barium sulfate
Dosage Form: oral and rectal suspension
LAFAYETTE
Tomocat™
BARIUM SULFATE SUSPENSION CONCENTRATE
FOR COMPUTED TOMOGRAPHY
Rx only
Tomocat Description
Tomocat is a strawberry flavored barium sulfate suspension concentrate for dilution and oral or rectal/colon administration as an aid for computed tomography of the gastrointestinal tract.
Tomocat contains approximately 5% w/v barium sulfate USP, suspending agents, sorbitol, citric acid, simethicone, flavoring, potassium sorbate, saccharin sodium and water. Barium sulfate has the empirical formula of BaSO4.
Tomocat - 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 Tomocat
Tomocat is indicated for use as a diagnostic aid (contrast medium) for computed tomography 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 cuff 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.
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 pruritis, 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.
Tomocat Dosage and Administration
Individual technique will determine the suspension quantity and specific procedure used. The following are suggested for Tomocat use as an aid for computed tomography.
Orally administered Tomocat may be served chilled for more rapid transit from the stomach into the small bowel. Rectally administered Tomocat should be at room temperature to body temperature.
Patient Preparation
In order to provide a clear delineation of the G.I. tract, a low residue diet the day prior to the examination is preferred.
Your doctor has scheduled you for a CT scan. Tomocat will help your doctor see your stomach and intestinal tract during the CT scan. The doctor or nurse will tell you what time you should take Tomocat and the suspension concentration to be used.
At the time prescribed by your doctor, add water to the appropriate Fill Mark on the bottle. Replace the cap tightly and shake for 30 seconds. Drink the entire contents of the bottle.
Oral Administration
Tomocat Unit Dose Bottle (Catalog No. 169505): Add water to the fill mark on the back of the bottle near the top. Secure the cap and shake the container well to yield a 1.5% w/v barium sulfate suspension. Have the patient drink the diluted suspension 30 minutes to one hour before the CT scan. See bottle for patient instructions.
Rectal/Colon Administration
Transfer the desired quantity of diluted Tomocat into an enema administration unit, such as an Empty Enema Kit. Close the slide clamp. Lubricate the tip and carefully insert.
If an Empty Enema Kit is used, invert and squeeze the red plug into the bag. Return the bag upright and with the patient in the left lateral position, open the slide clamp to administer the suspension. Coating of the entire colon may be achieved by rotating the patient 360°. For increased patient comfort, excess suspension may be drained back into the enema bag.
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 Tomocat Supplied
Tomocat: Catalog No. 169505. NDC 68240-222-24. 145 mL unit dose bottle packaged in 16 oz. bottle for dilution. Twenty-four (24) bottles with straws per case.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.
Shake well before using.
Tomocat is a trademark of Lafayette Pharmaceuticals, Incorporated
Made in Mexico
Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com
MID 1295020 Rev 03/2009
CT CONTRAST
G.I. EXAMS
- Concentrate
- For dilution
- Flavored
tyco
Healthcare
Mallinckrodt
Package Label - Principal Display Panel - 145 mL Bottle
L A F A Y E T T E
Tomocat™
BARIUM SULFATE SUSPENSION CONCENTRATE
Catalog No. 169505
O3™ ANTIMICROBIAL TECHNOLOGY
CT CONTRAST / G.I. EXAMS
Rx only
145 mL
Tomocat
Barium Sulfate Suspension Concentrate USP
NDC 68240-222-24
Catalog No. 169505
A strawberry flavored 5% w/v barium sulfate USP suspension concentrate for dilution and administration as a diagnostic aid in computed tomography of the gastrointestinal tract.
Contents: Barium sulfate USP, suspending agents, sorbitol, citric acid, simethicone, flavoring, potassium sorbate, saccharin sodium and water.
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.
Shake well before using.
For single patient use only. Properly discard unused portion.
Storage: Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from freezing.
Patient Instructions: Your doctor has scheduled you for a CT scan. Tomocat will help your doctor see your stomach and intestinal tract during the CT scan. The doctor or nurse will tell you what time you should take Tomocat and the suspension concentration to be used.
At the time prescribed by your doctor, add water to the appropriate Fill Mark on the bottle. Replace the cap tightly and shake for 30 seconds. Drink the entire contents of the bottle.
Net Contents: 145 mL
Made in Mexico
Manufactured by:
Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com
MID 1170005
Rev 05/2009
tyco
Healthcare
Mallinckrodt
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 12/01/2009 | 11/30/2010 | |
| Labeler - Mallinckrodt Inc. (810407189) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mallinckrodt Medical, S.A. de C.V. | 810407189 | analysis, manufacture | |
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