GENERAL PRECAUTIONS SECTION.

General. Diagnostic procedures which involve the use ofradiopaque contrast agents should be carried out under the directionof personnel with the requisite training and with thorough knowledgeof the particular procedure to be performed. history of bronchialasthma, atopy, as evidenced by hay fever and eczema, or previousreaction to contrast agent, warrant special attention.Use with caution in patients withcomplete or nearly complete esophageal or gastric obstruction.

HOW SUPPLIED SECTION.

HOW SUPPLIED. E-Z-DISK(TM) is white tablet with EZEM on oneside and 778 on the other side and is supplied in the following manner:Bottles of 100 1/2 -inch diameter, flat-sided tablets; Cat. No. 778,NDC 10361-778-31. Storage. Store product at USP Controlled Room Temperature,20 to 25C (68 to 77F). Protect from moisture.

DOSAGE & ADMINISTRATION SECTION.

DOSAGEAND ADMINISTRATION. This tabletis most useful in patients experiencing dysphagia, particularly inthose whose findings are deemed inconclusive by conventional methods.The problems associated with obtaining satisfactory films exhibitingcomplete filling of the pharynx and cricopharyngeal area make fordifficult diagnosis in this region. In such cases, failure of thetablet to freely pass this site may indicate significant esophagealdisease as cause of the symptoms, and may warrant further videographicstudies.The patientshould be instructed to swallow one tablet intact, with the aid ofone or two swallows of water, just prior to fluoroscopic examination. Note: Using tablet of known diameter 1/2 inch) notonly illustrates the presence of significant narrowing of the esophagus,but also provides simple technique to measure the lumen at the siteof the stricture. The most routinely used esophagoscope has externaldiameter of 36 French, and thus tablet of corresponding half-inchdiameter was selected. The actual diameter (in inches) of the narrowsite is one-half the ratio of its measure value on the film to themeasure of the tabletUpon swallowing the tablet, the patient experiencesno significant discomfort, and fluid passes around the tablet withoutdifficulty.

ADVERSE REACTIONS SECTION.

ADVERSEREACTIONS. Adverse reactions,such as nausea, vomiting, diarrhea and abdominal cramping accompanyingthe use of barium sulfate suspensions are infrequent, usually mild,and generally do not occur with this product. Procedural complicationsare rare, but may include aspiration pneumonitis, granuloma formation,intravasation, embolization and peritonitis following intestinal perforation,vasovagal and syncopal episodes, and fatalities. It is of the utmostimportance to be completely prepared to treat any such occurrence.

CLINICAL PHARMACOLOGY SECTION.

CLINICALPHARMACOLOGY. Barium sulfate, due to its highmolecular density is opaque to x-rays and therefore acts as positivecontrast agent for radiographic studies. Barium sulfate is biologicallyinert and therefore is not absorbed or metabolized by the body, andis eliminated unchanged from the body.. Absorptionand Metabolism. E-Z-DISK tabletsdisintegrate within 30 minutes after ingestion, and the fragmentsare eliminated with the feces without absorption of the barium sulfate.A brief delay in transit may sometimes be seen in elderly patients,particularly above the hiatus, or at the level of the aortic arch.In such instances, sip of water is sufficient to carry the tabletdown the esophagus.

DESCRIPTION SECTION.

DESCRIPTION. E-Z-DISK(TM) is an oral solid radiographic contrastagent. Each tablet contains 700 mg of barium sulfate and is 1/2 inchin diameter. The active ingredient is barium sulfate and its structuralformula is BaSO4. Barium sulfate occurs asa fine, white, odorless, tasteless, bulky powder which is free fromgrittiness. Its aqueous suspensions are neutral to litmus. It is practicallyinsoluble in water, solutions of acids and alkalies, and organic solvents.. Each tablet contains thefollowing inactive ingredients: magnesium stearate, microcrystallinecellulose, povidone, corn starch, croscarmellose sodium and confectionerssugar.

INFORMATION FOR PATIENTS SECTION.

InformationFor Patients. Before administrationof this product, patients receiving barium sulfate diagnostic agentsshould be instructed to:Inform their physician if they are pregnant.Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).Inform their physician about any other medications theyare currently taking.. Inform their physician if they are pregnant.. Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).. Inform their physician about any other medications theyare currently taking.

PRECAUTIONS SECTION.

PRECAUTIONS. General. Diagnostic procedures which involve the use ofradiopaque contrast agents should be carried out under the directionof personnel with the requisite training and with thorough knowledgeof the particular procedure to be performed. history of bronchialasthma, atopy, as evidenced by hay fever and eczema, or previousreaction to contrast agent, warrant special attention.Use with caution in patients withcomplete or nearly complete esophageal or gastric obstruction.. InformationFor Patients. Before administrationof this product, patients receiving barium sulfate diagnostic agentsshould be instructed to:Inform their physician if they are pregnant.Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).Inform their physician about any other medications theyare currently taking.. Inform their physician if they are pregnant.. Inform their physician if they are allergic to any drugsor food, or if they have had any prior reactions to barium sulfateproducts or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).. Inform their physician about any other medications theyare currently taking.. Usagein Pregnancy. Radiation is known to cause harmto the unborn fetus exposed in utero. Therefore, radiographic proceduresshould be used only when, in the judgment of the physician, theiruse is deemed essential to the welfare of the pregnant patient.. NursingMothers. Barium sulfate productsmay be used during lactation.

PREGNANCY SECTION.

Usagein Pregnancy. Radiation is known to cause harmto the unborn fetus exposed in utero. Therefore, radiographic proceduresshould be used only when, in the judgment of the physician, theiruse is deemed essential to the welfare of the pregnant patient.

SPL UNCLASSIFIED SECTION.

Absorptionand Metabolism. E-Z-DISK tabletsdisintegrate within 30 minutes after ingestion, and the fragmentsare eliminated with the feces without absorption of the barium sulfate.A brief delay in transit may sometimes be seen in elderly patients,particularly above the hiatus, or at the level of the aortic arch.In such instances, sip of water is sufficient to carry the tabletdown the esophagus.

WARNINGS SECTION.

WARNINGS. Rarely, severe allergic reactions of an anaphylactoidnature have been reported following administration of barium sulfatecontrast agents. Appropriate facilities and trained personnel shouldbe available for emergency treatment of severe reactions and shouldremain available for at least 30 to 60 minutes following administration,since delayed reactions can occur.