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Identification
- Summary
Urea C-14 is a diagnostic agent used for the detection of urease associated with Helicobacter pylori in the human stomach and initial diagnosis or post-treatment monitoring of Helicobacter pylori infection in adults.
- Brand Names
- Pytest
- Generic Name
- Urea C-14
- DrugBank Accession Number
- DB09513
- Background
Urea 14C is a urea molecule radiolabelled with a radioactive carbon-14. It is currently used for the Urea Breath Test (UBT) and is available as a rapid diagnostic test (marketed as PyTest) for the detection of Helicobacter pylori infections. H pylori is a common stomach bacteria that has been linked to a variety of upper gastrointestinal disorders such as gastritis, gastric and peptic ulcers, stomach cancer, and gastric mucosa-associated lymphoid-tissue (MALT) lymphoma. The UBT is indicated to confirm H. pylori infection and to monitor post-treatment for its eradication.
Radiolabelled urea is available in two forms as 13C and 14C. Both forms can be used within the Urea Breath Test, however some may prefer 13C as it is non-radioactive compared to 14C, which may be preferable in pregnant women and children.
The Urea Breath Test is based on the ability of the H. pylori enzyme urease to cleave urea into ammonia and carbon dioxide. As the urease enzyme is not present in mammalian cells, the presence of urease (and the products of urea cleavage) in the stomach is evidence that H. pylori bacteria are present. To detect H. pylori, urea labeled with 14C is swallowed by the patient. If gastric urease from H. pylori is present, urea is split to form CO2 and NH3 at the interface between the gastric epithelium and lumen and 14CO2 is absorbed into the blood and exhaled in the breath. Exhaled breath samples can then be collected and measured for the presence of radioactivity.
- Type
- Small Molecule
- Groups
- Approved
- Structure
Structure for Urea C-14 (DB09513)
- Weight
- Average: 62.048
Monoisotopic: 62.035604745 - Chemical Formula
- CH4N2O
- Synonyms
- 14C-urea
- Carbon 14 urea
- Carbon-14 urea
- Urea (14C)
- Urea 14 C
- Urea C 14
- Urea-14C
- Urea, C-14
Pharmacology
- Indication
14C-urea 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 14CO2 in breath samples.
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Diagnostic agent Helicobacter pylori infection •••••••••••• - Contraindications & Blackbox Warnings
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Not Available
- Mechanism of action
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. To detect H. pylori, urea labeled with 14C is swallowed by the patient. If gastric urease from H. pylori is present, urea is split to form CO2 and NH3 at the interface between the gastric epithelium and lumen and 14CO2 is absorbed into the blood and exhaled in the breath. Following ingestion of the capsule by a patient with H. pylori, 14CO2 excretion in the breath peaks between 10 and 15 minutes and declines thereafter with a biological half-life of about 15 minutes. Therefore, the detection of isotope-labelled carbon dioxide in exhaled breath indicates that urease is present in the stomach, and hence that H. pylori bacteria are present.
Target Actions Organism AUrease substrateHelicobacter pylori - Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
14C-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 14C remains in the body at 72 hours and is gradually excreted with a biological half-life of 40 days.
- Clearance
Not Available
- Adverse Effects
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Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- Take on an empty stomach. Avoid eating and drinking for 4-6 hours before doing a urea breath test with Urea C-14.
Products
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Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image PYtest Capsule 1 uCi/1 Oral Avent, Inc. 1997-05-09 Not applicable US 
PYtest Capsule 1 uCi/1 Oral Avent, Inc. 1997-05-09 Not applicable US
Categories
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- This compound belongs to the class of organic compounds known as ureas. These are compounds containing two amine groups joined by a carbonyl (C=O) functional group.
- Kingdom
- Organic compounds
- Super Class
- Organic acids and derivatives
- Class
- Organic carbonic acids and derivatives
- Sub Class
- Ureas
- Direct Parent
- Ureas
- Alternative Parents
- Organopnictogen compounds / Organonitrogen compounds / Organic oxides / Hydrocarbon derivatives / Carbonyl compounds
- Substituents
- Aliphatic acyclic compound / Carbonyl group / Hydrocarbon derivative / Organic nitrogen compound / Organic oxide / Organic oxygen compound / Organonitrogen compound / Organooxygen compound / Organopnictogen compound / Urea
- Molecular Framework
- Aliphatic acyclic compounds
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- WBZ6M63TEE
- CAS number
- 594-05-8
- InChI Key
- XSQUKJJJFZCRTK-NJFSPNSNSA-N
- InChI
- InChI=1S/CH4N2O/c2-1(3)4/h(H4,2,3,4)/i1+2
- IUPAC Name
- (¹⁴C)urea
- SMILES
- N[14C](N)=O
References
- General References
- Ferwana M, Abdulmajeed I, Alhajiahmed A, Madani W, Firwana B, Hasan R, Altayar O, Limburg PJ, Murad MH, Knawy B: Accuracy of urea breath test in Helicobacter pylori infection: meta-analysis. World J Gastroenterol. 2015 Jan 28;21(4):1305-14. doi: 10.3748/wjg.v21.i4.1305. [Article]
- Raju GS, Smith MJ, Morton D, Bardhan KD: Mini-dose (1-microCi) 14C-urea breath test for the detection of Helicobacter pylori. Am J Gastroenterol. 1994 Jul;89(7):1027-31. [Article]
- External Links
- PubChem Compound
- 11457650
- PubChem Substance
- 347827870
- ChemSpider
- 9632491
- 253158
- ChEBI
- 134711
- ChEMBL
- CHEMBL2096635
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Urea_breath_test
- FDA label
- Download (3.89 MB)
Clinical Trials
- Clinical Trials
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Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Capsule Oral 37 kBq Capsule, coated Oral 37 kBq Capsule Oral 1 mcg Capsule Oral 1 uCi/1 - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
- Predicted Properties
Property Value Source Water Solubility 412.0 mg/mL ALOGPS logP -1.8 ALOGPS logP -1.4 Chemaxon logS 0.84 ALOGPS pKa (Strongest Acidic) 15.73 Chemaxon pKa (Strongest Basic) -2.4 Chemaxon Physiological Charge 0 Chemaxon Hydrogen Acceptor Count 1 Chemaxon Hydrogen Donor Count 2 Chemaxon Polar Surface Area 69.11 Å2 Chemaxon Rotatable Bond Count 0 Chemaxon Refractivity 13.14 m3·mol-1 Chemaxon Polarizability 5.1 Å3 Chemaxon Number of Rings 0 Chemaxon Bioavailability 1 Chemaxon Rule of Five Yes Chemaxon Ghose Filter No Chemaxon Veber's Rule No Chemaxon MDDR-like Rule No Chemaxon - Predicted ADMET Features
- Not Available
Spectra
- Mass Spec (NIST)
- Not Available
- Spectra
- Chromatographic Properties
Collision Cross Sections (CCS)
Adduct CCS Value (Å2) Source type Source [M-H]- 117.03944 predictedDeepCCS 1.0 (2019) [M+H]+ 118.93199 predictedDeepCCS 1.0 (2019) [M+Na]+ 126.48814 predictedDeepCCS 1.0 (2019)
Targets
Drug created at November 30, 2015 19:10 / Updated at October 09, 2021 02:48