VOLUMEN- barium sulfate suspension
E-Z-EM Canada Inc
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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.
Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. Barium sulfate is biologically inert and, therefore, is not absorbed or metabolized by the body, and is eliminated from the GI tract unchanged.
INDICATIONS AND USAGE
For use in Computed Tomography to opacify the GI tract.
This product should not be used in patients with known or suspected gastrointestinal perforation or hypersensitivity to barium sulfate or any component of this barium sulfate formulation.
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.
nformation for Patients
Before administration of this product, patients receiving barium sulfate diagnostic agents should be instructed to:
Inform their physician if they are pregnant.
Inform their physician if they are allergic to any drugs or food, or if they have had any prior reactions to barium sulfate products or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).
Inform their physician about any other medications they are currently taking.
Seek immediate medical attention if they experience an allergic reaction after using this product.
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.