ethiodized oil (Rx)

Brand and Other Names:Lipiodol
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable oil

  • 480mg/mL (iodine)

Hysterosalpingography

Inject into the endometrial cavity with fluoroscopic control

Inject increments of 2 mL until tubal patency is determined; stop the injection if patient develops excessive discomfort

Reimage after 24 hr to establish whether ethiodized oil has entered the peritoneal cavity

Before use, exclude the presence of these conditions: pregnancy, uterine bleeding and endocervicitis, acute pelvic inflammatory disease, the immediate premenstrual or postmenstrual phase, or within 30 days of curettage or conization

Lymphography

Inject into a lymphatic vessel under radiologic guidance to prevent inadvertent venous administration or intravasation

Unilateral lymphography of the upper extremities: 2-4 mL

Unilateral lymphography of the lower extremities: 6-8 mL

Penile lymphography: 2-3 mL

Cervical lymphography: 1-2 mL

Upper or lower extremities administration

  • Start the injection into a lymphatic channel at a rate not to exceed 0.2 mL/min
  • Inject the total dose in no less than 1.25 hr
  • Use frequent radiologic monitoring to determine the appropriate injection rate and to follow the progress within the lymphatics
  • Interrupt the injection if the patient experiences pain
  • Terminate the injection if lymphatic blockage is present to minimize introduction of ethiodized oil into the venous circulation via lymphovenous channels
  • Terminate the injection as soon as ethiodized oil is radiographically evident in the thoracic duct to minimize entry into the subclavian vein and pulmonary embolization
  • Obtain immediate postinjection images
  • Reimage at 24 or 48 hr to evaluate nodal architecture

Hepatocellular Carcinoma

Selective hepatic intra-arterial use is indicated for imaging tumors in adults with known hepatocellular carcinoma

Determine the dose depending on the tumor size, local blood flow in the liver, and local blood flow in the tumor

Inject from 1.5-15 mL slowly under continuous radiologic monitoring

Stop the injection when stagnation or reflux is evident

Limit the dose to only the quantity required for adequate visualization

Total dose administered should not exceed 20 mL

Dosing Considerations

Screen all patients for renal dysfunction by obtaining history and/or laboratory tests

Administration

Preparation

  • Use the smallest possible amount according to the anatomical area to be visualized
  • Inspect visually for particulate matter and discoloration before administration
  • Do not use the solution if particulate matter is present or if the container appears damaged
  • Normal is clear, pale-yellow to amber-colored oil; do not use if the color has darkened
  • Draw into a glass syringe and use promptly
  • Discard any unused portion of ampoule
  • Observe patient for hypersensitivity during injection and for 30 min following

Storage

  • Store at controlled room temperature 15-30°C (59-86°F)
  • Protect from light
  • Remove from carton only upon use

Dosage Forms & Strengths

injectable oil

  • 480mg/mL (iodine)

Lymphography

Use the smallest possible amount according to the anatomical area to be visualized

Inject into a lymphatic vessel under radiologic guidance to prevent inadvertent venous administration or intravasation

Inject a minimum of 1 mL to a maximum of 6 mL according to the anatomical area to be visualized

Do not exceed 0.25 mL/kg

Upper or lower extremities administration

  • Start the injection into a lymphatic channel at a rate not to exceed 0.2 mL/min
  • Inject the total dose in no less than 1.25 hr
  • Use frequent radiologic monitoring to determine the appropriate injection rate and to follow the progress within the lymphatics
  • Interrupt the injection if the patient experiences pain
  • Terminate the injection if lymphatic blockage is present to minimize introduction of ethiodized oil into the venous circulation via lymphovenous channels
  • Terminate the injection as soon as ethiodized oil is radiographically evident in the thoracic duct to minimize entry into the subclavian vein and pulmonary embolization
  • Obtain immediate postinjection images
  • Reimage at 24 or 48 hr to evaluate nodal architecture

Dosing Considerations

Screen all patients for renal dysfunction by obtaining history and/or laboratory tests

Administration

Preparation

  • Inspect visually for particulate matter and discoloration before administration
  • Do not use the solution if particulate matter is present or if the container appears damaged
  • Normal is clear, pale yellow to amber colored oil; do not use if the color has darkened
  • Draw into a glass syringe and use promptly
  • Discard any unused portion of ampoule
  • Observe patient for hypersensitivity during injection and for 30 min following

Storage

  • Store at controlled room temperature 15-30°C (59-86°F)
  • Protect from light
  • Remove from carton only upon use
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Interactions

Interaction Checker

and ethiodized oil

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                Monitor Closely (3)

                • iodixanol

                  iodixanol decreases effects of ethiodized oil by unknown mechanism. Use Caution/Monitor. Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy in patients with thyroid carcinoma. Decreased efficacy lasts for 6-8 weeks. .

                • metformin

                  ethiodized oil increases toxicity of metformin by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Administration of intravascular iodinated contrast agents in metformin-treated patients has led to rare cases of acute decrease in renal function and the occurrence of lactic acidosis. The American College of Radiology Guidelines (2018) recommend temporarily stopping metformin in patients with eGFR is <30 mL/min/1.73 m2 or who are undergoing arterial catheter studies that might result in emboli to the renal arteries. Continue to withhold metformin for 48 hr subsequent to the procedure and reinstituted only after renal function has been reevaluated and found to be normal. .

                • sodium iodide I-131

                  ethiodized oil will decrease the level or effect of sodium iodide I-131 by Other (see comment). Modify Therapy/Monitor Closely. Ethiodized oil remains in the body for several months following administration, and may interfere with thyroid function testing for up to 2 yr; interferes with radioactive iodine uptake by thyroid tissue for several weeks to months and may impair visualization of thyroid scintigraphy and reduce effectiveness of iodine 131 treatment

                Minor (0)

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                  Adverse Effects

                  Postmarketing Reports

                  Endocrine disorders: Hypothyroidism, hyperthyroidism, thyroiditis

                  Eye disorders: Retinal vein thrombosis

                  Gastrointestinal disorders: Nausea, vomiting, diarrhea

                  General disorders and administration site: Fever, pain, granuloma

                  Hepatobiliary disorders: Hepatic vein thrombosis

                  Immune system disorders: Hypersensitivity, anaphylactic reaction, anaphylactoid reaction

                  Nervous system disorders: Cerebral embolism

                  Respiratory, thoracic, and mediastinal disorders: Pulmonary embolism, dyspnea, cough, acute respiratory distress syndrome

                  Urinary system disorders: Renal insufficiency

                  Hysterosalpingography

                  • Abdominal pain
                  • Foreign body reactions
                  • Exacerbation of pelvic inflammatory disease

                  Lymphography

                  • Cardiovascular collapse
                  • Lymphangitis
                  • Thrombophlebitis
                  • Edema or exacerbation of preexisting lymphedema
                  • Dyspnea and cough
                  • Fever
                  • Iodism (headache, soreness of mouth and pharynx, coryza, and rash)
                  • Allergic dermatitis Lipogranuloma Delayed healing at the site of incision

                  Hepatic intra-arterial injection

                  • Common reactions: Fever, abdominal pain, nausea, and vomiting
                  • Other reactions: Hepatic ischemia, liver enzymes abnormalities, temporary decrease in liver function, liver decompensation, and renal insufficiency
                  • Procedural risks: Vascular complications and infections
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                  Warnings

                  Black Box Warnings

                  For intralymphatic, intrauterine, and selective hepatic intra-arterial use only

                  Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of ethiodized oil

                  Inject slowly with radiologic monitoring; do not exceed recommended dose

                  Contraindications

                  NOT for IV, IM, IT, or SC use (see Black Box Warnings)

                  Hypersensitivity

                  Hyperthyroidism

                  Traumatic injuries

                  Recent hemorrhage or bleeding

                  Hysterosalpingography

                  • Pregnancy
                  • Acute pelvic inflammatory disease
                  • Marked cervical erosion
                  • Endocervicitis and intrauterine bleeding In the immediate premenstrual or postmenstrual phase
                  • Within 30 days of curettage or conization

                  Lymphography

                  • Right to left cardiac shunt
                  • Advanced pulmonary disease
                  • Tissue trauma or hemorrhage
                  • Advanced neoplastic disease with expected lymphatic obstruction
                  • Previous surgery interrupting the lymphatic system
                  • Radiation therapy to the examined area

                  Hepatic intra-arterial use

                  • Areas of the liver where the bile ducts are dilated (unless external biliary drainage was performed before injection)

                  Cautions

                  Embolism

                  • Embolization to lungs, brain, and other major organs may occur
                  • Pulmonary embolization (PE) may occur immediately or after a few hours to days from inadvertent systemic vascular injection or intravasation; this may cause decreased pulmonary diffusing capacity and pulmonary blood flow, pulmonary infarction, acute respiratory distress syndrome, and fatalities
                  • Avoid use in patients with severely impaired lung function, cardiorespiratory failure, or right–sided cardiac overload
                  • Perform radiological monitoring during the injection
                  • Do not exceed the recommended maximum dose and rate of injection
                  • During lymphography, minimize the risk of PE by obtaining radiographic confirmation of intralymphatic (rather than venous) injection, and terminate the procedure when ethiodized oil becomes visible in the thoracic duct or lymphatic obstruction is observed

