Pranactin-Citric

PRANACTIN-CITRIC — urea c-13 powder, for solution
Otsuka America Pharmaceutical

Note: This “Introduction and Test Instructions” contains information for:

Test Collection Kit Breath Test Instrument
BreathTek™UBT for H. pylori 1. UBiT® -IR 300 Infrared Spectrophotometer
2. POCone™ Infrared Spectrophotometer

I. Intended Use

The BreathTek™ UBT Collection Kit is intended 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 13 CO2 to 12 CO2 in breath samples.

For administration by health care professionals. To be administered under a physician’s supervision.

II. Summary and Explanation

Since the isolation of the spiral urease-producing Helicobacter pylori bacteria (H. pylori) in 1983 by Drs. Marshall and Warren1 , a significant body of evidence has accumulated indicating that the bacteria is an important pathogen in the upper GI tract of humans.2.3 The causal relationship between H. pylori and chronic active gastritis, duodenal ulcer, and gastric ulcer is well documented.4.5 Methods available for detecting current infection of the human stomach by H. pylori are generally divided into two (2) general types: Invasive and Non-invasive.

Invasive methods are so named because they include, as a first step, an esophagogastroduodenoscopy (“EGD”) with collection of gastric biopsies. These biopsies are then examined by one or more detection methods: histological examination of stained tissue, microbiological culture of the organism, or direct detection of urease activity in the tissue (for example, the CLOtest®). Biopsy based methods are expensive, entail some patient risk and discomfort and may give false negative results due to sampling errors when colonization of the gastric mucosa is patchy.6

The non-invasive, non-radioactive method for detecting current H. pylori infection is based on the BreathTek™ UBT which is described in the next section. Several serological tests that detect serum antibodies to H. pylori are commercially available. A positive result with these tests cannot distinguish between current infection and past exposure to infection and, therefore, is not a conclusive indicator of current gastrointestinal colonization by H. pylori.

III. Principle of the BreathTek™ UBT for H. pylori

  1. Description of the Pranactin® -Citric Diagnostic Drug Component
    The diagnostic drug component of the kit is 13 C-urea, a synthetic urea contained in a granulated powder (Pranactin® -Citric) for reconstitution with potable water to provide a clear solution for oral administration. The carbon in the drug component is predominantly Carbon-13, a stable, naturally occurring, non-radioactive isotope of carbon; the relative abundance of Carbon-13 is greater than or equal to 99%. Each three (3) gram dose of Pranactin® -Citric is supplied in a polyethylene-lined foil pouch and contains 75 mg of 13 C-urea, citric acid7 , aspartame and mannitol. 13 C-urea is the diamide of 13 C-carbonic acid and is highly soluble in water (1 gram per mL at 25°C). It has the following chemical formula: 13 CH4 N2 O. An average adult body normally contains about 9 grams of urea, which is a product of protein metabolism. Urea in the body is referred to as natural isotopic abundance urea since it is composed of 98.9% 12 C-urea and 1.1% 13 C-urea.
  2. Principle of the Test
    Pranactin® -Citric drug product is a component of the BreathTek™ UBT for H. pylori kit. Three (3) g of reconstituted Pranactin® -Citric containing 75 mg of 13 C-urea is ingested by the patient. In the presence of urease associated with gastric H. pylori , 13 C-urea is decomposed to 13 CO2 and NH4 + according to the following equation:
    (NH2 )2 13 CO + H2 O + 2H+ HP Urease 13 CO2 + 2NH4 + 13 C-urea
    13 CO2 , is absorbed in the blood, then exhaled in the breath. This results in an increase in the ratio of 13 CO2 to 12 CO2 in a POST-DOSE breath sample taken after the Pranactin® -Citric solution was consumed, compared to a BASELINE sample taken before the Pranactin® -Citric solution was consumed. Analysis of the breath samples is performed by UBiT® -IR300 Infrared Spectrophotometer or POCone™ Infrared Spectrophotometer [located at your testing laboratory, physician office or hospital].
    The BreathTek™ UBT can detect very low levels of H. pylori colonization and, by assessing the entire gastric mucosa, avoids the risk of sampling errors inherent in biopsy based methods. In the absence of gastric H. pylori , the 13 C-urea does not produce 13 CO2 in the stomach. The ratio of 13 CO2 in the POST-DOSE breath sample remains essentially the same as the BASELINE.

