GASTROGRAFIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for GASTROGRAFIN (GASTROGRAFIN).
Gastrografin is a water-soluble iodinated contrast agent that increases the radiodensity of the gastrointestinal tract, allowing visualization on X-ray. It acts by absorbing X-rays due to its high iodine content.
| Metabolism | Not metabolized; primarily eliminated unchanged via feces. Small amounts absorbed systemically are excreted renally. |
| Excretion | Renal: 80-90% (glomerular filtration, unchanged); Biliary/Fecal: <5% (minor biliary excretion of absorbed fraction). |
| Half-life | Terminal elimination half-life: 1-2 hours (for absorbed diatrizoate); prolongation in renal impairment (up to 20 hours in anuria). |
| Protein binding | Low (~10-15%), primarily to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg (confined to extracellular fluid); higher in neonates due to larger ECF. |
| Bioavailability | Oral: <5% (minimal absorption from intact GI tract); Rectal: <1%. |
| Onset of Action | Oral: 30-60 minutes; Rectal: 15-30 minutes; Intravenous (not typical for GI use): immediate. |
| Duration of Action | Oral: 3-6 hours (time to reach colon); Rectal: 1-2 hours; clinical effect persists until contrast is excreted in feces. |
Oral or rectal: 50-100 mL of a 1:1 dilution with water (or full strength as needed) for CT or fluoroscopic studies. Typically single dose.
| Dosage form | SOLUTION |
| Renal impairment | No specific GFR-based dose adjustments required; however, use caution in severe renal impairment (eGFR <30 mL/min/1.73m²) due to risk of osmotic nephropathy. |
| Liver impairment | No specific Child-Pugh based modifications; no significant hepatic metabolism. |
| Pediatric use | Neonates (0-1 month): 15-30 mL orally; Infants (1-12 months): 30-60 mL; Children (1-6 years): 40-100 mL; Children >6 years: 50-100 mL. Administered as a single dose. Dilute with water if needed. |
| Geriatric use | Caution in elderly due to higher risk of dehydration and renal impairment. Use lowest effective volume (e.g., 50 mL diluted 1:1). Monitor hydration status. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for GASTROGRAFIN (GASTROGRAFIN).
| Breastfeeding | GASTROGRAFIN is not significantly absorbed systemically after oral or rectal administration. Excretion into breast milk is minimal and considered clinically insignificant. The M/P (milk-to-plasma) ratio is not defined due to negligible plasma levels. The American College of Radiology (ACR) states that breastfeeding can continue without interruption after maternal administration of iodinated contrast agents. No adverse effects in nursing infants have been reported. |
| Teratogenic Risk | GASTROGRAFIN (diatrizoate meglumine and diatrizoate sodium) is an iodinated contrast agent with limited systemic absorption after oral or rectal administration. No teratogenic effects are reported in animal studies at clinically relevant doses. In humans, first trimester exposure is unlikely to pose significant risk due to negligible systemic absorption; second and third trimester use is considered safe when diagnostic benefit outweighs theoretical risks of fetal thyroid suppression due to free iodide. No known association with congenital anomalies. |
■ FDA Black Box Warning
Not available (no black box warning for Gastrografin)
| Serious Effects |
["Hypersensitivity to iodinated contrast agents","Known or suspected gastrointestinal perforation","Intestinal obstruction (absolute if complete; relative if partial)","Severe dehydration or electrolyte imbalance"]
| Precautions | ["Risk of aspiration pneumonitis if aspirated into lungs","Hypersensitivity reactions including anaphylaxis","Dehydration and electrolyte imbalance due to hyperosmolarity","May cause bowel perforation in patients with compromised bowel wall","Use with caution in patients with known or suspected bowel obstruction"] |
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| Fetal Monitoring | No specific fetal monitoring is required for GASTROGRAFIN due to minimal systemic absorption. Maternal monitoring should focus on rare hypersensitivity reactions (e.g., urticaria, anaphylaxis) and potential aspiration if administered orally in patients with impaired swallowing. Fetal thyroid function (TSH, free T4) may be checked in neonates if repeated high-dose maternal exposures occurred, though not routinely indicated for single diagnostic use. |
| Fertility Effects | No known effects on fertility in males or females. GASTROGRAFIN does not undergo systemic absorption sufficient to impact gametogenesis or reproductive function. No fertility studies in humans; animal studies do not indicate impairment of fertility at clinically relevant doses. |