INFORMATION FOR HEALTH PROFESSIONALS
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Regional Health Limited
IOMERON solutions are clear, colourless solutions containing the following
concentrations of iomeprol:
IOMERON 300 contains iomeprol 61.24 g per 100 ml
IOMERON 350 contains iomeprol 71.44 g per 100 ml
IOMERON 400 contains iomeprol 81.65 g per 100 ml
Iomeron contains as its active principal iomeprol, a tri-iodinated, non-ionic contrast agent, and is for use in X ray examinations.
The pharmacokinetics, tolerability and diagnostic efficacy of iomeprol in solutions containing up to 400 mg iodine/ml have been determined in healthy volunteers and patients requiring urographic, angiographic, computed tomography (CT) and body cavity examinations.
There were no clinically significant changes in laboratory test values and vital signs.
The pharmacokinetics of iomeprol, for intravascular administration, when described by a two-compartment model, shows a rapid phase for drug distribution and a slower phase for drug elimination. In 18 healthy volunteers the mean half lives of the distribution and elimination phases of iomeprol were 23 ± 14 (s) min and 109 ± 20 (s) min, respectively, with an excretion of 50% by the urinary tract within 2 hours after the administration.
| Iomeron® 300 | Intravenous urography (in adults and paediatrics), peripheral
phlebography, CT (brain and body), cavernosography, intravenous DSA,
conventional angiography, intraarterial DSA, angiocardiography (in adults
and paediatrics), conventional selective coronary arteriography,
interventional coronary arteriography, ERCP, arthrography,
hysterosalpingography, fistulography, discography, galactography,
cholangiography, dacryocystography, sialography, retrograde urethrography,
retrograde pyelo-ureterograpy, myelography. |
|---|---|
| Iomeron® 350 | Intravenous urography (in adults and paediatrics), CT (body),
intravenous DSA, conventional angiography, intraarterial DSA,
angiocardiography (in adults and paediatrics), conventional selective
coronary arteriography, interventional coronary arteriography,
arthrography, hysterosalpingography, fistulography, galactography,
retrograde cholangiography, dacryocystography, sialography. |
| Iomeron® 400 | Intravenous urography (in adults including those with renal impairment or diabetes), CT (body), conventional angiography, intraarterial DSA, angiocardiography (in adults and paediatrics), conventional selective coronary arteriography, interventional coronary arteriography, fistulography, galactography, dacryocystography, sialography. |
CT:Computed Tomography, DSA:Digital Subtraction Angiography
ERCP:Endoscopic Retrograde Cholangio- Pancreatography, MCU:Micturating Cisto-Urethrography
| Indication | Formulation Mg (iodine)/ml |
Proposed dosages | |
|---|---|---|---|
| Intravenous urography | 300,350,400 | Adults: | 50 - 150 ml |
| Neonates: | 3 - 4.8 ml/kg | ||
| Babies: | 2.5 - 4 ml/kg | ||
| Children: | 1 - 2.5 ml/kga | ||
| Peripheral phlebography | 300 | Adults: | 10 - 100 ml. Repeat as necessaryb (10 - 50 ml upper extremities; 50 - 100 ml lower extremities) |
| CT brain | 300 | Adults: Childrena |
50 - 200 ml |
| CT body | 300,350,400 | Adults: Childrena |
100-200ml |
| Cavernosography | 300 | Adults: | Up to 100 ml |
| Intravenous DSA | 300,350,400 | Adults: Childrena |
100 - 250 ml |
| Conventional angiography | |||
| Arteriography of upper Extremities | 300,350 | Adultsb | |
| Arteriography of pelvis and Lower extremities | 300,350,400 | Adultsb | |
| Abdominal arteriography | 300,350,400 | Adultsb | |
| Arteriography of descending Aorta | 300,350 | Adultsb | |
| Pulminary angiography | 300,350,400 | Adults: | Up to 170 ml |
| Cerebral angiography | 300,350 | Adults: | Up to 100 ml |
| Paediatric arteriography | 300 | Children: | Up to 130mla |
| Interventional | 300,350,400 | Adultsb | |
| Intraarterial DSA | |||
| Cerebral | 300,350 | Adults: | 30 - 60 ml for general view; 5 - 10 ml for selective injections |
| Childrena | |||
| Thoracic | 300 | Adultsb: | 20 - 25 ml (aorta) repeat as necessary 20 ml (bronchial arteries) |
| Aortic arch | 300,350 | Adultsc | |
| Abdomen | 250,300 | Adultsc | |
| Aortography | 300,350 | Adultsc | |
| Translumbar aortography | 300 | Adultsb | |
| Peripheral arteriography | 300 | Adults: | Adults: 5 - 10 ml for selective injections up to 250 ml |
| Childrena | |||
| Interventional | 300 | Adults: | 10-30 ml for selective injections up to 250 ml |
| Childrena | |||
| Angiocardiography | 300,350,400 | Adultsb | |
| Children: | 3-5 ml/kg | ||
| Conventional selective coronary arteriography | 300,350,400 | Adults: | 4-10 ml artery repeat as necessary |
| ERCP | 300 | Adults: | up to 100 ml |
