INFORMATION FOR HEALTH PROFESSIONALS
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ISOVUE is presented as a clear colourless sterile injection solution in the following concentrations:
ISOVUE 300, 61.2 grams iopamidol/100 ml equivalent to 300 mg iodine/ml
ISOVUE 370, 75.5 grams iopamidol/100 ml equivalent to 370 mg iodine/ml
Iopamidol is a tri-iodinated non-ionic water-soluble contrast medium suitable for intravascular, intrathecal and body cavity administration in radiographic procedures. Iopamidol doses in dogs at two to four times higher the probable dose for clinical use caused transient bradycardia and hypotension followed by mild hypertension, and increase in respiratory frequency. These effects were reversible in 2-4 minutes after cessation of treatment.
Following intravenous administration, iopamidol is excreted rapidly and predominantly through the kidneys (> 90% within 24 hours) with an elimination half-life of 90 - 120 minutes. After intrathecal administration, peak plasma level is within 90 - 150 minutes and total excretion in 24 hours. Iopamidol is not significantly metabolised.
Lumbar myelography, thoraco-cervical myelography.
Cerebral angiography, peripheral arteriography, venography, angiocardiography, left ventriculography, selective coronary angiography, aortography, selective visceral arteriography, digital subtraction angiography (D.S.A). Urography. Arthrography. CT enhancement.
300, 5-10 ml
300, 5-10 ml
300, 5-10 ml
300 - 370, 20-50 ml
300, 20-50 ml
300 - 370, 30-80 ml
300 -370, 30-80 ml
300-370, 4-8 ml/artery
300-370, 30-80 ml
30 ml
5-10 ml
300-370, 30-70 ml
300-370, 40-70 ml
300-370, 25-70 ml
300-370, 5-30 ml
300-370, 30-50 ml (10-20 ml/sec) of '300', '370' i.v.
25 ml (left ventricle)
2-5 ml (coronary arteries)
15 ml/sec of '300', '370' i.a. for cardiac imaging
300, 370 40-80 ml i.v. up to 1.5 ml/kg in severe renal disease
Children 1-2.5 ml/kg
300 1-10 ml
300 50-100 ml in brain scanning procedure, 40-100 ml in whole body scanning 4 ml of '200' in spinal canal CT
A slow sub-arachnoid injection is made through a fine lumbar puncture needle into one of the lower interspinous spaces (L3-L4 or L4-L5). Optimum contrast appears immediately after injections and films should be obtained promptly.
Following a slow sub-arachnoid injection the patient should be turned on his/her side and tilted 10°-20° head down under fluoroscopic control. In this manner it is possible to control movement of the contrast medium column into the dorsal region.
If the cervical region is to be examined, the contrast medium should be run into the cervical region first, before the examination of the dorsal areas where it is progressively diluted. ISOVUE may also be injected sub-occipitally or by lateral puncture technique. Care should be taken to ensure that the contrast medium does not move intracranially. It is generally recommended that in intrathecal use the patient should remain with a raised bedhead and be kept well hydrated; following hydration it is preferable that the patient be allowed to be ambulatory.
Any of the current techniques is suitable for radiological visualisation of the cerebral vasculature with ISOVUE 300 injection. Carotid and vertebral angiography, performed by catheterisation or percutaneous injection techniques, require rapid injection which, if necessary, may be repeated.
Percutaneous injection into the appropriate blood vessel is used for visualisation of peripheral arteries and veins.
ISOVUE injection may be administered by rapid injection through a catheter into a suitable peripheral artery or vein. It can also be introduced under pressure through a cardiac catheter into any of the heart chambers, or injected into large vessels for immediate visualisation. The contrast medium may also be administered during selective catheterisation of the coronary arteries.
The contrast medium may be introduced directly by intra-arterial injection (retro-grade method) for visualisation of the aorta and its main branches.
Visualisation can be achieved by selective catheterisation and injection into the hepatic, coeliac or mesenteric arteries.
