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
Structure for Urea C-13 (DB09510)
- 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.
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- 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.
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
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- 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
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- International/Other Brands
- Helicosol
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Helicobacter Test Infai Powder, for solution 75 mg Oral Infai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H 2016-09-08 Not applicable EU 
Helicobacter Test Infai Powder, for solution 75 mg Oral Infai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H 2016-09-08 Not applicable EU Helicobacter Test Infai Powder, for solution 75 mg Oral Infai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H 2016-09-08 Not applicable EU Helicobacter Test Infai Powder, for solution 75 mg Oral Infai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H 2016-09-08 Not applicable EU Helicobacter Test Infai for Children Of The Age 3-11 Powder, for solution 45 mg Oral Infai, Institut Für Biomedizinische Analytik Nmr Imaging Gmb H 2016-09-08 Not applicable EU Pranactin-Citric Powder, for solution 75 mg/3000mg Oral Otsuka Pharmaceutical Co., Ltd. 2001-05-10 Not applicable US 
Pylobactell Tablet 100 mg Oral Torbet Laboratories Ireland Limited 2016-09-08 Not applicable EU - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image IDkit HP ONE Urea C-13 (75 mg/1) + Citric acid monohydrate (4 g/1) Solution Oral Exalenz Bioscience Ltd. 2009-12-28 Not applicable US
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
- 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
- KEGG Drug
- D01749
- PubChem Compound
- 636363
- PubChem Substance
- 347827869
- ChemSpider
- 552162
- 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
Phase Status Purpose Conditions Count 0 Recruiting Diagnostic Prostate Cancer 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Solution Oral 75 MG/10ML Powder, for solution Oral Tablet Oral Powder Oral 75 mg Kit; powder, for solution Oral Powder, for solution Oral Powder, for solution Oral 45 MG Powder, for solution Oral 75 MG Tablet Oral 37.5 MG Tablet, soluble Oral 75 MG Solution Oral Powder, for solution Oral 75 mg/3000mg Tablet, soluble Oral 100 MG Tablet Oral 100 mg - 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
Spectrum Spectrum Type Splash Key Predicted GC-MS Spectrum - GC-MS Predicted GC-MS Not Available Predicted MS/MS Spectrum - 10V, Positive (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 20V, Positive (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 40V, Positive (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 10V, Negative (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 20V, Negative (Annotated) Predicted LC-MS/MS Not Available Predicted MS/MS Spectrum - 40V, Negative (Annotated) Predicted LC-MS/MS Not Available
Targets
Drug created at November 30, 2015 19:10 / Updated at October 06, 2020 17:43