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Ethiodol Recall
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Side Effects & Adverse Reactions
WARNINGS
Ethiodol is not intended for use in bronchography and, therefore, is not to be introduced into the bronchial tree. A history of sensitivity to iodine or to other contrast materials is not an absolute contraindication to Ethiodol, but calls for extreme caution. All procedures utilizing contrast media carry a definite risk of adverse reactions. While most reactions are minor, life threatening and fatal reactions may occur without warning. The risk/benefit factor should always be carefully evaluated. At all times a fully equipped emergency cart and resuscitation equipment should be readily available, and personnel competent in recognizing and treating reactions of all severity should be on hand.
WARNINGSThe use of intralymphatic Ethiodol presents a significant hazard in patients with pre-existing pulmonary disease characterized by a decrease in pulmonary diffusing capacity and/or pulmonary blood flow. A few fatalities have been noted in such patients. With reference to this potential complication, recent studies indicate a significant decrease in both pulmonary diffusing capacity and pulmonary capillary blood flow following Ethiodol lymphography without appreciable concomitant clinical manifestations. Also, care should be exercised in patients with other types of pulmonary disease in view of the more frequent incidence of overt pulmonary complications such as pulmonary infarction, in these groups. However, it is to be noted that pulmonary infarction, although rare, has occurred in patients without evidence of pre-existing pulmonary disease.
The safety of intralymphatic Ethiodol has not been established in pregnant women, and accordingly, its use should be restricted to such situations where it is deemed necessary.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Ethiodol is indicated for use as a radio-opaque medium for hysterosalpingography and lymphography.
History
There is currently no drug history available for this drug.
Other Information
Ethiodol, brand of ethiodized oil, is a sterile injectable radio-opaque diagnostic agent for use in hysterosalpingography and lymphography. It contains 37% iodine (475 mg/mL) organically combined with ethyl esters of the fatty acids (primarily as ethyl monoiodostearate and ethyl diiodostearate) of poppyseed oil. Stabilized with poppyseed oil, 1%. The precise structure of Ethiodol is unknown at this time. Ethiodol is a straw to amber colored, oily fluid, which because of simplified molecular structure, possesses a greatly reduced viscosity (1.280 specific gravity at 15° C yields viscosity of 0.5 - 1.0 poise). This high fluidity provides a new flexibility for radiographic exploration.
Sources
Ethiodol Manufacturers
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Savage Laboratories
Ethiodol | Savage Laboratories
DOSAGE AND ADMINISTRATIONThe hysterosalpingogram is preferably taken during the patient's preovulatory phase (as determined from her basal body temperature record) and not less than two days after cessation of her menstrual flow. It has been frequently observed that some bleeding will occur during or after the onset of pregnancy which cannot be distinguished by the patient from a normal menstrual period. In such cases a basal body temperature record will reveal a sustained high temperature phase, and thus enable an operator to avoid hysterosalpingography when a pregnancy may exist. Salpingography should not be performed if the blood is exuding from the cervical os (which occasionally occurs without the patient being aware of it) or if any gross evidence of endocervicitis exists.
Careful aseptic technique should be employed as for any operative procedure in which the uterus is entered. A self-retaining cannula should be used thereby permitting removal of the vaginal speculum so that the outline of the cervical canal may be seen in the film. The use of a radio-opaque aluminum speculum may be employed in patients where a lacerated or patulous cervix does not permit the use of a retaining cannula.
The radio-opaque agent is introduced under pressure and preferably with fluoroscopic control. A preliminary film is exposed and a skiagram is made after the injection of 5 mL of the agent. The pressure is raised to 80-90 mm Hg. In cases of normal bilateral tubal patency, the pressure falls immediately to below 60 mm Hg. The wet film may be viewed immediately and if both tubes are seen to "fill", the apparatus is removed and the procedure is finished, except for the 24 hour follow-up to establish whether or not "spill" into the peritoneal cavity has occurred.
Increments of 2 mL of the agent are injected and successive films exposed until tubal patency is established or until the patient's limit of tolerance to discomfort is reached. Few patients will complain of discomfort at pressures under 200 mm Hg.
DOSAGE AND ADMINISTRATIONThis method applies for both the upper and lower extremities. A lymphatic vessel is selected for cannulization.
