Oxilan
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Questions & Answers
Side Effects & Adverse Reactions
SEVERE ADVERSE EVENTS-INADVERTENT INTRATHECAL ADMINISTRATION: Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.
Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.
Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state, and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three way stopcocks, frequent catheter flushing with heparinized saline solutions, and minimizing the length of the procedure.
Serious or fatal reactions have been associated with the administration of iodine-containing radiopaque media. It is of utmost importance to be completely prepared to treat any contrast agent reaction.
Caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. (See PRECAUTIONS.)
Intravascularly administered iodine-containing radiopaque media are potentially hazardous in patients with multiple myeloma or other paraproteinacious diseases, who are prone to disease-induced renal insufficiency and/or failure. Although neither the contrast agent nor dehydration has been proven to be the cause of renal insufficiency (or worsening renal insufficiency) in myelomatous patients, it has been speculated that the combination of both may be causative. Special precautions, including maintenance of normal hydration and close monitoring, are required. Partial dehydration in the preparation of these patients prior to injection is not recommended since this may predispose the patient to precipitation of the myeloma protein.
Reports of thyroid storm following the intravascular use of iodinated radiopaque agents in patients with hyperthyroidism, or with an autonomously functioning thyroid nodule, suggest that this additional risk be evaluated in such patients before use of any contrast agent.
Administration of radiopaque materials to patients with known or suspected pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure and measures for treatment of a hypertensive crisis should be available. These patients should be monitored very closely during contrast enhanced procedures.
Contrast agents may promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
OXILAN® Injection (300 mgI/mL) is indicated for cerebral arteriography. OXILAN® Injection (350 mgI/mL) is indicated for coronary arteriography and left ventriculography, visceral angiography, aortography, and peripheral arteriography.
OXILAN® Injection (300 mgI/mL) and OXILAN® Injection (350 mgI/mL) are indicated for excretory urography and contrast enhanced computed tomographic (CECT) imaging of the head and body.
History
There is currently no drug history available for this drug.
Other Information
OXILAN® (Ioxilan Injection) formulations are stable, aqueous, sterile, and non- pyrogenic solutions for intravascular administration as diagnostic radiopaque media. Ioxilan is designated chemically as N-(2,3-dihydroxypropyl)-N’-(2- hydroxyethyl)-5-[N-(2,3-dihydroxypropyl) acetamido]-2,4,6-triiodoisophthal-amide and has the following structural formula:
The molecular weight of ioxilan is 791.12 and the organically bound iodine content is 48.1%. Ioxilan is nonionic and does not dissociate in solution.
OXILAN® (Ioxilan Injection) Pharmacy Bulk Package is available in two strengths: OXILAN® (Ioxilan Injection) 300 mgI/mL and OXILAN® (Ioxilan Injection) 350 mgI/mL.
Each mL of OXILAN® (Ioxilan Injection) 300 mgI/mL provides 623 mg ioxilan.
Each mL of OXILAN® (Ioxilan Injection) 350 mgI/mL provides 727 mg ioxilan.
Each mL of OXILAN® (Ioxilan Injection) 300 mgI/mL Pharmacy Bulk Package provides 623 mg ioxilan.
Each mL of OXILAN® (Ioxilan Injection) 350 mgI/mL Pharmacy Bulk Package provides 727 mg ioxilan.
Each mL of OXILAN® solution contains 0.1 mg edetate calcium disodium (anhydrous basis), 1.0 mg tromethamine, 0.5 mg sodium chloride and a minimum of 0.2 mg (0.01 mEq) sodium. The pH is adjusted to 6.8 (5.5 to 7.5) with hydrochloric acid and sodium hydroxide. The solutions contain no preservative.
Pertinent physicochemical data are below. OXILAN® (Ioxilan Injection) is hypertonic compared to plasma (approximately 285 mOsm/kg water).
| Concentration (mgI/mL) | Concentration W/V | |
| 300 | 350 | |
| Measured Osmolality (mOsm/kg water) @ 37°C |
610 |
721 |
| Viscosity (cPs) @ 37°C @ 20°C |
5.1 9.4 |
8.1 16.3 |
| Specific Gravity @ 37°C @ 20°C |
1.319 1.327 |
1.373 1.382 |
The OXILAN® formulations are clear, colorless to pale yellow solutions containing no undissolved solids. Crystallization does not occur at room temperature. OXILAN® solutions have osmolalities of 2.1 and 2.5 times that of plasma (285 mOsm/kg water) and are hypertonic under conditions of use.
Each bottle of OXILAN® Pharmacy Bulk Package is to be used for dispensing multiple single dose preparations utilizing a suitable transfer device.
Sources
Oxilan Manufacturers
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Guerbet Llc
![Oxilan (Ioxilan Injection) Injection, Solution [Guerbet Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Oxilan | Guerbet Llc
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