Pl call
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 glass 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. Re-image after 24 hours to establish whether Lipiodol has entered the peritoneal cavity.
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.
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 glass 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.
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.
