LIPIODOL

LIPIODOL- ethiodized oil injection
Guerbet LLC

WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY

Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol.
Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose (5.1).

1 INDICATIONS AND USAGE

Lipiodol is an oil-based radio-opaque contrast agent indicated for:

  • hysterosalpingography in adults
  • lymphography in adult and pediatric patients
  • selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Guidelines

Draw Lipiodol into a disposable syringe.
Use the smallest possible amount of Lipiodol according to the anatomical area to be visualized.

Hysterosalpingography

Using aseptic technique inject Lipiodol into the endometrial cavity with fluoroscopic control. Inject increments of 2 mL of Lipiodol until tubal patency is determined; stop the injection if patient develops excessive discomfort. The total volume to be injected depends on the
volume of the uterine cavity, usually not exceeding 15 mL. A 24-hour image can be obtained if, after slow peritoneal spillage, the evaluation of adhesions is needed. Perform the procedure during the follicular phase of the menstrual cycle.

Before using Lipiodol exclude the presence of these conditions: pregnancy, uterine bleeding and endocervicitis, acute pelvic inflammatory disease, the immediate pre-or postmenstrual phase or within 30 days of curettage or conization. [see Contraindications (4) & Pregnancy (8.1)].

Lymphography

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

Adults:

  • unilateral lymphography of the upper extremities 2 to 4 mL
  • unilateral lymphography of the lower extremities 6 to 8 mL
  • penile lymphography 2 to 3 mL
  • cervical lymphography 1 to 2 mL

Pediatric patients:

  • 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.

The following method is recommended for lymphography of the upper or lower extremities. Start the injection of Lipiodol into a lymphatic channel at a rate not to exceed 0.2 mL per minute. Inject the total dose of Lipiodol in no less than 1.25 hours. Use frequent radiologic monitoring to determine the appropriate injection rate and to follow the progress of Lipiodol within the lymphatics. Interrupt the injection if the patient experiences pain. Terminate the injection if lymphatic blockage is present to minimize introduction of Lipiodol into the venous circulation via lymphovenous channels. Terminate the injection as soon as Lipiodol is radiographically evident in the thoracic duct to minimize entry of Lipiodol into the subclavian vein and pulmonary embolization. Obtain immediate post-injection images. Re-image at 24 or 48 hours to evaluate nodal architecture.

Selective Hepatic Intra-arterial Injection

Determine the dose depending on the tumor size, local blood flow in the liver and in the tumor(s).

  • Inject from 1.5 to 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. The total dose of Lipiodol administered should not exceed 20 mL.

2.2 Drug Handling

Inspect Lipiodol visually for particulate matter and discoloration before administration. Do not use the solution if particulate matter is present or if the container appears damaged. Lipiodol is a clear, pale yellow to amber colored oil; do not use if the color has darkened.

Draw Lipiodol into a disposable syringe and use promptly. Discard any unused portion of Lipiodol.

3 DOSAGE FORMS AND STRENGTHS

Each milliliter of Lipiodol contains 480 mg/mL of Iodine organically combined with ethyl esters of fatty acids of poppy seed oil.

4 CONTRAINDICATIONS

Lipiodol is contraindicated in patients with hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding.

Hysterosalpingography

Lipiodol hysterosalpingography is contraindicated in pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis and intrauterine bleeding, in the immediate pre-or postmenstrual phase, or within 30 days of curettage or conization. [see Use in Specific Populations (8.1) ].

Lymphography

Lipiodol Lymphography is contraindicated in patients with a 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.

Selective Hepatic Intra-arterial Use Patients with HCC

Lipiodol use is contraindicated in areas of the liver where the bile ducts are dilated unless external biliary drainage was performed before injection.

5 WARNINGS AND PRECAUTIONS

5.1 Pulmonary and Cerebral Embolism

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

5.2 Hypersensitivity Reactions

Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Lipiodol administration. Avoid use in patients with a history of sensitivity to other iodinated contrast agents, bronchial asthma or allergic disorders because of an increased risk of a hypersensitivity reaction to Lipiodol. Administer Lipiodol only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, including personnel trained in resuscitation; ensure continuous medical monitoring and maintain an intravenous access line. Most hypersensitivity reactions to Lipiodol occur within half an hour after administration. Delayed reactions can occur up to several days after administration. Observe patients for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes following Lipiodol administration.

5.3 Exacerbation of Chronic Liver Disease

Lipiodol hepatic intra-arterial administration can exacerbate the following conditions: portal hypertension and cause variceal bleeds due to obstruction of the intrahepatic portal channels by opening a pre sinusoidal 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 have been reported. Procedural risks include vascular complications and infections.

5.4 Thyroid Dysfunction

Iodinated contrast media can affect thyroid function because of the iodide content and can cause hyperthyroidism or hypothyroidism. Ethiodized oil may remain in the body for several months, depending on dose administered and route of administration. Keep the dose of Lipiodol as low as possible and consider monitoring thyroid function closely for several months after administration of Lipiodol.

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