GASTROVIST
Clinical safety rating: caution
Comprehensive clinical and safety monograph for GASTROVIST (GASTROVIST).
Gastrovist (diatrizoate meglumine) is a iodinated radiographic contrast agent that attenuates X-rays, enhancing visualization of the gastrointestinal tract. It acts as a hyperosmolar agent, drawing fluid into the bowel lumen and providing positive contrast for imaging.
| Metabolism | Diatrizoate meglumine is not significantly metabolized; it is excreted unchanged primarily via renal filtration and in feces following oral administration. |
| Excretion | Primarily renal (glomerular filtration): >95% of iodinated contrast is excreted unchanged in urine within 24 hours; <5% fecal or biliary. |
| Half-life | Terminal elimination half-life is approximately 2 hours in patients with normal renal function (creatinine clearance >90 mL/min); prolonged to >20 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Approximately 5-10% bound to serum albumin; binding is low and clinically insignificant. |
| Volume of Distribution | 0.4-0.6 L/kg, reflecting distribution primarily in extracellular fluid (plasma and interstitial space) with minimal intracellular penetration. |
| Bioavailability | Oral: negligible systemic absorption (<0.1% due to poor gastrointestinal uptake and high polarity). Intravenous/intra-arterial: 100% by definition. |
| Onset of Action | Oral: within 30-60 minutes for gastrointestinal opacification. Intravenous: immediate (seconds) for vascular enhancement. Intra-arterial: immediate. |
| Duration of Action | Oral: adequate bowel opacification persists for 2-6 hours depending on transit time. Intravenous: vascular enhancement peaks at 1-2 minutes and declines rapidly; diagnostic enhancement lasts 5-10 minutes for renal excretion phase. |
Oral: 50-100 mL of a 30% w/v solution (300 mg iodine/mL) administered orally 30-60 minutes before imaging. Repeat dose if necessary for adequate visualization. Rectal: 100-200 mL of a 30% w/v solution as enema for CT colonography.
| Dosage form | SOLUTION |
| Renal impairment | For GFR <30 mL/min/1.73m²: Use only if benefit outweighs risk; consider alternative imaging. No specific dose adjustment recommended; ensure adequate hydration. GFR <15 mL/min: Contraindicated. |
| Liver impairment | No dose adjustment required for Child-Pugh Class A or B. For Child-Pugh Class C: Use with caution; no specific dose recommendation. |
| Pediatric use | Oral: 5-10 mL/kg of a 15% w/v solution (150 mg iodine/mL) for children >2 years. Maximum 100 mL. For neonate/infant: 2-5 mL/kg of 15% solution. Rectal: 5-10 mL/kg of 15% solution as enema. |
| Geriatric use | No specific dose adjustment; ensure adequate hydration due to increased risk of dehydration and renal impairment. Use lowest effective dose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for GASTROVIST (GASTROVIST).
| Breastfeeding | Diatrizoic acid is excreted in breast milk in small amounts. M/P ratio not established. The American College of Radiology recommends that breastfeeding can be continued without interruption after contrast administration, though the infant should be monitored for potential adverse effects such as rash or gastrointestinal upset. |
| Teratogenic Risk | GASTROVIST (diatrizoic acid) is a radiocontrast agent. No adequate studies in pregnant women. In first trimester, theoretical risk of fetal thyroid suppression if iodine crosses placenta, though typically used as single diagnostic dose. Second and third trimester: minimal risk with proper use; avoid repeated or high doses due to potential fetal hypothyroidism. |
■ FDA Black Box Warning
No FDA black box warning exists for this formulation. Use with caution in patients with known hypersensitivity to iodinated contrast agents.
| Serious Effects |
["Known hypersensitivity to diatrizoate or other iodinated contrast agents","Active gastrointestinal bleeding or perforation","Severe dehydration or electrolyte imbalance","Myasthenia gravis (may exacerbate weakness)"]
| Precautions | ["Risk of hypersensitivity reactions ranging from urticaria to anaphylaxis, especially in patients with history of allergy or asthma","Potential for aspiration if administered to patients with impaired swallowing or decreased consciousness","Dehydration and electrolyte disturbances due to osmotic diarrhea","Use with caution in patients with renal impairment or pre-existing renal disease"] |
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| Fetal Monitoring | Monitor maternal renal function before administration (eGFR). Assess for allergic reactions during and after administration. In pregnancy, consider fetal heart rate monitoring if clinically indicated, though not routine. Post-procedure, monitor for any signs of neonatal hypothyroidism if high-dose or multiple exposures occurred. |
| Fertility Effects | No known direct effects on human fertility. In animal studies, no evidence of impaired fertility at clinically relevant doses. However, diagnostic use is single exposure, unlikely to impact reproductive capacity. |