Data from FDA - Curated by EPG Health - Last updated 03 May 2018

Indication(s)

INDICATIONS AND USAGE For use in Computed Tomography to opacify the GI tract.

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Advisory information

contraindications
CONTRAINDICATIONS This product should not be used in patients with known or suspected gastric or intestinal perforation, or hypersensitivity to barium sulfate or any component of this barium sulfate formulation.
Special warnings and precautions
PRECAUTIONS General Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease. Ingestion of barium is not recommended in patients with a history of food aspiration. If barium studies are required in these patients or in patients in whom integrity of the swallowing mechanism is unknown, proceed with caution. If barium is aspirated into the larynx, further administration should be immediately discontinued. After any barium study of the GI tract, it is important to rehydrate the patient as quickly as possible to prevent impaction of the barium. To prevent barium impaction in the colon, the use of mild laxatives such as milk of magnesia or lactulose following completion of the examination may also be required. These mild laxatives are recommended on a routine basis and in patients with a history of constipation unless clinically contraindicated. Information for Patients Before using this product patients should be instructed to tell the physician ordering the procedure and the imaging technologist: if they are pregnant. if they are allergic to any foods or medication, or if they have had any prior reactions to barium sulfate products or other x-ray contrast agents. if they are currently taking any medications, have any serious medical condition for which they are being treated or followed, or had any recent surgery. seek immediate medical attention if they experience an allergic reaction after using this product. Drug Interactions The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered. Usage in Pregnancy Radiation is known to cause harm to the unborn fetus exposed in utero. Therefore, radiographic procedures should only be used when, in the judgement of the physician, its use is deemed essential to the welfare of the pregnant patient. Nursing Mothers Barium sulfate products may be used during lactation.
Adverse reactions
ADVERSE REACTIONS Adverse reactions, such as nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. Severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been reported following or during barium enema procedures. It is of the utmost importance to be completely prepared to treat any such occurrence.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION The volume and concentration of the CT barium sulfate suspension to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed. Suggested 30 Minute Barium Administration Protocol for Abdomen Studies: Administer 300 mL CT barium suspension 30 minutes before scan and 150 mL immediately prior to scan; or use as directed by physician. Suggested 90 Minute Barium Administration Protocol for Abdomen/Pelvis Studies: Administer 450 mL CT barium suspension 90 minutes before scan, another 300 mL 30 minutes before scan, and finally 150 mL immediately prior to scan; or use as directed by physician. Other dosing regimens may be followed as applicable.
Pregnancy and lactation
Nursing Mothers Barium sulfate products may be used during lactation.

Interactions

Drug Interactions The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered.

More information

Category Value
Agency product number 25BB7EKE2E
Orphan designation No
Product NDC 32909-755,32909-725,32909-775,32909-723,32909-715
Date Last Revised 23-05-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder E-Z-EM Canada Inc