Barosperse

Generic Name: barium sulfate
Dosage Form: powder, for suspension

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

LAFAYETTE
Barosperse™
BARIUM SULFATE FOR SUSPENSION

Rx only

Barosperse Description

Barosperse is a vanilla flavored barium sulfate product for use as a contrast medium during x-ray diagnosis of the gastrointestinal tract. An aqueous suspension of the product is to be prepared at the time of administration.

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The contrast medium contains 95% barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium. Barium sulfate has the empirical formula of BaSO4.

Barosperse - 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 Barosperse

Barosperse is indicated for use as a contrast medium in x-ray diagnosis of the gastrointestinal tract.

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.

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.

Barium sulfate suspension intravasation can be a serious complication. Mortality has been reported as a result of vaginal or rectal intravasation and is believed to be due to massive pulmonary embolism occurring within minutes of the inciting event.

In patients with increased cranial pressure, barium sulfate suspension enemas present an additional risk of further increasing intracranial pressure.

Care must be taken during the insertion of an enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Cardiac arrhythmia or other cardiovascular side effects can occur as a result of colon distention.

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.

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. EKG changes have been shown to occur following or during barium sulfate suspension enemas. 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.

Transient bacteremia, beginning almost immediately and lasting up to 15 minutes, may also occur during rectal administration of barium sulfate suspension, and rarely septicemia has 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.

Allergic reactions to the enema accessories, in particular to retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately and result in the previously mentioned acute allergic-like responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients, particularly those with a history of asthma or eczema, should be evaluated for alternative methods of administration in order to avoid these adverse reactions. These plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.

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, 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.

Barosperse Dosage and Administration

Individual technique will determine the suspension quantity and concentration to be used.

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 patient 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

Orally administered suspension may be served chilled for more rapid transit from the stomach into the small bowel. Rectally administered suspension should be at room temperature to body temperature.

Suspension Preparation

Barosperse will form stable suspensions when shaken vigorously with water. Add water and shake vigorously for 20 to 30 seconds. Some practitioners prefer to use a blender.

Always shake again just before patient administration.

Suspensions of Barosperse should be used within six (6) hours of preparation. For best results, the Barosperse and the water should be accurately measured.

The following tables will serve as a guide for suspension preparation.

ORAL ADMINISTRATION DILUTION TABLE
Suspension % w/v: 110 95 85 70 60
Concentration % w/w: 60 55 50 45 40
Barosperse Wt. Water required to prepare suspension (in mLs)
225 gm (8 oz.) 150 185 225 275 335
900 gm 600 735 900 1100 1350

Note: Do not store suspension after mixing; shake vigorously just prior to administration.

Esophagus Swallow Study

Optimum coating is obtained with 2 to 3 teaspoonfuls of a freshly prepared suspension (225 gm Barosperse vigorously mixed with 75 mL of water). For evaluation of distensibility and peristaltic motion use 110% w/v suspension.

Upper Gastrointestinal Series

Initial gastric coating can be accomplished with 75 mL of a 110% w/v suspension. This is followed by 195 mL of a 85% w/v suspension.

Small Bowel Examinations

When done concomitantly with the Upper G.I. Series, the above volumes and concentrations are usually sufficient. However, if desired, an additional 240 mL of 85% w/v suspension may be used. When the small bowel examination is done independently, 240 to 480 mL of 85% w/v suspension may be used.

Note: Do not store suspension after mixing; shake vigorously just prior to administration.

Filled Colon Examination

The usual dose is 2000 mL of a 25% w/v suspension. If low concentration (“see through”) is desired, use 2500 mL of a 17% w/v suspension. (Note: low concentration suspension should be agitated immediately before use.)

RECTAL ADMINISTRATION DILUTION TABLE
Suspension % w/v: 110 35 30 25 20 17
Concentration % w/w: 60 28 23 20 18 15
Barosperse Wt. Water required to prepare suspension (in mLs)
225 gm (8 oz.) 150 580 755 900 1027 1278
340 gm (12 oz.) 225 875 1140 1360 1550 1925
454 gm (16 oz.) 305 1170 1525 1820 2090 2500
900 gm 600 - - - - -

Double Contrast Colon Examination

400 mL of 110% w/v suspension is usually adequate for this technique.

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 Barosperse Supplied

Catalog No. 179208. NDC 68240-621-08. 225 gm bottle; thirty-six (36) bottles and thirty-six (36) straws per case.

Catalog No. 139132. NDC 68240-626-09. 900 gm bottle; eight (8) bottles per case.

Catalog No. 116412. NDC 68240-621-12. 340 gm (12 oz.) enema kit with screw cap spout and rigid enema tip. Twenty-four (24) kits per case.

Catalog No. 116416. NDC 68240-621-16. 454 gm (16 oz.) enema kit with screw cap spout and rigid enema tip. Twenty-four (24) kits per case.

Catalog No. 116414. NDC 68240-621-32. 340 gm (12 oz.) enema kit with screw cap spout and flexible enema tip with silicone retention cuff. Twenty-four (24) kits per case.

Catalog No. 116418. NDC 68240-621-36. 454 gm (16 oz.) enema kit with screw cap spout and flexible enema tip with silicone retention cuff. Twenty-four (24) kits per case.

Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF).

Barosperse is a trademark of Lafayette Pharmaceuticals, Incorporated.

DIN: 00776629
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 1304679

Rev. 2008/10

SINGLE CONTRAST
G.I. EXAMS
  • Multi-Purpose
  • Mix-to-need
  • Flavored

tyco
Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 225 gm Bottle

L A F A Y E T T E

Barosperse™
BARIUM SULFATE FOR SUSPENSION

Catalog No. 179208

SINGLE CONTRAST / UPPER G.I.