The patient should be comfortably arranged in a supine position on a portable stretcher or an x-ray table. When available, a radiolucent pad will add to the patient's comfort during the one to two hours required for completion of the examination. It is important that the patient be in a cooperative state. Premedication might be advisable in the unusually apprehensive patient.
In the unusually restless patient, the extremities should be immobilized during the entire procedure to prevent displacement of the needle. Thomas splints have been satisfactorily employed for the legs and simple arm boards for the upper extremities. The cut-down and injection instruments and materials include the following:
Sterile pediatric cut-down set
Sterile towels for draping, sponges, etc.
Local anesthetic, such as procaine hydrochloride, and a syringe
Bactericidal painting solution
20 mL syringe containing 15 mL of Ethiodol with an 18 inch catheter to which is affixed a 27 or 30 gauge needle. (If bilateral lymphography is scheduled, two syringes should be prepared.)
A manually driven or motorized unit (a pressure regulated pump) to provide for slow injection.Under local infiltration anesthesia, a transverse, curvilinear or longitudinal small skin incision should be made near the ankle or wrist (just lateral and distal to the first metatarsal head on the dorsum of the foot, or just over the "snuff-box" in the dorsum of the hand).
Upon superficial dissection (but not penetrating the subcutaneous layer of tissue) lymph vessels will be noted in the immediate subcutaneous tissue, while larger lymph vessel trunks are found in the extrafascial plane. The deeper lymph trunks will be easier to cannulate.
One lymph vessel is then exposed, avoiding circumferential dissection. The less manipulation performed, the better the results that will be obtained. The lymphatic, thus isolated, is then cannulated with a 27 or 30 gauge5/8 inch needle, depending upon the size of the lymphatic selected for injection. It is rarely possible to cannulate with a needle greater than 27 gauge. Insertion of the needle through the skin flap before cannulating the lymphatic serves to reduce the movement of the needle within the vessel. Additional security of the needle in the lymphatic is obtained by strapping, with sterile tape, the polyethylene tubing to the patient's foot.
The injection should be started at a slow rate, i.e., 0.1 mL to 0.2 mL per minute. Radiographic monitoring either by fluoroscopy or serial radiographs after 1 mL to 2 mL has been injected, will confirm the proper intralymphatic placement of the needle, rule out accidental intravenous injection or extravasation of the medium by perforation or rupture of the lymphatic. Monitoring will also permit prompt termination of the procedure in the event that lymphatic blockage is present. In such situations, continuation of the injection will result in unnecessary introduction of contrast material in the venous system via the lymphovenous communication channels. If the injection is satisfactory, approximately 6 to 8 mL, are then injected. However, as soon as it becomes radiographically evident that Ethiodol has entered the thoracic duct, the procedure should be terminated to minimize entry of the contrast material into the subclavian vein. Two to four mL of Ethiodol injected into the upper extremity will suffice to demonstrate the axillary and supraclavicular nodes. In penile lymphography approximately 2 to 3 mL of Ethiodol is required. In infants and children, a minimum of 1 mL to a maximum of 6 mL should be employed.
The rate of speed at which the contrast material may be introduced varies and is dependent upon receptivity of the lymphatics in the individual patient. If the injection is proceeding at too rapid a rate, extravasation will be noted and the patient may refer to pain in the foot, leg or arm.
At the completion of the injection, anteroposterior roentgenograms are obtained of the legs or arms, thighs, pelvis, abdomen and chest (dorsal spine technique). Lateral or oblique views as well as laminograms are obtained when indicated. Follow-up films at 24 or 48 hours provide better demonstration of lymph nodes and permit more concise evaluation of nodal architecture.
As a general rule, the smallest possible amount of Ethiodol should be employed according to the anatomical area to be visualized. Therefore, and to prevent inadvertent venous administration, fluoroscopic monitoring or serial radiographic guidance of patients is recommended during the injection of Ethiodol.
Average dose in the adult patient for unilateral lymphography of the upper extremities is 2 to 4 mL; of lower extremities, 6 to 8 mL; of penile lymphography, 2 to 3 mL; of cervical lymphography, 1 to 2 mL.
In the pediatric patient, a minimum of 1 mL to a maximum of 6 mL may be employed according to the anatomical area to be visualized.
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