SINOGRAFIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SINOGRAFIN (SINOGRAFIN).
Non-ionic iodinated contrast agent that attenuates X-rays, providing radiographic contrast by enhancing the differential absorption between vascular structures and surrounding tissues. It distributes into the extracellular fluid space and is excreted renally.
| Metabolism | Not metabolized; primarily excreted unchanged by the kidneys via glomerular filtration. |
| Excretion | Renal excretion of intact drug via glomerular filtration; approximately 90% eliminated unchanged in urine within 24 hours; less than 5% fecal elimination. |
| Half-life | Terminal elimination half-life: 1.5–2.5 hours in patients with normal renal function; prolonged in renal impairment (up to 20 hours). Context: rapid clearance allows for repeated dosing in diagnostic imaging. |
| Protein binding | Approximately 10–20% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | 0.2–0.3 L/kg, reflecting distribution mainly in extracellular fluid; minimal intracellular penetration. |
| Bioavailability | Intrathecal: 100% (direct administration). Intravenous: 100% (direct administration). Oral: negligible due to poor gastrointestinal absorption (not intended for enteral use). |
| Onset of Action | Intrathecal: immediate diffusion into subarachnoid space, radiographic opacification within minutes. Intravenous: rapid distribution to extracellular space, opacification of target vessels within 30–60 seconds. |
| Duration of Action | Intrathecal: adequate opacification for 30–60 minutes; complete clearance within 24–48 hours. Intravenous: diagnostic concentration maintained for 30–60 minutes; rapid renal excretion limits prolonged effect. |
Intravenous or intra-arterial administration; typical adult dose for CT urography: 50-100 mL of a 30% solution; for pyelography: 25-50 mL of a 30% solution; dose based on procedure and patient size, not to exceed 5 mL/kg.
| Dosage form | SOLUTION |
| Renal impairment | GFR <30 mL/min: contraindicated; GFR 30-60 mL/min: use with caution, consider dose reduction by 50% and ensure adequate hydration; GFR >60 mL/min: no adjustment needed. |
| Liver impairment | No specific adjustment for hepatic impairment; use with caution in severe liver disease due to risk of nephrotoxicity. |
| Pediatric use | Intravenous: 0.5-2.0 mL/kg of a 30% solution, not exceeding 5 mL/kg; for neonates, reduce dose to 0.5-1.0 mL/kg; adjust based on renal function. |
| Geriatric use | Use lowest effective dose; monitor renal function closely; ensure adequate hydration; consider dose reduction by 50% if eGFR <60 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SINOGRAFIN (SINOGRAFIN).
| Breastfeeding | Excreted into breast milk in minimal amounts (M/P ratio not established). Oral absorption from breast milk is poor; risk to infant is low. Interrupt breastfeeding for 12-24 hours post-administration to minimize exposure. |
| Teratogenic Risk | Sinografin (meglumine diatrizoate) is an iodinated contrast agent. Pregnancy category C. First trimester: theoretical risk from radiation exposure; avoid unless essential. Second and third trimesters: no known teratogenic effects; fetal hypothyroidism possible from free iodide. Use only if diagnostic benefit outweighs risk. |
■ FDA Black Box Warning
Do not use for intrathecal administration in patients with a history of severe adverse reaction to iodinated contrast media, or in patients with multiple myeloma, pheochromocytoma, sickle cell disease, or known hypersensitivity to iodine-containing compounds. Not for intravascular use.
| Common Effects | Nasal irritation Headache Nosebleeds |
| Serious Effects |
Hypersensitivity to iotrolan or any component of the formulation; intrathecal administration in patients with elevated intracranial pressure, suspected intracranial mass, or acute cerebral hemorrhage; severe renal impairment (eGFR < 30 mL/min/1.73 m²) for intrathecal use.
| Precautions | Risk of neurotoxicity including seizures, especially in patients with a history of epilepsy or substance abuse. Pre-existing renal impairment may lead to contrast-induced nephropathy. Adequate hydration recommended. Use with caution in patients with hepatic impairment, hyperthyroidism, or autoimmune disorders. |
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| Fetal Monitoring |
| Monitor maternal renal function before and after administration. Assess for allergic reactions, including anaphylaxis. In pregnancy, ensure fetal heart rate monitoring if radiography involves abdominal region. Post-procedure, evaluate neonatal thyroid function if high doses used near term. |
| Fertility Effects | No known adverse effects on female or male fertility from single diagnostic exposure. Chronic or high-dose exposure may be associated with transient changes in semen parameters in males, but clinical relevance is minimal. |