Drugs List

Therapeutic Indications

Uses

Unlicensed product

Unlicensed Uses

Tuberculosis - investigation of susceptibility

Tuberculin skin testing for diagnostic use in patients infected with tuberculous mycobacteria.

Some countries recommend tuberculin testing in conjunction with BCG vaccination, either to ensure that only tuberculin-negative individuals are vaccinated or as a post-vaccination test.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book

Administration

For intradermal injection only, in the middle third of the forearm, as a reaction might be weaker near the wrist or the elbow joint.

Contraindications

None known

Precautions and Warnings

Elderly
Immunosuppressive treatment including radiotherapy
Infectious mononucleosis
Viral infection
Within 4 weeks of other live vaccines
Diabetes mellitus
Immunodeficiency syndromes
Malignant neoplasm
Malnutrition
Renal impairment
Sarcoidosis
Tuberculosis

Administer tuberculin test before, with or 4-6 weeks after live vaccination
Avoid administration to eczematous or inflamed skin
Avoid occlusive dressings
Professional and patient should be aware that this is an unlicensed product
Resuscitation facilities must be immediately available
Retest before BCG if URI or viral infection at time of first test
Follow national immunisation guidelines

Repeated tuberculin skin testing in patients previously vaccinated with BCG vaccine may be complicated by a booster phenomenon. Repetition of the skin test in a short period of time (less than 1 year) should be avoided, or apparent conversions of the reaction from negative to positive may be created.

Factors such as young or old age, poor nutrition, immunosuppression by disease or drugs, viral infections (particularly measles, mononucleosis, varicella and influenza) can lower tuberculin reactivity. After vaccinations with vaccines containing live virus (e.g. vaccines against measles, mumps and rubella) a reduced reactivity may be observed. This decreased reactivity may result in false negative reactions. Many patients co-infected with HIV and Mycobacterium tuberculosis have anergy for tuberculin with or without anergy to other skin test antigens. In patients with severe tuberculosis (e.g. miliary tuberculosis) tuberculin reactivity may be suppressed.

Recent infection with environmental non-tuberculous mycobacteria can result in cross-sensitisation and a false-positive reaction to a tuberculin PPD test.

After vaccinations with vaccines containing live virus (e.g. vaccines against measles, mumps and rubella) a reduced reactivity may be observed. This decreased reactivity may result in false negative reactions. Therefore, if tuberculin skin testing cannot be done at the same time as measles, mumps and rubella immunisation, the test should be postponed for 4 to 6 weeks.

Pregnancy and Lactation

Pregnancy

Testing with tuberculin PPD is considered safe during 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

Testing with tuberculin PPD is considered safe during 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

Anaphylactic reaction
Fever
Headache
Hypersensitivity reactions
Irritation (injection site)
Itching (injection site)
Local pain (injection site)
Lymph node enlargement
Necrosis (injection site)
Urticaria
Vesiculation (injection site)

Presentation

Solution for injection containing tuberculin PPD

Drugs List

Therapeutic Indications

Uses

Unlicensed product

Unlicensed Uses

Tuberculosis - investigation of susceptibility

Tuberculin skin testing for diagnostic use in patients infected with tuberculous mycobacteria.

Some countries recommend tuberculin testing in conjunction with BCG vaccination, either to ensure that only tuberculin-negative individuals are vaccinated or as a post-vaccination test.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book

Dosage

Adults

Elderly

Children

Additional Dosage Information

Administration

For intradermal injection only, in the middle third of the forearm, as a reaction might be weaker near the wrist or the elbow joint.

Contraindications

None known

Precautions and Warnings

Elderly
Immunosuppressive treatment including radiotherapy
Infectious mononucleosis
Viral infection
Within 4 weeks of other live vaccines
Diabetes mellitus
Immunodeficiency syndromes
Malignant neoplasm
Malnutrition
Renal impairment
Sarcoidosis
Tuberculosis

Administer tuberculin test before, with or 4-6 weeks after live vaccination
Avoid administration to eczematous or inflamed skin
Avoid occlusive dressings
Professional and patient should be aware that this is an unlicensed product
Resuscitation facilities must be immediately available
Retest before BCG if URI or viral infection at time of first test
Follow national immunisation guidelines

Repeated tuberculin skin testing in patients previously vaccinated with BCG vaccine may be complicated by a booster phenomenon. Repetition of the skin test in a short period of time (less than 1 year) should be avoided, or apparent conversions of the reaction from negative to positive may be created.

Factors such as young or old age, poor nutrition, immunosuppression by disease or drugs, viral infections (particularly measles, mononucleosis, varicella and influenza) can lower tuberculin reactivity. After vaccinations with vaccines containing live virus (e.g. vaccines against measles, mumps and rubella) a reduced reactivity may be observed. This decreased reactivity may result in false negative reactions. Many patients co-infected with HIV and Mycobacterium tuberculosis have anergy for tuberculin with or without anergy to other skin test antigens. In patients with severe tuberculosis (e.g. miliary tuberculosis) tuberculin reactivity may be suppressed.

Recent infection with environmental non-tuberculous mycobacteria can result in cross-sensitisation and a false-positive reaction to a tuberculin PPD test.

After vaccinations with vaccines containing live virus (e.g. vaccines against measles, mumps and rubella) a reduced reactivity may be observed. This decreased reactivity may result in false negative reactions. Therefore, if tuberculin skin testing cannot be done at the same time as measles, mumps and rubella immunisation, the test should be postponed for 4 to 6 weeks.

Pregnancy and Lactation

Pregnancy

Testing with tuberculin PPD is considered safe during 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

Testing with tuberculin PPD is considered safe during 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

Anaphylactic reaction
Fever
Headache
Hypersensitivity reactions
Irritation (injection site)
Itching (injection site)
Local pain (injection site)
Lymph node enlargement
Necrosis (injection site)
Urticaria
Vesiculation (injection site)

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: August 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

BNF for Children (2013-2014) Pharmaceutical Press, London.

Immunisation against infectious diseases: 'The Green Book', Department of Health.
Available at: https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
Last accessed: August 15, 2013.

Summary of Product Characteristics: Tuberculin PPD RT 23. Statens Serum Institut. November 2011.