Rx only

225 gm

Barosperse
Barium Sulfate for Suspension

NDC 68240-621-08
Catalog No. 179208

A vanilla flavored 95% barium sulfate USP formulation for aqueous suspension and use in x-ray diagnosis of the gastrointestinal tract.

Contents: Barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium.

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.

Mixing Directions: For accurate suspension preparation, measure water and add to contents of bottle. The dilution marks may be used for approximate suspension volume.

45% w/w (70% w/v) - 275 mL water
50% w/w (85% w/v) - 225 mL water
60% w/w (110% w/v) - 150 mL water

  • Add water and shake vigorously for 20 to 30 seconds.
  • Add water to the desired Final Concentration Line and remix.
  • Always shake again just before patient administration.
  • Use within 6 hours of preparation.

For single patient use only. Properly discard unused portion.

Storage: Store at 25°C (77°F); excursions permitted to 15º to 30ºC (59° to 86°F).

Net Contents: 225 gm

DIN: 00776629
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 1170085
Rev 02/2009

tyco
Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 454 gm Enema Kit (with Smooth Rigid Enema Tip)

L A F A Y E T T E

Barosperse™ ENEMA KIT
BARIUM SULFATE FOR SUSPENSION ENEMA KIT

(with Smooth Rigid Enema Tip)

Catalog No. 116416

SINGLE CONTRAST / LOWER G.I.

Rx only

454 gm (16 oz.)

NDC 68240-621-16
Catalog No. 116416

A one piece disposable 3 liter enema bag with positive seal closure, attached 5/16” lumen tubing, rigid enema tip and 454 gm of barium sulfate for suspension (95% barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium) for aqueous suspension and use in x-ray diagnosis of the colon.

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 reverse side for abbreviated information.

For single patient use only. Properly discard unused portion.

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

Net Contents: 454 gm (16 oz.)

SMOOTH RIGID ENEMA TIP

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

DIN: 00776629
Distributed in Canada by:
tyco Healthcare
POINTE-CLAIRE, QC, CANADA H9R 5H8
Establishment License # 100689-A

MID 1304641
Rev. 2008/10

tyco
Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 454 gm Enema Kit (with Flexible Enema Tip)

L A F A Y E T T E

Barosperse™ ENEMA KIT
BARIUM SULFATE FOR SUSPENSION ENEMA KIT

(with Flexible Enema Tip)

Catalog No. 116418

SINGLE CONTRAST / LOWER G.I.

Rx only

454 gm (16 oz.)

NDC 68240-621-36
Catalog No. 116418, screw cap

A one piece disposable 3 liter enema bag with positive seal closure, attached 5/16” lumen tubing, flexible enema tip with SILICONE rubber inflatable cuff and 454 gm of barium sulfate for suspension (95% barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium) for aqueous suspension and use in x-ray diagnosis of the colon.

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 reverse side for abbreviated information.

For single patient use only. Properly discard unused portion.

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

Net Contents: 454 gm (16 oz.)

Flexible Enema Tip with Retention Cuff

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

DIN: 00776629
Distributed in Canada by:
tyco Healthcare
POINTE-CLAIRE, QC, CANADA H9R 5H8
Establishment License # 100689-A

MID 1304659
Rev. 2008/10

tyco
Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 900 gm Bottle

L A F A Y E T T E

Barosperse™
BARIUM SULFATE FOR SUSPENSION

SINGLE CONTRAST / G.I. EXAMS

Rx only

NDC 68240-626-09
Catalog No. 139132

A vanilla flavored, 95% barium sulfate USP formulation, for aqueous suspension and use in x-ray diagnosis of the gastrointestinal tract.

Contents: Barium sulfate USP, dispersing and suspending agents, flavoring, simethicone, and saccharin sodium.

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.

Mixing Directions:

  • Add water according to the dilution tables found in the package insert.
  • Shake vigorously for 20 to 30 seconds until thoroughly mixed.
  • Allow to stand for 1 to 3 minutes.
  • Always shake again just before patient administration.
  • Use within 6 hours of preparation.

For single patient use only. Properly discard unused portion.

Storage: Store at 25°C (77°F); excursions permitted to 15º to 30ºC (59º to 86ºF).

Net Contents: 900 gm

DIN: 00776629
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 1304697
Rev 02/2009

tyco
Healthcare

Mallinckrodt

Barosperse 
barium sulfate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-621
Route of Administration ORAL, RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .95 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM  
SORBITOL  
MANNITOL  
ETHYL VANILLIN  
SODIUM TRIPOLYPHOSPHATE  
Product Characteristics
Color      Score     
Shape Size
Flavor VANILLA Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68240-621-08 36 BOTTLE, PLASTIC (BOTTLE) in 1 CASE
1 225 g in 1 BOTTLE, PLASTIC
2 NDC:68240-621-12 24 BAG (BAG) in 1 CASE
2 340 g in 1 BAG
3 NDC:68240-621-16 24 BAG (BAG) in 1 CASE
3 454 g in 1 BAG
4 NDC:68240-621-32 24 BAG (BAG) in 1 CASE
4 340 g in 1 BAG
5 NDC:68240-621-36 24 BAG (BAG) in 1 CASE
5 454 g in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/2009 11/30/2011
Barosperse 
barium sulfate for suspension powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-626
Route of Administration ORAL, RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .95 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM  
SORBITOL  
MANNITOL  
ETHYL VANILLIN  
SODIUM TRIPOLYPHOSPHATE  
Product Characteristics
Color      Score     
Shape Size
Flavor VANILLA Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68240-626-09 8 BOTTLE, PLASTIC (BOTTLE) in 1 CASE
1 900 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/2009 11/30/2011
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.
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