Indication/Directions for Use

HEALTHCARE PROVIDER INFORMATION

INDICATION FOR USE:

SITZMARKS capsule is a diagnostic test indicated for aiding in the evaluation of colonic motility in patients with severe constipation, as diagnosed by your healthcare professional, but otherwise negative GI evaluations. SITZMARKS capsule, for use in adult and pediatric patients (at least 2 years old), is to be dispensed only by physicians 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).

SIMPLIFIED SITZMARKS METHOD: (1 capsule: each capsule with 24 markers.)

Use the Simplified SITZMARKS Method to detect a blockage or colonic inertia in a constipated patient.

 STEP A:

  1. On day 1, direct patient to take one SITZMARKS capsule by mouth with water, preferably with confirmation by office observation. Instruct patient to use no laxatives, enemas or suppositories for 5 days.
  2. Arrange a flat plate abdominal X-ray on day 5 to determine the location and extent of elimination of the radiopaque markers.
  3. Patients who expel at least 80% (19 or more) of the markers have grossly normal colonic transit.
  4. Patients who retain 6 or more markers may have follow-up abdominal X-rays within several days.
  5. For patients whose markers accumulate in the rectosigmoid, or when markers are retained diffusely, STEP B may be warranted.

STEP B:              

  1. Have patient take a bulking agent (such as Konsyl® Original) daily for 1 to 2 weeks. Encourage liquid intake to maximize product efficacy.
  2. 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.

SEGMENTAL (METCALF) SITZMARKS METHOD: (3 capsules: each capsule with 24 markers in three different shapes.) Use the Segmental Method to track the amount of time that it takes to pass through each section of the intestinal tract. Take the O-ring capsule on day one, the Double D capsule on day two, and the Tri-Chamber capsule on day three.

  1. On day one, day two, and day three, administer one SITZMARKS capsule by mouth with water, preferably with confirmation by office observation. Instruct patient to use no laxatives, enemas or suppositories for the duration of the test.
  2. Arrange a flat plate abdominal X-ray on day four and, if necessary, again on day seven to determine the location and extent of elimination of the radiopaque markers.
  3. The total number of markers in each segment is used to determine whole transit time regardless of the type.

Example: Total number of markers present in each segment will be equivalent to the transit time hours.

 

Right Colon

Left Colon

Rectosigmoid

Colon

Total

4th Day

12

14

14

40

 

7th Day

0

0

2

2

 

Transit Time

12 hours

14 hours

15 hours

42 hours

 

Normal Value

11.3 hours

11.3 hours

12.4 hours

 

35 hours

READING THE RESULTS (BOTH METHODS):

  1. When over 80% of the markers are passed by day 6, colonic transit is not grossly abnormal.
  2. When remaining markers are scattered about the colon, condition is most likely hypomotility or colonic inertia.
  3. 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 healthcare provider if SITZMARKS may interact with any other medicines that you take. Check with your 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.