PYTEST Capsule (14C-Urea Breath Test) (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Avent, Inc.
Λέξεις κλειδιά
42536-6046
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1. Description
PYtest<sup>1</sup> (<sup>14</sup>C-Urea Breath Test) is a qualitative and non-invasive method for the diagnosis of <em>Helicobacter pylori (H.pylori)</em>. To detect <em>H.pylori</em>, <sup>14</sup>C-urea ...
2. Clinical Pharmacology
The urease enzyme is not present in mammalian cells, so the presence of urease in the stomach is evidence that bacteria are present. The presence of urease is not specific for <em>H.pylori</em>, but other ...
3. Indications and Usage
PYtest<sup>1</sup> (<sup>14</sup>C-Urea Breath Test) is indicated for use in the detection of gastric urease as an aid in the diagnosis of <em>H.pylori</em> infection in the human stomach. The test utilizes ...
4. Contraindications
None.
5. Warnings
None.
6. Precautions
Limitations of the Test The test has been evaluated in outpatients before elective endoscopy. Test results should be evaluated with clinical signs and patient history when diagnosing <em>H.pylori</em> ...
6.1. General
After the patient ingests the <sup>14</sup>C-urea capsule, the sample collected for test purposes is for in vitro diagnostic use only. A false positive test could occur in patients who have achlorhydria. ...
6.2. Information for Patients
It is necessary for the patient to fast for 6 hours before the test. The patient should also be off antibiotics and bismuth for 1 month, and proton pump inhibitors and sucralfate for 2 weeks prior to the ...
6.4. Drug Interactions
Antibiotics, proton pump inhibitors, sucralfate, and bismuth preparations are known to suppress H.pylori. Ingestion of antibiotics or bismuth within 4 weeks and proton pump inhibitors or sucralfate within ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted with <sup>14</sup>C-urea to evaluate its potential for carcinogenicity, impairment of fertility, or mutagenicity.
6.7. Pregnancy
Pregnancy category C. Animal reproduction studies have not been conducted with PYtest<sup>1</sup> (<sup>14</sup>C-urea). It is also not known whether PYtest<sup>1</sup> can cause fetal harm when administered ...
6.9. Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PYtest<sup>1</sup> is administered to a nursing woman.
6.10. Pediatric Use
Clinical studies in children have not been conducted. However, PYtest<sup>1</sup> is expected to work the same in children as in adults. While the dose (1 capsule) does not need to be adjusted, the child ...
7. Adverse Reactions
No adverse reactions were reported in clinical trials.
9. Overdosage
Risk from radiation is negligible even with a 1000 capsule overdose (0.3 rem). If overdose occurs, the patient may drink one glass of water (150 mL) every hour to hasten excretion of the isotope. Maximum ...
10. Dosage and Administration
Materials provided As shown in Figure 2, the PYtest<sup>1</sup> Kit contains: PYtest<sup>1</sup> capsule Two 30 mL disposable cups One drinking straw One mylar collection balloon One report form One mailing ...
11. How Supplied
PYtest<sup>1</sup> Kit (<sup>14</sup>C-Urea Breath Test) is supplied as a kit containing a PYtest<sup>1</sup> Capsule, a clear gelatin capsule containing 1µCi of <sup>14</sup>C--urea and breath collection ...
12. Storage and Handling
PYtest<sup>1</sup> Capsules and Kit should be stored at 15°-30°C (59°-86°F) in an area designated by each individual institutions regulations.
13. Clinical Studies
Two studies were performed. In both studies, patients with gastrointestinal symptoms underwent the breath test and an endoscopy. During the endoscopy, biopsy samples were taken from the antral gastric ...
14. References
1 Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc.