Ethiodol

ETHIODOL- ethiodized oil injection
SAVAGE LABORATORIES

BRAND OF ETHIODIZED OIL INJECTION
A Low Viscosity Radio-Opaque Diagnostic Agent

NOT FOR INTRAVASCULAR, INTRATHECAL OR INTRABRONCHIAL USE

Rx only

DESCRIPTION

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.

CLINICAL PHARMACOLOGY

There has been little detailed investigation of the metabolic fate of Ethiodol in either man or animals. However, the fate of Ethiodol following Lymphangiography in dogs has been reported.1 Koehler et al. employed I131 –tagged Ethiodol for lymphangiography in dogs and analyses of individual organs at various time intervals were done. The investigators reported an average of only 25% of the injected medium was retained in the lymphatics at the end of three days. An average of 50% was recovered from the lungs. They found the remainder of injected activity was fairly uniformly distributed throughout the body. Urinary excretion in the form of inorganic iodine was revealed as the chief mode of iodine loss from the system.

INDICATIONS

Ethiodol is indicated for use as a radio-opaque medium for hysterosalpingography and lymphography.

IN HYSTEROSALPINGOGRAPHY

CONTRAINDICATIONS

Ethiodol is contraindicated in patients hypersensitive to it. Ethiodol should not be injected intrathecally or intravascularly, or used in bronchography. A history of sensitivity to iodine contraindicates the use of Ethiodol; iodine is split off from fatty compounds and becomes free iodine in the body. Hysterosalpingography is contraindicated in intrauterine pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis in the presence of intrauterine bleeding, in the immediate pre-or postmenstrual phase, or within 30 days of curettage or conization.

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.

PRECAUTIONS:

General: Since iodine-containing contrast materials may alter the results of certain thyroid function tests, such tests, if indicated, should be performed prior to the administration of this drug. Pulmonary embolization of the contrast material may occur if hysterosalpingography is performed under conditions which may lead to intravasation of the contrast materials. These conditions include uterine bleeding, recent curettage or conization and injection of the contrast material under excessive pressure.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenesis, or whether Ethiodol can affect fertility in males or females.

Pregnancy Category C: Animal reproduction studies have not been conducted with Ethiodol. It is also not known whether Ethiodol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ethiodol should be administered to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Ethiodol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

ADVERSE REACTIONS

Hypersensitivity reactions, foreign body reactions and exacerbation of pelvic inflammatory disease, although infrequent, have been reported. In an occasional patient, abdominal pains may occur. Such pains may be the result of tubal torsion, or possibly due to too rapid a rate of instillation or excessive pressure, or both. The condition is usually only transitory, lasting one or two hours at most, and may be relieved by the administration of any of the commonly used analgesics.

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.

IN LYMPHOGRAPHY

CONTRAINDICATIONS

Ethiodol is contraindicated in patients hypersensitive to it. Ethiodol should not be injected intrathecally or intravascularly or introduced into the bronchial tree. Patients with known sensitivity to iodine should not have lymphography performed. Iodine is split off from fatty compounds and becomes free iodine in the body. Lymphography is contraindicated in patients with a right to left cardiac shunt, in patients with advanced pulmonary disease, especially those with alveolar-capillary block, and in patients who have had radiotherapy to the lungs.

WARNINGS

The 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.

PRECAUTIONS:

General: Although subclinical pulmonary embolization occurs in a majority of patients following Ethiodol lymphography, clinical evidence of such embolization is infrequent and is usually of a transient nature. Such clinical manifestations are usually immediate, but may be delayed from a few hours to days. It would appear that it is advantageous to use the smallest volume of Ethiodol necessary for radiographic visualization. For this reason, and to prevent inadvertent venous administration, radiographic monitoring of patients is recommended during the injection of Ethiodol.

The timing and choice of anesthesia following Ethiodol injection may be influenced by consideration of the above noted decrease in pulmonary and capillary blood flow and diffusing capacity. It should be noted that although an average of 2 to 3 days was required for complete reversibility for such tests, an occasional patient required up to 12 days to return to baseline values.

PBI determination of thyroid uptake studies should be carried out prior to the lymphographic procedure because interference with these tests may be anticipated for as long as one year. In the presence of known iodine sensitivity, Ethiodol lymphography should be carried out with greatest precaution.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenesis, or whether Ethiodol can affect fertility in males or females.

Pregnancy Category C: Animal reproduction studies have not been conducted with Ethiodol. It is also not known whether Ethiodol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ethiodol should be administered to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Ethiodol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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