Identification

Summary

Urea C-13 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
Helicobacter Test Infai, Pylobactell
Generic Name
Urea C-13
DrugBank Accession Number
DB09510
Background

Urea 13C is a urea molecule radiolabelled with the non-radioactive element carbon-13. It is currently used for the Urea Breath Test (UBT) and is available as a rapid diagnostic test (marketed as Pranactin-Citric) 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 13C 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 13CO2 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: 61.048
Monoisotopic: 61.035717592
Chemical Formula
CH4N2O
Synonyms
  • (13C)urea
  • 13C-urea
  • Carbon 13 urea
  • Carbon-13 urea
  • Urea (13C)
  • Urea 13 C
  • Urea C 13
  • Urea-13C
  • Urea, C-13

Pharmacology

Indication

Urea-13C is indicated for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four (4) weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.

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Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

Not Available

Mechanism of action

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 13C 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 13CO2 is absorbed into the blood and exhaled in the breath. Exhaled breath samples can then be collected and measured for the presence of radioactivity.

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

Not Available

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 separate from meals. The urea breath test using Urea C-13 should be done at least 1 hour before and after food and drink.

Products

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International/Other Brands
Helicosol
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Helicobacter Test InfaiPowder, for solution75 mgOralInfai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H2016-09-08Not applicableEU flag
Helicobacter Test InfaiPowder, for solution75 mgOralInfai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H2016-09-08Not applicableEU flag
Helicobacter Test InfaiPowder, for solution75 mgOralInfai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H2016-09-08Not applicableEU flag
Helicobacter Test InfaiPowder, for solution75 mgOralInfai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H2016-09-08Not applicableEU flag
Helicobacter Test Infai for Children Of The Age 3-11Powder, for solution45 mgOralInfai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H2016-09-08Not applicableEU flag
Pranactin-CitricPowder, for solution75 mg/3000mgOralOtsuka Pharmaceutical Co., Ltd.2001-05-10Not applicableUS flag
PylobactellTablet100 mgOralTorbet Laboratories Ireland Limited2016-09-08Not applicableEU flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
IDkit HP ONEUrea C-13 (75 mg/1) + Citric acid monohydrate (4 g/1)SolutionOralExalenz Bioscience Ltd.2009-12-28Not applicableUS flag

Categories

ATC Codes
V04CX05 — 13c-urea
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
urea (CHEBI:32285)
Affected organisms
Not Available

Chemical Identifiers

UNII
W6KX9E6D8X
CAS number
58069-82-2
InChI Key
XSQUKJJJFZCRTK-OUBTZVSYSA-N
InChI
InChI=1S/CH4N2O/c2-1(3)4/h(H4,2,3,4)/i1+1
IUPAC Name
(13C)urea
SMILES
N[13C](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]
KEGG Drug
D01749
PubChem Compound
636363
PubChem Substance
347827869
ChemSpider
552162
RxNav
226724
ChEBI
32285
ChEMBL
CHEMBL2096648
Drugs.com
Drugs.com Drug Page
Wikipedia
Urea_breath_test
FDA label
Download (3.98 MB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
0Active Not RecruitingDiagnosticProstate Cancer1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SolutionOral75 MG/10ML
Powder, for solutionOral
TabletOral
PowderOral
Kit; powder, for solutionOral
Powder, for solutionOral
Powder, for solutionOral45 MG
Powder, for solutionOral75 MG
TabletOral37.5 MG
Tablet, solubleOral75 MG
SolutionOral
Powder, for solutionOral75 mg/3000mg
Tablet, solubleOral100 MG
TabletOral100 mg
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 06, 2020 17:43