DIONOSIL OILY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIONOSIL OILY (DIONOSIL OILY).
DIONOSIL OILY is a radiographic contrast agent containing propyliodone, which is an iodine-containing compound that absorbs X-rays, thereby enhancing the visualization of body structures during imaging procedures.
| Metabolism | Propyliodone is metabolized in the liver via deiodination and conjugation, with metabolites excreted in urine. |
| Excretion | Primarily renal excretion of the water-soluble metabolite (propiodone) after hepatic deiodination; approximately 60-80% of the administered iodine is excreted in urine within 48 hours. Fecal excretion is negligible (<5%). |
| Half-life | Terminal elimination half-life of the iodine moiety is approximately 60 days due to slow release from fatty tissues. This long half-life reflects the persistence of the oily vehicle and slow deiodination, necessitating monitoring for cumulative iodine effects. |
| Protein binding | Negligible binding to plasma proteins; the parent compound is highly lipophilic and predominantly distributed in adipose tissue and lipid-rich environments. |
| Volume of Distribution | Apparent volume of distribution is approximately 5-10 L/kg, indicating extensive sequestration in adipose tissue and slow redistribution. |
| Bioavailability | Not applicable for oral route; administered only via intratracheal instillation. Absorption from the respiratory tract is minimal; local retention is the intended effect. |
| Onset of Action | Onset of bronchographic effect is immediate upon intratracheal instillation; coating of bronchial mucosa occurs within seconds to minutes. |
| Duration of Action | Duration of radiographic contrast effect is 3-5 days due to slow clearance of the oily vehicle. Residual oil may persist in alveoli for weeks, with potential for granuloma formation. |
Adults: 10 mL intraurethral instillation as a sterile oily suspension (50% w/v) once daily for 3-5 days.
| Dosage form | SUSPENSION |
| Renal impairment | No specific recommendations; contraindicated in severe renal impairment (eGFR <30 mL/min/1.73m²) due to potential propyliodone accumulation. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B or C: Use with caution due to limited data; monitor for adverse effects. |
| Pediatric use | Not recommended for children due to lack of safety and efficacy data. |
| Geriatric use | No specific dose adjustment; use with caution due to increased risk of prostatic hypertrophy and urinary retention. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIONOSIL OILY (DIONOSIL OILY).
| Breastfeeding | No specific data on propyliodone excretion in breast milk. Iodinated contrast agents are expected to transfer minimally. The milk-to-plasma ratio is unknown. Caution advised; consider discontinuing breastfeeding for 24 hours after administration. |
| Teratogenic Risk | Dionosil Oily (propyliodone) is an iodinated contrast agent. In the first trimester, theoretical risk of fetal thyroid dysfunction due to iodine overload. Second and third trimesters: no known teratogenic effects, but transient neonatal hypothyroidism has been reported with other iodinated contrast agents. Avoid use unless essential. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to propyliodone or any component","Severe pulmonary hypertension","Active pulmonary hemorrhage"]
| Precautions | ["Risk of hypersensitivity reactions including anaphylaxis","Caution in patients with history of asthma or allergies","Potential for bronchospasm during bronchography","Avoid extravasation as it may cause tissue irritation"] |
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| Fetal Monitoring | Monitor maternal thyroid function if high doses are used. For the fetus, assess for neonatal hypothyroidism if significant maternal exposure occurred. No specific fetal monitoring required. |
| Fertility Effects | No known effects on fertility in humans. Animal studies are not available. |