ADVERSE REACTIONS SECTION.

ADVERSEREACTIONS. Adverse reactions,such as nausea, vomiting, diarrhea and abdominal cramping, accompanyingthe use of barium sulfate formulations are infrequent and usuallymild. Severe reactions (approximately in 1,000,000) and fatalities(approximately in 10,000,000) have occurred. Procedural complicationsare rare, but may include aspiration pneumonitis, barium sulfate impaction,granuloma formation, intravasation, embolization and peritonitis followingintestinal perforation, vasovagal and syncopal episodes, and fatalities.It is of the utmost importance to be completely prepared to treatany 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. This product should not be used in patients withknown gastric or intestinal perforation or hypersensitivity to bariumsulfate products.

DESCRIPTION SECTION.

DESCRIPTION. E-Z-PASTE(R) Barium Sulfate Esophageal Cream (60% w/w) is barium sulfate creamfor oral administration. Each 100 contains 60 barium sulfate.Barium sulfate, due to its high molecular density is opaque to x-raysand, therefore, acts as positive contrast and agent for radiographicstudies. 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.. Inactive Ingredients: carboxymethylcellulosesodium, citric acid, ethyl vanillin, glycerin, methylparaben, propylparaben,purified water, saccharin sodium, simethicone emulsion, sodium citrate,and sorbitol solution.

DOSAGE & ADMINISTRATION SECTION.

DOSAGEAND ADMINISTRATION. Usual doseis one to four teaspoons as required.

DRUG INTERACTIONS SECTION.

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

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. Caution shouldbe exercised with the use of radiopaque media in severely debilitatedpatients and in those with marked hypertension or advanced cardiacdisease.Caution shouldbe used during the administration of this product to patients witha history of food aspiration or to patients in whom integrity of theswallowing mechanism is unknown. If this product is aspirated intothe larynx, further administration should be discontinued immediately.After any barium study of theGI tract, it is important to rehydrate the patient as quickly as possibleto prevent impaction of the bowel by barium sulfate. To prevent bariumsulfate impaction in the bowel, the use of mild laxatives such asmilk of magnesia or lactulose, following completion of the examinationmay also be required. These mild laxatives are recommended on routinebasis and in patients with history of constipation unless contraindicated.Use with caution with completeor nearly complete esophageal or gastric obstruction.

HOW SUPPLIED SECTION.

HOW SUPPLIED. E-Z-PASTE(R) is suppliedin the following quantity:454 Tube, Cat. No. 770; NDC32909-770-01Manufactured by E-Z-EM Canada Inc.for E-Z-EM, Inc.a subsidiary of Bracco Diagnostics Inc.Monroe Township,NJ 08831Tel: 1-516-333-8230 1-800 544-4624rev. 10/17 CL80E01 TX1887.

INACTIVE INGREDIENT SECTION.

Inactive Ingredients: carboxymethylcellulosesodium, citric acid, ethyl vanillin, glycerin, methylparaben, propylparaben,purified water, saccharin sodium, simethicone emulsion, sodium citrate,and sorbitol solution.

INDICATIONS & USAGE SECTION.

INDICATIONSAND USAGE. For use in singlecontrast radiography of the esophagus, pharynx, hypopharynx and forcardiac series.

INFORMATION FOR PATIENTS SECTION.

Informationfor Patients. Before administrationof this product patients should 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.

NURSING MOTHERS SECTION.

NursingMothers. Barium sulfate productsmay be used during lactation.

OVERDOSAGE SECTION.

OVERDOSAGE. On rare occasions following repeated administration,severe stomach cramps, nausea, vomiting, diarrhea or constipationmay occur. These are transitory in nature and are not considered serious.Symptoms may be treated according to currently accepted standardsof medical care.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

E-Z-Paste- Barium Sulfate Esophageal CreamNDC: 32909-770-01. E-Z-Paste Label Tube.

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. Caution shouldbe exercised with the use of radiopaque media in severely debilitatedpatients and in those with marked hypertension or advanced cardiacdisease.Caution shouldbe used during the administration of this product to patients witha history of food aspiration or to patients in whom integrity of theswallowing mechanism is unknown. If this product is aspirated intothe larynx, further administration should be discontinued immediately.After any barium study of theGI tract, it is important to rehydrate the patient as quickly as possibleto prevent impaction of the bowel by barium sulfate. To prevent bariumsulfate impaction in the bowel, the use of mild laxatives such asmilk of magnesia or lactulose, following completion of the examinationmay also be required. These mild laxatives are recommended on routinebasis and in patients with history of constipation unless contraindicated.Use with caution with completeor nearly complete esophageal or gastric obstruction.. Informationfor Patients. Before administrationof this product patients should 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.. Drug Interactions. The presence of barium sulfate formulations inthe GI tract may alter the absorption of therapeutic agents takenconcomitantly. In order to minimize any potential change in absorption,the separate administration of barium sulfate from that of other agentsshould be considered.. Usagein Pregnancy. Radiation is known to cause harmto the unborn fetus exposed in utero. Therefore, radiographic proceduresshould only be used when, in the judgement of the physician, its useis 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 only be used when, in the judgement of the physician, its useis deemed essential to the welfare of the pregnant patient.

SPL UNCLASSIFIED SECTION.

ALLERGIC REACTIONS. Due to the increased likelihood of allergicreactions in atopic patients, it is important that complete historyof known and suspected allergies as well as allergic-like symptoms,e.g., rhinitis, bron-chial asthma, eczema and urticaria, must be obtainedprior to any medical procedure utilizing these products. mild allergicreaction would most likely include generalized pruritus, erythemaor urticaria (approximately in 250,000). Such reactions will generallyrespond to an antihistamine such as 50 mg of diphenhydramine or itsequivalent. In the rarer, more serious reactions (approximately 1in 1,000,000) laryngeal edema, bronchospasm or hypotension could develop.Severe reactions which may require emergency measures are often characterizedby peripheral vasodilation, hypotension, reflex tachycardia, dyspnea,agitation, confusion and cyanosis progressing to unconsciousness.Treatment should be initiated immediately with 0.3 to 0.5 mL of 1:1000epinephrine subcutaneously. If bronchospasm predominates, 0.25 to0.50 grams of intravenous aminophylline should be given slowly. Appropriatevasopressors might be required. Adrenocorticosteroids, even if givenintravenously, exert no significant effect on the acute allergic reactionsfor few hours. The administration of these agents should not beregarded as emergency measures for the treatment of allergic reactions.Apprehensive patients may developweakness, pallor, tinnitus, diaphoresis and bradycardia followingthe administration of any diagnostic agent. Such reactions are usuallynon-allergic in nature and are best treated by having the patientlie flat for an additional 10 to 30 minutes under observation.

STORAGE AND HANDLING SECTION.

Storage. Store product at USP Controlled Room Temperature,20 to 25C (68 to 77F). Protect from freezing.

WARNINGS SECTION.

WARNINGS. Rarely, severe allergic reactions of an anaphylactoidnature, have been reported following administration of barium sulfatecontrast agents. Appropriately trained personnel and facilities 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.