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
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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 |
Sources
Isovue-m 200 Manufacturers
-
General Injectables & Vaccines, Inc.
![Isovue-m 200 (Iopamidol) Injection, Solution [General Injectables & Vaccines, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Isovue-m 200 | General Injectables & Vaccines, Inc.
In adults a solution that is approximately isotonic (ISOVUE-M 200) is recommended for examination of the lumbar region. For movement of the contrast medium to distant target areas the more concentrated ISOVUE-M 300 preparation should be used to compensate for dilution of ISOVUE-M (lopamidol Injection) with cerebrospinal fluid.
The usual recommended adult dose range for iopamidol is 2000-3000 mg iodine. Iopamidol formulated to contain more than 300 mgl/ml should not be used intrathecally in adults. The minimum dose needed to perform a procedure should always be used.In pediatric patients, a solution that is approximately isotonic (ISOVUE-M 200) is recommended for all intrathecal procedures. In children, loss of contrast due to mixing on movement of the medium is less apt to occur because of their shorter spinal cord.
The usual recommended pediatric dose range for iopamidol is 1400-2400 mg iodine. Iopamidol formulated to contain more than 200 mgl/ml should not be used. See pediatric dosage table for recommended dosage.
Pediatric Dosage Table ISOVUE-M 200 (200mgl/mL)
Anesthesia is not necessary. However, young children may require general anesthesia for technical reasons. Premedication with sedatives or tranquillizers is usually not needed. In patients with a history of seizure activity who are on anticonvulsant therapy, premedication with barbiturates or phenytoin should be considered.
Lumbar puncture is usually made between L3 and L4; if pathology is suspected at this level, the interspace immediately above or below may be selected. A lateral cervical puncture may also be used.
Rate of Injection: To avoid excessive mixing with cerebrospinal fluid and consequent loss of contrast as well as premature cephalad dispersion, injection must be made slowly over one to two minutes; the needle may
then be removed.
An interval of at least 48 hours should be allowed before repeat examination; however, whenever possible five to seven days is
recommended.
As with all radiopaque contrast agents, only the lowest dose of ISOVUE-M necessary to obtain adequate visualization should be used. A lower dose reduces the possibility of an adverse reaction. Most procedures do not require use of either a maximum dose or the highest available concentration of ISOVUE-M; the combination of dose and ISOVUE-M concentration to be used should be carefully individualized, and factors such as age, body size, anticipated pathology and degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered. Following are the usual recommended pediatric and adult doses of ISOVUE-M.
The pediatric doses listed below, intended as a guideline, are based on age rather than weight because the brain and CSF capacity is independent of weight. Variations will depend on such factors as height, suspected pathology, the patient's condition, technique used, etc. (e.g. CT or standard radiology or movement of the contrast media directed distal to the sit of injection).
Usual
Age
Recommended
Procedure
Years
Dose (mL)
Lumbar, thoracic myelogram
2-7
7-9
8-12
8-11
13-18
10-12
Adult Dosage Table
Usual
Concentration
Recommended
of Solution
Dose
(mgl/mL)
(mL)
Lumbar myelogram
200
10 to 15
Thoracic myelogram
200
10 to 15
Cervical myelogram
200
10 to 15
(via lumbar injection)
300
10
Cervical myelogram
200
10
(via lateral cervical injection)
Total columnar myelography
300
10
CT cisternography
200
4 to 6
(via lumbar injection)
Following subarachnoid injection, conventional radiography will continue to provide good diagnostic contrast for at lease 30 minutes. At about one hour, diagnostic degree of contrast will not usually be available. However, suffiicient contrast for CT myelography will be available for several hours. CT myelography following conventional myelography should be deferred for at least four hours to reduce the degree of contrast. Aspiration of iopamidol is unnecessary following intrathecal administration (see CLINICAL PHARMACOLOGY).
It is desirable that solutions of radio paque diagnostic agents for intrathecal use be at body temperature when injected. In the even that crystallization of the medium has occurred, place the vial in hot (60 degree to 100 degree C) water for about five minutes, then shake gently to obtain a clear solution. Cool to body temperature before use.
Discard vial without use if solids persist.
Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions with sterile syringes. Spinal puncture must always be performed under sterile conditions.
Parenteral drug products should be inspected visually for particulate matter and discolorationprior to administration, whenever solution and container permit. Iopamidol solutions should be used only if clear and within the normal colorless to pale yellow range.
Patients should be well hydrated prior to and following ISOVUE-M (Iopamidol Injection) administration.
Suggestions for Usual Patient Management
Preprocedure
* See WARNINGS regarding discontinuation of neuroleptic agents
* Maintain normal diet up to 2 hours before procedure
* Ensure hydration-fluids up to time of procedure
During Procedure
* Use minimum dose and concentration required for satisfactory contrast.
* Inject slowly over 1 to 2 minutes to avoid excessive mixing.
* Abrupt or active patient movement causes excessive mixing with CSF.
* Instruct patient to remain passive. Move patient slowly and only as necessary.
* To maintain as a bolus, move medium to distal area very slowly under fluoroscopic control.
* In all positioning techniques keep the patient's head elevated above highest level of spine.
* Do not lower head of table more than 15 degrees during thoraco-cervical procedures.
* In patients with excessive lordosis, consider lateral position for injection and movement of the medium cephalad.
* Avoid intracranial entry of a bolus.
* Avoid early and high cephalad dispersion of the medium.
* At completion of direct cervical or lumbo-cervical procedures, raise head of table steeply (45 degrees) for about 2 minutes to restore medium to lower levels.
Post procedure
* Raise head of stretcher to at lease 30 degrees before moving patient onto it.
* Movement onto stretcher, and off the stretcher to bed, should be done slowly with patient completely passive, maintaining head up position.
* Before moving patient onto bed, raise head of be 30 degree to 45 degree and maintain the patient in this position under close observation for 12 to 24 hours.
* Advise patient to remain still in bed, in head up position for the first 24 hours.
* Obtain visitors cooperation in keeping the patient quiet and in head up position, especially in first few hours.
* Encourage oral fluids and diet as tolerated.
* Antinauseants of the phenothiazine class should not be administered to treat the postprocedural nausea or vomiting (see WARNINGS). Since persistent nausea and vomiting may result in dehydration, prompt consideration of volume replacement by intravenous fluids is recommended.
Drug Incompatibilities
Many radiopaque contrast agents are incompatible in vitro with some antihistamines and many other drugs; therefore, no other pharmaceuticals should be admixed with contrast agents.
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