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Polibar ACB

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Overview

What is Polibar ACB?

Polibar® ACB is a barium sulfate for suspension (96% w/w) for rectal administration. Each 100 g contains 96 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, acidic or alkaline solutions, and organic solvents. Excipients: citric acid, pectin, polysorbate 80, simethicone, sodium citrate, sorbitol, tragacanth.



What does Polibar ACB look like?



What are the available doses of Polibar ACB?

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What should I talk to my health care provider before I take Polibar ACB?

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How should I use Polibar ACB?

This product is indicated for single and double contrast radiographic visualization of the colon.

Use diluted for either single or double contrast radiography of the colon. The volume and concentration of Polibar ACB 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.


What interacts with Polibar ACB?

This product should not be used in patients with known or suspect-ed colonic perforation, toxic megacolon, recent rectal surgery or radiotherapy to the rectum or prostate, or hypersensitivity to barium sulfate or any component of this barium sulfate formu-lation. It should also not be used within six days of large forceps or “hot” colonic biopsy or a snare polypectomy.



What are the warnings of Polibar ACB?

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.


What are the precautions of Polibar ACB?

General

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrants special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.

This product contains sorbitol. Patients with hereditary fructose intolerance should not take this product without first consulting their physician.

This medicine contains approximately1.462 mg of sodium for each gram of powdered product. This should be taken into consideration by patients on a controlled sodium diet.

After any barium study of the GI tract, it is important to re-hydrate the patient as quickly as possible, in order to prevent impaction of the bowel by barium sulfate. To prevent barium sulfate impaction in the bowel, the use of mild laxatives such as milk of magnesia or lactulose following completion of the examination may also be required. These mild laxatives are rec-ommended on a routine basis in patients with a history of constipation unless contraindicated.

Precautions for Enema System

Use with caution when obstructive lesions of the colon are suspected. Care should be taken to minimize the amount of barium sulfate allowed to flow proximal to obstructive lesions of the colon. Care must be taken during insertion of the enema tip not to exert undue pressure to the neuromuscular plexus, which can lead to vasovagal reactions and syncopal episodes. Forceful or deep insertion may also cause tearing or perforation of the rectum. The enema tip should not be moved unnecessarily once inserted.

Information for Patients

  • 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 ).
  • Inform their physician about any other medications they are currently taking.


Before administration of this product patients should be instructed to:

Drug Interactions

Barium sulphate is biologically inert and there are no known interactions with other medicinal products, however, 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 medicinal agents from that of barium sulfate should be considered.

Usage in Pregnancy

While this product is not contraindicated in pregnancy, it should be noted that radiographic procedures may be harmful to the fetus. Barium sulfate is not absorbed systemically and is therefore not contraindicated during lactation and breast-feeding.


What are the side effects of Polibar ACB?

Adverse reactions, such as nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. Severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, appendicitis, granuloma formation, intravasation, embolization and peritonitis following intestinal 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 treat any such occurrence.


What should I look out for while using Polibar ACB?

This product should not be used in patients with known or suspect-ed colonic perforation, toxic megacolon, recent rectal surgery or radiotherapy to the rectum or prostate, or hypersensitivity to barium sulfate or any component of this barium sulfate formu-lation. It should also not be used within six days of large forceps or “hot” colonic biopsy or a snare polypectomy.

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.


What might happen if I take too much Polibar ACB?

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.


How should I store and handle Polibar ACB?

Polibar® ACB Disposable Barium Enema Kit with Rigid Tip is supplied in the following quantity: 397 g Bag; Cat. No. AP14, NDC 32909-804-01 454 g Bag; Cat No. AP16, NDC 32909-804-02Manufactured by E-Z-EM Canada Inc. for E-Z-EM, Inc. a subsidiary of Bracco Diagnostics Inc. Monroe Township, NJ 08831 Tel : 1-516-333-8230    1-800 544-4624Polibar® ACB Disposable Barium Enema Kit with Rigid Tip is supplied in the following quantity: 397 g Bag; Cat. No. AP14, NDC 32909-804-01 454 g Bag; Cat No. AP16, NDC 32909-804-02Manufactured by E-Z-EM Canada Inc. for E-Z-EM, Inc. a subsidiary of Bracco Diagnostics Inc. Monroe Township, NJ 08831 Tel : 1-516-333-8230    1-800 544-4624


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Clinical Information

Chemical Structure

No Image found
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.

Non-Clinical Toxicology
This product should not be used in patients with known or suspect-ed colonic perforation, toxic megacolon, recent rectal surgery or radiotherapy to the rectum or prostate, or hypersensitivity to barium sulfate or any component of this barium sulfate formu-lation. It should also not be used within six days of large forceps or “hot” colonic biopsy or a snare polypectomy.

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.

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrants special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.

This product contains sorbitol. Patients with hereditary fructose intolerance should not take this product without first consulting their physician.

This medicine contains approximately1.462 mg of sodium for each gram of powdered product. This should be taken into consideration by patients on a controlled sodium diet.

After any barium study of the GI tract, it is important to re-hydrate the patient as quickly as possible, in order to prevent impaction of the bowel by barium sulfate. To prevent barium sulfate impaction in the bowel, the use of mild laxatives such as milk of magnesia or lactulose following completion of the examination may also be required. These mild laxatives are rec-ommended on a routine basis in patients with a history of constipation unless contraindicated.

Adverse reactions, such as nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. Severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, appendicitis, granuloma formation, intravasation, embolization and peritonitis following intestinal 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 treat any such occurrence.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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