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Entrobar

Generic Name: barium sulfate suspension
Dosage Form: oral suspension

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LAFAYETTE
Entrobar™
BARIUM SULFATE SUSPENSION

Rx only

Entrobar Description

Entrobar is a raspberry flavored barium sulfate suspension. It is a contrast medium developed for use in enteroclysis and follow-through x-ray examinations of the small intestine.

The product contains 50% w/v barium sulfate USP, suspending and dispersing agents, simethicone, citric acid, potassium sorbate, flavoring, sodium citrate, saccharin sodium and water. Barium sulfate has the empirical formula of BaSO4.

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Entrobar - Clinical Pharmacology

Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.

Indications and Usage for Entrobar

Entrobar is indicated for use in small bowel contrast x-ray examinations. The professional literature indicates that enteroclysis is the preferred procedure in radiographic evaluation of:

•    Intermittent or partial small bowel obstruction.

•    Occult gastrointestinal bleeding when gastroduodenal or colon evaluation is unrevealing.

•    Crohn’s disease when surgery is contemplated or when clinical suspicion is high and the follow-through is non-diagnostic.

•    Clinically diagnosed malabsorption for the demonstration of structural abnormalities.

•    When contrast evaluation of the small bowel is needed in very elderly or critically ill patients.

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.

Warnings

Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.

Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.

Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.

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.

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.

Adverse Reactions

Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. It is of the utmost importance to be completely prepared to treat any such occurrence.

Due to the increased likelihood of allergic reactions in atopic patients, a complete history of known and suspected allergies as well as allergic-like symptoms, such as rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.

Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have been reported.

A rare mild allergic reaction would most likely be generalized pruritus, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will often respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.

Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.

Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature.

Postmarketing Experiences

The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, nausea, procedural site reactions, rash and vomiting.

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.

Entrobar Dosage and Administration

Individual technique will determine the suspension quantity and barium sulfate content to be used. Undiluted Entrobar may be used for a “dedicated” small bowel follow-through examination or when performing the “biphasic” enteroclysis technique. Entrocel™ (methylcellulose solution) may be used for the second phase of the biphasic examination.
Dilute Entrobar to the desired density when performing single contrast enteroclysis.

% BARIUM SULFATE (w/v) Entrobar WATER TO BE ADDED
50% 500 mL Use undiluted
45% 500 mL 55 mL
40% 500 mL 125 mL
35% 500 mL 215 mL
30% 500 mL 355 mL

The basic principles for intubation and infusion, as published in the medical literature, should be followed for a faster and more diagnostic examination.

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.

How is Entrobar Supplied

Catalog No. 153218. NDC 68240-322-12. 500 mL bottles; twelve (12) bottles per case.

Related products for enteroclysis examinations:

Entrocel: Catalog No. 153318. NDC 68240-057-12. 500 mL bottles. Twelve (12) per case.

Entrobag Set: Catalog No. 153180. Enteroclysis administration set containing two 3 liter bags, Y connector and luer adapter tubing. Six (6) sets per case.

Enteroclysis Catheter: Catalog No. 153404. Sterile 155 cm x 13 French enteroclysis catheter with retention balloon and guide wire. One (1) per case.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.

All trademark rights reserved.

DIN: 00652881
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 1295090        Rev 04/2009

ENTEROCLYSIS
G.I. EXAMS
  • Pre-mixed
  • Ready-to-use
  • Flavored

tyco
Healthcare

Mallinckrodt

Package Label - Principal Display Panel - Entrobar

L A F A Y E T T E

Entrobar™
BARIUM SULFATE
SUSPENSION

Catalog No. 153218

O3 ANTIMICROBIAL TECHNOLOGY

ENTEROCLYSIS / LOWER G.I. EXAMS

Rx only

500 mL

Entrobar
Barium Sulfate Suspension USP

NDC 68240-322-12
Catalog No. 153218

A raspberry flavored, 50% w/v, barium sulfate USP suspension for use as a diagnostic aid for enteroclysis procedures of the small intestine.

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

Shake well before using.

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.

Net Contents: 500 mL

DIN: 00652881
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 1170150
Rev 04/2009

tyco
Healthcare

Mallinckrodt

Package Label - Principal Display Panel - Entrocel

L A F A Y E T T E

ENTROCEL™
METHYLCELLULOSE
SOLUTION

Catalog No. 153318

O3 ANTIMICROBIAL TECHNOLOGY

ENTEROCLYSIS / LOWER G.I. EXAMS

Rx only

500 mL

ENTROCEL
Methylcellulose Solution

NDC 68240-057-12
Catalog No. 153318

A raspberry-vanilla-lemon flavored, low viscosity, 1.8% w/v hydroxypropyl methylcellulose solution for use as an aid for enteroclysis procedures for the small bowel.

Contents: Hydroxypropyl methylcellulose, simethicone, flavoring, citric acid, potassium sorbate, saccharin sodium, sodium citrate and water.

Contraindications: Do not use in patients where barium sulfate suspension administration is contraindicated. Do not use when intubation is contraindicated.

Dosage and Administration: Dilute one bottle of Entrocel with 1500 mL water and use following Entrobar™ (barium sulfate suspension) for double contrast of the small bowel.

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.

Net Contents: 500 mL

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

MID 1170310
Rev 04/2009

tyco
Healthcare

Mallinckrodt

Entrobar 
barium sulfate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-322
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE 500 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM  
SODIUM HYPOCHLORITE  
POTASSIUM SORBATE  
WATER  
HYDROGEN PEROXIDE  
TRISODIUM CITRATE DIHYDRATE  
CROSCARMELLOSE SODIUM  
CITRIC ACID MONOHYDRATE  
BENTONITE  
SODIUM POLYMETAPHOSPHATE  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
Product Characteristics
Color      Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68240-322-12 12 BOTTLE, PLASTIC (BOTTLE) in 1 CASE
1 500 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 10/31/2012
ENTROCEL 
methylcellulose solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-057
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYPROMELLOSES (HYPROMELLOSES) HYPROMELLOSES 18 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM  
SODIUM HYPOCHLORITE  
POTASSIUM SORBATE  
HYDROGEN PEROXIDE  
WATER  
TRISODIUM CITRATE DIHYDRATE  
CITRIC ACID MONOHYDRATE  
Product Characteristics
Color      Score     
Shape Size
Flavor RASPBERRY, VANILLA, LEMON Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68240-057-12 12 BOTTLE, PLASTIC (BOTTLE) in 1 CASE
1 500 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 10/31/2012
Labeler - Mallinckrodt Inc. (810407189)
Establishment
Name Address ID/FEI Operations
Mallinckrodt Medical, S.A. de C.V. 810407189 analysis, manufacture
Revised: 11/2010
 
Mallinckrodt Inc.
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