"The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape B"...
ISOVUE-M (lopamidol 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 (lopamidol Injection) is indicated for thoraco-lumbar myelography in children over the age of two years.
DOSAGE AND ADMINISTRATION
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 intrathecally in children. The minimum dose needed to perform a procedure should always be used. See pediatric dosage table for recommended dosage.
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 not on anticonvulsant therapy, premedication with barbiturates or phenytoin should be considered.
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 site of injection).
Pediatric Dosage Table ISOVUE-M 200 (200 mgl/mL)
|Procedure||Age Years||Usual Recommended Dose (mL)|
|Lumbar, thoracic myelogram||2-7||7-9|
|Adult Dosage Table|
|Concentration of Solution(mgI/mL)||Usual Recommended Dose (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 (via lateral cervical injection)||200||10|
|Total columnar myelography||300||10|
|CT cisternography (via lumbar injection)||200||4 to 6|
Following subarachnoid injection, conventional radiography will continue to provide good diagnostic contrast for at least 30 minutes. At about one hour, diagnostic degree of contrast will not usually be available. However, sufficient 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).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Iopamidol solutions should be used only if clear and within the normal colorless to pale yellow range.
Discard any product which shows signs of crystallization or damage to the container-closure system, which includes the glass container, stopper and/or crimp.
It is desirable that solutions of radiopaque diagnostic agents for intrathecal use be at body temperature when injected. 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.
Patients should be well hydrated prior to and following ISOVUE-M (Iopamidol Injection) administration.
Suggestions for Usual Patient Management
- See WARNINGS regarding discontinuation of neuroleptic agents.
- Maintain normal diet up to 2 hours before procedure.
- Ensure hydration-fluids up to time of 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° 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°) for about 2 minutes to restore medium to lower levels.
- Raise head of stretcher to at least 30° 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 bed 30° to 45° 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 the treat 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.
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.
ISOVUE-M 200 (lopamidol Injection 41%)
Ten 10 mL single dose vials (NDC 0270-1411-11)
Ten 20 mL single dose vials (NDC 0270-1411-25)
ISOVUE-M 300 (lopamidol Injection 61%)
Ten 15 mL single dose vials (NDC 0270-1412-15)
Store at 20-25° C (68-77° F). [See USP]. Protect from light.
Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by BIPSO GmbH 78224 Singen (Germany). Revised August 2012
Last reviewed on RxList: 8/28/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Isovue-M Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.