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Oxilan

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Oxilan

Indications
Dosage
How Supplied

INDICATIONS

Intraarterial

OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection (300 mgI/mL) is indicated for cerebral arteriography.

OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection (350 mgI/mL) is indicated for coronary arteriography and left ventriculography, visceral angiography, aortography, and peripheral arteriography.

Intravenous

OXILAN® (ioxilan) Injection (300 mgI/mL) and OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection (350 mgI/mL) are indicated for excretory urography and contrast enhanced computed tomographic (CECT) imaging of the head and body.

DOSAGE AND ADMINISTRATION

General

The combination of volume and OXILAN® (ioxilan (ioxilan (ioxilan) ) ) 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® (ioxilan (ioxilan (ioxilan) ) ) . As with all iodinated contrast agents, lower doses of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection may have less risk. The efficacy of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection below doses recommended has not been studied. Other factors such as anticipated pathology, degree and extent of opacification required, structure® 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 are action occurs, the injection should be immediately stopped. Patients should be adequately hydrated prior to and following intravascular administration of OXILAN® Injection. (See WARNINGS and PRECAUTIONS.)

Intraarterial Procedures

Coronary Arteriography and Left Ventriculography

OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection (350 mgl/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:

2mLto10mL (0.7 to 3.5 gl) of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection - 350 (350 mgl/mL)

Left Ventricle:

25 mL to 50 mL (8.75 to 17.5 gl) of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection - 350 (350 mgl/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® (ioxilan (ioxilan (ioxilan) ) ) Injection (350 mgl/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® (ioxilan (ioxilan (ioxilan) ) ) Injection (350 mgl/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:

45mLto100 mL (26 to 70 gl) of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection - 350 (350 mgl/mL) Subclavian or femoral artery:

10 mL to 40 mL (4 to 14gl) of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection - 350 (350 mgl/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® (ioxilan (ioxilan (ioxilan) ) ) Injection (300 mgl/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 gl) of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection - 300 (300 mgl/mL). Total dose for the procedure should not usually exceed 150 mL.

Intravenous Procedures

Intravenous Excretory Urography

OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection (300 mgl/mL or 350 mgl/mL) is indicated for intravenous injection for routine excretory urography. A volume of contrast which gives a dose of approximately 250 to 390 mgl/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® (ioxilan (ioxilan (ioxilan) ) ) Injection (300 mgl/mL or 350 mgl/mL) is indicated for intravenous injection for contrast-enhancement in the evaluation of neoplastic and non-neoplastic lesions of the head and body (intra thoracic, intra abdominal, and retro peritoneal regions).

CECTof the Head:

The usual dose is 100 mL to 200 mL (30 to 60 gl) of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection (300 mgl/mL) or 86 mL to 172 mLof OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection (350 mgl/mL). Scanning may be performed immediately after completion of the intravenous administration.

Total dose for the procedure should not usually exceed 200 mL.

CECTof the Body:

OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection (300 mgl/mL or 350 mgl/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 gl) of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) (300 mgl/mL) or 43 mL to172 mL of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) (350 mgl/mL). Total dose for the procedure should not usually exceed 200 mL.

Drug Handling

As with all contrast media, because of the potential for chemical incompatibility, OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection should not be mixed with, or injected in, intravenous administration lines containing other drugs, solutions, or total nutritional admixtures.

Sterile technique must be used in all vascular injections involving contrast media.

It is desirable that intravascularly administered iodinated contrast agents be at or close to body temperature when injected.

If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleaning agents.

Withdrawal of contrast agents from their containers should be accomplished under aseptic conditions using only sterile syringes and transfer devices. Contrast agents which have been transferred into other delivery systems should be used immediately.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Ioxilan (ioxilan (ioxilan) ) solutions should be used only if clear and within the normal colorless to pale yellow range.

OXILAN® (ioxilan (ioxilan (ioxilan) ) ) formulations are supplied in single dose containers. Discard unused portion.

HOW SUPPLIED

OXILAN® (Ioxilan (ioxilan (ioxilan) ) lnjection) 300 mgl/mL-

Ten 50 mLsingledose bottles, NDC 67684-1000-1
Ten 100 mLsingledose bottles, NDC 67684-1000-2
Ten 150 mLsingledose bottles, NDC 67684-1000-3
Ten 200 mLsingledose bottles, NDC 67684-1000-4

OXILAN® (Ioxilan (ioxilan (ioxilan) ) lnjection) 350 mgl/mL-

Ten 50 mLsingledose bottles, NDC 67684-1001-1
Ten 100 mLsingledose bottles, NDC 67684-1001-2
Ten 150 mLsingledose bottles, NDC 67684-1001-3
Ten 200 mLsingledose bottles, NDC 67684-1001-4

Storage

Store at room temperature between 15°and30°C (59° and 86°F) and protect from light. Do not freeze.

Guerbet LLC - Bloomington, IN 47403. Distributed by Guerbet LLC - Bloomington, IN 47403. For further information or ordering, call 1-877-729-6679. Revised 06/05.

Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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