Cheetah Suspension

Cheetah is a quick-flowing, ready-to-use barium sulfate suspension for use as an aid for computed tomography of the gastrointestinal tract.

The contrast medium contains 2.2% w/w barium sulfate USP, sorbitol, simethicone, suspending agent, sodium benzoate, flavoring, potassium sorbate, citric acid, saccharin sodium and water. Barium sulfate has the empirical formula of BaSO4.

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.

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 hayfever 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.

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. When balloon retention tips are used, care should be taken to avoid overinflation of the balloon, since overfilling or asymmetrical filling with displacement of the tip may occur. 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.

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.

Catalog No. 169715. NDC 68240-523-45. Butterscotch-Cream flavor. 450 mL (15 fl. oz.) bottle; twenty-four (24) bottles with straws per case.

Catalog No. 169730. NDC 68240-523-09. Butterscotch-Cream flavor. 900 mL (30 fl. oz.) bottle; twelve (12) bottles per case.

Catalog No. 169740. NDC 68240-523-04. Dreamy Orange flavor. 450 mL (15 fl. oz.) bottle; twenty-four (24) bottles with straws per case.

Catalog No. 169750. NDC 68240-523-05. Creamy Raspberry flavor. 450 mL (15 fl. oz.) bottle; twenty-four (24) bottles with straws per case.

Catalog No. 169760. NDC 68240-523-06. Chocolaty-Fudge flavor. 450 mL (15 fl. oz.) bottle; twenty-four (24) bottles with straws per case.

Catalog No. 169785. NDC 68240-523-85. Flavor variety pack. 450 mL (15 fl. oz.) bottle; twenty-four (24) bottles with straws per case. Contains: eight bottles Dreamy Orange; eight bottles Creamy Raspberry; eight bottles Chocolaty-Fudge.

Shake well before using.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.
Cheetah is a trademark of Lafayette Pharmaceuticals, Incorporated.

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

MID 1295200 Rev 03/2009

CT CONTRAST
G.I. EXAMS

• Quick-flowing
• Ready-to-use
• Flavored

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 CheeTah) 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 CheeTah) formulations have been infrequent and usually mild.[Ref]

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