Hexabrix (Ioxaglate Meglumine / Ioxaglate Sodium) - Indications and Dosage

CT SCANNING OF THE BODY

HEXABRIX may also be used for enhancement of computed tomographic scans performed for detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity and retroperitoneal space.

In non-neural tissues (during computed tomography of the body), HEXABRIX diffuses rapidly from the vascular to the extra-vascular space. Increase in x-ray absorption is related to blood flow, concentration of the contrast medium and extraction of the contrast medium by interstitial tissue since no barrier exists; contrast enhancement is thus due to the relative differences in extra-vascular diffusion between normal and abnormal tissue, a situation quite different than that in the brain.

The pharmacokinetics of HEXABRIX in normal and abnormal tissues has been shown to be variable.

Enhancement of CT with HEXABRIX may be of benefit in establishing diagnoses of certain lesions in some sites with greater assurance than is possible with unenhanced CT and in supplying additional features of the lesions. In other cases, the contrast medium may allow visualization of lesions not seen with CT alone or may help to define suspicious lesions seen with unenhanced CT.

Contrast enhancement appears to be greatest within the 30-90 seconds after bolus administration of the contrast agent, and after intra-arterial rather than intravenous administration. Therefore, the use of a continuous scanning technique (a series of two to three second scans beginning at the injection — dynamic CT scanning) may improve enhancement and diagnostic assessment of tumors and other lesions such as an abscess, occasionally revealing more extensive disease.

Because unenhanced scanning may provide adequate information in the individual patient, the decision to employ contrast enhancement, which is associated with additional risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological and unenhanced CT findings.

INDICATIONS AND USAGE

HEXABRIX is indicated for use in pediatric angiocardiography, selective coronary arteriography with or without left ventriculography, peripheral arteriography, aortography, selective visceral arteriography, cerebral angiography, intra-arterial digital subtraction angiography, intravenous digital subtraction angiography, peripheral venography (phlebography), excretory urography, contrast enhancement of computed tomographic head imaging and body imaging, arthrography and hysterosalpingography.

DOSAGE AND ADMINISTRATION

It is advisable that HEXABRIX be at or close to body temperature when injected.

The patient should be instructed to omit the meal that precedes the examination. Appropriate premedication, which may include a barbiturate, tranquilizer or analgesic drug, may be administered prior to the examination.

A preliminary film is recommended to check the position of the patient and the x-ray exposure factors prior to the injection of the contrast medium.

If during administration a minor reaction occurs the injection should be slowed or stopped until the reaction has subsided. If a major reaction occurs the injection should be discontinued immediately.

Under no circumstances should other drugs be administered concomitantly in the same syringe or IV administration set because of a potential for chemical incompatibility.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

PEDIATRIC ANGIOCARDIOGRAPHY

HEXABRIX may be administered by catheter injection into the chambers of the heart or associated large blood vessels. Rapid injection is essential and satisfactory results usually require injection of the total dosage in 1-2 seconds.

Precautions

In addition to the general precautions previously described, it is advisable to monitor for ECG and vital signs changes throughout the procedure.

When large individual doses are administered sufficient time should be allowed for any observed changes to return to or near baseline prior to making the next injection.

Caution should be used when making right heart injections in patients with pulmonary hypertension or incipient heart failure since this may lead to increased right side pressures with subsequent bradycardia and systemic hypotension. Patients with pulmonary disease present additional risks.

Caution is advised in cyanotic infants since apnea, bradycardia, other arrhythmias and a tendency to acidosis are more likely to occur.

Since infants are more likely to respond with convulsions than are adults, the amount of total dosage is of particular importance. Repeated injections are hazardous in infants weighing less than 7 kg, particularly when these infants have pre-existing compromised right heart function or obliterated pulmonary vascular beds.

Adverse Reactions

In addition to the adverse reactions previously listed, this procedure has been complicated by intramural injection with marked adverse effects on cardiac function.

Usual Dosage

The volume of individual doses should be determined by the size of the structure to be visualized and the anticipated degree of hemodilution at the site of injection. Valvular competence should also be taken into consideration.

Older Children: Catheter angiocardiography usually requires single doses of 30-45 mL of HEXABRIX.

Infants and Young Children: The recommended single dose of HEXABRIX is about 1.5 mL/kg (range 1 mL/kg to 2 mL/kg). In addition, small test volumes of about 2 mL may be used for catheter placement.

The usual total dose of HEXABRIX per procedure, which includes diagnostic and test doses is about 4 mL/kg. This dosage may be as small as 1.5 mL/kg and should not normally exceed 5 mL/kg.

HYSTEROSALPINGOGRAPHY

Patient Preparation

It is preferable to perform the procedure approximately eight to ten days after the onset of menses. The patient should empty the bladder before the examination.

Precautions

Caution should be exercised in patients suspected of having cervical or tubal carcinoma to avoid possible spread of the lesion by the procedure. Delayed onset of pain and fever (1-2 days) may be indicative of pelvic infection.

Adverse Reactions

In addition to the general adverse reactions described previously, fever and pain, cramping and tenderness of the abdomen have been reported.

Usual Dosage

The total volume administered will vary depending upon anatomical variations and/or disease processes. The usual dose varies from 5 to 15 mL, administered slowly under fluoroscopic control, without undue pressure.

HOW SUPPLIED

HEXABRIX Glass Vials/Bottles	NDC Number
10x20 mL vials	0019-5505-51
25x50 mL vials	0019-5505-06
12x100 mL fill/150 mL bottles	0019-5505-08
12x150 mL bottles	0019-5505-10
12x200 mL fill/250 mL bottles	0019-5505-21

Storage: Store below 30° (86°). Do not freeze. If product is frozen or if crystallization of the salt has occurred, examine the container for physical damage. If no damage has occurred, the container should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are dissolved and that the container and closure have not been damaged.

This preparation is sensitive to light and must be protected from strong daylight or direct exposure to the sun.

As with all contrast media, glass containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used.

tyco
Healthcare

Mallinckrodt

Mallinckrodt Inc.
St. Louis, MO 63042 USA
www.Mallinckrodt.com

MKR 55052505
Revised 2/05
Printed in U.S.A.