Pytest
Urea, C-14
Avent, Inc.
Human Prescription Drug
NDC 42536-6044Pytest also known as Urea, C-14 is a human prescription drug labeled by 'Avent, Inc.'. National Drug Code (NDC) number for Pytest is 42536-6044. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Pytest drug includes Urea C-14 - 1 uCi/1 . The currest status of Pytest drug is Active.
Drug Information:
| Drug NDC: | 42536-6044 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Pytest |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Urea, C-14 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Avent, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | UREA C-14 - 1 uCi/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 09 May, 1997 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA020617 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Avent, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | WBZ6M63TEE
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 42536-6044-1 | 1 BLISTER PACK in 1 PACKAGE (42536-6044-1) / 1 CAPSULE in 1 BLISTER PACK | 09 May, 1997 | N/A | No |
| 42536-6044-2 | 10 CAPSULE in 1 PACKAGE (42536-6044-2) | 09 May, 1997 | N/A | No |
| 42536-6044-3 | 100 CAPSULE in 1 PACKAGE (42536-6044-3) | 09 May, 1997 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Pytest urea, c-14 urea c-14 urea c-14 light lemon yellow oval
Drug Interactions:
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 2 weeks prior to performing the test may give false negative results.
Indications and Usage:
Indications and usage pytest ( 14 c-urea breath test) is indicated for use in the detection of gastric urease as an aid in the diagnosis of h. pylori infection in the human stomach. the test utilizes a liquid scintillation counter for the measurement of 14 co 2 in breath samples.
Warnings:
Warnings none
General Precautions:
General after the patient ingests the 14 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. very rarely, a false positive test may occur due to urease associated with helicobacters other than h. pylori (i.e. helicobacter heilmanni ). 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 h. pylori infection. the performance characteristics of the test have not been established for monitoring the efficacy of antimicrobial therapies for the treatment of h. pylori infection. a negative result does not completely rule out the possibility of h. pylori infection. if clinical signs and patient history suggest h. pylori infection, repeat the pytest or use an alternative diagnostic method. radioactivity persons concerned about very low doses of radioactivity ma
Read more...y postpone the test or may decide to use an alternative means of diagnosis. the test produces radiation exposure equal to 24 hours of normal background. in animal experiments, such low doses of radiation do not carry measurable risk. preclinical studies were not conducted on 14 c-urea. the estimated dose equivalent received from a single administration of pytest (1 µci 14 c) is about 0.3 mrem.
Dosage and Administration:
Dosage and administration materials needed but not provided for analysis at test site breath sample collected into balloon (recommended method; see figure 2 ) breath test report form stopwatch/timer capable of timing an interval up to 10 minutes marking pen 1 â 20 ml scintillation vial breath transfer pump pipette (10 ml) for measuring fluids collection fluid (2.5 ml/vial) scintillation fluid (10 ml/vial) 1 â mylar collection balloon 1 â straw 2 â needles 2 â 30 ml medicine cups water (40 ml) any gas pump that is airtight and has a flow rate between .5 and 1 liter per minute may be used. figure 2: other components figure 2: other components for analysis on site breath sample collected into vial caution: kimberly-clark does not endorse breath sample collection by this method because patients might come into direct contact with the hyamine. breath test report form stopwatch/timer capable of timing an interval up to 10 minutes safety trap (figure 3) 1 â straw
Read more... 1 â 20 ml scintillation vial marking pen pipette (10 ml) for measuring fluids collection fluid (2.5 ml/vial) scintillation fluid (10 ml/vial) figure 3: typical safety trap figure 3: typical safety trap
Dosage Forms and Strength:
Dosage one pytest capsule.
Contraindications:
Contraindications none
Adverse Reactions:
Adverse reactions no adverse reactions were reported in clinical trials.
Drug Interactions:
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 2 weeks prior to performing the test may give false negative results.
Use in Pregnancy:
Pregnancy pregnancy category c animal reproduction studies have not been conducted with pytest ( 14 c-urea). it is also not known whether pytest can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. pytest should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use clinical studies in children have not been conducted. however, pytest is expected to work the same in children as in adults. while the dose (1 capsule) does not need to be adjusted, the child must be able to swallow the intact capsule and blow into a straw.
Overdosage:
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 excretion of urea is achieved at a urine output of ⥠2.0 ml/min.
