ENTERO VU 24%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ENTERO VU 24% (ENTERO VU 24%).
Entero-Vu 24% is a radiopaque contrast agent containing barium sulfate. It acts by coating the gastrointestinal mucosa, providing positive contrast on radiographs due to barium's high atomic number, which attenuates X-rays.
| Metabolism | Barium sulfate is not absorbed from the gastrointestinal tract and is excreted unchanged in feces. |
| Excretion | Renal: 100% of absorbed iodine is excreted unchanged in urine within 24-48 hours; no biliary or fecal elimination of significance. |
| Half-life | Terminal elimination half-life is approximately 2 hours in patients with normal renal function; may be prolonged in renal impairment. |
| Protein binding | Negligible (<1%); diatrizoate meglumine does not bind to plasma proteins. |
| Volume of Distribution | Approximately 0.2 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Not applicable (administered as an enteral solution; absorption is minimal and systemic bioavailability is negligible; the drug acts as a non-absorbable contrast agent). |
| Onset of Action | Oral: Onset of radiographic opacification occurs within 15-30 minutes; maximal opacification of the small intestine is achieved at 60-90 minutes. |
| Duration of Action | Oral: Adequate opacification of the small intestine persists for 30-90 minutes; colonic opacification may take 2-4 hours and lasts 1-3 hours depending on transit. |
Adults: 50 mL of 24% solution orally as a single dose, repeated once after 30 minutes if needed.
| Dosage form | SUSPENSION |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Children: 0.5 mL/kg of 24% solution orally as a single dose, maximum 50 mL. |
| Geriatric use | No specific dose adjustment; use same as adult dose with caution due to potential aspiration risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ENTERO VU 24% (ENTERO VU 24%).
| Breastfeeding | Iodinated contrast media are excreted into breast milk in small amounts (less than 1% of maternal dose). No adverse effects have been reported in nursing infants. The M/P ratio is not specifically reported for ioxaglate (the active ingredient in ENTERO VU 24%). It is recommended to discard breast milk for 24 hours after administration as a precaution. |
| Teratogenic Risk | Iodinated contrast media are classified as FDA Pregnancy Category B. Animal studies have not demonstrated teratogenic effects. In humans, no well-controlled studies exist; however, iodine exposure from contrast media may transiently suppress fetal thyroid function, especially in the second and third trimesters. Risk of neonatal hypothyroidism is theoretical but considered low with single diagnostic exposure. |
■ FDA Black Box Warning
There is no FDA black box warning for Entero-Vu 24%.
| Serious Effects |
["Known or suspected gastrointestinal perforation","Known or suspected gastrointestinal obstruction or fistula","High risk of aspiration (e.g., severe dysphagia, impaired gag reflex)","Severe active gastrointestinal bleeding","Hypersensitivity to barium sulfate or any component of the formulation"]
| Precautions | ["Risk of aspiration (especially in patients with swallowing difficulties, esophageal strictures, or impaired gag reflex)","Risk of perforation in patients with known or suspected GI perforation, obstruction, or fistula","Hypersensitivity reactions (rare)","Use with caution in patients with inflammatory bowel disease, ischemic colitis, or recent rectal biopsy/surgery"] |
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| Fetal Monitoring | Monitor maternal renal function prior to administration. During pregnancy, assess fetal thyroid function (TSH) if multiple exposures occur or if the neonate shows signs of hypothyroidism. No specific fetal monitoring required for single diagnostic use. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not reported impairment of fertility. |