                  Hypersensitivity reactions

                  • Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred
                  • Avoid use with a history of sensitivity to other iodinated contrast agents, bronchial asthma, or allergic disorders
                  • Observe patients for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes following administration

                  Exacerbation of chronic liver disease

                  • Hepatic intra-arterial injection may exacerbate chronic liver disease conditions including:
                  • Portal hypertension and cause variceal bleeds due to obstruction of the intrahepatic portal channels by opening a presinusoidal anastomosis
                  • Hepatic ischemia and cause liver enzyme elevations, fever, and abdominal pain
                  • Hepatic failure and cause ascites and encephalopathy
                  • Hepatic vein thrombosis, irreversible liver insufficiency, and fatalities reported
                  • Procedural risks include vascular complications and infections

                  Thyroid dysfunction

                  • Iodinated contrast media can affect thyroid function because of the free iodine content and can cause hyperthyroidism or hypothyroidism in predisposed patients
                  • Patients at risk are those with latent hyperthyroidism and those with Hashimoto thyroiditis or history of thyroid irradiation
                  • Ethiodized oil may remain in the body for several months; depending on dose administered and route of administration, therefore, thyroid diagnostic results can be affected for up to 2 years after lymphography; keep dose as low as possible and consider monitoring thyroid function closely for several months after administration of therapy
                  • Interferes with radioactive iodine uptake by thyroid tissue and may impair visualization of thyroid scintigraphy and reduce effectiveness of iodine 131 treatment

                  Overdose

                  • Overdose may lead to respiratory, cardiac or cerebral complications, which can potentially be fatal
                  • Microembolisms to multiple organs may occur more frequently after overdose
                  • Promptly initiate symptomatic treatment and support of vital functions
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                  Pregnancy & Lactation

                  Pregnancy

                  Therapy is contraindicated in pregnant women due to potential risk to fetus from an intrauterine procedure

                  Use before or during pregnancy may interfere with thyroid function in both the pregnant woman and her fetus and may affect fetal development; there are maternal, fetal, and neonatal clinical considerations for women who are exposed to drug either before or during pregnancy

                  Rare pregnancy outcomes reported in post-marketing setting in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects or miscarriage

                  Therapy administered before or during pregnancy may interfere with thyroid function of pregnant woman

                  Untreated hypothyroidism in pregnancy is associated with adverse perinatal outcomes, such as spontaneous abortion, preeclampsia, preterm birth, abruptio placentae, and fetal death; consider thyroid function testing during pregnancy if a woman was exposed to drug either before or during pregnancy or if clinically indicated

                  Therapy administration before or during pregnancy causes iodide transfer across the placenta which may interfere with fetal thyroid function and may affect fetal development

                  Untreated hypothyroidism is associated with increased fetal risk of low birth weight, fetal distress, and impaired neuropsychological development; consider thyroid function testing in infants whose mothers were exposed to drug before and during pregnancy or if clinically indicated

                  Confirm that the patient has a negative pregnancy test within 24 hours before drug administration for hysterosalpingography

                  Animal data

                  • Animal reproduction studies have not been conducted using indicated routes of administration; it was not embryotoxic or teratogenic in animal studies with oral administration

                  Lactation

                  Ethiodized oil is present in human milk; there are no data on effects of drug on breastfed infant, or effects on milk production, however, use may increase concentration of iodide in human milk and may interfere with thyroid function of breastfed infant

                  Consider thyroid function testing in a breastfed infant whose mother was exposed to drug or if clinically indicated

                  The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Iodinated contrast agent organically combined with ethyl esters of poppy seed oil fatty acids

                  Metabolism

                  Following intra-arterial administration, ethiodized oil retained in normal hepatic parenchyma is phagocytized by the Kupffer cells of the liver and washed out via the hepatic lymphatic system in about 2-4 weeks

                  In hepatocellular carcinoma, retention in the liver tumor is prolonged, allowing reimaging of the tumor for 4 weeks or longer

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                  Images

                  No images available for this drug.
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                  Patient Handout

                  Patient Education
                  ethiodized oil injection

                  NO MONOGRAPH AVAILABLE AT THIS TIME

                  USES: Consult your pharmacist.

                  HOW TO USE: Consult your pharmacist.

                  SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: Consult your pharmacist.

                  DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

                  OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                  NOTES: No monograph available at this time.

                  MISSED DOSE: Consult your pharmacist.

                  STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

                  Information last revised July 2016. Copyright(c) 2021 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.