Iopamiro

/ Dexcel

Neuroradiology:
Mieloradiculography (Iopamiro 300): 5-15 ml.
Cisternography & ventriculography (Iopamiro 300): 5-15 ml.
Angiography:
Cerebral arteriography (Iopamiro 300): 5-10 ml per bolus.
Coronary arteriography (Iopamiro 370): 8-15 ml per bolus.
Thoracic aortography (Iopamiro 370): 1.0-1.2 ml/kg.
Abdominal aortography (Iopamiro 370): 1.0-1.2 ml/kg.
Angiocardiography (Iopamiro 370): 1.0-1.2 ml/kg.
Selective visceral arteriography (Iopamiro 300, 370): depends on the vascular area to be examined.
Peripheral arteriography (Iopamiro 300, 370): 40-50 ml.
Digital Subtraction Angiography (Iopamiro 370): depends on the vascular area to be examined.
Venography (phlebography) (Iopamiro 300): 30-50 ml.
Urography:
The recommended dosage for this type of investigation is 30-50 ml for adults. The less marked osmotic diuresis induced by the non ionic agent makes Iopamiro 370 especially suitable for patients with mild or moderately severe renal insufficiency and for neonates. The new contrast medium affords diagnostically useful nephrography even in patients with major renal insufficiency.
Other Diagnostic Procedures:
Contrast enhancement in CT scanning (Iopamiro 300, 370): 0.5-2.0 ml/kg.
Artrography (Iopamiro 300): depending on examination.
Fistulography (Iopamiro 300): depending on examination.
See prescribing information for full details.

X-ray contrast medium in neuroradiology, angiography, urography, CT scanning, arthrography and fistulography.

Hypersensitivity to the active substance and the water-soluble contrast media or to any of the excipients.
Intrathecal administration:
The concomitant intrathecal administration of corticosteroids with Iopamidol is contraindicated.
Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated.

