Lipiodol (Ethiodized)

Brand Name

Lipiodol

Generic Name

Ethiodized

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FDA approval date: March 21, 2014

Form: Injection

What is Lipiodol (Ethiodized)?

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 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

Approved To Treat

Liver Cancer

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Brand Information

LIPIODOL (ethiodized oil)

1INDICATIONS 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)

2DOSAGE 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.

3CONTRAINDICATIONS

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, and within 30 days of curettage or conization or patients with known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm. [see

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.

4OVERDOSAGE

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.

5DESCRIPTION

Lipiodol, ethiodized oil injection, is a sterile injectable radio-opaque agent. Each milliliter contains 480 mg of Iodine organically combined with ethyl esters of fatty acids of poppy seed oil. The precise structure of Lipiodol is unknown.

Lipiodol is a sterile, clear, pale yellow to amber colored oil. Lipiodol has a viscosity of 34 – 70 mPa·s at 20°C, and a density of 1.28 g/cm

6HOW SUPPLIED/STORAGE AND HANDLING

Lipiodol is supplied in a box of one 10 mL ampoule, NDC 67684-1901-1.

Lipiodol is supplied in a box of one 10 mL vial, NDC 67684-1901-2.

Store at controlled room temperature 15°-30°C (59°-86°F) [see USP, Controlled Room Temperature (CRT)]. Protect from light. Remove from carton only upon use.

7PATIENT COUNSELING INFORMATION

Hypersensitivity Reactions

Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after Lipiodol administration. Advise

Thyroid Dysfunction

Advise patients concerning the risk of hyper- or hypothyroidism flowing the use of Lipiodol due to ethiodized oil remaining in the body