Visipaque (Injection, Solution)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/673

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
rdfs:label
Visipaque (Injection, Solution)
dailymed-instance:dosage
For Pediatric dosing see the end of this Dosage and Administration section.<br/>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 .<br/>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.<br/>INTRAVENOUS ADMINISTRATION:<br/>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.<br/>PEDIATRIC DOSING: The recommended dose in children over 1 year of age for the evaluation of:<br/>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.<br/>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.<br/>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. Do not use flexible container in series connections. 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.<br/>DIRECTIONS FOR PROPER USE OF VISIPAQUE PHARMACY BULK PACKAGE:
dailymed-instance:descripti...
VISIPAQUE���(iodixanol) Injection, 5,5'-[(2-hydroxy-1,3-propanediyl)bis (acetylimino)]bis[N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodo-1,3- benzenedicarboxamide], is a dimeric, isosmolar, nonionic, water-soluble, radiographic contrast medium with a molecular weight of 1550.20 (iodine content 49.1%). It is administered by intravascular injection. VISIPAQUE (CHINO) has the following chemical structure: VISIPAQUE Injection is provided as a ready-to-use sterile, pyrogen-free, colorless to pale yellow solution, in Pharmacy Bulk Package, in concentrations of 270 and 320 mg of organically bound iodine per mL (550 and 652 mg of iodixanol per mL, respectively). A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. Sodium chloride and calcium chloride have been added, resulting in an isotonic solution for injection. VISIPAQUE 270 (270 mgI/mL) contains 0.074 mg calcium chloride dihydrate per mL and 1.87 mg sodium chloride per mL, and VISIPAQUE 320 (320 mgI/mL) contains 0.044 mg calcium chloride dihydrate per mL and 1.11 mg sodium chloride per mL, providing for both concentrations a sodium/calcium ratio equivalent to blood. In addition, each milliliter contains 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. The pH is adjusted to 7.4 with hydrochloric acid and/or sodium hydroxide to achieve a range between pH 6.8 and 7.7 at 22��C. All solutions are terminally sterilized by autoclaving and contain no preservatives. The two concentrations of VISIPAQUE Injection (270 mgI/mL and 320 mgI/mL) have the following physical properties:
dailymed-instance:clinicalP...
GENERAL: Iodixanol is a dimeric, isosmolar, nonionic, water soluble, iodinated x-ray contrast agent for intravascular administration. Intravascular injection of iodixanol opacifies those vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant dilution and elimination occurs.<br/>PHARMACOKINETICS:<br/>Distribution: In an in vitro human plasma study, iodixanol did not bind to protein. The volume of distribution was 0.26 L/kg body weight, consistent with distribution to extracellular space.<br/>Metabolism: Iodixanol metabolites have not been demonstrated.<br/>Excretion: Plasma and urine levels suggest that body clearance of iodixanol is primarily due to renal clearance. In adults, approximately 97% of the injected dose of iodixanol is excreted unchanged in urine within 24 hours, with less than 2% excreted in feces within five days post-injection. In 40 healthy, young male volunteers receiving a single intravenous administration of VISIPAQUE Injection in doses of 0.3 to 1.2 gI/kg body weight, the elimination half-life was 2.1 hr (��0.1); and renal clearance was 110 mL/min (��14), equivalent to glomerular filtration (108 mL/min). These values were independent of the dose administered.<br/>Special Populations:<br/>PHARMACODYNAMICS: As with other iodinated contrast agents, following administration of VISIPAQUE Injection, the degree of enhancement is directly related to the iodine content in an administered dose; peak iodine plasma levels occur immediately following rapid intravascular injection. Iodine plasma levels fall rapidly within 5 to 10 minutes. This can be accounted for by the dilution in the vascular and extravascular fluid compartments.<br/>Intravascular Contrast: Contrast enhancement with iodinated contrast agents appears to be greatest immediately after bolus injections (15 seconds to 120 seconds). Thus, greatest enhancement may be detected by a series of consecutive two-to-three second scans performed within 30 to 90 seconds after injection (i.e., dynamic computed tomographic imaging). Iodinated contrast agents may be visualized in the renal parenchyma within 30-60 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 1-3 minutes, with optimum contrast occurring within 5-15 minutes.