Exceptionally, crystals can be detected in the product package. This is due to a damaged or otherwise imperfect carton box and therefore the use of this package is not recommended.
The use of organic iodinate contrast media should be limited to cases for which there is a precise need for contrastographic examination.
Diagnostic procedures which involve the use of any radiopaque medium 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 any complication of the procedure, as well as for emergency treatment of severe reaction to the contrast medium itself.
As with all other contrast media this product may provoke anaphylaxis or other manifestations of allergy with nausea, vomiting, dyspnoea, erythema, urticaria and hypotension. Occasional severe reactions with fatal outcome have been reported.
A positive history of allergy, asthma or untoward reaction during previous similar investigations indicates a need for extra caution; the benefit should clearly outweigh the risk in such patients.
After administration of the contrast medium, the risk of reactions that may induce bronchospasm is greater in asthmatic patients, particularly in patients who are taking beta blockers.
Pre-treatment with antihistamines or corticosteroids to prevent or minimize possible allergic reactions in such patients may be considered.
During the examination an intravenous route for emergency treatment in the event of severe reactions is required.
After the administration of the contrast medium, competent personnel, drugs and equipment for emergency resuscitation must be available. All patients should be observed for at least 30 minutes.
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 iodinated contrast media, in the radiology departments of public or private clinics, where such procedures are to take place, resuscitation equipment and therapeutic measures should be immediately available (AMBU, oxygen, antihistaminic, vasoconstrictors, cortisonics, etc.).
Patients with congestive heart failure should be observed for several hours following the procedure to detect delayed haemodynamic disturbances, which may be associated with a transitory increase in the circulating osmotic load.
The patient should also be informed that allergic reactions may develop up to several days after the procedure; in such case, a physician should be consulted.
Extreme caution during injection of contrast media is necessary to avoid extravasation.
Local tissue irritation can occur in the case of perivascular infiltration of the contrast media.
Patients must be sufficiently hydrated before and after radiographic procedures. Patients with severe functional impairment of the liver or myocardium, myelomatosis, diabetes, polyuria or oliguria, hyperuricemia, infants, elderly patients and patients with severe systemic disease should not be exposed to dehydration.
Fluid intake should not be limited and any abnormalities of fluid or electrolyte balance should be corrected prior to use of this hypertonic solution.
Particularly fluid intake should not be limited in infants and young children, and also any abnormalities of fluid or electrolyte balance should be corrected prior to use of hypertonic contrast media.
In patients who are known epileptics or have a history of epilepsy, anticonvulsant therapy should be maintained. In some instances anticonvulsant therapy may be increased for 48 hours before the examination.
The risk associated with a particular investigation may be increased by conditions such as advanced arteriosclerosis and hypertension.
Conditions exposing to a greater risk of serious adverse events
In all the following conditions, due to the increased risk of serious adverse events, a careful evaluation of the risk-benefit ratio is recommended prior to treatment.
Patients with increased risk include those for which there is a suspicion of previous reactions to contrast or iodinated media and those suffering from allergic diseases (bronchial asthma, hay fever or food allergies).
Patients with paraproteinaemia of Waldenström, with multiple myeloma or severely compromised hepatic and renal impairment are also at special risk; these patients should be adequately hydrated.
To prevent crises in patients with sickle cell disease adequate hydration should be assured and a minimal volume of low concentration should be used.
Care should be exercised in patients with moderate to severe impairment of renal function.
In patients with impaired renal function, administration of contrast media can cause episodes of acute renal failure.
Key preventive measures include identification of high-risk patients, ensuring adequate hydration prior to contrast agent administration, preferably maintaining the intravenous infusion before and during the procedure, until the contrast medium has not been eliminated by kidneys; avoid administration of nephrotoxic drugs or undergoing the patient to major surgery or procedures such as renal angioplastic, until the contrast medium has not been completely eliminated by the kidneys; monitor renal function parameters after the procedure; postpone a new examination with contrast medium until the return of renal function to pre-examination levels.
Patients with severe hepatic, renal or combined hepato-renal insufficiency should not be examined unless absolutely indicated.
Re-examination should be delayed for 5-7 days.
Patients on dialysis may receive contrast media such as this product, which can be removed without difficulty by dialysis.
The presence of renal damage in diabetic patients is one of the factors predisposing to acute renal impairment following intravascular contrast media administration. This may precipitate lactic acidosis in patients who are taking biguanides.
Caution should be exercised in performing iodinated contrast-enhanced examinations in patients with, or with suspicion of, hyperthyroidism or autonomously functioning thyroid nodule(s), as thyroid storms have been reported following administration of iodinated contrast media.
It is possible that hyperthyroidism may recur in patients previously treated for Graves’ disease.
In patients with hyperthyroidism, the radiological examination should be performed only if thought necessary by the physician.
In patients scheduled for thyroid examination and/or treatment with a radioactive iodine tracer, iodine update in the thyroid gland will be reduced for several days, sometimes up to 2 weeks after dosing with an iodinated contrast medium that is eliminated through the kidneys.
Use of this product might interfere with tests for thyroid function.
Patients with phaeochromocytoma can develop severe hypertensive crises following intravascular iopamidol administration. Premedication with α roleceptor blockers is recommended.
Contrast induced encephalopathy
