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Black Box Warning
Warning
See full prescribing information for complete Boxed Warning.
* NOT FOR INTRATHECAL USE
PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION
Overview
Ioxilan is a ioxilan that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
INTRAARTERIAL:
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.
INTRAVENOUS:
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.
Dosage
ADULT DOSAGE AND ADMINISTRATION - General
The combination of volume and OXILAN® concentration to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Specific dose adjustments for age, gender, weight, and renal function have not been studied for OXILAN®. As with all iodinated contrast agents, lower doses of OXILAN® Injection may have less risk. The efficacy of OXILAN® Injection below doses recommended has not been studied. Other factors such as anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should also be considered.
The maximum recommended total dose of iodine is 86 grams.
If during administration a reaction occurs, the injection should be immediately stopped.
Patients should be adequately hydrated prior to and following intravascular administration of OXILAN® Injection.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ioxilan in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ioxilan in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Ioxilan in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ioxilan in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ioxilan in pediatric patients.
Contraindications
OXILAN® Injection is not indicated for intrathecal use.
Warnings
Warning
See full prescribing information for complete Boxed Warning.
* NOT FOR INTRATHECAL USE
PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION
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.
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.
Adverse Reactions
Clinical Trials Experience
For demographics, see clinical trials section. The following table of incidence of reactions is based upon controlled clinical studies in which OXILAN® was compared with a nonionic contrast agent (iohexol) in 531 patients. It includes all reported adverse events, regardless of attribution. Adverse reactions are listed by body system and in decreasing order of occurrence greater than 0.5% in the OXILAN® group.
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One or more adverse reactions were reported in 76 of 531 (14.3%) of patients in the clinical trials, coincidental with the administration of OXILAN® or within the study follow-up period of 24 to 72 hours. The incidence and type of adverse reactions were similar to those associated with the nonionic comparator (iohexol) used in the clinical trials. OXILAN®, as do other iodinated contrast agents, often causes warmth and/or pain on injection. The rates are similar to that of the iohexol comparator.
Serious, life threatening and fatal reactions have been associated with the administration of iodine-containing contrast media. In all clinical trials 3/835 (0.3%) patients given OXILAN® and 3/542 (0.6%) given iohexol died 4 days or later after drug administration. In the controlled trials 8/531 (1.5%) patients given OXILAN® and 6/542 (1.1%) given iohexol had serious adverse events.
The following adverse reactions were observed ≤ 0.5% of patients receiving OXILAN® Injection:
Reproduction studies performed with ioxilan injection in rats at doses up to 6.5 gI/kg (3.7 times the recommended dose for a 50 kg human, or approximately 0.7 times the human dose following normalization of the data to body surface area estimates) and rabbits at doses up to 3.5 gI/kg (2 times the recommended dose for a 50 kg human, or approximately the same as the human dose following normalization of the data to body surface area estimates) did not reveal evidence of direct harm to the fetus. Embryolethality was not detected. Adequate and well-controlled studies in pregnant women have not been conducted. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ioxilan in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ioxilan during labor and delivery.
Nursing Mothers
It is not known whether ioxilan is excreted in human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast media are administered to nursing women because of potential adverse reactions, and consideration should be given to temporarily discontinuing nursing.
Pediatric Use
Safety and effectiveness in children have not been established.
Geriatic Use
There is no FDA guidance on the use of Ioxilan with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Ioxilan with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ioxilan with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ioxilan in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ioxilan in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ioxilan in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ioxilan in patients who are immunocompromised.
Administration and Monitoring
Administration
Intravenous
INTRAARTERIAL PROCEDURES
Coronary Arteriography and Left Ventriculography
OXILAN® Injection (350 mgI/mL) is indicated for intraarterial injection in the radiographic contrast evaluation of coronary arteries and the left ventricle. Injection rates should be approximately equal to flow rate in the vessel being injected.
The usual individual injection volumes for visualization of the coronary arteries and the left ventricle are as follows:
Left and Right Coronary: 2 mL to 10 mL (0.7 to 3.5 gI) of OXILAN® Injection - 350 (350 mgI/mL)
Left Ventricle: 25 mL to 50 mL (8.75 to 17.5 gI) of OXILAN® Injection - 350 (350 mgI/mL)
Total dose for the procedure should not usually exceed 250 mL.
