Barobag Suspension

Generic Name: barium sulfate
Dosage Form: 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
BAROBAG™ ENEMA KIT
BARIUM SULFATE FOR SUSPENSION ENEMA KIT

Rx only

Barobag Suspension Description

Barobag is a complete 3 liter enema kit containing a barium sulfate formulation for aqueous suspension and use in filled colon examinations. The contrast medium contains approximately 97% w/w barium sulfate USP, suspending agents, dispersing agents, and simethicone. Barium sulfate has the empirical formula of BaSO4.

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Barobag Suspension - 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 Barobag Suspension

Barobag is indicated for use as a contrast medium in filled colon examinations.

Contraindications

Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, inflammation or neoplastic lesions of the rectum, recent rectal biopsy or known hypersensitivity to barium sulfate formulation.

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.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties. Allergic responses following the use of barium sulfate suspensions have been reported.

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.

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.

Care must be taken during insertion of the enema tip 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 over-inflation 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.

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.

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.

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, 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.

Barobag Suspension Dosage and Administration

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

Patient Preparation

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.

Suspension Preparation

Fill Barobag to desired level (see Density Chart below) using warm water.

12 oz. BAROBAG DENSITY CHART
% w/v
Barium Sulfate
Total Suspension
Volume, mLs
% w/w
Barium Sulfate
Approximate
Specific Gravity
33.0 1000 26.1 1.266
22.0 1500 18.6 1.178
16.5
2000
14.6 1.129
13.2
2500 11.9
1.105
16 oz. BAROBAG DENSITY CHART
% w/v
Barium Sulfate
Total Suspension
Volume, mLs
% w/w
Barium Sulfate
Approximate
Specific Gravity
44.0 1000
33.2
1.352
29.3 1500 23.8
1.233
22.0 2000
18.7
1.178
17.6
2500
15.3
1.136
14.9
3000 13.5
1.107

Close cap securely. Shake Barobag vigorously until the barium sulfate formulation is completely suspended (normally 30 seconds).

Administration

Rectally administered suspension should be at room temperature to body temperature.

Just prior to administration, shake Barobag again several times to ensure the proper mixture. Turn the bag upside down and squeeze the plug at the top of the tubing into the bag. Return the bag to an upright position. Open the clamp and move it down the tubing to a position near the tip to allow air to bleed from the tubing. Close the clamp. Barobag is now ready to use.

Lubricate the enema tip and carefully insert. The enema tip should be inserted and the retention cuff (if a cuff tip is used) inflated by a physician or by qualified medical personnel under a physician’s supervision only.

If a retention cuff enema tip is used, do not insert the retention cuff beyond the anal-rectal junction. The inflated cuff should be at the level of the anal sphincter for best retention and maximum safety. If the cuff is beyond the anal-rectal junction, gently pull it back until its proximal end can be seen. Use only the single puff inflator included in the Barobag carton to inflate the retention cuff. Before inflating the cuff, visualize the rectum with contrast medium to ensure the absence of contraindications. Squeeze the inflator once only and close the clamp for the retention cuff inflation line.

Open the slide clamp on the enema bag tubing and allow the barium sulfate suspension to enter the colon. When the examination is complete, lower the enema bag and allow the barium sulfate suspension to reenter the enema bag.

Release the air in the retention cuff (if one is used) and gently remove the enema tip, using a slight twisting motion if necessary.

For single patient use only. Properly discard unused portion.

How is Barobag Suspension Supplied

Catalog No. 116112. NDC 68240-066-12. 340 gm (12 oz.) enema kit, SCREW cap spout, rigid enema tip. Twenty-four (24) kits per case.

Catalog No. 114312. NDC 68240-067-12. 340 gm (12 oz.) enema kit, SCREW cap spout, flexible enema tip with SILICONE retention cuff and single puff inflator (2 per case). Twenty-four (24) kits per case.

Catalog No. 116116. NDC 68240-066-16. 454 gm (16 oz.) enema kit, SCREW cap spout, rigid enema tip. Twenty-four (24) kits per case.

Catalog No. 114316. NDC 68240-067-16. 454 gm (16 oz.) enema kit, SCREW cap spout, flexible enema tip with SILICONE retention cuff and single puff inflator (2 per case). Twenty-four (24) kits per case.

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

Barobag is a trademark of Lafayette Pharmaceuticals, Incorporated.

DIN: 00626937
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 1295085  Rev 06/2009

SINGLE CONTRAST
LOWER G.I.
  • Complete kit
  • Rapidly suspending

tyco
Healthcare

Mallinckrodt

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 340 gm Bag

LAFAYETTE
BAROBAG™ ENEMA KIT
BARIUM SULFATE FOR SUSPENSION ENEMA KIT
(with Flexible Enema Tip)

Catalog No. 114312

SINGLE CONTRAST / LOWER G.I.

Rx only

340 gm (12 oz.)

NDC 68240-067-12

Catalog No. 114312

A one piece disposable 3 liter enema bag with positive seal closure, attached 5/16” lumen tubing, flexible enema tip with SILICONE inflatable retention cuff and 340 gm of 97% w/w barium sulfate USP formulation for aqueous suspension and use in filled colon examinations.

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

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: 340 gm (12 oz.)

Flexible Enema Tip with Retention Cuff

DIN: 00626937
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 1304677 Rev 06/2009

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 454 gm Bag

LAFAYETTE
BAROBAG™ ENEMA KIT
BARIUM SULFATE FOR SUSPENSION ENEMA KIT
(with Flexible Enema Tip)

Catalog No. 114316

SINGLE CONTRAST / LOWER G.I.

Rx only

454 gm (16 oz.)

NDC 68240-067-16

Catalog No. 114316

A one piece disposable 3 liter enema bag with positive seal closure, attached 5/16” lumen tubing, flexible enema tip with SILICONE inflatable retention cuff and 454 gm of 97% w/w barium sulfate USP formulation for aqueous suspension and use in filled colon examinations.

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

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

DIN: 00626937
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 1295001 Rev 06/2009

BAROBAG ENEMA KIT 
barium sulfate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-066
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .97 g  in 1 g
Packaging
# Item Code Package Description
1 NDC:68240-066-12 24 BAG (BAG) in 1 CASE
1 340 g in 1 BAG
2 NDC:68240-066-16 24 BAG (BAG) in 1 CASE
2 454 g in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2009 10/31/2011
BAROBAG ENEMA KIT 
barium sulfate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-067
Route of Administration RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .97 g  in 1 g
Packaging
# Item Code Package Description
1 NDC:68240-067-12 24 BAG (BAG) in 1 CASE
1 340 g in 1 BAG
2 NDC:68240-067-16 24 BAG (BAG) in 1 CASE
2 454 g in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2009 10/31/2011
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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