DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. General. The volume and concentration ofLIQUID POLIBAR PLUS(R) to be administeredwill depend on the degree and extent of contrast required in the area(s)under examination and on the equipment and technique employed. Seeapplicable system below for typical adult dose.. Patient Preparation forColon Examinations. In order to achieve optimum results, the colonmust be cleansed prior to the use of barium enema. This is usuallyaccomplished by placing the patient on low fat, low residue diet,combined with the use of laxatives and/or cathartics. cleansingenema may also be used unless contraindicated.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Oral Administration. This product should not be usedin patients with known gastric or intestinal perforation or hypersensitivityto barium sulfate products. Rectal Administration. This product should not be usedin patients with known intestinal perforation or hypersensitivityto barium sulfate products.

DESCRIPTION SECTION.

DESCRIPTION. LIQUID POLIBAR PLUS(R) Barium Sulfate Suspension (105% w/v, 58% w/w) isa barium sulfate suspension for oral and rectal administration. Each100 mL contains 105 barium sulfate. Barium sulfate, due to its highmolecular density is opaque to x-rays and, therefore, acts as positivecontrast agent for radiographic studies. The active ingredient isbarium sulfate and its structural formula is BaSO4. Barium sulfate occurs as fine, white, odorless, tasteless, bulkypowder which is free from grittiness. Its aqueous suspensions areneutral to litmus. It is practically insoluble in water, solutionsof acids and alkalies, and organic solvents.. Inactive Ingredients. acacia, citric acid, hydrochloricacid, natural and artificial vanilla flavor, polysorbate 80, potassiumchloride, potassium sorbate, purified water, saccharin sodium, simethiconeemulsion, sodium benzoate, sodium carrageenan, sodium citrate, sorbitolsolution and xanthan gum.

DRUG & OR LABORATORY TEST INTERACTIONS SECTION.

Drug Interactions. The presence of barium sulfate formulations in the GI tract may alterthe absorption of therapeutic agents taken concomitantly. In orderto minimize any potential change in absorption, the separate administrationof barium sulfate from that of other agents should be considered.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Adverse reactions, such as nausea,vomiting, diarrhea and abdominal cramping, accompanying the use ofbarium sulfate formulations are infrequent and usually mild. Severereactions (approximately in 1,000,000) and fatalities (approximately1 in 10,000,000) have occurred. Procedural complications are rare,but may include aspiration pneumonitis, barium sulfate impaction,granuloma formation, intravasation, embolization and peritonitis followingintestinal perforation, vasovagal and syncopal episodes, and fatalities.EKG changes have been reported following or during barium enema procedures.It is of the utmost importance to be completely prepared to treatany such occurrence.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Barium sulfate, due to its high molecular densityis opaque to x-rays and, therefore, acts as positive contrast agentfor radiographic studies. Barium sulfate is biologically inert and,therefore, is not absorbed or metabolized by the body, and is eliminatedunchanged from the body.

GENERAL PRECAUTIONS SECTION.

General. Diagnosticprocedures which involve the use of radiopaque contrast agents shouldbe carried out under the direction of personnel with the requisitetraining and with thorough knowledge of the particular procedureto be performed. history of bronchial asthma, atopy, as evidencedby hay fever and eczema, or previous reaction to contrast agent,warrant special attention. Caution should be exercised with the useof radiopaque media in severely debilitated patients and in thosewith marked hypertension or advanced cardiac disease.Ingestion of this product is not recommendedin patients with history of food aspiration. If barium studies arerequired in these patients or in patients in whom integrity of theswallowing mechanism is unknown, proceed with caution. If this productis aspirated into the larynx, further administration should be immediatelydiscontinued.After anybarium study of the GI tract, it is important to rehydrate the patientas quickly as possible to prevent impaction of the bowel by bariumsulfate. To prevent barium sulfate impaction in the bowel, the useof mild laxatives such as milk of magnesia or lactulose, followingcompletion of the examination may also be required. These mild laxativesare recommended on routine basis and in patients with historyof constipation unless contraindicated.

HOW SUPPLIED SECTION.

HOW SUPPLIED. LIQUID POLIBAR PLUS(R) is supplied as follows:750 mL jugs, NDC32909-167-55.Rx OnlySHAKE WELL PRIOR TO USE.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. For radiography of the gastrointestinaltract.

