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ISOVUE is a brand name for Iopamidol, supplied as a liquid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ISOVUE® (iopamidol) Injection is indicated for: Intravascular Procedures: Adults Peripheral venography (phlebography) (ISOVUE-200 (41% w/v, 200 mg I/mL)) Peripheral arteriography (ISOVUE-300 (61% w/v, 300 mg I/mL)) Cerebral arteriography (ISOVUE-300 (61% w/v, 300 mg I/mL)) Excretory urography (ISOVUE-300 (61%…
Verbatim from this product's HC label. Tap a section to expand.
). Intrathecal administration of ISOVUE with corticosteroids is contraindicated. Direct intracisternal administration or gravitational displacement of a concentrated bolus of iopamidol into the intracranial subarachnoid spaces is contraindicated.
Myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely when lumbar puncture is contraindicated. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Only the concentration recommended for the specific procedure should be used.
Serious adverse reaction can occur due to inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These include death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
1 Dosing Considerations It is desirable that solutions of radiopaque diagnostic agents be at or close to body temperature when injected. As other sterile parenteral products, contrast media should not be transferred into other delivery systems except immediately prior to use.
Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile syringes. The transferring of ISOVUE from the ISOVUE Multipack-300 (iopamidol injection, 300 mg I/mL) and ISOVUE Multipack-370 (iopamidol injection, 370 mg I/mL) pharmacy bulk package should be performed in a suitable work area, such as a laminar flow hood, using aseptic technique.
The container closure may be penetrated only one time, utilizing a suitable transfer device. Sterile techniques must be used with any subarachnoid and intravascular injections, and with catheters and guidewires and prolonged contact of the contrast medium with blood has to be avoided.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to Product Monograph ISOVUE® (iopamidol) Page 7 of 45 administration. ISOVUE (iopamidol injection) solutions should be used only if clear and within the normal colorless to pale yellow range.
Patients should be well hydrated prior to and following administration of ISOVUE. As with all radiopaque contrast agents, only the lowest dose of ISOVUE necessary to obtain adequate visualization should be used. A lower dose reduces the possibility of an adverse reaction.
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Administration:
The injection is usually made through a catheter introduced into the femoral artery with the tip placed to achieve lower aortic or aorto-iliac runoff for visualization of an individual femoral artery or its distribution throughout the lower limb.
Pressure injection is usually employed. Visualization is similar to that achieved with ionic media of similar dose and concentration. Sedative premedication may be employed for the procedure, however, anesthesia is usually not considered necessary (see "Peripheral arteriography and venography" under 8 ADVERSE REACTIONS - INTRAVASCULAR).
Coronary Arteriography and Left Ventriculography ISOVUE-370 (iopamidol injection, 370 mg I/mL) is recommended.
Adult Dosage:
The usual single dose for selective coronary artery injections is 2 to 10 mL; for left ventriculography, 35-50 mL. For nonselective opacification of multiple coronary arteries following injection at the aortic Product Monograph ISOVUE® (iopamidol) Page 8 of 45 root, the usual single dose is 15-35 mL.
These doses may be repeated if indicated, however 15-20 minutes should be allowed to elapse between injections to allow for subsidence of hemodynamic disturbances. The total procedural dose should be limited to the smallest volume necessary to obtain a diagnostic examination (see 7 WARNINGS AND PRECAUTIONS).
Continuous ECG monitoring and close observation are essential (see "Coronary arteriography and left ventriculography" under 8 ADVERSE REACTIONS - INTRAVASCULAR). Pediatric Angiocardiography ISOVUE-370 (iopamidol injection, 370 mg I/mL) is recommended.
Pediatric Dosage:
). Product Monograph ISOVUE® (iopamidol) Page 6 of 45 2 CONTRAINDICATIONS ISOVUE (iopamidol injection) is contraindicated in patients with known hypersensitivity to the product and in patients with significant impairment of both renal and hepatic functions.
Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated (see Interval Recommendations under 4 DOSAGE AND ADMINISTRATION). Intrathecal administration of ISOVUE with corticosteroids is contraindicated.
Direct intracisternal administration or gravitational displacement of a concentrated bolus of iopamidol into the intracranial subarachnoid spaces is contraindicated. Myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely when lumbar puncture is contraindicated.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Only the concentration recommended for the specific procedure should be used. Serious adverse reaction can occur due to inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use.
These include death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. 1 Dosing Considerations It is desirable that solutions of radiopaque diagnostic agents be at or close to body temperature when injected.
As other sterile parenteral products, contrast media should not be transferred into other delivery systems except immediately prior to use. Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile syringes.