For cardiac imaging the contrast medium may be administered intra-arterially by selective catheterisation to provide substrated images. ISOVUE 300 and 370 injected intravenously either centrally or peripherally is also recommended for use in this modality.
The contrast medium is injected intravenously and rapidly eliminated through the kidneys. In patients with severe renal failure, high dose urography should be used.
Visualisation of joint cavities and articular surfaces can be achieved in either single or double contrast examination.
Contrast enhancement for brain scans can be achieved between one and three minutes after i.v. injection. ISOVUE 200 and 300 are also used for total body scanning examinations after i.v. administration as a bolus, as a drip infusion or by a combination of the two methods.
Hypersensitivity to iodine-containing preparations of this type. Possibly, Waldenstroms macoglobulinemia, multiple myeloma and severe kidney disease.
ISOVUE should not be drawn into the syringe until immediately before use. The bottle, once opened, must be used immediately.
In consideration of possible serious side effects the use of organoiodinate contrast media should be limited to cases for which there is a precise need for radiographic contrast examination. This should be evaluated according to clinical status of the patient, in particular in relation to pathologies of the cardiovascular, urinary or hepatobiliary system.
In particular, contrast media designed for cardioangiography should be used in hospitals or clinics equipped and staffed for intensive care in emergencies. For other common diagnostic procedures requiring the use of iodinised contrast media, in the public or private institutions where such procedures take place, resuscitation equipment and therapeutic measures should be immediately available.
When examining small children or babies, do not limit fluid intake before administering a hypertonic contrast solution. Also, correct any existing water and electrolyte imbalance.
X-ray examination of women should also, if possible, be conducted during the pre-ovulation phase of the menstrual cycle.
In patients scheduled for thyroid examination with a radioactive iodine tracer, one must take into consideration that iodine uptake in the thyroid gland will be reduced for several days (up to 2 weeks) after dosing with an iodinised contrast medium that is eliminated through the kidneys.
Biguanide oral antidiabetic agents e.g. metformin, are excreted unchanged through the kidneys. They therefore compete for excretion in the kidneys with contrast media and this could lead to a reduction in kidney function. Patients with non-insulin dependent diabetes who are taking metformin or other biguanides should therefore be instructed note to take any doses of metformin for 48 hours before and 48 hours after the x-ray examination.
A characteristic of non-ionic contrast media is the extremely low interference with normal physiological functions. As a consequence of this, non-ionic contrast media have less anticoagulant activity in vitro than ionic media. Medical personnel performing vascular catheterisation procedures should be aware of this and pay meticulous attention to the angiography technique. Non-ionic media should not be allowed to remain in contact with blood in the syringe and intravascular catheters should be flushed frequently to minimise the risk of clotting, which rarely have led to thromboembolic complications after administration.
In patients who are know epileptics or have a history of epilepsy, anticonvulsant therapy should be maintained before and following myelographic procedures. In some instances anticonvulsant therapy may be increased for 48 hours before the examination. Neuroleptics must be absolutely avoided because they lower the seizure threshold. The same applies to analgesic, antiemetics, antihistamines and sedatives of the phenothiazine group. Whenever possible, treatment with such drugs should be discontinued at least 48 hours before administration of the contrast medium and not be resumed less than 12 hours after completion of the procedure.
In patients undergoing angiocardiographic procedures, special attention should be paid to the status of the right heart and pulmonary circulation.
Right heart insufficiency and pulmonary hypertension may precipitate bradycardia and systemic hypotension when the organic iodine solution is injected. Right heart angiography should be carried out only when absolutely indicated.
In paediatric roentgenology, one should proceed with great caution when injecting the contrast medium into the right chambers of cyanotic neonates with pulmonary hypertension and impaired cardiac function. In examinations of the aortic arch, the tip of the catheter should be positioned carefully to avoid hypotension, bradycardia and CNS injury due to excess pressure transmitted from the injector pump to the brachiocephalic branches of the aorta.
Likewise, in abdominal aortography, excess pressure from the pump may cause renal infarction, spinal cord injury, retropertoneal bleeding, intestinal infarction and necrosis.
