"May 8, 2015 -- The thyroid drug Synthroid continues to be the nation's most-prescribed medication. But Humira, which treats a variety of conditions, had the highest sales, according to the research firm IMS Health.
The firm released data on"...
Ethiodol (ethiodized oil) is indicated for use as a radio-opaque medium for hysterosalpingography and lymphography.
DOSAGE AND ADMINISTRATION
The 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.
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 (ethiodized oil) 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 (ethiodized oil) 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 (ethiodized oil) injected into the upper extremity will suffice to demonstrate the axillary and supraclavicular nodes. In penile lymphography approximately 2 to 3 mL of Ethiodol (ethiodized oil) 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 (ethiodized oil) 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 (ethiodized oil) .
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.
Summary Of Steps To Avoid Complications In Lymphography5
- Contraindicate patients:
- Proceed with caution:
- Patients having markedly advanced neoplastic disease with expected lymphatic obstruction.
- Patients having undergone previous surgery interrupting the lymphatic system.
- Patients having had deep radiation therapy to the examined area.
If in those cases in which extreme caution should be exercised, lymphography is still necessary, a smaller dose of oily contrast medium with protracted injection time with less pressure and careful monitoring is required.
- Skin testing should be done on all patients before submitting them to lymphography. Be aware of possible hypersensitivity to local anesthetics and skin disinfectants. Careful history taking is important.
- Technique of cannulation: extravasation is to be avoided and/or detected early. The injection site should be included on the “scout film” or observed under image amplification fluoroscopy. The needle tip must remain visible in the incision wound.
- Oily contrast materials: once opened, ampules should be discarded. Ampules of Ethiodol (ethiodized oil) should not be used if the color has darkened or if particulate matter is present. The average dose for each foot in an adult is 5 to 6 mL; one-half as much for the upper extremity. The amount for children should be deter- mined by careful monitoring. It should stay below 0.25 mL/kg.
- Injection pressure should be regulated to deliver the average dose in no less than 11/4 hours. Continuous monitoring helps to determine the speed most appropriate for each individual. Sensation of pain is a warning of too high pressure.
- Scout roentgenograms: if scout roentgenograms are used for monitoring, they should be developed and viewed immediately in order to apply corrective measures when needed; e.g., discontinuation of the study when one sees intravenous injection or lymphatico-venous anastomosis. Reduction of injection speed is needed if evidence of collateral circulation occurs or if the higher abdomino-aortic nodes do not opacify in spite of the usual injection pressure. This is highly suggestive of lymphatic obstruction. Scout roentgenograms should be taken more frequently in such cases.
- Surgical technique: strict aseptic surgical technique is followed including the wearing of a face mask. Before suturing the incision wound, the remnants of the lymphatic vessels and loose tissue are removed and the wound well washed with saline to remove any possible oil. In case of reflux type lymphedema, the cannulated large lymphatic vessel may have to be closed by catgut to avoid development of a lymphocyst.
The patient is instructed to elevate the legs as often as possible to promote healing. The sutures are removed from the feet on the 10th day, and on the 5th or 6th from the hands.
Ethiodol (ethiodized oil for injection) is supplied in a box of two 10 ml ampules, NDC 0281-7062-37.
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light. Remove from carton only upon use.
Parenteral and discoloration prior to administration, whenever solution and container permit. Ethiodol brand of ethiodized oil for injection is straw to amber color under normal conditions. (See DESCRIPTION).
2. Bronk, et. al.:“Oil Embolism in Lymphography”,Radiation, 80:194, February 1963.
3. Fuchs, S.A.,“Complications in Lymphography With Oily Contrast Media”, Acta Radiol., 57:247, November 1962.]
4. Viamonte, M. Jr., University of Miami, Jackson Memorial Hospital, Miami, Florida, Private Communication.
5. Kuisk, H., “Techniques of Lymphography and Principles of Interpretation”,1971, Warren H. Green, Inc., St. Louis, Missouri, 63105.
A development of Guerbet Laboratories.
Savage Laboratories, A Division Of Altana Inc., Melville, New York 11747, R7/99.
Last reviewed on RxList: 6/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Ethiodol 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.