ISOVUE-M® 200 (Iopamidol Injection 41%)
ISOVUE-M® 300 (Iopamidol Injection 61%)
Indications and Usage:
ISOVUE-M (Iopamidol Injection) is indicated for intrathecal administration in adult neuroradiology including myelography (lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. ISOVUE-M 200 (Iopamidol Injection 41%) is indicated for thoraco-lumbar myelography in children over the age of two years.
IMPORTANT SAFETY INFORMATION:
Intrathecal administration of corticosteroids with iopamidol is contraindicated. Because of overdosage considerations, immediate repeat myelography in the event of technical failure is contraindicated. Myelography should not be performed in the presence of significant local or systemic infection where bacteremia is likely.
Patients on anticonvulsant medication should be maintained on this therapy.
Direct intracisternal or ventricular administration for standard radiography (without computerized tomographic enhancement) is not recommended. Inadvertent intracranial entry of a large or concentrated bolus of the contrast medium, which increases the risk of neurotoxicity, can be prevented by careful patient management. Also, effort should be directed to avoid rapid dispersion of the medium causing inadvertent rise to intracranial levels (e.g., by active patient movement). If such intracranial entry of the medium occurs, prophylactic anticonvulsant treatment with diazepam or barbiturates orally for 24 to 48 hours should be considered.
Use of medications that may lower the seizure threshold (phenothiazine derivatives, including those used for their antihistaminic properties; tricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics; antipsychotic agents) should be carefully evaluated. While the contributory role of such medications has not been established, some physicians have discontinued these agents at least 48 hours before and for at least 24 hours following intrathecal use.
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ISOVUE-M is currently manufactured for Bracco Diagnostics Inc. at two locations: BIPSO GmbH, Singen (Germany) and Patheon Italia S.p.A., Ferentino, (Italy).
ISOVUE-M is a registered trademark of Bracco Diagnostics Inc.