Indications/Directions
for Use
Healthcare Provider Information
Indications for Use
SITZMARKS® is a diagnostic test indicated for aiding in the evaluation of colonic motility in patients with severe pediatric constipation, as diagnosed by your healthcare provider, but otherwise negative GI evaluations. SITZMARKS® capsule, for use in pediatric patients at least 2 years old, is to be dispensed only by healthcare providers to patients for oral intake.
Pediatric Instructions
Ensure that children are able to swallow a capsule of this size. Alternative methods for those who cannot swallow the capsule include opening the capsule and emptying the contents into applesauce (or other similar food), ensuring all markers are ingested.
Simplified SITZMARKS® for Kids Method
(1 capsule: 24 radiopaque markers per capsule)
Use the Simplified SITZMARKS® for Kids Method to detect a blockage or colonic inertia in a chronically constipated patient.
Step A
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On day 1, direct patient to take one SITZMARKS® capsule by mouth with water, preferably with confirmation by office observation. Instruct the child and their caregiver to use no laxatives, enemas, or suppositories for 5 days.
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Arrange a flat plate abdominal X-ray on day 5 to determine the location and extent of elimination of the radiopaque markers.
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Patients who expel at least 80% (19 or more) of the markers have grossly normal colonic transit.
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Patients who retain 6 or more markers may have follow-up abdominal X-rays within several days.
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For patients whose markers accumulate in the rectosigmoid, or when markers are retained diffusely, Step B may be warranted.
Step B
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Have patient take a bulking agent (such as Konsyl® Daily Psyllium Fiber) daily for 1 to 2 weeks. Encourage liquid intake to maximize product efficacy.
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Have patient take another SITZMARKS® capsule in 1 to 2 weeks and repeat X-rays in 5 days to determine the location and extent of elimination of the markers.
Reading the Results (Both Methods)
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When over 80% of the markers are passed by day 5, colonic transit is not grossly abnormal.
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When remaining markers are scattered about the colon, condition is most likely pediatric hypomotility or colonic inertia.
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When remaining markers are accumulated in the rectum or rectosigmoid, the condition is most likely functional outlet delay, e.g., internal rectal prolapse, anismus.
Contraindications
This product should not be used in patients with known or suspected hypersensitivity to barium sulfate or any component of SITZMARKS®.
Warnings
Ask your child’s healthcare provider if SITZMARKS® for Kids may interact with any other medicines that your child takes. Check with your child’s healthcare provider before you start, stop, or change the dose of any medicine. Patients should be evaluated for their ability to swallow the capsule and/or its contents. Make sure each SITZMARKS® capsule is consumed with a large glass of water.
Rx only.