In the United States: Visipaque is not for Intrathecal Use. All non-ionic, iodinated contrast media currently available inhibit blood coagulation in vitro less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing non-ionic contrast media. Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxlcosis myelomatosis, or anuria, particularly when large doses are administered. (See Precautions).
Prescribing Information(1) Visipaque(TM) iodixanol
Please refer to full national Summary of Product Characteristics (SPC) before prescribing.
Presentation
An isotonic, aqueous solution containing iodixanol, a non-ionic, dimeric contrast medium, available in three strengths containing either 150 mg, 270 mg or 320 mg iodine per ml.
Indications
X--ray contrast medium for use in adults in cardioangiography, cerebral angiography, peripheral arteriography, abdominal angiography, urography, venography, CT enhancement, studies of the upper gastrointestinal tract, arthrography, hysterosalpinography (HSG) and endoscopic retrograde cholangiopancreatography (ERCP). Lumbar, thoracic and cervical myelography in adults. In children for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
Dosage and Administration
Adults and children: Dosage for intravascular and oral use varies depending on the type of examination, age, weight, cardiac output, general condition of patient and the technique used (see SPC and package leaflet).
Contra-Indications
Manifest thyrotoxicosis. History of serious hypersensitivity reaction to Visipaque.
Precautions, Warnings, etc.
A positive history of allergy, asthma, or reaction to iodinated contrast media indicates need for special caution. Premedication with corticosteroids or H1 and H2 antagonists should be considered in these cases. Although the risk of serious reactions with Visipaque is regarded as low, iodinated contrast media may provoke serious, hypersensitivity reactions. Therefore the necessary drugs and equipment must be available for immediate treatment. Patients should be observed for at least 30 minutes following administration of contrast medium, however delayed reactions may occur. Non-ionic contrast media have less effect on the coagulation system in vitro, compared to ionic contrast media. When performing vascular catheterisation procedures one should pay meticulous attention to the angiographic technique and flush the catheter frequently (e.g. with heparinised saline) so as to minimise the risk of procedure-related thrombosis and embolism. Ensure adequate hydration before and after examination especially in patients with renal dysfunction, diabetes mellitus, paraproteinemias, the elderly, children and infants. Special care should also be taken in patients with hyperthyroidism, serious cardiac disease, pulmonary hypertension, patients predisposed to seizures (acute cerebral pathology, tumours, epilepsy, alcoholics and drug addicts), and patients with myasthenia gravis or phaeochromocytoma. Particular care is required in patients with severe disturbance of both renal and hepatic function as they may have significantly delayed contrast medium clearance. All iodinated contrast media may interfere with laboratory tests for thyroid function, bilirubin, proteins, or inorganic substances (e.g. iron, copper, calcium, and phosphate). In diabetic patients metformin should be stopped when contrast media are used. The timing of this should be amended based upon serum creatine/renal function levels. (refer to SPC) An increased risk of delayed reactions (flu like or skin reactions) has been associated with patients treated with interleukin-2 up to two weeks previously. The safety of Visipaque in pregnancy has not been established. The degree of excretion into human milk is not known. Breast feeding should be discontinued prior to administration and not recommenced until at least 24 hours after administration.
Side Effects
Usually mild to moderate, and transient in nature, they include discomfort, general sensation of warmth or cold, pain at the injection site or distally. Serious reactions are only seen on very rare occasions. Nausea, vomiting, and abdominal discomfort are rare. Hypersensitivity reactions occur occasionally with symptoms such as rash, urticaria and pruritus (immediate or delayed). Severe reactions such as bronchospasm, angioedema, dyspnoea and fatal anaphylaxis are very rare. Neurological reactions, headache, dizziness, seizures, and transient motor or sensory disturbance (e.g. taste or smell alteration) are very rare. Also reported very rarely; vagal reactions, cardiac arrhythmia, hypertension and 'iodide mumps'. Arterial spasm may follow injection. A minor transient rise in creatinine is common. Renal failure is very rare. Post phlebographic phlebitis or thrombosis is very rare. Gastrointestinal disturbances including diarrhoea, nausea/vomiting and abdominal pain and systemic hypersensitivity reactions occur occasionally (<1:10, >1:100).
Overdose
In the event of accidental overdosing, renal function should be monitored for at least 3 days in addition to supportive measures. Haemodialysis should be considered if needed.
Marketing Authorisation Number
Visipaque 150 mg I/ml - 60.635, 270mg I/ml - 60.636, 320mg I/ml - 60.637; Visipaque USP 150 mg I/ml - 62.916; Visipaque USP 270 mg I/ml - 62.917; Visipaque USP 320 mg I/ml - 62.918.
Marketing Authorisation Holder
Amersham Health AS, Nycoveien 1-2, Postboks 4220 Nydalen, N-0401 Oslo, Norway.
Further information on request from: Amersham Health, The Grove Centre, White Lion Road, Amersham, Bucks HP7 9LL.
Date of preparation: October 2004.
(1) Indications and approvals may vary in different countries. Consult your local package insert for details. Further information available on request.
Media contact:
Sebastien Duchamp
Communications Director
GE Healthcare International
+33-6-73-19-59-64
Sebastien Duchamp, Communications Director, GE Healthcare International, +33-6-73-19-59-64