| Arthrography | 300,350 | Adults: | up to 10 ml per injection |
| Hysterosalpingography | 300,350 | Adults: | up to 35 ml |
| Fistulography | 300,350,400 | Adults: | up to 100 ml |
| Discography | 300 | Adults: | up to 4 ml |
| Galactography | 300,350,400 | Adults: | 0.15 - 1.2 ml per injection |
| Dacryocystography | 300,350,400 | Adults: | 2.5 - 8 ml per injection |
| Sialography | 300,350,400 | Adults: | 1 - 3 ml per injection |
| Retrograde cholangiography | 300, 350 | Adults: | up to 60 ml |
| Retrograde ureterography | 300 | Adults: | 20 - 100 ml |
| Retrograde pyelo-ureterography | 300 | Adults: | 10 - 20 ml per injection |
| Myelography | 300 | Adults: | 13-22 ml 10-18 ml 8-15 ml |
a = According to body weight and age
b = Do not exceed 250 ml. Single injection volume depends on the vascular area to be examined
c = Do not exceed 350 ml
There are no precise and absolute contraindications to the use of Iomeron.
Investigations of the female genitalia are contraindicated in suspected or confirmed pregnancy and in cases of acute inflammation.
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 contrastographic examination. The need should be evaluated on the basis of the clinical status of the patient, in particular in relation to pathologies on the cardiovascular, urinary or hepatobiliary systems.
The use should be avoided in case of Waldenstroem's paraproteinemia, multiple myeloma and severe liver or renal impairment.
Contrast media designed for angiocardiographic procedures should be used in hospitals or clinics equipped and staffed for intensive care in emergencies. For other more common diagnostic procedures calling for the use of iodinized contrast media, in the institutions, where such procedures are to take place, resuscitation equipment and therapeutic measures should be immediately available.
Neonates, infants, children. Young infants (age < 1 year) expecially neonates are particularly susceptible to electrolyte imbalances and haemodynamic alterations. Care should be taken regarding the dosage to be used, the details of the procedure and the patient's status.
Elderly. The elderly are at special risk of reactions due to CM high dosage. Myocardial ischemia, major arrhythmias and extrasystoles are more likely to occur in these patients. The frequently encountered combination of neurological disturbances and severe vascular pathologies constitutes a serious complication. The probability of acute renal insufficiency is higher in these subjects.
Hypersensitivity to iodinated contrast media. Hypersensitivity or a previous history of a reaction to iodinated contrast media also increases the risk of recurrence of a severe reaction with non ionic media.
Allergic disposition. It is generally agreed that adverse reactions to iodinated contrast media are more common in patients having a history of allergy: hay fever, hives and food allergy.
Asthmatic patients. The risk of bronchospasm - inducing reactions in asthmatic patients is higher after contrast media administration.
Hyperthyroidism, nodular goitre. The small amount of free inorganic iodide that may be present in contrast media, might have some effects on thyroid function: these effects appear more evident in patients with hyperthyroidism or goitre. Thyroid storms have been reported following administration of ionic contrast media.
Renal failure. Preexisting renal impairment may predispose to acute renal disfunction following contrast media administration. Preventive measures include: identification of high risk patients; ensuring adequate hydration before CM administration, preferably by maintaining i.v. infusion before and during the procedure and until the CM has been cleared by the kidneys; avoiding whenever possible, the administration of nephrotoxic drugs or major surgery or procedure such as renal angioplasty, until the CM has been cleared; postponing a new contrast agent examination until renal function returns to pre-examination levels. Patients on dialysis may receive CM, such as iomeprol, which may be cleared by dialysis.
Diabetes mellitus. The presence of renal damage in diabetic patients is one of the factors predisposing to renal impairment following CM administration. This may precipitate lactic acidosis in patients who are taking biguanides. As a precaution, biguanides should be stopped 48 hours prior tothe CM examination and reinstated only after control of renal function has been regained.
Multiple myeloma, paraproteinaemia. The use of the product is generally contraindicated. It is necessary to consider that the presence of myelomatosis or paraproteinaemias is a factor predisposing to renal impairment following CM administration. Adequate hydration is recommended.