INFORMATION FOR PATIENTS SECTION.

Information for Patients. Before administration of this product patientsshould 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.

LABORATORY TESTS SECTION.

Rectal Administration. Use with caution when obstructivelesions of the colon are suspected. Care should be taken to minimizethe amount of barium sulfate allowed to flow proximal to obstructivelesions of the colon. When used rectally, care must be taken duringinsertion of the enema tip into the patient, since forceful or toodeep insertion may cause tearing or perforation of the rectum.

NURSING MOTHERS SECTION.

Nursing Mothers. Barium sulfate products may beused during lactation.

OVERDOSAGE SECTION.

OVERDOSAGE. On rare occasions following repeatedadministration, severe stomach cramps, nausea, vomiting, diarrheaor constipation may occur. These are transitory in nature and arenot considered serious. Symptoms may be treated according to currentlyaccepted standards of medical care.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Liquid PolibarPlus CartonNDC:32909-168-02Liquid Polibar Plus BottleNDC:32909-167-55. liquid-polibar-plus-carton. liquid-polibar-plus-bottle.

PRECAUTIONS SECTION.

PRECAUTIONS. General. Diagnosticprocedures which involve the use of radiopaque contrast agents shouldbe carried out under the direction of personnel with the requisitetraining and with thorough knowledge of the particular procedureto be performed. history of bronchial asthma, atopy, as evidencedby hay fever and eczema, or previous reaction to contrast agent,warrant special attention. Caution should be exercised with the useof radiopaque media in severely debilitated patients and in thosewith marked hypertension or advanced cardiac disease.Ingestion of this product is not recommendedin patients with history of food aspiration. If barium studies arerequired in these patients or in patients in whom integrity of theswallowing mechanism is unknown, proceed with caution. If this productis aspirated into the larynx, further administration should be immediatelydiscontinued.After anybarium study of the GI tract, it is important to rehydrate the patientas quickly as possible to prevent impaction of the bowel by bariumsulfate. To prevent barium sulfate impaction in the bowel, the useof mild laxatives such as milk of magnesia or lactulose, followingcompletion of the examination may also be required. These mild laxativesare recommended on routine basis and in patients with historyof constipation unless contraindicated.. Oral Administration. Use with caution in patient withcomplete or nearly complete obstruction of the gastrointestinal tract.. Rectal Administration. Use with caution when obstructivelesions of the colon are suspected. Care should be taken to minimizethe amount of barium sulfate allowed to flow proximal to obstructivelesions of the colon. When used rectally, care must be taken duringinsertion of the enema tip into the patient, since forceful or toodeep insertion may cause tearing or perforation of the rectum.. Information for Patients. Before administration of this product patientsshould 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 in the GI tract may alterthe absorption of therapeutic agents taken concomitantly. In orderto minimize any potential change in absorption, the separate administrationof barium sulfate from that of other agents should be considered.. Usage in Pregnancy. Radiation is known to cause harmto the unborn fetus exposed in utero. Therefore,radiographic procedures should only be used when, in the judgementof the physician, their use is deemed essential to the welfare ofthe pregnant patient.. Nursing Mothers. Barium sulfate products may beused during lactation.

PREGNANCY SECTION.

Usage in Pregnancy. Radiation is known to cause harmto the unborn fetus exposed in utero. Therefore,radiographic procedures should only be used when, in the judgementof the physician, their use is deemed essential to the welfare ofthe pregnant patient.

SPL UNCLASSIFIED SECTION.

Inactive Ingredients. acacia, citric acid, hydrochloricacid, natural and artificial vanilla flavor, polysorbate 80, potassiumchloride, potassium sorbate, purified water, saccharin sodium, simethiconeemulsion, sodium benzoate, sodium carrageenan, sodium citrate, sorbitolsolution and xanthan gum.

STORAGE AND HANDLING SECTION.

STORAGE. USP Controlled Room Temperature,20 to 25C (68 to 77F). Protect from freezing.

WARNINGS SECTION.

WARNINGS. Rarely, severe allergic reactionsof an anaphylactoid nature, have been reported following administrationof barium sulfate contrast agents. Appropriately trained personneland facilities should be available for emergency treatment of severereactions and should remain available for at least 30 to 60 minutesfollowing administration, since delayed reactions can occur.