Active Substance: Urea ( C13 Urea ).
Overview
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This medicine contains an important and useful components, as it consists of
Urea ( C13 Urea )is available in the market in concentration
Urea ( C13 Urea )
Ensure patient has fasted (typically 6 hours) before administration. Avoid use of antibiotics, bismuth preparations, or proton pump inhibitors (PPIs) at least 2–4 weeks before testing, as these may yield false-negative results. Not intended for therapeutic use—diagnostic only. Use cautiously in patients with respiratory disorders if exhalation tests are performed. Ensure the patient can adequately cooperate with breath sampling instructions.
Primary use: Detection of Helicobacter pylori infection in the stomach using the C¹³-Urea Breath Test. It is especially helpful in: Diagnosing active H. pylori infection. Confirming eradication after treatment. Non-invasive monitoring in peptic ulcer disease and gastritis.
Hypersensitivity or known allergy to urea or test components. Not for use in children below a certain age (often under 3 years), unless recommended by guidelines. Patients with difficulty exhaling or breath-holding (e.g., severe COPD) may not be able to undergo testing properly. Patients with metabolic disorders affecting urea metabolism.
C¹³ Urea is generally very well tolerated. However, minor side effects may include: Gastrointestinal: Nausea, abdominal discomfort (rare). Allergic reactions: Extremely rare, but hypersensitivity is possible. Breath collection discomfort: Mild inconvenience or coughing during sampling.
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Upon ingestion, C¹³-labeled urea is hydrolyzed by the H. pylori enzyme urease in the stomach. This releases labeled carbon dioxide (C¹³O₂), which is absorbed into the bloodstream and exhaled in the breath. Detection of increased C¹³O₂ in exhaled air confirms the presence of active H. pylori infection.
Medications affecting test accuracy: Antibiotics Proton pump inhibitors (PPIs) Bismuth compounds These can suppress H. pylori and lead to false-negative results. Antacids and H₂-receptor antagonists may also impact test accuracy to a lesser degree.
Typically categorized as Pregnancy Category C (US) due to lack of definitive studies. Since it's used for diagnostic purposes and not absorbed systemically in therapeutic doses, risk is minimal. Should be used in pregnancy only if clearly needed and under medical supervision.
Standard dose: One oral dose of 75–100 mg of C¹³-labeled urea. Administered with a test meal (e.g., citric acid) to ensure accurate gastric exposure. Followed by timed breath sample collection (typically at 30 minutes post-ingestion).
Dosage may be weight-based; typically lower than adult dose. Follow product-specific guidelines and consult pediatric protocols. Breath sampling in young children may be challenging and needs supervision.
No specific renal dose adjustment is necessary for diagnostic use. Urea and carbon dioxide metabolism are generally not impaired in renal disease with respect to breath test interpretation.
Route: Oral Form: Tablet or solution containing C¹³ Urea. Instructions: Fast for 6 hours prior to the test. Ingest the urea with a citric acid-based test drink if required. Remain seated and still during the waiting period. Provide breath samples before and 30 minutes after ingestion.