LIPIODOL

Clinical summary

Indications and usage 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) Lipiodol is an oil-based radiopaque 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) Dosage and administration 2 DOSAGE AND ADMINISTRATION Use a disposable syringe to draw and inject Lipiodol. Hysterosalpingography Inject increments of 2 mL of Lipiodol into the endometrial cavity until tubal patency is determined; stop the injection if the patient develops excessive discomfort. Inject with radiologic monitoring. Lymphography Inject Lipiodol into a lymphatic vessel with radiologic monitoring. 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. Selective Hepatic Intra-arterial Use Inject 1.5 to 15 mL of Lipiodol slowly under continuous radiologic monitoring. Do not exceed 20 mL total dosage. 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. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Pulmonary and cerebral embolism: avoid use in patients with severely impaired lung function, cardiorespiratory failure or right-sided cardiac overload ( 5.1 ) Hypersensitivity reactions: 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 reactio