Drugs List

Therapeutic Indications

Uses

In vivo diagnosis of gastro-duodenal Helicobacter pylori infection

Contraindications

Children under 3 years
Atrophic gastritis
Gastrectomy

Precautions and Warnings

Children aged 3 to 18 years

Do not use until 2 weeks after last dose of gastric antisecretory agent
Exclude gastrointestinal infection before commencing treatment
Not all available brands are licensed for all age groups
Do not use until 4 weeks after treatment with systemic antibacterials
If re- testing is required, repeat procedure after 24 hours
If test is +ve, consider other diagnostic methods for complicating factors

If the patient vomits during the test procedure and the test has to be repeated, it should be performed after fasting and not before the following day. If the test has to be repeated for any other reason, it should be performed after fasting and not before the following day.

A positive breath test alone does not clinically confirm that eradication therapy is indicated. Alternative diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, such as gastric ulcer, autoimmune gastritis and malignancies.

Pregnancy and Lactation

Pregnancy

Helicobacter pylori breath test is considered safe for use in pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Helicobacter pylori breath test is considered safe for use in breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Fatigue
Parosmia
Stomach pain

Presentation

Kits containing oral formulations of carbon-13 labelled urea

Drugs List

Therapeutic Indications

Uses

In vivo diagnosis of gastro-duodenal Helicobacter pylori infection

Dosage

Adults

Elderly

Children

Adolescents

Contraindications

Children under 3 years
Atrophic gastritis
Gastrectomy

Precautions and Warnings

Children aged 3 to 18 years

Do not use until 2 weeks after last dose of gastric antisecretory agent
Exclude gastrointestinal infection before commencing treatment
Not all available brands are licensed for all age groups
Do not use until 4 weeks after treatment with systemic antibacterials
If re- testing is required, repeat procedure after 24 hours
If test is +ve, consider other diagnostic methods for complicating factors

If the patient vomits during the test procedure and the test has to be repeated, it should be performed after fasting and not before the following day. If the test has to be repeated for any other reason, it should be performed after fasting and not before the following day.

A positive breath test alone does not clinically confirm that eradication therapy is indicated. Alternative diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, such as gastric ulcer, autoimmune gastritis and malignancies.

Pregnancy and Lactation

Pregnancy

Helicobacter pylori breath test is considered safe for use in pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Helicobacter pylori breath test is considered safe for use in breastfeeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Advise patient that they must fast for at least 6 hours, preferably over night before taking the test.

Side Effects

Fatigue
Parosmia
Stomach pain

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2014

Reference Sources

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press Accessed on 21 October 2014.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 21 October 2014.

Summary of Product Characteristics: Diabact UBT 50 mg tablets. Kibion AB. Revised March 2011.

Summary of Product Characteristics: Helicobacter Test INFAI 75 mg powder for oral solution. INFAI UK Ltd. Revised August 2007.

Summary of Product Characteristics: Helicobacter Test INFAI for children of the age 3-11 45 mg powder for oral solution. INFAI UK Ltd. Revised August 2007.

Summary of Product Characteristics: Pylobactell 100 mg soluble tablet. Torbet Laboratories Limited. Revised May 2008.