The transferring of ISOVUE from the ISOVUE Multipack-300 (iopamidol injection, 300 mg I/mL) and ISOVUE Multipack-370 (iopamidol injection, 370 mg I/mL) pharmacy bulk package should be performed in a suitable work area, such as a laminar flow hood, using aseptic technique.
ISOVUE (iopamidol injection) is contraindicated in patients with known hypersensitivity to the product and in patients with significant impairment of both renal and hepatic functions. Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated (see Interval Recommendations under
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Most procedures do not require use of either a maximum dose or the highest available concentration of ISOVUE; the combination of dose and ISOVUE concentration to be used should be carefully individualized, and factors such as age, body size, size of the vessel and its blood flow rate, anticipated pathology and 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.
If antihistamines or corticosteroids are to be used, they should not be mixed with the contrast medium because of chemical incompatibility. 2 Recommended Dose and Dosage Adjustment Only the concentration recommended for the particular procedure to be performed should be used (see 3 SERIOUS WARNINGS AND PRECAUTIONS).
INTRAVASCULAR USE Peripheral Arteriography ISOVUE-300 (iopamidol injection, 300 mg I/mL) is recommended.
Adult Dosage:
For injection into the femoral artery, a single dose of 15-40 mL may be used; for the subclavian artery, 5 to 20 mL; for injection into the aorta for a distal runoff, 25 to 50 mL is the usual single dose. These doses may be repeated if indicated, however 15-20 minutes should be allowed to elapse between injections to allow for subsidence of hemodynamic disturbances, and the total procedural dose should be limited to the smallest volume necessary to obtain a diagnostic examination (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
Administration:
The injection is usually made through a catheter introduced into the femoral artery with the tip placed to achieve lower aortic or aorto-iliac runoff for visualization of an individual femoral artery or its distribution throughout the lower limb.
Pressure injection is usually employed. Visualization is similar to that achieved with ionic media of similar dose and concentration. Sedative premedication may be employed for the procedure, however, anesthesia is usually not considered necessary (see "Peripheral arteriography and venography" under 8 ADVERSE REACTIONS - INTRAVASCULAR).
Coronary Arteriography and Left Ventriculography ISOVUE-370 (iopamidol injection, 370 mg I/mL) is recommended.
Adult Dosage:
The usual single dose for selective coronary artery injections is 2 to 10 mL; for left ventriculography, 35-50 mL. For nonselective opacification of multiple coronary arteries following injection at the aortic Product Monograph ISOVUE® (iopamidol) Page 8 of 45 root, the usual single dose is 15-35 mL.
These doses may be repeated if indicated, however 15-20 minutes should be allowed to elapse between injections to allow for subsidence of hemodynamic disturbances. The total procedural dose should be limited to the smallest volume necessary to obtain a diagnostic examination (see 7 WARNINGS AND PRECAUTIONS).
Continuous ECG monitoring and close observation are essential (see "Coronary arteriography and left ventriculography" under 8 ADVERSE REACTIONS - INTRAVASCULAR). Pediatric Angiocardiography ISOVUE-370 (iopamidol injection, 370 mg I/mL) is recommended.
Pediatric Dosage:
Pediatric angiocardiography may be performed by injection into a large peripheral vein or by direct catheterization of the heart. The amount to be administered will depend on the number of injections required, the anatomical sites to be studied, the anticipated pathology, the size of the patient, diseases processes affecting the patient, and possibly other factors.
In all cases, the minimum […]
Pediatric angiocardiography may be performed by injection into a large peripheral vein or by direct catheterization of the heart. The amount to be administered will depend on the number of injections required, the anatomical sites to be studied, the anticipated pathology, the size of the patient, diseases processes affecting the patient, and possibly other factors.
In all cases, the minimum amount of contrast necessary to obtain an adequate imaging study should be used.
The following table serves as a guide for single dose injections:
Age mL 6 weeks - 2 years 2 - 9 years 10 - 18 years 10 - 15 15 - 30 20 - 50 The maximum cumulative doses recommended are as follows: Age mL 6 weeks - 2 years 2 - 4 years 5 - 9 years 10 - 18 years 40 50 100 125 (see "Pediatric angiocardiography" under 8 ADVERSE REACTIONS - INTRAVASCULAR) Excretory Urography ISOVUE-300 (iopamidol injection, 300 mg I/mL) is recommended.
Adult Dosage:
The usual dose is 50 mL administered by intravenous injection. Doses up to 100 mL may be required in some patients. 0 mL/kg by intravenous injection. It should not be necessary to exceed a total dose of 30 grams of iodine.
