HD 200 Plus

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.

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.

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.

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

• Unit dose
• High density
• Low viscosity

tyco
Healthcare

Mallinckrodt

Applies to barium sulfate: oral cream, oral liquid, oral paste, oral powder for suspension, oral suspension, oral tablet

Along with its needed effects, barium sulfate (the active ingredient contained in HD 200 Plus) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking barium sulfate:

• Bloating
• constipation (severe, continuing)
• cramping (severe)
• nausea or vomiting
• stomach pain
• tightness in the chest
• troubled breathing

• Anxiety
• blood in the stools
• blood in the urine
• blurred vision
• bruising
• chest pain
• confusion
• cough
• coughing or vomiting blood
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast heartbeat
• hives or welts, itching, or skin rash
• noisy breathing
• persistent bleeding or oozing from puncture sites, mouth, or nose
• redness of the skin
• sudden shortness of breath or troubled breathing
• sweating
• unusual tiredness or weakness

Some side effects of barium sulfate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation or diarrhea
• cramping

Applies to barium sulfate: compounding powder, oral capsule, oral cream, oral paste, oral powder for reconstitution, oral suspension, oral tablet, oral and rectal powder for reconstitution, oral and rectal suspension, rectal powder for reconstitution, rectal suspension

General

General side effects including severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have been reported.[Ref]

Other

Other side effects caused by procedural complications have been rare. Procedural complications have included aspiration pneumonitis, barium impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities.[Ref]

Cardiovascular

It is of the utmost importance to be completely prepared to treat any EKG changes.[Ref]

Cardiovascular side effects including EKG changes have been reported following or during barium enema procedures.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, diarrhea, and abdominal cramping accompanying the use of barium sulfate (the active ingredient contained in HD 200 Plus) formulations have been infrequent and usually mild.[Ref]

Some side effects of HD 200 Plus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.