Tagitol V

TAGITOL V is indicated
for use in adult patients for use in computed tomography (CT) colonography
as a fecal tagging agent.

• The recommended dose is:
  • One 20 mL bottle (8g barium sulfate) with each meal (breakfast,
    lunch and dinner) the day
    before
    the CT colonography
    examination (
    2.1 Recommended Dosing

    • 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).
    ).
  • Total dose = 3 bottles (24 g barium sulfate)
• For oral use only (
  2.2 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.
  ).

Oral suspension: barium sulfate (40% w/v) supplied as a ready-to-use suspension in a 20 mL, single-dose, bottle for oral administration. Each 20 mL bottle contains 8 g of barium sulfate.

TAGITOLV

• Hypersensitivity reactions: Emergency equipment and trained
  personnel should be immediately available (
  5.1 Hypersensitivity Reactions

  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: May occur in conditions
  which increase the risk of perforation such as - carcinoma, GI fistula,
  inflammatory bowel disease, gastric or duodenal ulcer, appendicitis,
  diverticulitis, or severe stenosis or obstructing lesions of the GI
  tract (
  5.2 Intra-abdominal Barium Leakage

  The use of TAGITOL V is contraindicated in patients at high risk of perforation of the GI tract

  [see Contraindications ].

  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 GI transit and obstruction: Patients should maintain
  adequate hydration in days following a barium sulfate procedure to
  avoid obstruction or impaction by baroliths (
  5.3 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.
  )
• Aspiration pneumonitis: Caution is recommended in patients
  with a history of food aspiration and in patients with known swallowing
  disorders (
  5.4 Aspiration Pneumonitis

  The use of TAGITOL V is contraindicated in patients at high risk of aspiration

  [see Contraindications ].

  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.
  )