DOSAGE AND ADMINISTRATION
The recommended dosage of GastroMARK is 600 mL (105 mg Fe) administered orally at a rate of about 300 mL over 15 minutes. The maximum oral dose is 900 mL (157.5 mg Fe).
GastroMARK should be taken after fasting at least 4 hours.
Before use, the bottles should be shaken vigorously for at least 1 full minute to assure uniform suspension of contents. Chilling before ingestion improves palatability. Any unused portion should be discarded.
GastroMARK contains 175 μg iron per milliliter. The amount of iron absorbed varies with the patient’s iron stores. (See CLINICAL PHARMACOLOGY Section).
Imaging: After ingestion of GastroMARK, imaging may begin immediately.
Generally, optimal results occur within 30 minutes. In some patients, delayed images (4 to 7 hours after ingestion) may be useful in delineating the lower gastrointestinal regions.
GastroMARK is packaged in white polyethylene bottles sealed with tamper-evident screw closures. Each bottle contains 300 mL of GastroMARK.
GastroMARK is supplied in boxes of twelve bottles each.
12 x 300 mL bottle NDC Number: 0019-1120-06
GastroMARK is distributed by Mallinckrodt Inc., Raleigh, NC, under license from Advanced Magnetics, Inc., Cambridge, MA.
GastroMARK is a trademark of Mallinckrodt Inc.
Storage: Store at controlled room temperature or refrigerate between 2- 25°C (36°-77°F). Protect from freezing. The product should be discarded if frozen.
The following patents have claims directed to the drug: USP 4,695,392, USP 4,695,393, USP 4,770,183, USP 4,827,945, USP 4,951,675, USP 5,055,288, USP 5,069,216, USP 5,219,554.
St. Louis, MO 63042 USA
Printed in U.S.A.