What is isovue injection?
Each bottle is to be used as an Imaging Bulk Package for dispensing multiple single doses of iopamidol injection for multiple patients, using an automated contrast injection system or contrast management system approved or cleared for use with this contrast agent in this Imaging Bulk Package.
What is isovue used for?
Isovue (Iopamidol Injection) may be used for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, abdominal cavity, pelvis and retroperitoneal space.
What is intravascular injection?
Intravascular injection of a radiopaque diagnostic agent opacifies those vessels in the path of flow of the contrast medium, permitting radiographic visualization of the internal structures of the human body until significant hemodilution occurs.
How long does it take for isovue to appear in the renal parenchyma?
Isovue may be visualized in the renal parenchyma within 30-60 seconds following rapid intravenous administration. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 1 to 3 minutes, with optimum contrast occurring between 5 and 15 minutes.
How long does iopamidol last in the body?
The elimination serum or plasma half-life is approximately two hours; the half-life is not dose dependent. No significant metabolism, deiodination, or biotransformation occurs.
How long does it take for iodine to peak?
These levels fall rapidly within five to ten minutes.
What percentage of adverse reactions are associated with intravascular contrast?
Approximately 95 percent of adverse reactions accompanying the use of other water-soluble intravascularly administered contrast agents are mild to moderate in degree. However, life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred.
Isovue-300 Injectable solution, intrathecal solution
Isovue-300, an organic Iodine compound and used as a non-ionic water soluble radiographic contrast medium. Isovue-300 blocks X-rays as they pass through the body, thereby allowing body structures not containing Iodine to be visualized.
Uses
Angiography: Cerebral angiography, selective coronary angiography, left ventriculography, aortography, angiocadiography, selective visceral arteriography, peripheral arteriography, digital subtraction angiography, venography, urography
Side Effects
Common side effects are arrhythmias, arterial spasm, flushing, vasodilatation, angina, cardiopulmonary arrest; dizziness, confusion, paraesthesia, visual disturbances, seizure, paralysis, coma, temporary amnesia; inj site pain, pallor, periorbital and facial oedema; coughing, sneezing, rhinitis, asthma, apnoea, laryngeal oedema, chest tightness; watery itchy eyes, lachrymation, conjunctivitis; muscle spasm, involuntary leg movement; tremors, malaise; severe retching and choking, abdominal pain; urogenital pain, haematuria..
Precaution
May inhibit blood coagulation. Multiple myeloma or other paraproteinaemia. Sickle-cell disease. Known or suspected phaeochromocytoma (monitor closely). Hyperthyroidism. Ensure adequate hydration. History of a previous sensitivity to a contrast medium, sensitivity to iodine, bronchial asthma, hay fever and food allergy. Monitor patients with CHF.
Interaction
Isovue-300 may interfere with thyroid function. Biguanide compete for excretion in the kidneys with contrast media and this could lead to reduction in kidney function. Patient taking Metformin or other Biguanides should therefore not take any doses of Metformin for 48 hours before or 48 hours after the X-ray examination.
Pregnancy & Breastfeeding use
Isovue-300 injection should be administered in pregnancy only if the procedure is considered essential by the physician.
Contraindication
There are no definite or absolute contraindications to the use of Amidol, with the possible exception of waldenstrom's macroglobulinemia, multiple myeloma and severe liver and kidney disease.
What is ISOVUE used for?
ISOVUE (lopamidol Injection) may be used for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, abdominal cavity, pelvis and retroperitoneal space.
What is the recommended dose of isovue-m 200?
The usual recommended adult dose range for iopamidol is 2000-3000 mg iodine. Iopamidol formulated to contain more than 300 mgl/mL should not be used intrathecally in adults. The minimum dose needed to perform a procedure should always be used. In pediatric patients, a solution that is approximately isotonic (ISOVUE-M 200) is recommended for all intrathecal procedures. In children, loss of contrast due to mixing on movement of the medium is less apt to occur because of their shorter spinal cord. The usual recommended pediatric dose range for iopamidol is 1400-2400 mg iodine. Iopamidol formulated to contain more than 200 mgl/mL should not be used intrathecally in children. The minimum dose needed to perform a procedure should always be used. See pediatric dosage table for recommended dosage.
What is intravascular injection?
Intravascular injection of a radiopaque diagnostic agent opacifies those vessels in the path of flow of the contrast medium, permitting radiographic visualization of the internal structures of the human body until significant hemodilution occurs.
How long does it take for iopamidol to cause headaches?