Description:
Description pytest registered trademark or trademark of kimberly-clark worldwide, inc. ( 14 c-urea capsules) is intended for use in the detection of gastric urease as an aid in the diagnosis of helicobacter pylori ( h. pylori ) infection in the human stomach. the test utilizes a liquid scintillation counter for the measurement of 14 co 2 in breath samples. the capsules are to be used when analysis is planned at the site where the sample is taken. pytest capsule is a gelatin capsule for oral administration containing 1 µci of 14 c labeled urea. the urea is adsorbed on sugar spheres and colored yellow with fluorescein. data on 14 c-urea structural formula ( 14 c-urea): nh 2 14 conh 2 radiation emission: beta-emission, 49 kev mean , 156 kev max , no other emissions external emission: no external radiation hazard. low-energy beta emissions only. maximum range of 0.3 mm in water. radiological half-life: 5730 years maximum effective dose equivalent (ede) : 0.3 mrem/µci
Clinical Pharmacology:
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 h. pylori , but other bacteria are not usually found in the stomach. the principle of the breath test is shown in figure 1. figure 1: principle of breath test to detect h. pylori , urea labeled with 14 c is swallowed by the patient. if gastric urease from h. pylori is present, urea is split to form co 2 and nh 3 at the interface between the gastric epithelium and lumen and 14 co 2 is absorbed into the blood and exhaled in the breath. following ingestion of the capsule by a patient with h. pylori , 14 co 2 excretion in the breath peaks between 10 and 15 minutes and declines thereafter with a biological half-life of about 15 minutes. 14 c-urea that is not hydrolyzed by h. pylori is excreted in the urine with a half-life of approximately 12 hours. about 10% of the 14 c remains in the body at 72
Read more... hours and is gradually excreted with a biological half-life of 40 days. figure 1: principle of breath test 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 mucosa for histological analysis (2 samples, giemsa stain) and rapid urease test (1 sample, clotest ). breath samples were mailed to the tri-med lab where they were read in a liquid scintillation counter. results were reported as disintegrations per minute (dpm). analysis for accuracy used the ten minute breath sample. a breath sample dpm <50 was defined as a negative result. dpm ⥠200 was defined as a positive result. dpm in the range of 50â199 was classified as indeterminate. study 1 of 186 patients who had histopathology and clotest (80 men, 106 women), 53 were infected with h. pylori as determined by agreement between histology and clotest . the study results are summarized below: table 1: study #1 (n = 186, indeterminate results included) histology and clotest h. pylori positive negative total notes: pytest at 10 min. was compared to the gold standard of biopsy results in which histology and clotest concurred. patients who did not have both biopsy tests performed, or in whom the tests differed, were excluded from analysis. there was no statistical difference in test accuracy based on gender of patient. ppv = positive predictive value (true positive divided by total pytest positive) npv = negative predictive value (true negative divided by total pytest negative) pytest positive 51 8 59 ppv. 86% (dpm indeterminate 1 8 9 10 min.) negative 1 117 118 npv. 99% total 53 133 186 sensitivity specificity 96% 88% study 2 breath tests were performed on 436 outpatients attending gastroenterology practices at sites in the united states. seventy-six patients (40 men, 36 women) who had histology and clotest were evaluated. the results are summarized below: table 2: study #2 (n = 76, indeterminate results included) histology and clotest h. pylori positive negative total notes: pytest at 10 min. was compared to the gold standard of biopsy results in which histology and clotest concurred. patients who did not have both biopsy tests performed, or in whom the tests differed, were excluded from analysis. there was no statistical difference in test accuracy based on gender of patient. ppv = positive predictive value (true positive divided by total pytest positive) npv = negative predictive value (true negative divided by total pytest negative) pytest positive 22 0 22 ppv. 100% (dpm indeterminate 4 2 6 10 min.) negative 1 47 48 npv. 98% total 27 49 76 sensitivity specificity 82% 96%
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no studies have been conducted with 14 c-urea to evaluate its potential for carcinogenicity, impairment of fertility, or mutagenicity.
Clinical Studies:
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 mucosa for histological analysis (2 samples, giemsa stain) and rapid urease test (1 sample, clotest ). breath samples were mailed to the tri-med lab where they were read in a liquid scintillation counter. results were reported as disintegrations per minute (dpm). analysis for accuracy used the ten minute breath sample. a breath sample dpm <50 was defined as a negative result. dpm ⥠200 was defined as a positive result. dpm in the range of 50â199 was classified as indeterminate.
How Supplied:
How supplied pytest capsules, clear gelatin capsules each containing 1 μci of 14c-urea in unit dose packages of 1, 10 and 100. pytest kit ( 14 c-urea breath test) is also supplied as a kit containing a pytest capsule and breath collection equipment. the pytest capsule has a shelf life of two years. the expiration date is printed on the capsule label. pytest capsules and kit should be stored at 15â30 °c (59â86 °f) in an area designated by each individual institution's regulations.
Information for Patients:
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 test. instruct the patient not to handle the capsule directly as this may interfere with the test result. the capsule should be swallowed intact. do not chew the capsule.
Package Label Principal Display Panel:
Principal display panel - 10 capsule package label avanos* pytest* 14 c-urea breath test capsules for the detection of helicobacter pylori contents â 10 pytest* capsules each containing 1 µci 14 c-urea for dosage information, please see package insert 14 c-urea (5730 years1/2, 156 kev [max.] β-emission) ndc 42536-6044-2 for in vitro diagnostic use rx only store at 15°â30°c (59°â86°f) ref 60442 principal display panel - 10 capsule package label