IV. Warnings and Precautions

  1. For in vitro diagnostic use only. The Pranactin® -Citric drug solution is taken orally as part of the diagnostic procedure.
  2. Phenylketonurics: Contains Phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.)
  3. A negative result does not rule out the possibility of Helicobacter pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, retest with a new sample or an alternate method.
  4. Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori. Ingestion of these within two (2) weeks prior to performing the BreathTek™ UBT may give false negative results.
  5. A false positive test may occur due to urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii.
  6. Premature POST-DOSE breath collection time can lead to a false negative diagnosis for a patient with a marginally positive BreathTek™ UBT result.
  7. A false positive test could occur in patients who have achlorhydria.8
  8. If particulate matter is visible in the reconstituted Pranactin® -Citric solution after thorough mixing, the solution should not be used.

V. Shelf Life and Storage

The BreathTek™ UBT Collection Kit should be stored at 15°-30°C (59°-86°F). Pranactin® -Citric has an expiration date. Do not use beyond the expiration date stated on the label.

VI. Patient Preparation

  1. Remind the patient that Pranactin® -Citric contains phenylalanine (one of the protein components of Aspartame). Phenylketonurics restrict dietary phenylalanine.
  2. The patient should have fasted at least one (1) hour before administering the BreathTek™ UBT.
  3. The patient should not have taken antimicrobials, proton pump inhibitors, or bismuth preparations within two (2) weeks prior to administering the BreathTek™ UBT.

VII. Procedure for Collecting Breath Samples Using BreathTek™ UBT Kit, for Analysis by Infrared Spectrophotometer

A.
Materials
  1. Materials provided
    Each sealed single-patient BreathTek™ UBT Collection Kit contains:
    • One (1) plastic kit tray containing
      One (1) “How To” guide
      Test instructions
      One (1) pouch of Pranactin® -Citric powder (3 g)
      A set of four (4) self-adhesive bar-code stickers. All bar-codes should bear the same number.
      Two (2) breath collection bags, one (1) blue bag for the BASELINE sample and one (1) pink bag for the POST-DOSE sample.
      One (1) sample transport bag
      One (1) plastic straw
      One (1) plastic drinking cup
  2. Materials needed but not provided
    • A timer capable of timing an interval up to fifteen (15) minutes.
    • Scissors for opening the Pranactin® -Citric pouch.

Note: An Infrared Spectrophotometer (UBiT® -IR3000 or POCone™, Otsuka Pharmaceutical Co., Ltd.) is required for analysis of breath samples.

B.
Step-By-Step Procedure
Time intervals listed in the following step-by-step procedure are critical. They are highlighted by the timer icon:
  1. Verify that the patient has been prepared for the test as specified in Section VI.
  2. Open the BreathTek™ UBT Collection Kit, which should contain all the materials listed in Step VII. Slide out the kit tray. Label each breath collection bag to maintain patient identification using the bar-code labels provided, or according to your laboratory or office procedure.
  3. Collect the BASELINE breath sample according to the following procedure:
    1. Remove the blue breath collection bag from the kit tray.
    2. Remove the pull-off cap from the mouthpiece of the breath collection bag.
    3. Instruct the patient to: (1) breathe normally; (2) take a deep breath then pause momentarily; (3) exhale into the mouthpiece of the bag.
    4. Replace the cap firmly until it clicks on the mouthpiece of the bag.
  4. Prepare the Pranactin® -Citric solution no more than sixty (60) minutes before administering it to the patient. Urea slowly decomposes in water.
    1. Remove the Pranactin® -Citric pouch from the kit tray. Tap the upright packet of Pranactin® -Citric to settle the contents in the bottom half.
    2. With clean scissors, cut off the top of the packet and carefully empty the contents into the drinking cup provided, making sure to transfer all of the contents by tapping on the bottom of the pouch.
    3. Add potable water to the fill line indicated on the outside of the cup by a raised plastic ridge.
    4. Replace the lid securely and swirl the mixture for up to two (2) minutes to dissolve the packet contents; typically, only one (1) minute is required for complete dissolution. The resulting solution should be clear with no particulate matter. If particulate matter is present after thorough mixing, the solution should not be used.
  5. Instruct the patient to drink all of the solution with the straw provided, without stopping. Advise the patient NOT to ‘rinse’ the inside of his/her mouth with the solution before swallowing. Discard the straw.
  6. Set the timer for fifteen (15) minutes. The patient should sit quietly and should not eat, drink or smoke during the fifteen (15) minute interval.
  7. After fifteen (15) minutes have elapsed, remove the pink breath collection bag from the kit tray. Collect the POST-DOSE breath sample according to the procedure described in Steps VII B.3.b through B.3.d.
  8. Store the specimens at 15°-30°C (59°-86°F) until analysis is performed.
  9. Perform breath sample analysis within seven (7) days of breath sample collection. If desired, use the plastic sample transport bag for transport of the breath samples.
Page 1 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.