What is Entero Vu and how is it used?
What are side effects of Entero Vu?
Side effects of Entero Vu are uncommon and usually mild and include:
- diarrhea and abdominal cramping
ENTERO VU™ 24%
(barium sulfate) 24% Suspension
ENTERO VU™ 24% Barium Sulfate Suspension (24% w/v, 20% w/w) is a barium sulfate suspension for oral administration. Each 100 mL contains 24 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 : acacia, carrageenan, citric acid, methylcellulose, natural and artificial blueberry flavor, polysorbate 80, potassium chloride, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, and xanthan gum.
DOSAGE AND ADMINISTRATION
- The recommended oral dose of ENTERO VU 24% is:
- Adults: 600 mL
- For oral use only
- Shake bottle vigorously prior to oral administration to fully suspend product
- Administer undiluted
- Discard any unused suspension
- Advise patients to hydrate following the barium sulfate procedure
- Advise patient at risk for constipation or delayed gastrointestinal transit to monitor for worsening of their condition after administration of barium sulfate and seek medical attention if worsening and advise using laxatives to enhance gastrointestinal transit.
Dosage Forms And Strengths
Oral suspension: barium sulfate (24% w/v) supplied in a single-dose white HDPE plastic bottle as a ready-to-use suspension for oral administration. Each bottle contains 600 mL of suspension.
ENTERO VU 24% (barium sulfate) is supplied as a suspension (24% w/v) in a single-dose HDPE plastic bottle containing 600 mL of barium sulfate suspension (24% w/v).
Provided as: 12 x 600 mL bottles (NDC 32909-145-06)
Storage And Handling
Store at USP controlled room temperature 20°C to 25°C (68°F to 77° F). Protect from freezing.
Manufactured by: EZEM Canada Inc, Anjou (Quebec) Canada H1J 2Z4. Revised: May 2020
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
No Information Provided
No Information Provided
ENTERO VU 24% is contraindicated in patients with the following conditions:
- known or suspected perforation of the GI tract
- known obstruction of the GI tract
- 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
- high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation
- known severe hypersensitivity to barium sulfate or any of the excipients of ENTERO VU 24%
Mechanism Of Action
Due to its high atomic number, barium (the active ingredient in ENTERO VU 24%) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.
Barium sulfate is biologically inert and has no known pharmacological effects.
Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.
After administration, advise patients to:
- Maintain adequate hydration [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
- Seek medical attention for worsening of constipation or slow gastrointestinal passage [see WARNINGS AND PRECAUTIONS].
- Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see WARNINGS AND PRECAUTIONS].
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.