Barosperse Liquid

Name: Barosperse Liquid

Barosperse Liquid Description

Liquid Barosperse is a vanilla flavored barium sulfate suspension. It is a contrast medium developed for use in x-ray diagnosis of the gastrointestinal tract.

The product contains 60% w/v barium sulfate USP, suspending agents, flavoring, citric acid, simethicone, potassium sorbate, saccharin sodium and water. Barium sulfate has the empirical formula of BaSO4.

Contraindications

Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis, inflammation or neoplastic lesions of the rectum, recent rectal biopsy, or known hypersensitivity to barium sulfate formulations.

Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected. Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as necrotizing enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.

Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex. The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone. The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.

Precautions


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, a family history of allergy, or a previous reaction to a contrast agent warrant 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.

Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used.

An increased risk of perforation has been reported in neonates with intussusception. In patients with cystic fibrosis or blind loops of the bowel or ileus, there is a risk of inspissation leading to partial or complete obstruction.

In neonates and infants with motility disorders such as Hirschsprung’s Disease, retention of large amounts of barium sulfate suspension may result in absorption of water from the suspension and fluid overload. The addition of small amounts of salt to the barium sulfate suspension has been reported to reduce the problem.

Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.

Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.

Where enema tips are used, care must be taken during insertion into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. Insertion of an enema tip should be done only after digital examination by qualified medical personnel. When balloon retention tips are used, care should be taken to avoid overinflation of the balloon, since overfilling or asymmetrical filling may cause displacement of the tip. Such a displacement can lead to rectal perforation or barium sulfate granulomas. Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel. Do not unnecessarily move the enema tip once inserted.

A specially designed enema tip is required for a barium sulfate suspension examination of a colostomy patient.

Intubation of an enteroclysis catheter should be done by qualified medical personnel. Perforation of the duodenum has been reported.

Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered.

Pregnancy

Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.

Pediatric Use

The radiographic contrast agents used for examination of children do not differ substantially from those used for adults. The variation in physical sizes of pediatric patients requires more thorough attention to individualizing dosage. The volume of barium sulfate suspension and the barium sulfate content required will also depend upon the technique used and the clinical need.

Overdosage

In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.

Barosperse Liquid Dosage and Administration


Patient Preparation

Successful examination of the upper gastrointestinal tract requires that the stomach be empty and essentially free of fluid. This can usually be accomplished by instructing the patient to abstain from eating or drinking anything after the evening meal before the examination. The preparation for small bowel examinations, done separately or combined with an upper gastrointestinal series, is the same.

For examinations of the colon, the patients should be given a low solid diet for a minimum of 24 hours before the examination. Laxatives should also be used to clean the colon. In order to obtain thorough cleansing of the colon, a 2 liter water enema one hour before the examination may be necessary.

Administration

Individual technique will determine the suspension quantity and barium sulfate content to be used. The following dilutions are suggested for Liquid Barosperse.

EXAMINATION DILUTION FORMULA % BARIUM SULFATE (w/v)
Filled Stomach Use undiluted or 60%
3 parts Liquid Barosperse to 1 part water 45%
Esophageal Swallow Use undiluted 60%
Enteroclysis 3 Parts Liquid Barosperse to 1 part water 45%
Routine Filled Colon 1 part Liquid Barosperse to 2 parts water 20%

Shake well before using.

It is recommended that Liquid Barosperse be served chilled for upper gastrointestinal studies. This will give a more rapid transit of Liquid Barosperse from the stomach into the small bowel. For lower gastrointestinal studies, Liquid Barosperse should be administered at room temperature to body temperature.

Pediatric Use

The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.

For single patient use only. Properly discard unused portion.

Package Label - Principal Display Panel - 355 mL Bottle

L A F A Y E T T E

LIQUID BAROSPERSE™
BARIUM SULFATE
SUSPENSION

Catalog No. 179312

O3™ ANTIMICROBIAL TECHNOLOGY

UPPER G.I. EXAMS

Rx only

355 mL

LIQUID BAROSPERSE
Barium Sulfate Suspension USP

NDC 68240-325-24
Catalog No. 179312

A vanilla flavored 60% w/v barium sulfate USP suspension for use in x-ray diagnosis of the gastrointestinal tract.

Contents: Barium sulfate USP, suspending agents, flavoring, citric acid, simethicone, potassium sorbate, saccharin sodium and water.

Contraindications: Do not use in patients with suspected gastrointestinal tract
perforation or known hypersensitivity to barium sulfate formulations.

Dosage and Administration: See package insert for complete instructions. See box below for mixing directions. Individual technique will determine the suspension quantity and barium sulfate content to be used. The following dilutions are suggested for Liquid Barosperse.


EXAMINATION DILUTION FORMULA % BARIUM SULFATE (w/v)
Filled Stomach Use undiluted or 60%
3 parts Liquid Barosperse to 1 part water 45%
Esophageal Swallow Use undiluted 60%
Enteroclysis 3 Parts Liquid Barosperse to 1 part water 45%
Routine Filled Colon 1 part Liquid Barosperse to 2 parts water 20%

For single patient use only. Properly discard unused portion.

Storage: Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from freezing. Shake well before using.

Net Contents: 355 mL (12 fl. oz.)

DIN: 02196190
Distributed in
Canada by:
tyco Healthcare
Pointe-Claire, QC
Canada H9R 5H8
Establishment
License # 100689-A

Made in Mexico
Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com

MID 1170125
Rev. 02/2009

tyco/Healthcare

MALLINCKRODT

LIQUID BAROSPERSE 
barium sulfate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-325
Route of Administration ORAL, RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE 600 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM  
SODIUM HYPOCHLORITE  
POTASSIUM SORBATE  
WATER  
HYDROGEN PEROXIDE  
CROSCARMELLOSE SODIUM  
ANHYDROUS CITRIC ACID  
BENTONITE  
VANILLA  
Product Characteristics
Color      Score     
Shape Size
Flavor VANILLA Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:68240-325-24 24 BOTTLE, PLASTIC (30 BOTTLE) in 1 CASE
1 355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2009 09/30/2012
Labeler - Mallinckrodt, Inc. (810407189)
Establishment
Name Address ID/FEI Operations
Mallinckrodt Medical, S.A. de C.V. 810407189 analysis, manufacture
Revised: 08/2010   Mallinckrodt, Inc.
(web3)