DIONOSIL AQUEOUS
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIONOSIL AQUEOUS (DIONOSIL AQUEOUS).
DIONOSIL AQUEOUS contains propyliodone, a radiocontrast agent that absorbs X-rays, providing visualization of bronchial structures. It acts by coating the bronchial mucosa and filling the airways, allowing radiographic imaging.
| Metabolism | Propyliodone is deiodinated in the liver and excreted via the kidneys. The free iodide may be metabolized to iodine-containing compounds. |
| Excretion | Renal excretion of unchanged drug accounts for >95% of elimination; <5% is eliminated via biliary/fecal routes. |
| Half-life | Terminal elimination half-life is 2-4 hours in patients with normal renal function; prolonged in renal impairment. |
| Protein binding | Approximately 10-20% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is 0.2-0.3 L/kg, indicating distribution primarily within the extracellular fluid compartment. |
| Bioavailability | Intravenous: 100%; intramuscular: 100% (as it is administered directly into systemic circulation); oral: not applicable (not absorbed intact). |
| Onset of Action | Intravenous: immediate within 1-2 minutes; intramuscular: 5-10 minutes; oral: not applicable (diagnostic use only via IV/IM). |
| Duration of Action | Duration of diagnostic enhancement is 30-60 minutes post-injection, corresponding to the vascular phase; contrast effect diminishes as drug distributes. |
Intra-articular injection: 2-3 mL of 1% solution (20-30 mg) per joint; maximum 4 joints per session. Intravenous: 2-4 mL of 20% solution (400-800 mg) diluted in 20 mL water, administered slowly over 5-10 minutes, for peripheral angiography.
| Dosage form | SUSPENSION |
| Renal impairment | Contraindicated in severe renal impairment (eGFR <30 mL/min/1.73 m²). No dose adjustment required for mild-to-moderate impairment (eGFR 30-89 mL/min/1.73 m²) but monitor renal function. |
| Liver impairment | Contraindicated in severe hepatic impairment (Child-Pugh class C). No dose adjustment recommended for Child-Pugh class A or B; use with caution due to potential hepatotoxicity. |
| Pediatric use | Not recommended for use in children; safety and efficacy not established. |
| Geriatric use | Use with caution; reduce maximum dose by 25-50% due to increased risk of adverse reactions. Consider lower volume for intra-articular administration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIONOSIL AQUEOUS (DIONOSIL AQUEOUS).
| Breastfeeding | Iophendylate is poorly absorbed orally; minimal excretion into breast milk is expected. Based on similar iodinated contrast media, the amount ingested by the infant is negligible (<0.01% of maternal dose). No adverse effects reported in breastfed infants. The M/P ratio is unknown but likely very low. Lactation may continue; if concerned, temporarily pump and discard for 24 hours after administration. |
| Teratogenic Risk | DIONOSIL AQUEOUS (iophendylate) is an iodinated contrast medium. In pregnant patients, use should be avoided unless absolutely necessary. Animal studies have not established fetal risk, but there are no adequate human studies. Iodinated contrast agents cross the placenta; theoretical risk of fetal thyroid dysfunction (hypothyroidism) exists if exposure occurs, particularly during the second and third trimesters due to fetal thyroid maturation. However, the risk is low for single diagnostic exposure. No evidence of teratogenicity in standard animal reproductive studies. |
■ FDA Black Box Warning
None
| Serious Effects |
Known hypersensitivity to propyliodone or iodinated contrast media; severe bronchial asthma; active pulmonary infection; advanced pulmonary tuberculosis; severe respiratory insufficiency; pregnancy (category D).
| Precautions | Risk of hypersensitivity reactions including anaphylaxis; bronchospasm; aspiration pneumonitis; renal impairment; thyroid dysfunction in patients with pre-existing thyroid disease; interference with thyroid function tests. |
Loading safety data…
| Fetal Monitoring | Monitor maternal vital signs (heart rate, blood pressure) during and after administration due to risk of anaphylactoid reactions, vasovagal reactions, and contrast-induced nephropathy. Assess renal function via serum creatinine and eGFR before use. For fetal monitoring: ultrasound or fetal heart rate monitoring if late pregnancy exposure; consider neonatal thyroid function testing (TSH, free T4) after birth if significant exposure occurred in third trimester. |
| Fertility Effects | No specific studies on fertility in humans. In animal studies, no adverse effects on fertility or reproductive performance have been reported with iodinated contrast agents. Theoretical risk of temporary ovarian exposure to radiation if used with fluoroscopy, but the contrast itself is not known to impair fertility. |