<br/>Contrast Enhanced Computerized Tomography (CECT): AS WITH OTHER IODINATED CONTRAST AGENTS, THE USE OF VISIPAQUE INJECTION CONTRAST ENHANCEMENT MAY OBSCURE SOME LESIONS WHICH WERE SEEN ON PREVIOUSLY UNENHANCED CT SCANS. In CECT some performance characteristics are different in the brain and body. In CECT of the body, iodinated contrast agents diffuse rapidly from the vascular into the extravascular space. Following the administration of iodinated contrast agents, the increase in tissue density to x-rays is related to blood flow, the concentration of the contrast agent, and the extraction of the contrast agent by various interstitial tissues. Contrast enhancement is thus due to relative differences in extravascular diffusion between adjacent tissues. In normal brain with an intact blood-brain barrier, contrast enhancement is generally due to the presence of iodinated contrast agent within the intravascular space. The radiographic enhancement of vascular lesions, such as arteriovenous malformations and aneurysms, depends on the iodine content of the circulating blood pool. In tissues with a break in the blood-brain barrier, contrast agent accumulates within interstitial spaces of the brain. The time to maximum contrast enhancement can vary from the time that peak blood iodine levels are reached to one hour after intravenous bolus administration. This delay suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine-containing medium within the lesion and outside the blood pool. The mechanism by which this occurs is not clear. IN PATIENTS WITH NORMAL BLOOD-BRAIN BARRIERS and RENAL FAILURE, iodinated contrast agents have been associated with blood-brain barrier DISRUPTION and ACCUMULATION OF CONTRAST IN THE BRAIN. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated. Calcified lesions are less likely to enhance. The enhancement of tumors after therapy may decrease. The opacification of the inferior vermis following contrast agent administrationhas resulted in false-positive diagnosis. Cerebral infarctions of recent onset may be better visualized with contrast enhancement. Older infarctions may be obscured by the contrast agent. For information on coagulation parameters, platelets, erythrocytes and complement system, please refer to the LABORATORY TEST FINDINGS section.
dailymed-instance:activeIng...
dailymed-instance:contraind...
VISIPAQUE Injection is not indicated for intrathecal use. In the pediatric population prolonged fasting and the administration of a laxative before VISIPAQUE injection are contraindicated.
dailymed-instance:supply
VISIPAQUE (iodixanol) Injection 270 mgI/mL: 500 mL in +PLUSPAK���(polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-2222-23) VISIPAQUE (iodixanol) Injection 320 mgI/mL: 500 mL in +PLUSPAK���(polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-2223-23)<br/>SPECIAL HANDLING AND STORAGE: SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES:DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING. Protect polymer bottles of VISIPAQUE Injection from strong daylight and direct exposure to sunlight. Visipaque should be stored at controlled room temperature, 20��-25��C (68-77��F); excursions permitted to 15��-30��C (59��-86��F) [see USP Controlled Room Temperature]. VISIPAQUE polymer bottles may be stored at 37��C (98.6��F) for up to one month in a contrast agent warmer utilizing circulating air. Do not freeze or use if the product is inadvertently frozen. Freezing may compromise the closure integrity of these packages.
dailymed-instance:genericDr...
dailymed-instance:activeMoi...
dailymed-instance:inactiveI...
dailymed-instance:overdosag...
The adverse effects of overdosage of any contrast agent may be life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. VISIPAQUE Injection does not bind to plasma or serum protein and can be dialyzed.
dailymed-instance:genericMe...
Iodixanol
dailymed-instance:fullName
Visipaque (Injection, Solution)
dailymed-instance:indicatio...
INTRA-ARTERIAL VISIPAQUE Injection (270 mgI/mL) is indicated for intra-arterial digital subtraction angiography. VISIPAQUE Injection (320 mgI/mL) is indicated for angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography. INTRAVENOUS VISIPAQUE Injection (270 mgI/mL) is indicated for CECT imaging of the head and body, excretory urography, and peripheral venography. VISIPAQUE Injection (320 mgI/mL) is indicated for CECT imaging of the head and body, and excretory urography.
dailymed-instance:represent...
dailymed-instance:routeOfAd...
dailymed-instance:name
Visipaque