Iopamiro 370

Iopamiro 370 Side Effects

iopamidol

Manufacturer:

Bracco

Distributor:

DCH Auriga
Full Prescribing Info
Side Effects
NEURORADIOLOGY: In the event of CSF blockade, remove as much of the administered contrast solution as possible. The use of organic iodine contrast media may be contraindicated for patients with a history of epilepsy. Also the presence of blood in the CSF contraindicates the use of Iopamiro: in such cases, the operator should carefully assess the need for the diagnostic procedure against possible risk to the patient. 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. Neuroleptics must be absolutely avoided because they lower the seizure threshold. The same applies to analgesics, 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.
Clinical trials have shown that Iopamiro is readily tolerated by the vast majority of patients, both in general terms and, particularly, in terms of CNS tolerability. Reported side effects include headache (sometimes with a delayed onset), nausea, vomiting and pain at the site of injection, all these manifestations being generally mild and of short duration. More rarely or indeed exceptionally, patients have developed dizziness, neck rigidity, lumbar pain, or sciatic pain - the latter often as a transient exacerbation of pre-existing symptoms. Fever was reported in a few cases. Exceptionally, patients dosed with Iopamiro have developed muscular spasms or generalized convulsions, sometimes representing a recurrence of established epilepsy or attributable to accidental overdosage of neuroleptic drugs. Very few cases of transient mental confusion have been reported.
ANGIOGRAPHY: The use of Iopamiro as a contrast medium for cerebral angiography, may cause side effects, which are usually mild and of short duration. Many patients report a sensation of heat in the face and neck; a few complain of headache. A fairly frequent cardiovascular reaction to dosing with Iopamiro is bradycardia associated with systemic hypotension. The reaction is transient and requires no treatment. Severe neurological sequelae may arise as direct complications of pre-existing pathology in the individual patient. Such reactions are diverse and may include tonic/clonic convulsions, aphasia, fainting, transient narrowing of visual field, hemiparesis and coma. The risk associated with a particular investigation involved may be increased by conditions such as advanced arteriosclerosis, hypertension, heart failure, major systemic diseases and recent cerebral embolism or 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. In paediatric roentgenology, one should proceed with great caution when injecting the contrast medium into the right heart 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, retroperitoneal bleeding, intestinal infarction and necrosis. In peripheral arteriography Iopamiro 370 may sometimes cause a painful reaction in the involved limb.
This is usually not the case with the less concentrated solution Iopamiro 300.
A property of nonionic contrast media is the extremely low interference with normal physiological functions. As a consequence of this nonionic 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 angiographic technique and catheter flushing so as to minimize the risk of procedure-related thrombosis and embolism.
UROGRAPHY: The side effects that may arise in connection with intravenous urography are those described in Warnings.
OTHER DIAGNOSTIC PROCEDURES: The reactions reported in cases of arthrography and fistulography usually represent irritative manifestations superimposed on existing tissue inflammation.
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