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
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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Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

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.

TargetActionsOrganism
AUrease
substrate
Helicobacter 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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Toxicity

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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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
PYtestCapsule1 uCi/1OralAvent, Inc.1997-05-09Not applicableUS flag
PYtestCapsule1 uCi/1OralAvent, Inc.1997-05-09Not applicableUS flag

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
  1. 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]
  2. 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]
PubChem Compound
11457650
PubChem Substance
347827870
ChemSpider
9632491
RxNav
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
PhaseStatusPurposeConditionsCount

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
CapsuleOral37 kBq
Capsule, coatedOral37 kBq
CapsuleOral1 mcg
CapsuleOral1 uCi/1
CapsuleOral
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available
Predicted Properties
PropertyValueSource
Water Solubility412.0 mg/mLALOGPS
logP-1.8ALOGPS
logP-1.4Chemaxon
logS0.84ALOGPS
pKa (Strongest Acidic)15.73Chemaxon
pKa (Strongest Basic)-2.4Chemaxon
Physiological Charge0Chemaxon
Hydrogen Acceptor Count1Chemaxon
Hydrogen Donor Count2Chemaxon
Polar Surface Area69.11 Å2Chemaxon
Rotatable Bond Count0Chemaxon
Refractivity13.14 m3·mol-1Chemaxon
Polarizability5.1 Å3Chemaxon
Number of Rings0Chemaxon
Bioavailability1Chemaxon
Rule of FiveYesChemaxon
Ghose FilterNoChemaxon
Veber's RuleNoChemaxon
MDDR-like RuleNoChemaxon
Predicted ADMET Features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
SpectrumSpectrum TypeSplash Key
Predicted GC-MS Spectrum - GC-MSPredicted GC-MSNot Available
Predicted MS/MS Spectrum - 10V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 20V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 40V, Positive (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 10V, Negative (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 20V, Negative (Annotated)Predicted LC-MS/MSNot Available
Predicted MS/MS Spectrum - 40V, Negative (Annotated)Predicted LC-MS/MSNot Available

Targets

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Kind
Protein
Organism
Helicobacter pylori
Pharmacological action
Yes
Actions
Substrate
General Function
Not Available
Specific Function
Nickel cation binding
Gene Name
ureB
Uniprot ID
Q8KT33
Uniprot Name
Urease
Molecular Weight
40196.87 Da

Drug created at November 30, 2015 19:10 / Updated at October 09, 2021 02:48