Drug Detail:Visipaque (Iodixanol [ eye-oh-dix-an-ol ])
Generic Name: iodixanol
Dosage Form: injection
Drug Class: Non-ionic iodinated contrast media
For Pediatric dosing see the end of this Dosage and Administration section.
GENERAL
The combination of volume and concentration of VISIPAQUE Injection to be used should be individualized, accounting for factors such as age, body weight, size of the vessel, and rate of blood flow within the vessel. Specific dose adjustment studies for age, gender, weight and renal function have not been conducted with VISIPAQUE. As with other iodinated contrast agents, lower doses may have less risk. The efficacy of VISIPAQUE Injection below doses recommended has not been established. Other factors, such as pathology anticipated, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed, should be considered.
The maximum recommended total dose of iodine is 80 grams.
If an adverse reaction occurs during injection, consider stopping the injection immediately if warranted by the nature and severity of the event.
Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents (see WARNINGS and PRECAUTIONS).
INTRA-ARTERIAL ADMINISTRATION
VISIPAQUE 320mgI/mL is recommended for intra-arterial injection in the radiographic contrast evaluation of arterial lesions of the brain, the coronary arteries and left ventricle, and for intra-arterial injection in the radiographic contrast evaluation of peripheral arteries. VISIPAQUE is also recommended for intra-arterial digital subtraction angiography, as specified in the dosing chart below.
Injection rates should be approximately equal to the flow rate in the vessel being injected. The volume required will depend on the size, flow rate, and disease state of the injected vessel, on the size and condition of the patient, and on the imaging technique used. The usual single injection volumes or total dose per patient (mL/kg) for adults and adolescents over 12 years of age are listed in the tables below.
| ARTERIOGRAPHY | IA-DSA* | Maximum Total Dose | ||
|---|---|---|---|---|
| Intra-Arterial Injection Sites | 320 mgI/mL | 270 mgI/mL | 320 mgI/mL | |
|
||||
| Carotid Arteries | 10 - 14 mL | 5 - 8 mL | Usually Not to Exceed 175 mL | |
| Vertebral Arteries | 10 - 12 mL | 5 - 8 mL | ||
| Right Coronary Artery | 3 - 8 mL | Usually Not to Exceed 200 mL | ||
| Left Coronary Artery | 3 - 10 mL | |||
| Left Ventricle | 20 - 45 mL | |||
| Renal Arteries | 8 - 18 mL | 10 - 25 mL | — | Usually Not to Exceed 250 mL |
| Aortography | 30 - 70 mL | 20 - 50 mL | 10 - 50 mL | |
| Major Branches of Aorta | 10 - 70 mL | 5 - 30 mL | 2 - 10 mL | |
| Aortofemoral Runoffs | 20 - 90 mL | — | 6 - 15 mL | |
| Peripheral Arteries | 15 - 30 mL | — | 3 - 15 mL | |
INTRAVENOUS ADMINISTRATION
Contrast Enhanced Computed Tomography (CECT)
Intravenous administration of VISIPAQUE Injection (270mgI/mL and 320mgI/mL) is recommended for contrast enhancement in the evaluation of neoplastic and nonneoplastic lesions of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions), evaluations of renal function, and evaluations of the peripheral venous system. Selected dosing for different indications in adults and pediatric patients are shown in the following tables.
| Study Type | Comment | 270 mgI/mL | 320 mgI/mL | Maximum Total Volume |
|---|---|---|---|---|
| CECT of Head or Body | Bolus | 75 - 150 mL | 75 - 150 mL | 150 mL |
| Infusion | 100 - 150 mL | 100 - 150 mL | ||
| Excretory Urography | Normal Renal Function | 1 mL/kg | 1 mL/kg | 100 mL |
| Venography | Per lower extremity | 50 - 150 mL | 250 mL |
PEDIATRIC DOSING
The recommended dose in children over 1 year of age for the evaluation of:
Intra-arterial Administration for Cerebral, Cardiac chambers and related major arteries, and Visceral Studies
VISIPAQUE 320 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 4 mL/kg.
Intravenous Administration for Contrast Enhanced Computerized Tomography or Excretory Urography
VISIPAQUE 270 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 2 mL/kg.
The safety and efficacy relationships of other doses, concentrations or procedures have not been established. (See Clinical Pharmacology–Special Populations, and Precautions–Pediatric Use sections.)
The maximum total dose of iodine in the pediatric population has not been established.
DRUG HANDLING
As with all contrast agents because of the potential for chemical incompatibility, VISIPAQUE Injection should not be mixed with, or injected in, intravenous administration lines containing other drugs, solutions or total nutritional admixtures.
Sterile technique must be used in all procedures involving vascular injections of contrast agents.
VISIPAQUE Injection may be administered at body temperature as well as at room temperature.
If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
Withdrawal of contrast agents from their containers should be accomplished under strict aseptic conditions using only sterile syringes and transfer devices. Contrast agents which have been transferred into other delivery systems should be used immediately.
Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, and should not be used if particulates are observed or marked discoloration has occurred.
DIRECTIONS FOR PROPER USE OF VISIPAQUE PHARMACY BULK PACKAGE
- The transfer of VISIPAQUE (iodixanol) Injection from the Pharmacy Bulk Package is restricted to a suitable work area, such as a laminar flow hood.
- The container closure may be penetrated only one time, utilizing a suitable transfer device and aseptic technique.
- The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operations. The container should not be removed from the aseptic area during the entire 8 hour period.
- The temperature of the container should not exceed 30°C, after the closure has been entered.