Encephalopathy has been reported with the use of iopamidol. This may manifest with symptoms and signs of neurological dysfunction such as headache, visual disturbance, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness, coma and cerebral oedema within minutes to hours after administration and generally resolves within days. Factors which increase blood-brain barrier permeability will ease the transfer of contrast media to brain tissue and may lead to possible CNS reactions, for instance encephalopathy.
If contrast encephalopathy is suspected, iopamidol should not be re-administered and appropriate medical management should be initiated.
The administration of iodinated contrast media may aggravate signs and symptoms of myasthenia gravis.
Iopamidol should be administered with caution in patients with hyperkalaemia and cerebral vascular disease.
Iopamidol should be administered with caution in patients with symptomatic cerebrovascular disease, heart attack/recent stroke or transient ischemic attack (TIA), abnormal permeability of the blood-brain barrier, increased intracranial pressure, suspicion of intracranial tumour, abscess or hematoma/haemorrhage, previous seizures, alcoholism.
Neuroradiology
The contrast medium should be removed as much as possible in case of spinal fluid blockage. Patients receiving treatment with anticonvulsant drugs must continue such treatment before and after the procedure.
Should a convulsive seizure develop during the examination, administer diazepam or sodium phenobarbital intravenously.
Intrathecal administration
An accurate evaluation of the risk/benefit ratio is needed if from clinical history there is a previous history of epilepsy or in the presence of blood in the cerebrospinal fluid or presence of local or systemic infection where bacteraemia is likely.
The operator should evaluate in those cases the diagnostic need against possible risk to the patient.
After completion of direct cervical or lumbo-cervical procedures.
Angiography
The risk associated with a particular investigation may be increased by conditions such as advanced arteriosclerosis, hypertension, heart failure, severe systemic disease, embolism or recent cerebral thrombosis.
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.
During intracardiac and/or coronary arteriography, ventricular arrhythmias may infrequently occur.
Great caution should be paid when injecting the contrast medium into the heart chambers, especially in cyanotic neonates with pulmonary hypertension and impaired cardiac function.
The intravascular injection of a contrast medium can evolve in pulmonary oedema in patients with congestive heart failure.
In angiographic procedures, the possibility of dislodging plaque or damaging or perforating the vessel wall should be considered during catheter manipulation and contrast medium injection. Test injections to ensure proper catheter placement are recommended.
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.
Angiography should be avoided whenever possible in patients with homocystinuria due to an increased risk of thrombosis and embolism.
Vasospasm and subsequent cerebral ischemic phenomena may be caused by intra-arterial injections of contrast media. Even in abdominal angiography excessive pressure transmitted by the automatic pump can cause renal infarction, spinal cord injury, retroperitoneal haemorrhage, myocardial and intestinal necrosis.
In peripheral arteriography using the 370 mg/mL Solution for injection can cause the onset of painful effects that are not manifest with the 300 mg/mL Solution for injection.
In patients undergoing peripheral angiography, the pulsation of the artery in which the contrast medium should be injected needs to be appreciated. In patients with thromboangiitis obliterans, or ascending infections in association with severe ischemia caution should be exercised in performing angiography, if necessary.
In patients undergoing venography, special caution should be exercised in patients with suspected phlebitis, serious ischemia, local infections, or a complete venous occlusion.
It has been shown in vitro that the inhibitory effects of non-ionic contrast media on the mechanisms of haemostasis are lower than those of ionic contrast media at the same concentration.
Severe cutaneous adverse reactions
Severe cutaneous adverse reactions (SCARs), such Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (Lyell’s syndrome or TEN) and acute generalised exanthematous pustulosis (AGEP), which can be life threatening, have been reported in patients administered with this product. At the time of initiation, patients should be advised of the signs and symptoms and monitored closely for severe skin reactions. If signs and symptoms suggestive of these reactions appear, further use of this product should be withheld. If the patient has developed a severe cutaneous adverse reaction with the use of this product, it must not be re-administered in this patient at any time.
Use in Special Populations
Newborns, children: Infants (age<1 year), and especially newborns 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.
Transient thyroid suppression or hypothyroidism has been observed in children after exposure to iodinated contrast media.
Following a diagnostic procedure, this has been more frequently observed in neonates and premature infants and also following procedures associated with higher doses. Neonates may also be exposed via maternal exposure.
In neonates, especially preterm infants, who have been exposed to iopamidol, either through the mother during pregnancy or in the neonatal period, it is recommended to monitor thyroid function.
If hypothyroidism is detected, the need for treatment should be considered and thyroid function should be monitored until normalised.
Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age
Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media (ICM) in pediatric patients 0 to 3 years of age.
Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after ICM exposure. Pediatric patients with congenital cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures.
An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to ICM, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates.
Elderly: The elderly are at special risk of reactions due to reduced physiological functions, especially when high dosage of contrast medium is used. Myocardial ischemia, major arrhythmias and premature ventricular complexes are more likely to occur in these patients. The probability of acute renal insufficiency is higher in these patients.
Women of child-bearing potential: Appropriate investigations and measures should be taken when exposing women of child-bearing potential to any X-ray examination, whether with or without contrast medium.
See prescribing information for full details.