Administration:
Preparatory dehydration is not recommended since it is unnecessary and may even be dangerous (see 7 WARNINGS AND PRECAUTIONS – General). Peripheral Venography (Phlebography) ISOVUE-200 (iopamidol injection, 200 mg I/mL) is recommended.
Adult Dosage:
The usual dose is 30 to 125 mL for the lower extremity. The combined total dose for multiple injections should not exceed 250 mL (see "Peripheral arteriography and venography" under 8 ADVERSE REACTIONS - INTRAVASCULAR). Cerebral arteriography ISOVUE-300 (iopamidol injection, 300 mg I/mL) is recommended.
Adult Dosage:
The usual single adult doses are as follows: Common carotid artery Internal carotid artery External carotid artery Vertebral artery Aortic arch injection (four vessel studies) 6 - 12 mL 5 - 10 mL 4- 8 mL 5 - 10 mL 20 - 50 mL These doses may be repeated if indicated; however, the total procedural dose should be limited to the smallest volume necessary to achieve a diagnostic examination.
The total dose should not exceed 90 mL.
Administration:
Appropriate patient preparation is indicated. Cerebral arteriography should be undertaken with extreme care and special caution in patients with advanced vascular disease, increased intracranial pressure, slowed cerebral circulation, spasm, breached blood brain barrier, recent cerebral thrombosis, embolism or bleeding, and in patients in poor clinical condition (see 7 WARNINGS AND PRECAUTIONS).
This may include suitable premedication. It is advisable to inject at rates approximately equal to the flow rate of the vessel being injected. The incidence of adverse reactions appears to be related to the number of repeated injections, administration of doses higher than those recommended, and the method and technique of injection.
Serious adverse reactions include stroke, hemiparesis, cortical blindness, hypotension, bradycardia, Product Monograph ISOVUE® (iopamidol) Page 10 of 45 arrhythmias, convulsions, coma, death (see 7 WARNINGS AND PRECAUTIONS, and 8 ADVERSE REACTIONS – INTRAVASCULAR – “Cerebral arteriography").
Computed Tomography Since an unenhanced scan may be sufficient for diagnosis, and the injection of contrast media may obscure certain lesions visible on the plain scan, contrast enhancement is usually performed only if the unenhanced scan has not provided or cannot be expected to provide sufficient information.
The decision to employ contrast enhancement should be carefully weighed, taking into consideration the patient's clinical condition, renal and cardiac reserve, and the status of the blood-brain-barrier since contrast enhancement may be associated with increased risk (see 7 WARNINGS AND PRECAUTIONS).
Experience with children 1 year of age and younger is limited. Intravenous Contrast Enhancement in Computed Tomography of the Head ISOVUE-300 (iopamidol injection, 300 mg I/mL) is recommended.
Adult dosage:
The usual adult dose is 50 to 100 mL by intravenous administration. In clinical studies, patients have safely received doses up to 150 mL. 0 mL/kg by intravenous administration. It should not be necessary to […]
The container closure may be penetrated only one time, utilizing a suitable transfer device. Sterile techniques must be used with any subarachnoid and intravascular injections, and with catheters and guidewires and prolonged contact of the contrast medium with blood has to be avoided.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to Product Monograph ISOVUE® (iopamidol) Page 7 of 45 administration. ISOVUE (iopamidol injection) solutions should be used only if clear and within the normal colorless to pale yellow range.
Patients should be well hydrated prior to and following administration of ISOVUE. As with all radiopaque contrast agents, only the lowest dose of ISOVUE necessary to obtain adequate visualization should be used. A lower dose reduces the possibility of an adverse reaction.
Most procedures do not require use of either a maximum dose or the highest available concentration of ISOVUE; the combination of dose and ISOVUE concentration to be used should be carefully individualized, and factors such as age, body size, size of the vessel and its blood flow rate, anticipated pathology and 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.
If antihistamines or corticosteroids are to be used, they should not be mixed with the contrast medium because of chemical incompatibility. 2 Recommended Dose and Dosage Adjustment Only the concentration recommended for the particular procedure to be performed should be used (see 3 SERIOUS WARNINGS AND PRECAUTIONS).
INTRAVASCULAR USE Peripheral Arteriography ISOVUE-300 (iopamidol injection, 300 mg I/mL) is recommended.
Adult Dosage:
For injection into the femoral artery, a single dose of 15-40 mL may be used; for the subclavian artery, 5 to 20 mL; for injection into the aorta for a distal runoff, 25 to 50 mL is the usual single dose. These doses may be repeated if indicated, however 15-20 minutes should be allowed to elapse between injections to allow for subsidence of hemodynamic disturbances, and the total procedural dose should be limited to the smallest volume necessary to obtain a diagnostic examination (see 7 WARNINGS AND PRECAUTIONS and