FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Appropriately trained personnel and facilities should be available for emergency treatment of severe reactions and should remain available for at least 30 to 60 minutes following administration, since delayed reactions can occur.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For use in Computed Tomography to opacify the GI tract.
History
There is currently no drug history available for this drug.
Other Information
VoLumen® is a barium sulfate suspension 0.1% w/v, 0.1% w/w for oral administration. Each 100 mL contains 0.1 g barium sulfate. Barium sulfate, due to its high molecular density is opaque to x-rays and therefore, acts as a positive contrast agent for radiographic studies. The active ingredient is barium sulfate and its structural formula is BaSO4. Barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. Its aqueous suspensions are neutral to litmus. It is practically insoluble in water, solutions of acids and alkalies, and organic solvents.
Inactive Ingredients: citric acid, natural gum, benzoic acid, sodium citrate, natural and artificial blueberry flavor, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, and sorbitol.
Sources
Volumen Manufacturers
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E-z-em Canada Inc
Volumen | E-z-em Canada Inc
The volume 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 technique employed.
For Oral Administration: GI Tract MarkingThe patient should begin drinking VoLumen® approximately 20 – 30 minutes prior to the scheduled procedure. It is recommended that the patient consume multiple bottles, about 900 mL to 1,350 mL total volume prior to the exam or use as directed by physician. For improved gastric marking have patient consume the final 200 mL immediately prior to scan. Bowel marking is consistent due to the uniformity of the 0.1% concentration of BaSO4. Bowel lumen marking can be improved by increasing the volume of VoLumen® consumed (see below). Other dosing regimens may be followed as applicable. In patients where marking is problematic, such as obesity and delayed transit, improved marking may be possible by increasing the total volume of VoLumen® administered up to 1,800 mL or four (4) bottles.
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