Isovue-m 200

Isovue-m 200

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Questions & Answers

Side Effects & Adverse Reactions

The need for myelographic examination should be carefully evaluated. Iopamidol should be administered with caution in patients with increased intrcranial 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 ISOVUE-M 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 increase 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 thresnold (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. Therfore avoid:

  • Deviations from recommended neuroradiologic procedure or patient management.
  • Use in patients with a history of epilepsy unless medically justified.
  • Overdosage.
  • Intracranial entry of a bolus or premature diffusion of a high concentration of the medium.
  • Failure to maintain elvation of the head during the procedure, on the stretcher, and in bed.
  • Excessive and particularly active patient movement or straining.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

ISOVUE-M (Iopamidol Injection) is indicated for intrathecal administration in adult neuroradiology inculding myelography(lumbar, thoracic, cervical, total columnar), and for contrast enhancement of computed tomographic (CECT) cisternography and ventriculography. ISOVUE-M 200 (lopamidol Injection) is indicated for thoraco-lumbar myelography in children over the age of two years.

History

There is currently no drug history available for this drug.

Other Information

Diagnostic

NONIONIC RADIOPAQUE CONTRAST MEDIA

For Intrathecal Administration in Neuroradiology

Including Myelography (Lumbar, Thoracic, Cervical, Total Columnar) Pediatric Myelography (Lumbar, Thoracic), and for Contrast Enhancement of Computed Tomographic (CECT) Cisternography and Ventriculography


ISOVUE-M (Iopamidol Injection) formulations are stable, aqueous, sterile, and nonprrogenic solutions for intrathecal administration. Each mL of ISOVUE-M 200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1mg tromethamine and 0.26 mg edetate calcium disodium. The solution contains approximately 0.029 mg (0.001mEq) sodium and 200 mg organically bound iodine per mL. Each mL of ISOVUE-M 300 (lopamidol Injection 61%) provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. The pH of ISOVUE-M contrast media has been adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE-M (lopamidol Injection) is hypertonic as compared to plasma and cerbrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively).

                                                                                                                           


Iopamidol

Parameter 41% 61%
  Concentration 200 300
   (mgl/mL)

 Osmolality @ 37 degrees C 413 616
  (mOsm/kg water)

 Visosity (cP) @ 37 degrees C 2.0 4.7
                   @ 20 degrees C 3.3 8.8
Specific Gravity @37 degrees C 1.216 1.328
Iopamidol is designated chemically as (s)-N,N'-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2, 4, 6,-triiodo-5-lactamidoisophthalamide. Structural formula:

Formula1


Isovue-m 200 Manufacturers


  • General Injectables & Vaccines, Inc.
    Isovue-m 200 (Iopamidol) Injection, Solution [General Injectables & Vaccines, Inc.]

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