Citric acid and Urea c-13

IDkit Hp ® One and IDkit Hp ® Two are indicated for use as a diagnostic aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori (H. pylori) infection in adults and pediatric patients 3 years of age and older. IDkit Hp One and IDkit Hp Two are to be administered only by trained personnel as ordered by a licensed healthcare practitioner using the BreathID ® system device as identified in the BreathID ® system device labeling.

IDkit Hp One and IDkit Hp Two are administered using the BreathID system device, a non-invasive breath test that analyzes a breath sample before and after ingestion of 13 C- urea and citric acid. 75 mg 13 C-urea and 4. g citric acid is dissolved in water and administered orally to the patient. The presence of citric acid creates an acidic environment in the stomach and delays the gastric emptying of the ingested solution to the duodenum. These two characteristics facilitate the decomposition of the urea by H. pylori, if present. Thus, in the presence of urease produced by gastric H. pylori, 13 C-urea is decomposed to 13 CO 2 and NH 3 according to the following equation: The 13 CO 2 formed is absorbed into the blood and then exhaled in breath, enabling detection of elevated 13 CO 2 in H. pylori-positive patients.

IDkit Hp One and IDkit Hp Two each contain a 75 mg 13 C-urea tablet for oral solution, and 4 g Citrica (citric acid) for oral solution along with other materials for use with the BreathID system device o IDkit Hp One is co-packaged with a nasal canula to be used with the BreathID system device as identified in the BreathID system device labeling. o IDkit Hp Two is co-packaged with breath sample bags to be used with the BreathID system device as identified in the BreathID system device labeling. To prepare the oral solution for either kit, dissolve the 13 C-urea tablet and the Citrica (citric acid) for oral solution in 150 to 200 mL of water to provide a clear, colorless solution for oral administration. The resulting solution is ingested by the patient.

IDkit Hp One and IDkit Hp Two are contraindicated in patients with a known hypersensitivity to the 13 C-urea, Citrica (citric acid) or to any of the excipients. Hypersensitivity to the 13 C-urea, Citrica (citric acid) or to any of the excipients in the drug.

Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported in patients using IDkit Hp. Institute appropriate supportive measures if an allergic reaction occurs. Phenylketonuria: Citrica (citric acid) for oral solution, a component in the IDkit Hp, contains phenylalanine which can be harmful to patients with phenylketonuria.

The following clinically significant adverse reactions are discussed in the Warning and Precautions section of the labeling: Hypersensitivity Reactions Adult Patients: The most common adverse reactions (incidence >0.3%) using the IDkit Hp included nausea, throat burning, and lightheadedness. Pediatric Patients: The most common adverse reactions (incidence >1.5%) using the IDkit Hp included vomiting.

No formal drug interaction studies were conducted. Information on drugs that may interfere with test results are listed in the Table 1. Table 1: Drugs That Interfere with Test Results Interfering Drug Clinical Effect Prevention or Management Antimicrobials, bismuth-containing preparations May suppress H. pylori or urease activity, leading to false negative results Avoid use within 2 weeks prior to testing. If used within 2 weeks, postpone testing until at least 2 weeks after discontinuation. Proton pump inhibitors (PPIs) May reduce urease activity or alter gastric conditions, potentially causing false negative results. A positive result during PPI use may still indicate H. pylori presence. Avoid use within 2 weeks prior to testing. If a negative result is obtained during PPI use, repeat the test 2 weeks after PPI discontinuation.

Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).