When large individual volumes are administered, as in ventriculography and aortography, it is recommended that sufficient time be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.
Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure.
Aortography and Selective Visceral Arteriography
OXILAN® Injection (350 mgI/mL) is indicated for intraarterial injection in the radiographic contrast evaluation of the aorta and major visceral arterial branches. The volume and rate of contrast injection should be proportional to the blood flow through the vessels of interest, and related to the vascular and pathological characteristics of the specific vessels being studied.
Total dose for the procedure should not usually exceed 250 mL.
Peripheral Arteriography
OXILAN® Injection (350 mgI/mL) is indicated for intraarterial injection in the radiographic contrast evaluation of peripheral arteries. Injection rates should be approximately equal to flow rate in the vessel being injected. The usual individual injection volumes for visualization of various peripheral arteries are as follows:
Aortic bifurcation for distal runoff: 45 mL to 100 mL (26 to 70 gI) of OXILAN® Injection - 350 (350 mgI/mL)
Subclavian or femoral artery: 10 mL to 40 mL (4 to 14 gI) of OXILAN® Injection - 350 (350 mgI/mL)
Total dose for the procedure should not usually exceed 250 mL.
Pulsation should be present in the artery to be injected.
Cerebral Arteriography
OXILAN® Injection (300 mgI/mL) is indicated for intraarterial injection in the radiographic contrast evaluation of arterial lesions of the brain. The usual individual volumes per injection are 8 mL to 12 mL (2.4 to 3.6 gI) of OXILAN® Injection - 300 (300 mgI/mL).
Total dose for the procedure should not usually exceed 150 mL.
INTRAVENOUS PROCEDURES
Intravenous Excretory Urography
OXILAN® Injection (300 mgI/mL or 350 mgI/mL) is indicated for intravenous injection for routine excretory urography. A volume of contrast which gives a dose of approximately 250 to 390 mgI/kg of body weight is recommended as suitable for adults with normal renal function.
Total dose for the procedure should not usually exceed 100 mL.
Contrast Enhanced Computed Tomography
OXILAN® Injection (300 mgI/mL or 350 mgI/mL) is indicated for intravenous injection for contrast-enhancement in the evaluation of neoplastic and non-neoplastic lesions of the head and body (intrathoracic, intraabdominal, and retroperitoneal regions).
CECT of the Head:
The usual dose is 100 mL to 200 mL (30 to 60 gI) of OXILAN® Injection (300 mgI/mL) or 86 mL to 172 mL of OXILAN® Injection (350 mgI/mL). Scanning may be performed immediately after completion of the intravenous administration.
Total dose for the procedure should not usually exceed 200 mL.
CECT of the Body:
OXILAN® Injection (300 mgI/mL or 350 mgI/mL) may be administered intravenously by bolus, by rapid infusion, or by a combination of both. The usual dose is 50 mL to 200 mL (15 to 60 gI) of OXILAN(300 mgI/mL) or 43 mL to 172 mL of OXILAN® (350 mgI/mL).
Total dose for the procedure should not usually exceed 200 mL.
Monitoring
There is limited information regarding Monitoring of Ioxilan in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Ioxilan in the drug label.
Overdosage
The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.
OXILAN® Injection binds negligibly to plasma or serum protein and can, therefore, be dialyzed.
Pharmacology
There is limited information regarding Ioxilan Pharmacology in the drug label.
Mechanism of Action
Structure
File:Ioxilan01.pngThis image is provided by the National Library of Medicine.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Ioxilan in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Ioxilan in the drug label.
Nonclinical Toxicology
Long-term animal studies have not been performed with ioxilan to evaluate carcinogenic potential or effects on fertility. Ioxilan was not genotoxic in a series of studies including the Ames test, an in vitro human lymphocytes analysis of chromosomal aberrations, an in vivo mouse micronucleus assay, and in an in vivo mouse dominant lethal assay.
Clinical Studies
There is limited information regarding Clinical Studies of Ioxilan in the drug label.
How Supplied
Storage
There is limited information regarding Ioxilan Storage in the drug label.
Images
Drug Images
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