Tx1263-1.qxd

WARNINGS: Rarely, severe and occasionally
fatal allergic reactions have been reported TAGITOL V following administration of barium sulfate
contrast agents. Such a reaction can occur up BARIUM SULFATE SUSPENSION
to 60 minutes following administration.
(40% w/v, 30% w/w)
Allergic reactions are more likely to occur inindividuals with a history of allergic reactionsto barium sulfate products.
PRECAUTIONS: General: Diagnostic proce-
dures 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
DESCRIPTION: TAGITOL V is a barium sulfate
or advanced cardiac disease. Ingestion of barium is not recommended in patients with a administration. Each 100 mL contains 40 g history of food aspiration. If barium studies are barium sulfate. Barium sulfate, due to its high required in these patients or in patients in molecular density is opaque to x-rays and whom integrity of the swallowing mechanism therefore, acts as a positive contrast agent for is unknown, proceed with caution. If barium is radiographic studies. The active ingredient is aspirated into the larynx, further administration barium sulfate and its structural formula is should be immediately discontinued, and a white, odorless, tasteless, bulky powderwhich is free from grittiness. Its aqueous Information for Patients: Before administration
suspensions are neutral to litmus. It is practi- of this product, patients receiving barium cally insoluble in water, solutions of acids sulfate diagnostic agents should be instructed to: 1. Inform their physician if they are pregnant.
Inactive Ingredients: artificial and natural
2. Inform their physician if they are allergic to apple flavor, carboxymethylcellulose sodium, any drugs or food, or if they have had any citric acid, glycerin, maltodextrin, natural gum, prior reactions to barium sulfate products or polysorbate 80, potassium sorbate, purified other contrast agents used in x-ray proce- water, saccharin sodium, simethicone emulsion, dures (see PRECAUTIONS-General).
sodium benzoate, sodium citrate and xylitol.
3. Inform their physician about any other medications they are currently taking.
CLINICAL PHARMACOLOGY: Barium sulfate,
4. Seek immediate medical attention if they due to its high molecular density is opaque to experience an allergic reaction after using x-rays and, therefore, acts as a positive contrast agent for radiographic studies. Barium sulfateis biologically inert and, therefore, is not Drug Interactions: The presence of barium
absorbed or metabolized by the body, and is sulfate formulations in the GI tract may alter eliminated from the GI tract unchanged.
the absorption of therapeutic agents takenconcomitantly. In order to minimize any potential INDICATIONS AND USAGE: For use in
change in absorption, the separate administra- opacifying residual stool in the colon in CT tion of barium sulfate from that of other agents CONTRAINDICATIONS: This product should not
Usage in Pregnancy:
pected gastric and intestinal perforation, or hypersensitivity to barium sulfate or any component of this barium sulfate formulation.
PRECAUTIONS Continued
Apprehensive patients may develop weakness,pallor, tinnitus, diaphoresis and bradycardia Therefore, radiographic procedures should following the administration of any diagnostic only be used when, in the judgement of the agent. Such reactions are usually non-allergic physician, its use is deemed essential to the in nature and are best treated by having the patient lie flat for an additional 10 to 30minutes under observation.
Nursing Mothers: Barium sulfate products
may be used during lactation.
All E-Z-EM barium sulfate contrast and bariumcontrast delivery systems are latex-free.
ADVERSE REACTIONS: Adverse reactions,
such as nausea, vomiting, diarrhea and
abdominal cramping, accompanying the use
OVERDOSAGE: On rare occasions following
of barium sulfate formulations are infrequent and usually mild. Severe reactions (approxi- cramps, nausea, vomiting, diarrhea or consti- pation may occur. These indicated responses can be present in both fluoroscopic and CT occurred. Procedural complications are rare, procedures. These are transitory in nature and are not considered serious. Symptoms may be intravasation, embolization and peritonitis following intestinal perforation, vasovagaland syncopal episodes, and fatalities.
DOSAGE AND ADMINISTRATION: For Oral
Administration 24-hours prior to the procedure:
ALLERGIC REACTIONS: Due to the increased
likelihood of allergic reactions in atopic patients, it is important that a complete history (noon) and dinner. Patient should be instructed of known and suspected allergies as well as that if a dose is missed they should take it allergic-like symptoms, e.g., rhinitis, bronchial asthma, eczema and urticaria, must beobtained prior to any medical procedure utilizing STORAGE: Store product to protect from
these products. A mild allergic reaction would freezing and excessive heat (above 40°C).
most likely include generalized pruritus,erythema or urticaria (approximately 1 in SHAKE WELL PRIOR TO USE
250,000). Such reactions will generallyrespond to an antihistamine such as 50 mg of HOW SUPPLIED: TAGITOL™ V is supplied in a
diphenhydramine or its equivalent. In the rarer, carton containing 3 individual bottles, each more serious reactions (approximately 1 in 1,000,000) laryngeal edema, bronchospasm or hypotension could develop. Severe reactionswhich may require emergency measures areoften characterized by peripheral vasodilation, Only (USA)
hypotension, reflex tachycardia, dyspnea,agitation, confusion and cyanosis, progressingto unconsciousness. All of the allergic symp-toms mentioned above can occur as either animmediate or delayed (up to 24 hours) reactions.
Treatment should be initiated immediately with0.3 to 0.5 cc of 1:1000 epinephrine subcuta-neously. If bronchospasm predominates, 0.25to 0.50 grams of intravenous aminophyllineshould be given slowly. Appropriate vasopres-sors 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.

Source: http://host-81-88-52-98.dedicatedservers.it/images/stories/pdf/ray/ct_colonoscopy/tagitol_pi_11.14.08.pdf