Intravascular administration:
Common: Headache, nausea, feeling hot.
Intrathecal administration:
Very common: Headache.
Common: Redness, nausea, vomiting, back pain, neck pain, pain in extremity, sensation of heaviness.
See prescribing information for full details.

To prevent onset of lactic acidosis in diabetic patients under treatment with oral anti-diabetic agents of the biguanide class, biguanides should be stopped 48 hours before the administration of the contrast medium and re-instated only after renal function has been demonstrated to have returned to pre-examination values.
In emergency patients in whom renal function is either impaired or unknown, the physician shall weigh out risk and benefit of an examination with a contrast medium.
Metformin should be stopped from the time of contrast medium administration. After the procedure, the patient should be monitored for signs of lactic acidosis. Metformin should be restarted 48 hours after contrast medium if serum creatinine/eGFR is unchanged from the pre-imaging level.
Patients with normal renal function can continue to take Metformin normally.
Cardiac and/or hypertensive patients under treatment with diuretics, ACE-inhibitors, and/or beta-blocking agents are at higher risk of adverse reactions when administered iodinated contrast media.
Following administration of iopamidol atypical adverse reactions e.g. erythema, fever and flu symptoms have been reported in patients treated with interleukin-2 and interferon.
Following administration of iopamidol, the capacity of the thyroid tissue to take up iodine is reduced for 2-6 weeks.
Arterial thrombosis has been reported when iopamidol was given following papaverine. The administration of vasopressors strongly potentiates the neurological effects of intra-arterial contrast media.
Renal toxicity has been reported in patients with liver dysfunction who were given oral cholecystographic agents followed by intravascular contrast agents.
However, recent studies have not shown interactions of contrast agents excreted by the kidney with oral cholecystographic contrast agent.
Contrast media may interfere with laboratory tests for bilirubin, proteins or inorganic substances (e.g. iron, copper, calcium, and phosphate). These substances should not be assayed during the same day following the administration of contrast media.
In patients receiving beta-blockers there is an elevated risk of more severe anaphylactoid reactions.
Beta-blockers may impair the response to treatment of bronchospasm induced by contrast medium.
Intrathecal administration
Intrathecal corticosteroids should never be concurrently administered when Iopamidol is used.
Neuroleptics should be avoided as they lower the seizure threshold. This is also true for drugs such as analgesics, antiemetics, antihistaminics, or sedatives of the phenothiazine group. Wherever possible the therapy with such drugs must be discontinued at least 48 h before the radiological investigation and treatment can be resumed not earlier than 24 h afterwards.
Alcoholism or drug addiction increase the permeability of the blood brain barrier. This facilitates the passage of iodinated agents in brain tissue with possible CNS disorders. A possible lowering of seizure threshold should be kept in mind.
See prescribing information for full details.

Pregnancy
The safety of iopamidol injection during pregnancy has not been established.
Since radiation exposure during pregnancy should be avoided anyway, regardless of whether a contrast agent is used or not, the benefit of X-ray examination has to be considered carefully. Apart from radiation exposure of the foetus, benefit-risk consideration for iodine-containing contrast agents should also take into account the sensitivity of the foetal thyroid towards iodine.

Animal studies do not indicate direct or indirect effects on pregnancy and embryonal/fetal development. Caution is needed in prescribing the contrast medium in pregnant women.
Lactation
Iodine-containing X-ray contrast agents are excreted into the breast milk in low amounts. At therapeutic doses harmful effects on the nursing infant are unlikely. However, although no side effects in nursing infants have been reported, caution should be exercised when administering endovascular X-ray contrast media to nursing women because of potential adverse events and discontinuation of breastfeeding for 24 hours after treatment with iodinated contrast should be considered.
Fertility
There are no adequate and controlled clinical trials on fertility.

Most side effects are not dose-dependent and may therefore require therapeutic interventions.
In the event of voluntary or accidental administration of higher than normal doses, excretion should be facilitated by ensuring patient hydration, as clearance almost totally occurs via the kidney. In the event of renal insufficiency, whether pre-existing or manifesting after contrast medium introduction, dialysis will eliminate the contrast medium.
Dosages exceeding the specific doses as recommended in section Dosage, are not recommended, as they might lead to life-threatening adverse effects.
If needed, haemodialysis can be used to eliminate iopamidol from the body.
Treatment of overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy.
Intravascular administration
In the event of accidental intravascular overdose, the water and electrolyte losses must be compensated by infusion. Renal function should be monitored for at least three days.
Intrathecal administration
Signs of intrathecal overdose may be: ascending hyperreflexia, tonic-clonic spasms, up to sudden seizures, and, in severe cases of central involvement, hyperthermia, stupor and respiratory depression.