Version May 2024
Helicobacter pylori (H. pylori) detection: Oral: One capsule
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "14-C Urea breath test: Pediatric drug information")
Helicobacter pylori ( H. pylori ) detection: Children (must be able to swallow capsule whole and blow through a straw) and Adolescents: Oral: One capsule.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no adverse reactions listed in the manufacturer's labeling.
There are no contraindications listed in the manufacturer’s labeling.
Concerns related to adverse effects:
• Radioactivity: This test produces radiation exposure equal to 24 hours of normal background; patients concerned about very low doses of radioactivity may need to use other means for diagnosis. In animal experiments, such low doses of radiation do not carry measurable risk.
Disease-related concerns:
• Achlorhydria: A false positive test may occur in patients who have achlorhydria.
• Other bacteria: Other Helicobacters like Helicobacter heilmanni also produce urease and may rarely, lead to a false-positive test.
Concurrent drug therapy issues:
• Antibiotics and bismuth use: Patients should be off antibiotics and bismuth for at least 1 month prior to test.
• Proton pump inhibitors and sucralfate use: Patients should be off proton pump inhibitors and sucralfate at least 2 weeks prior to test.
Special populations:
• Pediatric: This test is expected to work the same in children; however, children need to be able to swallow the intact capsule and blow into a straw.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and health care personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Appropriate use: Patient should be fasting (at least 6 hours) prior to administration. Capsule should not be handled directly to avoid interference with test results.
• Test sample: After the patient ingests the 14C urea capsule, the sample collected for test purposes is for in vitro diagnostic use only.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Pytest: 1 µCi
No
Radiopharmaceutical: Use appropriate precautions for handling and disposal. Do not handle capsule directly.
For oral administration. Perform test while the patient is fasting (at least 6 hours prior to administration). Instruct patient to swallow capsule whole with 20 mL of lukewarm water; do not chew or open. At 3 minutes, have patient drink another 20 mL of lukewarm water to ensure capsule reaches gastric mucosa. At 10 minutes, have patient hold breath for 5 to 10 seconds and then blow up the balloon with a slow breath through the straw, filling the balloon completely.
Radiopharmaceutical: Use appropriate precautions for handling and disposal. Do not handle capsule directly.
Oral: Perform test while the patient is fasting (at least 6 hours prior to administration). Instruct patient to swallow capsule whole with 20 mL of lukewarm water; do not chew or open. At 3 minutes, have patient drink another 20 mL of lukewarm water to ensure capsule reaches gastric mucosa. At 10 minutes, have patient hold breath for 5 to 10 seconds and then blow up the balloon with a slow breath through the straw, filling the balloon completely.
Helicobacter pylori detection: Radioactive agent used in the detection of gastric urease which aids in the diagnosis of Helicobacter pylori (H. pylori) infection in the stomach.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
There are no known significant interactions.
Women of reproductive potential should be evaluated for pregnancy prior to administration.
Animal reproductive studies have not been conducted. Radiopharmaceuticals have the potential to cause fetal harm.
It is not known if Carbon 14 urea is excreted in breast milk. The manufacturer recommends that caution be exercised when administering Carbon 14 urea to nursing women.
Pytest uses a liquid scintillation counter for the measurement of 14CO2 in breath samples.
Distribution: ~10% of dose remains in the body 72 hours after administration
Half-life elimination: ~12 hours
Time to peak: Excretion in breath: 10-15 minutes
Excretion: Urine
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