, and therefore, missing a dose is not a concern.
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.
This medication is administered via injection into a vein or artery. Before receiving the injection, it is essential to be properly hydrated. Consult your doctor to determine if you need to consume extra fluids beforehand.
After receiving the medication, 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 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.
Missing a Dose
Since this medication is given in a healthcare setting, you will not be responsible for administering it yourself, and therefore, missing a dose is not a concern.
Lifestyle & Tips
- Stay well-hydrated before and after the procedure, especially if you have kidney problems.
- Inform your healthcare provider about all your medications, allergies (especially to iodine or shellfish), and medical conditions (especially kidney disease, diabetes, thyroid problems, or asthma).
- Follow all instructions given by your healthcare team regarding fasting or medication adjustments before the procedure.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on procedure and patient weight. Typical single doses range from 20 mL to 250 mL. Maximum cumulative dose in 24 hours typically up to 350 mL.
Dose Range:
20 - 250 mg
Condition-Specific Dosing:
Coronary Angiography:
Typically 50-150 mL total, administered in multiple injections.
CT Angiography:
Typically 75-150 mL, administered as a bolus.
Peripheral Angiography:
Typically 30-100 mL per limb, total dose varies.
Urography:
Typically 50-100 mL.
Pediatric Dosing
Neonatal:
Not established for routine use; use with extreme caution and reduced doses if absolutely necessary. Dosing is weight-based.
Infant:
Weight-based dosing, typically 1-3 mL/kg, not to exceed 4 mL/kg or 150 mL total, whichever is less. Max single dose 150 mL.
Child:
Weight-based dosing, typically 1-3 mL/kg, not to exceed 4 mL/kg or 150 mL total, whichever is less. Max single dose 150 mL.
Adolescent:
Weight-based dosing, typically 1-3 mL/kg, not to exceed 4 mL/kg or 150 mL total, whichever is less. Max single dose 150 mL.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment; ensure adequate hydration.
Moderate:
No specific dose adjustment; ensure adequate hydration. Increased risk of contrast-induced nephropathy (CIN).
Severe:
Use with extreme caution; consider alternative imaging. If necessary, ensure maximal hydration and monitor renal function closely. Increased risk of CIN.
Dialysis:
Can be used in patients on dialysis; however, timing relative to dialysis session is not critical as it is removed by dialysis. Increased risk of CIN in patients with underlying renal disease.
Hepatic Impairment:
Mild:
No adjustment.
Moderate:
No adjustment.
Severe:
No adjustment.
Pharmacology
Mechanism of Action
Iodixanol is a dimeric, non-ionic, iso-osmolar iodinated contrast medium. It increases the attenuation of X-rays in the areas where it is distributed, allowing for visualization of internal structures during diagnostic imaging procedures. Its iso-osmolarity to blood is thought to contribute to a lower incidence of adverse events compared to hyperosmolar contrast agents.
Pharmacokinetics
Absorption:
Bioavailability:
100%
Tmax:
Immediate (after intravenous injection)
FoodEffect:
Not applicable (IV 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 100 mL/min (renal clearance)
ExcretionRoute:
Renal (primarily glomerular filtration)
Unchanged:
>97%
Pharmacodynamics
OnsetOfAction:
Immediate (upon injection)
PeakEffect:
Immediate (upon injection, then rapid distribution)
DurationOfAction:
Short (rapidly eliminated, typically minutes to hours depending on circulation and 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 medical attention immediately:
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 bothered by 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 about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 immediately:
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 bothered by 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 about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Difficulty breathing, wheezing, or shortness of breath (signs of allergic reaction)
- Hives, rash, or itching (signs of allergic reaction)
- Swelling of the face, lips, tongue, or throat (angioedema)
- Dizziness or lightheadedness (may indicate low blood pressure)
- Severe nausea or vomiting
- Unusual weakness or fatigue
- Decreased urination or swelling in the legs/feet (signs of kidney problems)
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 you experienced, including any symptoms that occurred.
If you are dehydrated, have been experiencing poor nutrition, or have recently used a laxative or diuretic (water pill) before starting this medication.
If you have had a skin reaction to this medication or a similar drug 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 other drugs. Never start, stop, or adjust the dose of any medication without first consulting your doctor to ensure your safety.
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 you experienced, including any symptoms that occurred.
If you are dehydrated, have been experiencing poor nutrition, or have recently used a laxative or diuretic (water pill) before starting this medication.
If you have had a skin reaction to this medication or a similar drug 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 other drugs. Never start, stop, or adjust the dose of any medication without first consulting your doctor to ensure your safety.
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 also interfere with 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.
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 for an extended 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 also interfere with 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.