Phaeochromocytoma. These patients may develop severe (rarely uncontrollable) hypertensive crises following intravascular CM-usage during radiological procedures.
Severe liver and renal dysfunctions. The use of the product is generally contraindicated. It is necessary to consider that a combination of severe hepatic and renal impairment can delay CM excretion, therefore predisposing to untoward reactions.
Severe cardiovascular disease. There is an increased risk of severe reactions in individuals with severe cardiac disease and particularly in those with heart failure and coronary artery disease. The intravascular CM injection may precipitate pulmonary oedema in patients with manifest or incipient heart failure, whereas CM administration, in pulmonary hypertension and heart valvular diseases, may lead to pronounced haemodynamic changes. Ischaemic ECG changes and major arrhythmias are commonest in elderly patients and in those with preexisting cardiac disease: their frequency and severity appear to be related to the severity of cardiac impairment. Severe and chronic hypertension may increase the risk of renal damage following CM administration and the risks associated with the catheterisation procedure.
CNS disorders. Particular care should be paid to the intravascular administration of CM in patients with acute cerebral infarction, acute intracranial haemorrhage, and conditions involving blood-brain-barrier (BBB) damage, brain oedema and acute demyelination. The presence of intracranial tumors or metastases and a history of epilepsy may increase the probability of the occurrence of convulsive seizures. Neurological symptoms due to degenerative, inflammatory or neoplastic cerebrovascular pathologies may be exacerbated by CM administration. Vasospasm and consequent cerebral ischaemic phenomena may be caused by intravascular injections of CM. Patients with symptomatic cerebrovascular diseases, recent stroke or frequent TIA (transient ischaemic attack) have an increased risk of transient neurological complications.
Alcoholism. Acute and chronic alcoholism have been proven both experimentally and clinically to increase BBB permeability. This facilitates the passage of iodinated agents into the cerebral tissue, possibly leading to CNS disorders.
Caution must be exercised in alcoholics because of the possibility of a reduced seizure threshold.
Drug addiction. Caution must be exercised in drug addicts because of the possibility of a reduced seizure threshold.
Hydration. Any severe disorders of water and electrolyte balance should be corrected. Especially in patients with multiple myeloma, diabetes mellitus, polyuria, oliguria, hyperuricemia, as well as in babies, small children and elderly patients adequate hydration must be ensured before examination.
Dietary suggestions. Unless otherwise instructed by the doctor, a normal diet may be maintained on the day of the examination. Adequate fluid intake must be ensured. However, for two hours prior to the procedure the patient should refrain from eating.
Premedication. In patients with phaeochromocytoma premedication with alpha-receptor blockers is recommended because of the risk of blood pressure crises.
History of hypersensitivity. In patients with an allergic disposition, known hypersensitivity to iodinated contrast media and a history of asthma, premedication with antihistamines and/or corticoids may be considered in order to prevent possible anaphylactoid reactions.
Anxiety. Pronounced states of excitement, anxiety and pain can be the cause of side effects or intensify contrast-related reactions. These patients may be given a sedative.
Co-medication. Neuroleptics and antidepressants should be discontinued 48 hours before the examination because they reduce the seizure threshold. Treatment should not be resumed until 24 hours post-procedure. Anticonvulsant therapy must not be discontinued and should be administered in optimal dosage.
Coagulation, Flushing of catheters. A property 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 anti-coagulant activity in-vitro than ionic media. Medical personnel performing vascular catheterisation procedures should be aware of this and pay meticulous attention to the angiographic technique and catheter flushing so as to minimize the risk of procedure-related thrombosis and embolism.
Observation of the patient. Intravascular administration of contrast media should, if possible, be done with the patient lying down. The patient should be kept under observation for at least 30 minutes, after the administration.
Pretesting. Sensitivity test doses are not recommended since severe or fatal reactions to contrast media are not predictable from a patient's history or a sensitivity test.
Animal studies have not shown any teratogenicity or embryotoxicity after iomeprol administration. As with other non-ionic contrast media, there are no controlled studies in pregnant women to confirm the safety for use in humans too. Since, wherever possible, exposure to radiation should be avoided during pregnancy, the benefits of any X ray examination, whether with or without contrast material, should for this reason alone be carefully weighed against the possible risk.
Contrast media are poorly excreted in human breast milk. From experience gained so far, harm to the nursing infant is unlikely to occur.
No data are available but, since delayed reactions can rarely occur after administration of iodinated contrast media, driving or operating machinery is not advisable for the first 24 hours following (contrast medium) CM examination.
