VARIBAR THIN LIQUID- barium sulfate powder, for 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.
DESCRIPTION
VARIBAR� THIN LIQUID (Target Viscosity 4 CPS) is a barium sulfate for suspension (40% w/v After Reconstitution) for oral administration. Each 100 g contains 81 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: carboxymethylcellulose sodium, citric acid, maltodextrin, natural and artificial apple flavor, polysorbate 80, saccharin sodium, simethicone, sodium citrate, sorbitol and xylitol.
INDICATIONS AND USAGE
This product is indicated for use in radiography of the esophagus, pharynx and hypopharynx.
CLINICAL PHARMACOLOGY
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 unchanged from the body.
CONTRAINDICATIONS
This product should not be used in patients with known or suspected gastrointestinal perforation; or hypersensitivity to barium sulfate or any components of this barium sulfate formulation.
WARNINGS
Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Appropriate facilities and trained personnel 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.
Information for Patients
Before administration of this product patients 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.
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, their use is deemed essential to the welfare of the pregnant patient.
OVERDOSAGE
On rare occasions following repeated administration, severe stomach cramps, nausea, vomiting, diarrhea or constipation may occur. These are transitory in nature and are not considered serious. Symptoms may be treated according to currently accepted standards of medical care.
Mixing Instructions for VARIBAR� THIN LIQUID Cat. No. D105: Add water to the 40% w/v line on the VARIBAR� THIN LIQUID bottle label and replace the lid securely. Invert the bottle and tap with fingers to mix the powder into the water. Shake vigorously for 30 seconds. Wait 5 minutes, and refill with water to the 40% w/v line. Then reshake thoroughly.
After reconstitution with water, VARIBAR� THIN LIQUID has been shown to be stable for up to 72 hours if refrigerated at 2�-8� C. With refrigeration, notate the information on the label to track usage time. Enter date opened and use by date.
DOSAGE AND ADMINISTRATION
The dose of VARIBAR� THIN LIQUID 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.
STORAGE
Store VARIBAR� THIN LIQUID to protect from freezing and excessive heat (above 40�C).
HOW SUPPLIED
VARIBAR� THIN LIQUID is supplied in the following quantity: 148 g bottle, Cat. No. D105, NDC 32909-105-10
