Iopamidol - Warnings and Precautions

WARNINGS The need for myelographic examination should be carefully evaluated.

Iopamidol should be administered with caution in patients with increased intracranial pressure or suspicion of intracranial tumor, abscess or hematoma, those with a history of convulsive disorder, severe cardiovascular disease, chronic alcoholism, or multiple sclerosis, and elderly patients.

Particular attention must be given to state of hydration, concentration of medium, dose, and technique used in these patients.

Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when injected intravenously or intra-arterially.

Although Iopamidol Injection is not injected intravascularly, measurable plasma levels are attained after intrathecal administration of iopamidol.

If frankly bloody cerebrospinal fluid is observed, the possible benefits of a myelographic examination should be considered in terms of risk to the patient.

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.

Focal and generalized motor seizures have been reported after intrathecal use of water-soluble contrast agents including iopamidol.

In several of those cases reported with iopamidol, higher than recommended doses were employed.

Therefore avoid : Deviations from recommended neuroradiologic procedure or patient management.

Use in patients with a history of epilepsy unless medically justified.

Intracranial entry of a bolus or premature diffusion of a high concentration of the medium.

Failure to maintain elevation of the head during the procedure, on the stretcher, and in bed.

Excessive and particularly active patient movement or straining.

Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration.

These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS).

Reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions.

Avoid administering Iopamidol Injection to patients with a history of a severe cutaneous adverse reaction to Iopamidol Injection.