The use of iodinated compounds may cause untoward effects, which are generally of mild or moderate nature, as well as more severe ones, with possible fatal anaphylactoid reactions.
Mild and moderate symptoms include heat and pain sensation (site of injection, chest, back), chills, fever, asthenia, dizziness, fainting, nausea, vomiting, sweating, pallor, dyspnoea, moderate hypotension, widespread erythema, and oedema. Furthermore agitation, headache, laryngeal oedema or nasal congestion have been described. Skin reactions may be present in the form of diversified rashes or diffuse pomphus formation, and sometimes itching. More severe effects may involve the cardiovascular system, including peripheral vasodilation with pronounced hypotension, hypertension, tachycardia or bradycardia, cyanosis, dyspnea and circulatory collapse.
The intravenous or intra-arterial injection of contrast agents may cause symptoms related to CNS disturbances: tremor, muscular spasms, mental confusion, loss of consciousness, disturbances of visual field, muscular palsies, aphasia, convulsive seizures, and coma.
However symptoms are usually mild, of short duration and self limiting. More severe neurological sequelae may be the result of complications of a pre-existing pathology.
A transient renal failure with oliguria, proteinuria and an increase of serum creatinine level may arise, particularly in patients with pre-existing impairment of renal function. Pain, haemorrhage and oedema may arise at the site of injection. In the case of extravasation a tissue reaction may ensue, but this is rare.
Thyroid function tests. Following administration of iodinated contrast media, the capacity of the thyroid tissue to take up radioisotopes for the diagnosis of thyroid disorders is reduced for up to two weeks, or even longer in individual cases.
Laboratory tests. High concentrations of contrast media in serum and urine can interfere with laboratory test results of bilirubin, proteins or inorganic substances (e.g. iron, copper, calcium, phosphate).
Interactions with oral cholecystographics. Literature search has revealed no evidence of interactions of renally excreted contrast media with oral cholecystographics contrast media.
Overdose may lead to life threatening adverse effects mainly through effects on the pulmonary and cardiovascular system.
Treatment of overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy. Iomeprol does not bind to plasma or serum proteins and is therefore dialyzable.
LD50 values (g iodine/kg) for iomeprol in animals are:
| Intravenous administration: | 19,9 (19,3 - 20,5) (mouse) |
|---|---|
| 14,5 (13,2 - 16,0) (rat) | |
| >12,5 (dog) | |
| intraperitoneal: | 26,1 (13,1 - 29,2) (mouse) |
| 10 (8,9 - 11,3) (rat) | |
| intracerebral: | 1,3 (1,2 - 1,5) (mouse) |
| intracisternal: | > 1,2 (rat) |
| intracarotid: | 5,8 (4,64 - 7,25) (rat) |
IOMERON® solutions contain: Iomeprol, trometamol (tromethamine USP), hydrochloric acid (Ph.Eur.), water for injection (Ph.Eur.).
In order to avoid possible incompatibilities, contrast media must not be mixed with other drugs.
Five years.
Protect from light. Although the sensitivity of iomeprol to X-rays is low, it is advisable to store the product out of reach of ionizing radiation.
Vials containing contrast media solution are not intended for the withdrawal of multiple doses. The rubber stopper should never be pierced more than once. The use of proper withdrawal cannulas for piercing the stopper and drawing up the contrast medium is recommended. The contrast medium should not be drawn into the syringe until immediately before use. Solutions not used in one examination session must be discarded.
General Sale Medicine
Iomeron® is packaged in ampoules or bottles made of Type 1 glass (Ph.Eur). The bottles are closed with halobutyl stoppers and an aluminium crimp seal.
Presentations:
| IOMERON® 300 | Vials | 20 ml |
|---|---|---|
| Bottles | 50 ml | |
| Bottles | 100 ml | |
| IOMERON® 350 | Bottles | 50 ml |
| Bottles | 100 ml | |
| Bottles | 200 ml | |
| IOMERON® 400 | Bottles | 50 ml |
| Bottles | 100 ml |
Results from studies in rats, mice and dogs demonstrate that iomeprol has an acute intravenous or intra-arterial toxicity similar to that of the other non ionic contrast media, as well as a good systemic tolerability after repeated intravenous administrations in rats and dogs. After intravenous administration in rats iomeprol is distributed between plasma and the extracellular space. It does not bind to plasma proteins. It is not metabolised and is eliminated almost exclusively through the kidneys. In the rat 94% of the administered dose is found unchanged in the urine within the first 8 hours.
Regional Limited
P O Box 101-140
North Shore Mail Centre
Auckland
Ph: (09) 414-0040
Fax (09) 414-0041
28 July 2006