Tagitol V Suspension
Generic Name: barium sulfate
Dosage Form: suspension
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
- The recommended oral dose of TAGITOL V is one 20 mL bottle (8 g barium sulfate) with each meal (breakfast, lunch and dinner) the day before the colonography examination. Total dose = 3 bottles (24 g barium sulfate).
Important Administration Instructions
- TAGITOL V is typically provided to the patient for self-administration. Advise patients to carefully read and follow the Patient Instructions for Use to be provided to the patient.
- Shake bottle for 15 seconds prior to administration.
- For oral use only.
- Encourage patients to hydrate following the barium sulfate procedure.
- Discard any unused suspension.
3 DOSAGE FORMS AND STRENGTHS
- high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis;
5 WARNINGS AND PRECAUTIONS
Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, dermal reactions including rashes, urticaria and itching. A history of bronchial asthma, atopy, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.
Intra-abdominal Barium Leakage
The use of TAGITOL V is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications (4)]. Administration of TAGITOL V may result in leakage of barium from the GI tract in the presence of conditions that increase the risk of perforation such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the gastrointestinal tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation.
Delayed Gastrointestinal Transit and Obstruction
Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired gastrointestinal motility, electrolyte imbalance, dehydration, on a low residue diet, on medications that delay GI motility, constipation, cystic fibrosis, Hirschsprung disease, and the elderly. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration following a barium sulfate procedure.
The use of TAGITOL V is contraindicated in patients at high risk of aspiration [see Contraindications (4)]. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis.
Barium sulfate products may occasionally intravasate into the venous drainage of the large bowel and enter the circulation as a "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of barium sulfate products, monitor patients for potential intravasation when administering barium sulfate.
6 ADVERSE REACTIONS
The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure:
- Nausea, vomiting, diarrhea and abdominal cramping
- Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes.
8 USE IN SPECIFIC POPULATIONS
TAGITOLVis not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)].
TAGITOL V is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the infant to the drug [see Clinical Pharmacology (12.3)]
Clinical studies of TAGITOL V do not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
TAGITOL V (barium sulfate) is a radiographic contrast agent that is supplied as a 40% w/v, off-white to lightly colored, free-flowing, ready-to-use suspension with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol and the following chemical structure:
TAGITOL V contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum, and xylitol.
12 CLINICAL PHARMACOLOGY
Mechanism of Action
13 NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
Storage and Handling
17 PATIENT COUNSELING INFORMATION
- Maintain adequate hydration [see Dosage and Administration (2.2) and Warnings and Precautions (5.3)].
- Seek medical attention for worsening of constipation or slow gastrointestinal passage [see Warnings and Precautions (5.3)].
- Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see Warnings and Precautions (5.1)].
Read this Instructions for Use before you drink TAGITOL V (barium sulfate) oral suspension. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Take TAGITOL V exactly as your healthcare provider tells you. Your healthcare provider will prescribe the dose that is right for you. You can ask your healthcare provider or pharmacist if you have any questions about how to take TAGITOL V.
- Before using TAGITOL V store at room temperature between 68°F and 77°F (20°C and 25°C).
- Do not freeze.
- 1 box containing 3 bottles of TAGITOL V. Each bottle contains 20 mL of TAGITOL V
- Breakfast: Shake 1 bottle of TAGITOL V for 15 seconds, open the bottle, and drink the liquid with breakfast.
- Lunch: Shake 1 bottle of TAGITOL V for 15 seconds, open the bottle, and drink the liquid with lunch.
- Dinner: Shake 1 bottle of TAGITOL V for 15 seconds, open the bottle, and drink the liquid with dinner.
barium sulfate suspension
|Labeler - E-Z-EM Canada Inc (204211163)|
|Registrant - E-Z-EM, INC. (002041226)|
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- Drug class: non-iodinated contrast media