HD 200 Plus

Generic Name: barium sulfate
Dosage Form: oral 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
HD 200™ PLUS
BARIUM SULFATE FOR SUSPENSION

Rx only

HD 200 Plus Description

HD 200 Plus is a strawberry flavored, high density barium sulfate formulation for aqueous suspension and use as a contrast medium in air contrast stomach examinations.

The product contains 98% w/w barium sulfate USP, suspending agents, sucrose, saccharin sodium, simethicone and artificial flavoring. Barium sulfate has the empirical formula BaSO4.

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HD 200 Plus - 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

HD 200 Plus is indicated for use as a contrast medium in double contrast stomach examinations.

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, 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.

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 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 may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of a 115% w/v barium sulfate suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.

HD 200 Plus Dosage and Administration

Individual technique will determine the suspension quantity, concentration, and specific procedure used. The following are suggested for HD 200 Plus use in double contrast stomach examinations.

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.

Mixing Directions

• Fill the water measuring cup supplied with HD 200 Plus to overflow (approximately 68 mL) and add to the contents of the bottle.

• Secure the bottle cap, invert and shake vigorously for 5 seconds in an up and down motion.

• Allow 5 minutes for complete hydration, then vigorously reshake for 5 seconds.

• Just prior to patient administration remix to assure suspension uniformity.

The HD 200 Plus unit dose bottle prepares approximately 135 mL of 225% w/v high density barium sulfate suspension. Use within 6 hours of preparation. Discard unused suspension.

Administration

While techniques may vary, it is suggested that the patient place a gas producing agent such as sodium bicarbonate on the tongue and wash down with 10 mL of water. Immediately following the sodium bicarbonate and while the patient is in the upright position, have the patient drink the HD 200 Plus suspension. Instruct the patient not to burp. (Depending upon physician preference, the barium sulfate suspension may be given prior to sodium bicarbonate).

For single patient use only. Properly discard unused portion.

How is HD 200 Plus Supplied

Catalog No. 149311. NDC 68240-128-08. 312 gm bottle; thirty-six (36) bottles with straws and one (1) water measuring cup per case.

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

HD 200 Plus is a trademark of Lafayette Pharmaceuticals, Incorporated.

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

MID 1295075   Rev 04/2009

DOUBLE CONTRAST
UPPER G.I.
  • Unit dose
  • High density
  • Low viscosity

tyco
Healthcare

Mallinckrodt

Package Label - Principal Display Panel - 312 gm Bottle

L A F A Y E T T E

HD 200™ PLUS
BARIUM SULFATE
FOR SUSPENSION

Catalog No. 149311

DOUBLE CONTRAST /
UPPER G.I. EXAMS

Rx only

312 gm

HD 200 Plus
Barium Sulfate for Suspension

NDC 68240-128-08
Catalog No. 149311

A strawberry flavored, high density, 98% w/w barium sulfate formulation for aqueous suspension and use as a contrast medium in air contrast stomach examinations.

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

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:

  • Fill the water measuring cup to overflow and add to the contents of the bottle.
  • Secure the bottle cap, invert and shake vigorously for 5 seconds in an up and down motion.
  • Allow 5 minutes for complete hydration, then vigorously reshake for 5 seconds.
  • Just prior to patient administration, remix to assure suspension uniformity.
  • Use within 6 hours of preparation.

For single patient use only. Properly discard unused portion.

This bottle prepares approximately 135 mL of 225% w/v high density barium sulfate suspension.

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

Net Contents: 312 gm

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

MID 1170100
Rev 04/2009

tyco/Healthcare

MALLINCKRODT

HD 200   PLUS
barium sulfate for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68240-128
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .98 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM  
SODIUM CITRATE  
SORBITOL  
CROSCARMELLOSE SODIUM  
SUCROSE  
CARRAGEENAN  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68240-128-08 36 BOTTLE, PLASTIC (BOTTLE) in 1 CASE
1 312 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: 11/2010
 
Mallinckrodt Inc.
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