In peripheral arteriography, iopamidol 370 injection may sometimes cause a painful reaction to the involved limb. This is usually not the case with the less concentrated IOPAMIDOL 300 injection.
Care should be exercised in patients with moderate to severe impairment of renal function (as reflected by a raised blood urea). Substantial deterioration in renal function is minimised if the patient is well hydrated. Renal function parameters, especially urinary output, should be monitored after the examination in these patients.
Re-examination should be delayed 5 to 7 days.
In pregnant women, iopamidol injection should be administered only if the procedure is considered essential by the physician.
Fertility and mutagenicity studies have shown that iopamidol has no influence on these parameters. Teratogenicity studies in rats and rabbits have shown no influence of iopamidol up to 8.2 g/kg (rat) and 4.1 g/kg (rabbit).
No data are available.
The use of organic iodine compounds may cause untoward side effects and manifestations of anaphylaxis. The symptoms include nausea, vomiting, widespread erythema, generalised heat sensation, headache, coryza or laryngeal oedema, fever, sweating, asthenia, dizziness, pallor, dyspnea and moderate hypotension. Skin reactions occur in the form of various types of rash or diffuse blister formation.
More severe reactions involving the cardiovascular system such as peripheral vasodilation with pronounced hypotension, tachycardia, dyspnea, agitation, cyanosis and loss of consciousness, may require emergency treatment.
During intracardiac and/or coronary arteriography, ventricular arrythmias may infrequently occur.
Hyperthyroidism may recur in patients previously treated for Grave's disease.
Thyroid function test - use of ISOVUE may interfere with tests or thyroid function.
Biguanide oral antidiabetic agents e.g. metformin, are excreted unchanged through the kidneys. They therefore compete for excretion in the kidneys with contrast media and this could lead to a reduction in kidney function. Patients with non-insulin dependent diabetes who are taking metformin or other biguanides should therefore be instructed note to take any doses of metformin for 48 hours before and 48 hours after the x-ray examination.
No other specific interferences with physiological functions have been noted.
Treatment of overdose is directed toward the support of all vital functions and the elimination of the contrast medium while keeping the patient well hydrated.
Keep iopamidol away from light. Store below 30ºC.
Exceptionally, crystallisation of iopamidol injections can occur. It has been shown that such a phenomenon is caused by a damaged or defective container and therefore the product should not be used in this case.
The bottle, once opened, must be used immediately. Any residue of contrast medium must be discarded.
ISOVUE injection, as other iodinated contrast media, can react with metallic surfaces containing copper (eg brass), therefore the use of equipment in which the product comes into direct contact with such surfaces should be avoided.
General Sale Medicine.
ISOVUE injection is presented in glass bottles made of type II glass (Ph, Eur.). Bottles are closed with halobutyl stoppers and aluminium crimp top seal-polypropylene caps.
ISOVUE 300: Bottles, 50 ml, 100 ml; Vials, 20 ml
ISOVUE 370: Bottles, 50 ml, 100 ml, 200 ml; Vials, 20 ml.
| ISOVUE 300 | ISOVUE 370 | |
|---|---|---|
| mg iodine/ml | 300 | 370 |
| g iopamidol/100 ml | 61.2 | 75.5 |
| Viscosity mPa.s | ||
| at 20°C | 8.8 | 20.9 |
| at 37°C | 4.7 | 9.4 |
| Relative density g/ml at 20°C |
1.33 | 1.41 |
| Osmometrics at 37°C | ||
| Osmolality (osml/kg) | 0.616 | 0.796 |
| Osmotic pressure (atm) | 15.7 | 20.3 |
| pH | 7 ± 0.5 | 7 ± 0.5 |
ISOVUE injection also contains edetate calcium disodium, trometamol, hydrochloric acid and water for injections.
Regional Health Limited
PO Box 101-104
North Shore Mail Centre
Auckland
Ph: (09) 414-0040
Fax: (09) 414-0041
20 October 2006