DIABACT UBT 50MG Tablets

What is DIABACT UBT 50MG

DIABACT UBT 50MG is a specialized diagnostic tablet containing Urea labeled with Carbon-13 isotope (C¹³ Urea). It is used exclusively for conducting the Urea Breath Test (UBT), a non-invasive diagnostic tool for detecting active Helicobacter pylori (H. pylori) infection in the stomach. The presence of H. pylori is linked to conditions like gastritis, duodenal ulcers, gastric ulcers, and an increased risk of gastric cancer.

• Generic: Urea (C¹³-labeled)
• Form: Oral tablet, 50 mg strength
• Pack Size: 400 single tablets (1s blister x 400) for institutional or diagnostic center use
• Purpose: Diagnostic—used in conjunction with breath analysis devices to confirm or rule out active H. pylori infection
• Target Users: Adults and children capable of complying with the breath sampling protocol

DIABACT UBT does not have any therapeutic effect; it is not used for treatment but serves as a reliable diagnostic aid. Because it is non-radioactive, it is safe for children and pregnant women when clinically indicated. Its high specificity and accuracy make it a gold-standard test in gastroenterology.

How to use DIABACT UBT 50MG

DIABACT UBT 50MG is taken as a part of the Urea Breath Test procedure and must be administered under medical supervision. Strict adherence to pre-test and post-test instructions ensures accurate results.

• Fasting Requirement: Do not eat or drink (except water) for at least 6 hours before the test.
• Baseline Breath Sample: A breath sample is collected before taking the tablet to measure background C¹³ CO₂ levels.
• Administration: Swallow one 50 mg tablet with a citric acid solution (usually 100 mL of 1g citric acid) to delay gastric emptying and enhance urease activity.
• Post-Ingestion Period: Wait 30 minutes after ingestion before collecting the post-dose breath sample.
• Sample Analysis: Breath samples are analyzed via infrared spectrometry or isotope-ratio mass spectrometry for C¹³ carbon dioxide.

The test is easy to perform and typically takes 30–45 minutes. Patients should not chew the tablet. Breath samples are collected using a straw and bag system, which must be sealed immediately and sent to a specialized lab for analysis.

Mode of Action DIABACT UBT 50MG

The diagnostic action of DIABACT UBT 50MG is based on the enzymatic activity of H. pylori. The bacteria secrete urease, an enzyme that catalyzes the breakdown of urea into ammonia and carbon dioxide.

• Step 1: The patient ingests C¹³-labeled urea (DIABACT UBT 50MG).
• Step 2: If H. pylori is present, urease breaks down C¹³ urea into C¹³-labeled CO₂ and ammonia.
• Step 3: The labeled CO₂ is absorbed into the bloodstream and exhaled through the lungs.
• Step 4: The exhaled C¹³ CO₂ is collected and analyzed.

If the test detects increased levels of C¹³-labeled CO₂ in the breath sample compared to baseline, it confirms the presence of active H. pylori infection. This mechanism makes the UBT one of the most reliable tests for diagnosing current infections, unlike serological tests that can remain positive long after infection has cleared.

DIABACT UBT 50MG Interactions DIABACT UBT 50MG

As DIABACT UBT 50MG is a diagnostic agent and not systemically absorbed in a pharmacological way, drug interactions primarily affect the test’s accuracy rather than patient safety.

• Proton Pump Inhibitors (PPIs): Drugs like omeprazole, esomeprazole, and pantoprazole reduce urease activity and should be discontinued at least 2 weeks before testing.
• Antibiotics: Especially those targeting H. pylori (e.g., clarithromycin, amoxicillin, metronidazole) should be stopped 4 weeks prior to testing.
• Bismuth-containing Compounds: Interfere with bacterial viability and may suppress urease activity, leading to false negatives.
• H2 Receptor Antagonists: Drugs like ranitidine may also affect gastric pH and urease expression.
• Food and Beverages: Avoid alcohol, caffeine, and acidic foods before the test.

Always inform your healthcare provider of any recent medications or supplements taken to ensure the reliability of the test. Adjustments to the testing schedule may be required.

Dosage of DIABACT UBT 50MG

The dosage of DIABACT UBT 50MG is standardized for accurate diagnostic testing in both adults and children, depending on the testing protocol and the availability of breath collection equipment.

• Standard Adult Dose: One 50 mg tablet, taken orally with a suitable test drink (e.g., 100 mL of citric acid solution).
• Pediatric Use: Children who can reliably follow breath sampling instructions may also take one tablet under professional supervision. Adjustments based on body weight may be considered in some protocols.
• Breath Sampling: Performed 30 minutes after ingestion.
• Repeat Testing: May be performed 4–6 weeks after eradication therapy to confirm treatment success.

Only one tablet is required per test session, regardless of whether the pack contains 400 units. The larger pack is intended for high-volume testing environments such as hospitals or diagnostic laboratories.

Possible side effects of DIABACT UBT 50MG

DIABACT UBT 50MG is generally very well tolerated, as it is not systemically active and only serves a diagnostic purpose. Nonetheless, minor adverse effects may occasionally occur.

• Gastrointestinal Effects: Mild nausea, bloating, or abdominal discomfort due to the citric acid test drink or urea breakdown products.
• Taste Changes: Some patients may find the accompanying test drink unpleasant.
• Allergic Reactions: Very rare; may include rash, itching, or mild swelling in hypersensitive individuals.
• Breath Sample Discomfort: Rare reports of coughing or difficulty with breath collection in patients with respiratory conditions.

Side effects are usually mild and transient. If symptoms persist or worsen, or if an allergic reaction occurs, immediate medical attention is advised. Always use DIABACT UBT under healthcare supervision.

DIABACT UBT 50MG Contraindications DIABACT UBT 50MG

While DIABACT UBT 50MG is generally considered safe for diagnostic use, it should be avoided or used with caution in certain patient populations.

• Known Hypersensitivity: Allergic reactions to urea or excipients in the tablet formulation.
• Children Under 3 Years: Not suitable for very young children who cannot reliably perform breath sampling.
• Severe Respiratory Disorders: May interfere with effective breath collection and compromise results.
• Recent H. pylori Treatment: Avoid testing within 4 weeks after completing antibiotics or PPIs due to false-negative risk.

Proper patient selection and history-taking are essential before conducting the test. The test is not recommended during acute illness or when patients are unable to comply with the test procedure.

Storage of DIABACT UBT 50MG

Proper storage of DIABACT UBT 50MG is vital to maintain its diagnostic integrity, especially when handling large institutional packs like the 400s configuration.

• Temperature: Store at controlled room temperature, below 25°C.
• Humidity Control: Keep the blisters in a dry place, away from moisture and direct sunlight.
• Packaging: Maintain the tablets in their original foil blisters until use to prevent exposure to air and contamination.
• Handling: Use clean, dry hands or gloves when removing tablets from blister packs.
• Shelf Life: Check the expiration date on the packaging before use; expired tablets should be discarded.

Keep the medicine out of reach of children. Institutions handling bulk packs should implement standard inventory management to ensure proper rotation and quality control.