Hypaque Sodium (Page 7 of 7)

Dosage and Administration

Discography is usually performed with parenteral analgesia or sedation, and under local anesthesia. To minimize disc and tissue trauma, a two-needle technique is usually employed. An 18 to 20 gauge needle is used to penetrate to the disc and then a very fine (25 or 26 gauge) lumbar puncture-type needle is inserted through the needle to penetrate the disc.

Because of the resistance encountered, it is difficult to inject more than 0.2 mL to 0.3 mL of HYPAQUE meglumine 60 percent into a normal disc. Occasionally, however, a cervical disc can accept up to 0.5 mL and a lumbar disc, 1 mL (rarely, 2 mL) before resistance is encountered. Mild discomfort with little or no frank pain may indicate a normal disc.

In ruptured and some abnormal discs, 1 mL to 2 mL or more can be introduced without resistance; and, particularly if only one disc has pathology, the patient usually experiences pain, sometimes severe, with distribution characteristic of his symptoms. To minimize the amount of HYPAQUE extravasated, no more than 2 mL is injected in any one disc.

The procedure should be planned so that the duration of the discogram allows multiple exposures with a single dose. It has been recommended for diagnostic reasons that the procedure (injection and discogram) be performed on one disc at a time. Injection of a number of discs under suspicion, however, may be performed as part of one procedure.

CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING

Precautions

Metastatic Brain Lesions: Large doses of contrast media should be avoided in patients with suspected metastatic brain lesions. Intravenous administration of large doses to these patients is more likely to result in convulsions; however, these occurrences are rare. This has been attributed to tissue accumulation of the medium in the presence of blood brain barrier disruption caused by disease. Appropriate measures for seizure management should be immediately available.

Convulsion. (See PRECAUTIONS—General.)

Dosage and Administration

Bolus intravenous injection of 50 mL to 100 mL, or up to 150 mL by infusion. The rate of injection and the timing of scans will depend principally on the expected nature of the pathology. Dosage in children is proportional to adults, based on weight.

HOW SUPPLIED

Vials of 50 mL, rubber stoppered, box of 25 (NDC 0407-0746-04).

Vials of 100 mL, rubber stoppered, box of 10 (NDC 0407-0747-02).

Box of 10 calibrated 200 mL dilution bottles with hangers containing 150 mL HYPAQUE meglumine 60%; rubber stoppered (NDC 0407-0749-20).

Box of 10 calibrated 200 mL dilution bottles with hangers containing 200 mL HYPAQUE meglumine 60%; rubber stoppered (NDC 0407-0750-10).

Protect from light. Store at 15°C to 30°C (59° F to 86°F).

Distributed by Amersham Health Inc.
Princeton, NJ 08540

Printed in USA

Revised March 2002
HNC-8B

HYPAQUE SODIUM
diatrizoate meglumine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0407-0746
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diatrizoate Meglumine (diatrizoic acid) diatrizoic acid 60 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0407-0746-04 25 VIAL (25 VIAL) in 1 BOX contains a VIAL
1 50 mL (50 MILLILITER) in 1 VIAL This package is contained within the BOX (0407-0746-04)
HYPAQUE SODIUM
diatrizoate meglumine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0407-0747
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diatrizoate Meglumine (diatrizoic acid) diatrizoic acid 60 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0407-0747-02 10 VIAL (10 VIAL) in 1 BOX contains a VIAL
1 100 mL (100 MILLILITER) in 1 VIAL This package is contained within the BOX (0407-0747-02)
HYPAQUE SODIUM
diatrizoate meglumine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0407-0749
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diatrizoate Meglumine (diatrizoic acid) diatrizoic acid 60 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0407-0749-20 10 BOTTLE (10 BOTTLE) in 1 BOX contains a BOTTLE
1 150 mL (150 MILLILITER) in 1 BOTTLE This package is contained within the BOX (0407-0749-20)
HYPAQUE SODIUM
diatrizoate meglumine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0407-0750
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diatrizoate Meglumine (diatrizoic acid) diatrizoic acid 60 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0407-0750-10 10 BOTTLE (10 BOTTLE) in 1 BOX contains a BOTTLE
1 200 mL (200 MILLILITER) in 1 BOTTLE This package is contained within the BOX (0407-0750-10)
Labeler — Amersham Health Inc.

Revised: 08/2007 Amersham Health Inc.

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