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 for an extended 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 imbalance
- Acute renal failure
- Severe hypersensitivity reactions
What to Do:
Treatment is supportive. Monitor vital signs, fluid and electrolyte balance, and renal function. Hemodialysis can be used to remove iodixanol from the body if necessary, especially in cases of severe overdose or fluid overload. 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 (IL-2)
Moderate Interactions
- Beta-blockers
- Diuretics
- Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides)
Monitoring
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, especially in patients with risk factors for renal impairment.
Allergy history (to iodine or contrast media)
Rationale: To identify patients at increased risk of hypersensitivity reactions.
Timing: Prior to contrast administration.
Thyroid function (TSH, T4)
Rationale: In patients with known or suspected thyroid disease, as iodine can affect thyroid function.
Timing: Prior to contrast administration if indicated.
Routine Monitoring
Vital signs (blood pressure, heart rate, respiratory rate)
Frequency: During and immediately after injection, then as clinically indicated.
Target: Within patient's normal range.
Action Threshold: Significant deviations (e.g., hypotension, tachycardia, bradycardia, respiratory distress) require immediate intervention.
Signs and symptoms of hypersensitivity reaction
Frequency: Continuously during and for at least 30 minutes post-injection.
Target: Absence of symptoms.
Action Threshold: Rash, urticaria, pruritus, dyspnea, bronchospasm, angioedema, hypotension, or anaphylaxis require immediate medical attention.
Urine output
Frequency: Post-procedure, especially in high-risk patients.
Target: Adequate urine output.
Action Threshold: Oliguria or anuria may indicate CIN.
Symptom Monitoring
- Rash
- Urticaria
- Pruritus
- Dyspnea
- Bronchospasm
- Angioedema
- Hypotension
- Tachycardia
- Bradycardia
- Nausea
- Vomiting
- Headache
- Dizziness
- Oliguria
- Anuria
- Flank pain
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm, but 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, but general caution for drug exposure during organogenesis.
Second Trimester:
No specific increased risk identified.
Third Trimester:
No specific increased risk identified. Potential for transient hypothyroidism in the neonate due to iodine exposure, though rare with non-ionic agents.
Lactation
Minimal amounts of iodixanol are excreted into breast milk. Generally considered safe to continue breastfeeding. If concerns exist, a temporary interruption of breastfeeding for 24 hours after administration may be considered, but is often not necessary.
Infant Risk:
Low risk. Minimal systemic absorption by the infant. Potential for transient diarrhea or rash, but rare.
Pediatric Use
Dosing is weight-based. Increased susceptibility to fluid shifts and electrolyte imbalances. Careful monitoring of hydration status and renal function is crucial. Higher risk of adverse events in neonates and infants due to immature renal function.
Geriatric Use
Increased risk of contrast-induced nephropathy (CIN) due to age-related decline in renal function and higher prevalence of comorbidities (e.g., diabetes, hypertension, heart failure). Careful assessment of renal function and adequate hydration are essential.
Clinical Information
Clinical Pearls
- Iodixanol (Visipaque) is an iso-osmolar contrast medium, meaning its osmolality is similar to that of blood. This property is thought to contribute to a lower incidence of adverse events, particularly discomfort and vascular pain, compared to hyperosmolar contrast agents.
- Despite its iso-osmolarity, the risk of contrast-induced nephropathy (CIN) still exists, especially in patients with pre-existing renal impairment, diabetes, or dehydration. Adequate hydration before and after the procedure is crucial.
- Patients with a history of severe allergic reactions to contrast media should be pre-medicated with corticosteroids and antihistamines, or an alternative imaging modality should be considered.
- Always assess renal function (eGFR) prior to administration, especially in at-risk patients.
- Instruct patients on metformin to hold the medication for 48 hours after contrast administration and resume only after renal function is confirmed to be stable.
Alternative Therapies
- Iohexol (Omnipaque)
- Iopamidol (Isovue)
- Iopromide (Ultravist)
- Iomeprol (Iomeron)
- Ioversol (Optiray)
Cost & Coverage
Average Cost:
Highly variable, typically several hundred dollars per 150 mL vial. per 150 mL vial
Insurance Coverage:
Generally covered by medical insurance for diagnostic imaging procedures when medically necessary.
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 or take someone else's medication. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best disposal method, consult your pharmacist, as they can provide guidance on safe disposal practices. Additionally, you may want to inquire about drug take-back programs available in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea 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 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 occurred, as this will aid in prompt and effective treatment.
Proper disposal of unused or expired medications is crucial. Do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best disposal method, consult your pharmacist, as they can provide guidance on safe disposal practices. Additionally, you may want to inquire about drug take-back programs available in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea 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 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 occurred, as this will aid in prompt and effective treatment.