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Tagitol V 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.

NDC 32909-814-53
TAGITOL ™ V
BARIUM SULFATE SUSPENSION
(40% w/v, 30% w/w)

Tagitol V Suspension Description

TAGITOL™ V is a barium sulfate suspension 40% w/v, 30% w/w for oral administration. Each 100 mL contains 40 g barium sulfate. Barium sulfate, due to its high molecular density is opaque to x-rays and therefore, acts as a positive contrast agent for radiographic studies. The active ingredient is barium sulfate and its structural formula is BaSO4. Barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. Its aqueous suspensions are neutral to litmus. It is practically insoluble in water, solutions of acids and alkalies, and organic solvents.

Inactive Ingredients: artificial and natural apple flavor, carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural gum, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate and xylitol.

Tagitol V Suspension - Clinical Pharmacology

Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. Barium sulfate is biologically inert and, therefore, is not absorbed or metabolized by the body, and is eliminated from the GI tract unchanged.

Indications and Usage for Tagitol V Suspension

For use in opacifying residual stool in the colon in CT Colonography.

Contraindications

This product should not be used in patients with known or suspected gastric and intestinal perforation, or hypersensitivity to barium sulfate or any component of this barium sulfate formulation.

Warnings

Rarely, severe and occasionally fatal allergic reactions have been reported following administration of barium sulfate contrast agents. Such a reaction can occur up to 60 minutes following administration. Allergic reactions are more likely to occur in individuals with a history of allergic reactions to barium sulfate products.

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, 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. Ingestion of barium is not recommended in patients with a history of food aspiration. If barium studies are required in these patients or in patients in whom integrity of the swallowing mechanism is unknown, proceed with caution. If barium is aspirated into the larynx, further administration should be immediately discontinued, and a physician consulted.

Information for Patients

Before administration of this product, patients receiving barium sulfate diagnostic agents should be instructed to:

  1. Inform their physician if they are pregnant.
  2. Inform their physician if they are allergic to any drugs or food, or if they have had any prior reactions to barium sulfate products or other contrast agents used in x-ray procedures (see PRECAUTIONS-General).
  3. Inform their physician about any other medications they are currently taking.
  4. Seek immediate medical attention if they experience an allergic reaction after using this product.

Drug Interactions

The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered.

Usage in Pregnancy

Radiation is known to cause harm to the unborn fetus exposed in utero.

Therefore, radiographic procedures should only be used when, in the judgement of the physician, its use is deemed essential to the welfare of the pregnant patient.

Nursing Mothers

Barium sulfate products may be used during lactation.

Adverse Reactions

Adverse reactions, such as nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. Severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities.

ALLERGIC REACTIONS

Due to the increased likelihood of allergic reactions in atopic patients, it is important that a complete history of known and suspected allergies as well as allergic-like symptoms, e.g., rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure utilizing these products. A mild allergic reaction would most likely include generalized pruritus, erythema or urticaria (approximately 1 in 250,000). Such reactions will generally respond to an antihistamine such as 50 mg of diphenhydramine or its equivalent. In the rarer, more serious reactions (approximately 1 in 1,000,000) laryngeal edema, bronchospasm or hypotension could develop. Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis, progressing to unconsciousness. All of the allergic symptoms mentioned above can occur as either an immediate or delayed (up to 24 hours) reactions. Treatment should be initiated immediately with 0.3 to 0.5 cc of 1:1000 epinephrine subcutaneously. If bronchospasm predominates, 0.25 to 0.50 grams of intravenous aminophylline should be given slowly. Appropriate vasopressors might be required. Adrenocorticosteroids, even if given intravenously, exert no significant effect on the acute allergic reactions for a few hours. The administration of these agents should not be regarded as emergency measures for the treatment of allergic reactions.

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 and are best treated by having the patient lie flat for an additional 10 to 30 minutes under observation.

All E-Z-EM barium sulfate contrast and barium contrast delivery systems are latex-free.

Overdosage

On rare occasions following repeated administration, severe stomach cramps, nausea, vomiting, diarrhea or constipation may occur. These indicated responses can be present in both fluoroscopic and CT procedures. These are transitory in nature and are not considered serious. Symptoms may be treated according to currently accepted standards of medical care.

Tagitol V Suspension Dosage and Administration

For Oral Administration 24-hours prior to the procedure: Patient should drink one 20 mL bottle of TAGITOL™ V at each meal; breakfast, lunch (noon) and dinner. Patient should be instructed that if a dose is missed they should take it immediately.

STORAGE

USP Controlled Room Temperature, 20 to 25°C (68 to 77°F). Protect from freezing.

SHAKE WELL PRIOR TO USE

How is Tagitol V Suspension Supplied

TAGITOL™ V is supplied in a carton containing 3 individual bottles, each containing 20 mL; Cat. No. 8140; NDC 32909-814-53


Rx Only (USA)


Manufactured by E-Z-EM Canada Inc.
for E-Z-EM, Inc.
a subsidiary of Bracco Diagnostics Inc.
Monroe Township, NJ 08831
Tel: 1-516-333-8230 1-800 544-4624

rev. 06/14 TX1263-3


Tagitol™ V Label - Bottle

Tagitol™ V Carton
NDC 32909-814-53

TAGITOL V 
barium sulfate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:32909-814
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Barium Sulfate (Barium Sulfate) Barium Sulfate 400 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
carboxymethylcellulose sodium  
dimethicone 350  
dimethicone 1000  
glycerin  
maltodextrin  
polysorbate 80  
potassium sorbate  
saccharin sodium dihydrate  
silicon dioxide  
sodium benzoate  
trisodium citrate dihydrate  
water  
xanthan gum  
xylitol  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor APPLE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:32909-814-53 3 BOTTLE, PLASTIC in 1 CARTON
1 20 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 11/01/2003
Labeler - E-Z-EM Canada Inc (204211163)
Registrant - E-Z-EM, INC. (002041226)
Establishment
Name Address ID/FEI Operations
E-Z-EM Canada Inc 204211163 PACK(32909-814), ANALYSIS(32909-814), LABEL(32909-814), MANUFACTURE(32909-814)
Revised: 08/2014
 
E-Z-EM Canada Inc
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