The most frequently reported adverse reactions following intrathecal administration of iopamidol are headache, nausea, vomiting, and musculoskeletal pain. These reactions usually occur 1 to 10 hours after injection, almost all occurring within 24 hours. They are usually mild to moderate in degree, lasting for a few hours and usually disappearing within 24 hours. Rarely, headaches may be severe or persist for days. Headache is often accompanied by nausea and vomiting, and tends to be more frequent and persistent in patients not optimally hydrated. Backache, neck stiffness, numbness and paresthesias, leg or sciatic-type pain occurred less frequently, often in the form of a transient exacerbation of pre-existing symptomatology. Transient alterations in vital signs may occur and their significance must be assessed on an individual basis. The following table of incidence of reactions is based on clinical studies with ISOVUE-M (lopamidol Injection) in about 686 patients.
Can iodinated contrast be used with any nonionic agent?
Reactions known to occur with parenteral administration of iodinated ionic contrast agents (see the listing below) are possible with any nonionic agent. Approximately 95 percent of adverse reactions accompanying the use of other water-soluble #N#intravascularly administered contrast agents are mild to moderate in degree. However, life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred. Reported incidences of death from the administration of other iodinated contrast media #N#range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Most deaths occur during injection or 5 to 10 minutes later, the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor. Isolated #N#reports of hypotensive collapse and shock are found in the literature. The incidence of shock is estimated to be 1 out of 20,000 (0.005 percent) patients.
Is iopamidol excreted in milk?
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when iopamidol is administered to a nursing woman.
Can iopamidol be admixed with cholecystographic?
Other drugs should not be admixed with iopamidol .
What is ISOVUE imaging?
The ISOVUE (Iopamidol Injection) Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.
Is ISOVUE M iodine soluble?
ISOVUE-M® (Iopamidol Injection) is a nonionic, low-osmolar, low-viscosity, water-soluble, iodinated contrast medium that is indicated and packaged for intrathecal injection, for which it has been safely and effectively used for 30 years by thousands of physicians. It is one of only two iodinated contrast media approved by the U.S. Food and Drug Administration (FDA) for myelographic use.
Conditions
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Isovue Description
Isovue - Clinical Pharmacology
- Intravascular injection of a radiopaque diagnostic agent opacifies those vessels in the path of flow of the contrast medium, permitting radiographic visualization of the internal structures of the human body until significant hemodilution occurs. Following intravascular injection, radiopaque diagnostic agents are immediately diluted in the circulating plasma. Calculations of apparent vol…
Indications and Usage For Isovue
- Isovue (Iopamidol Injection) is indicated for intravenous contrast enhancement of computed tomographic (CECT) imaging of the head and body in adult and pediatric patients (see below). CECT Head Imaging Isovue may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized. Tumors Isovue m...
Warnings
- Severe Adverse Events-lnadvertent Intrathecal Administration Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, …
Precautions
- General
Diagnostic procedures which involve the use of any radiopaque agent should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with a… - Information for Patients
Patients receiving injectable radiopaque diagnostic agents should be instructed to: 1. Inform your physician if you are pregnant. 2. Inform your physician if you are diabetic or if you have multiple myeloma, pheochromocytoma, homozygous sickle cell disease, or known thyroid disorder (see …
Adverse Reactions
- Adverse reactions following the use of iopamidol are usually mild to moderate, self-limited, and transient. The following table of incidence of reactions is based on clinical studies with Isovue in about 2246 patients. The following adverse reactions have been reported for Iopamidol: Cardiovascular: arrhythmia, arterial spasms, flushing, vasodilation, chest pain, cardiopulmonary …
Overdosage
- Treatment of an overdose of an injectable radiopaque contrast medium is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.
Isovue Dosage and Administration
- General
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Iopamidol solutions should be used only if clear and within the normal colorless to pale yellow range. Discard any product whic… - Computed Tomography
CECT OF THE HEAD: The suggested dose for Isovue-300 is 100 to 200 mL by intravenous administration. Imaging may be performed immediately after completion of administration. CECT OF THE BODY: The usual adult dose range for Isovue-300 is 100 to 200 mL administered by rapi…
Drug Handling
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Iopamidol solutions should be used only if clear and within the normal colorless to pale yellow range. Discard any product which shows signs of crystallization or damage to the container-closure system, which includes the gl…
How Is Isovue Supplied
- Isovue-300 (Iopamidol Injection 61%) Ten 200 mL Imaging Bulk Packages (NDC 0270-1315-45) Six 500 mL Imaging Bulk Packages (NDC 0270-1315-95) Isovue-370 (Iopamidol Injection 76%) Ten 200 mL Imaging Bulk Packages (NDC 0270-1316-45) Six 500 mL Imaging Bulk Packages (NDC 0270-1316-95)