14-C urea breath test

Action and Spectrum

Drug Interaction

Adverse Reaction

None

Black Box Warning

Black box warning: 

None 

Contraindication / Caution

Contraindications/caution: 

Contraindications:

None

Cautions:

Once the patient has consumed the 14C-urea capsule, the sample obtained for testing is intended solely for in vitro diagnostic applications.

Patients with achlorhydria may experience a false positive test result. Rarely can urease linked to Helicobacter species other than H. pylori (e.g., Helicobacter heilmanni) cause a false positive test.

Pregnancy / Lactation

Pregnancy Warnings:  

Pregnancy category: C 

Lactation:  

Excretion of the drug in human breast milk is unknown.  

Pregnancy Categories:    

Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.    

<b>Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.    

Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.    

Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.    

Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

It is known that the stomach holds urease signifies that there is of pathogenic bacteria as mammalian cells lack this type of enzyme. 

Pharmacodynamics: 

To identify the H.Pylori, the patient swallowed 14c. 

If the presence of gastric urease is detected from H. pylori, then Urae will divide to form NH3 and CO2 at the junction of gastric epithelium and lumen. Hence, 14CO2 is absorbed into the bloodstream and released through the breath. 

Pharmacokinetics: 

Absorption 

It is absorbed into the blood stream rapidly. 

Distribution 

It is diffused freely across the cell membranes. 

Metabolism 

Urea is converted into NH3 and CO2. 

Elimination and Excretion 

14CO2 which is not hydrolyzed by the bacteria H. pylori will be excreted through urine. 

Half-life is 12 hours. 

Adminstartion

Administration: 

The drug is administered orally. 

The urea adsorbed on sugar spheres s yellow color due to the presence of Fluorescein.

Patient Information Leaflet

Patient information leaflet  

Generic Name: 14-C urea breath test  

Why do we use a 14-C urea breath test? 

14-C urea breath test is used to detect the presence of gastric urease which is released from H.pylori bacteria in the stomach.  

A liquid scintillation counter is used in the test to measure 14CO2 in breath samples.