Citric acid and urea c-13
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Helicobacter pylori Diagnostic
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Dosage and Administration Overview IDkit Hp One or IDkit Hp Two contain the same drug product, 75 mg 13 C-urea tablet and 4 g Citrica (citric acid) for oral solution and follow the same drug preparation and administration instructions. 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 that as identified in the BreathID system device labeling, is intended for use with IDkit Hp One and IDkit Hp Two.
For in vitro diagnostic use only. Inform the patient that each 4 g packet of Citrica (citric acid) for oral solution contains 84 mg of phenylalanine per dose. Phenylketonurics restrict dietary phenylalanine [see Warnings and Precautions] . The patient should have fasted for at least one hour before administering the test drink.
The patient should not have taken antimicrobials, proton pump inhibitors (PPI), or bismuth preparations within two weeks prior to administering the test. If PPIs are used within two weeks of breath testing, false negative test results may occur, and the test should be repeated two weeks after discontinuation of PPI treatment.
A positive result for a patient on PPI could be considered as indicative of the presence of urease enzyme associated with H. pylori . Before opening the kit (IDkit Hp One or IDkit Hp Two), verify that the entire package is intact [see How Supplied/Storage and Handling] .
Preparation of IDkit Hp One Single-use kit or IDkit Hp Two Single-use Kit Preparation Instructions with IDkit Hp One single-use kit or IDkit Hp Two single-use kit Dissolve the 13 C-urea tablet and Citrica (citric acid) for oral solution in 150 mL to 200 mL of tap water in a single drinking cup of at least eight ounces (236 mL) in capacity.
In the IDkit Hp Two kit a drinking cup is provided. Stir thoroughly with the provided straw until the 13 C-urea tablet and Citrica (citric acid) for oral solution are completely dissolved. Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes of stirring, discard the solution and repeat the procedure with a new kit.
Use the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability.
IDkit Hp One Single-use Kit: Instruction for Performing the BreathID H. pylori Test Preparing the BreathID System Device Refer to the BreathID system device labeling for additional details. Ensure that the BreathID system device is activated, and the status is Ready . The status appears on the top right of the screen. Follow the screen instructions Connecting the IDcircuit ® : Take the IDcircuit ® out of its bag and slide the tubing sleeve down as far as it will go.
Gently place the cannula tips into the patient’s nostrils, and place the cannula tubing over the ears, as shown in Figure 1. Figure 1 Slide the tubing sleeve up towards the neck to fit comfortably under the chin. Connect the IDcircuit to the BreathID system device by twisting the orange connector at the free end of the cannula clockwise until it is secured into the dedicated socket of the BreathID system device.
Verify that the IDcircuit is not twisted or kinked and that the cannula tips are in the nostrils. Ensure that the IDcircuit cannula tips moldings are positioned inwards. Press the START button on the touch screen to proceed. The baseline values will be measured by the BreathID system device, and the results will be shown on the screen.
Administering the Test Drink and Starting Measurement Do not administer the test drink until prompted by the screen instructions on the device (this makes certain that the baseline sample has been collected properly). Ensure that the patient drinks the solution through the straw. The patient, including pediatric patients 3 years of age and older, regardless of age and body weight, must drink the solution within two minutes and consume the entire amount.
After the patient finishes drinking the solution, press the Continue button on the touch screen to proceed. Measurement with the BreathID System Device The BreathID system device continually analyzes the trend of measured results. When the device determines that the final value will be positive or negative, i.e., greater or less than 5 Delta Over Baseline, it will automatically end the test and print out the results.
The breath sample is analyzed in real-time by the BreathID system device; therefore, the stability of the final breath sample will not affect the outcome of the results. Removing and Discarding the IDcircuit: When the measurement is complete, disconnect the IDcircuit from both the patient and the device. Dispose of the IDcircuit and all other used components of the kit according to standard operating procedures or local regulations for the disposal of used medical waste.
If you do not disconnect the IDcircuit, instructions will appear on the device screen reminding you to do so. The device will not proceed to the next screen until the IDcircuit is disconnected. Printing Results: After the measurement is complete, the device will automatically print the test results. The printout contains the graph as seen on the screen, including the Patient ID (if entered), date, time, test number, and Delta Over Baseline value of the last point measured.
Tear off the printed results and fill in additional patient data as required. Figure 1
Dosage and Administration Overview IDkit Hp One or IDkit Hp Two contain the same drug product, 75 mg 13 C-urea tablet and 4 g Citrica (citric acid) for oral solution and follow the same drug preparation and administration instructions. 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 that as identified in the BreathID system device labeling, is intended for use with IDkit Hp One and IDkit Hp Two.
For in vitro diagnostic use only. Inform the patient that each 4 g packet of Citrica (citric acid) for oral solution contains 84 mg of phenylalanine per dose. Phenylketonurics restrict dietary phenylalanine [see Warnings and Precautions] . The patient should have fasted for at least one hour before administering the test drink.
The patient should not have taken antimicrobials, proton pump inhibitors (PPI), or bismuth preparations within two weeks prior to administering the test. If PPIs are used within two weeks of breath testing, false negative test results may occur, and the test should be repeated two weeks after discontinuation of PPI treatment.
A positive result for a patient on PPI could be considered as indicative of the presence of urease enzyme associated with H. pylori . Before opening the kit (IDkit Hp One or IDkit Hp Two), verify that the entire package is intact [see How Supplied/Storage and Handling] .
Preparation of IDkit Hp One Single-use kit or IDkit Hp Two Single-use Kit Preparation Instructions with IDkit Hp One single-use kit or IDkit Hp Two single-use kit Dissolve the 13 C-urea tablet and Citrica (citric acid) for oral solution in 150 mL to 200 mL of tap water in a single drinking cup of at least eight ounces (236 mL) in capacity.
In the IDkit Hp Two kit a drinking cup is provided. Stir thoroughly with the provided straw until the 13 C-urea tablet and Citrica (citric acid) for oral solution are completely dissolved. Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes of stirring, discard the solution and repeat the procedure with a new kit.
Use the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability.
Drug interactions
Check citric acid and urea c-13 against a medication listLabel text (2 paragraphs)
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. Antimicrobials, Bismuth-containing preparations: Avoid use within 2 weeks prior to testing. ( 7 ) Proton pump inhibitors (PPIs): Avoid use within 2 weeks prior to testing. ( 7 )
Contraindications
4 CONTRAINDICATIONS 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 [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )] . Hypersensitivity to the 13 C-urea, Citrica (citric acid) or to any of the excipients in the drug. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Published data from other single oral dose 13 C-urea breath test kits containing urea and citric acid have not demonstrated a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are no available data on the use of IDkit Hp One or IDkit Hp Two use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are no animal data that meet current standards for nonclinical developmental toxicity studies.
Based on available literature, no significant developmental or reproductive toxicities were observed in nonclinical studies with urea or citric acid. A single oral dose of 13 C-urea and citric acid at the maximum recommended human dose (MRHD) are unlikely to pose a significant developmental or reproductive risk, since humans typically have higher circulating levels of urea, and citric acid exposure from the test is within the range of normal dietary intake. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S.
general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.