Tubersol (tuberculin, purified protein derivative)
Intradermal Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Tuberculin is a skin-test antigen preparation derived from culture media filtrates of a human strain of Mycobacterium tuberculosis. Tuberculin is commercially available as purified protein derivative (PPD).
Generic name: tuberculin, purified protein derivative
Therapeutic class: Diagnostic Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Tubersol
Indications
The following indications are listed for Tubersol:
- Delayed Hypersensitivity Skin Test For Tuberculin Purified Protein Derivative- Ppd
Also known as: Diagnostic Test For Tb Exposure, Mantoux Test, Ppd Skin Test, Ppd Test, Purified Protein Derivative Test, Tuberculin Skin Test.
Dosing
No dosing information is available for this tab.
Administer by intradermal injection only; do not inject IV, IM, or subcutaneously. If subcutaneous injection occurs, the test cannot be interpreted.
Store vials at 2-8oC; do not freeze and protect from light. Vials in use for more than 30 days should be discarded due to possible oxidation and degradationwhich may affect potency.
Inspect the vials for particulate matter and/or discoloration before use. If theseconditions exist, do not administer the product. Use a separate syringe and needle for each injection.
Administer by intradermal injection using the Mantoux method.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Tuberculin Testing/Live Vaccines
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Measles infection and severe acute and chronic infections may induce an anergic state resulting in a false-negative tuberculin test. The live measles vaccine, as well as other live vaccines (e.g. smallpox, varicella, yellow fever) theoretically may also suppress response to tuberculin testing, though the degree of suppression may be less than that expected from acute infection with wild-type virus.(1-4)
CLINICAL EFFECTS: Tuberculin testing that is performed more than one day but less than 28 days after administration of a live vaccine may result in a false negative tuberculin response. Tuberculin testing may be administered simultaneously with live vaccines.(1-4)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The CDC states that live vaccines (e.g. MMR and varicella) and tuberculin testing may be administered within one day of each other at separate administration sites. If it has been more than one day since tuberculin testing has been administered, the live vaccine can be given at any interval after the tuberculin test. However, if the live vaccine has been administered more than one day previously and tuberculin testing is indicated, tuberculin testing should be deferred for at least 4-6 weeks.(1-4)
DISCUSSION: Suppression of response to tuberculin testing has been observed following measles infection, live measles vaccination, and live smallpox vaccination. The degree of suppression after live virus vaccination is likely to be less than that from an acute infection with wild-type virus. There is no data on suppression of response to tuberculin testing with other live vaccines. In the absence of data, the CDC recommends tuberculin testing within one day that a live vaccine is administered. Otherwise the tuberculin test should be deferred for at least 4-6 weeks.(1-4)
There are no moderate interactions for this drug.
Contraindications
*Patients with known hypersensitivity or allergy to tuberculin PPD or any of itscomponents.
*Manufacturer of Tubersol(R) states that the tuberculin skin test should not be administered to persons with documented active tuberculosis or a clear history of treatment of TB infection or disease, and to persons with extensive burns or eczema.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Induration at the tuberculin PPD injection site is the expected reaction for a positive skintest; however, strongly positive reactions incuding vesiculation, ulceration, necrosis, or scarring may occur. Immediate erythematous or other reactions also may occur at the injection site.
Rare or Very Rare
- Anaphylaxis
- Angioedema
- Dermal necrosis
- Dyspnea
- Skin rash
- Skin ulcer
- Urticaria
Less Frequent
- Injection site sequelae
- Pain
- Pruritus of skin
Rare or Very Rare
- Fever
- Stridor
Precautions
No enhanced messaging available.
There is no contraindication to tuberculin skin testing of infants and children. Young children (e.g., infants <6 months ofage) who are infected with M. tuberculosis may not react to tuberculin PPD. The American Academy of Pediatricians (AAP) recommends that only children who have a risk factor for TB infection or are at risk for progressing to disease, are suspected of having TB disease, or who have immunosuppressive disease or about to start immunsuppressive therapy should be tested with either a tuberculin skin test (TST) or a TB blood test.
Animal reproduction studies have not been conducted with tuberculin PPD. It is also notknown whether the drug can cause fetal harm when administered to a pregnantwoman or can affect reproduction capacity. Tuberculin PPD should be given to a pregnantwoman only if clearly needed.
It is not known whether tuberculin PPD is excreted in human milk. Because many drugs areexcreted in human milk, caution should be exercised when tuberculin PPD is administered toa nursing woman.
Once acquired, tuberculin sensitivity tends to persist, although it often wanes with time and advancingage. In geriatric patients, the reaction maydevelop more slowly and may not be maximal until after 72 hours. A number of factors have been reported to cause a decreased ability to respond to thetuberculin test, such as elderly patients with waned sensitivity. Any condition that impairs or attenuatescell mediated immunity potentially can cause a false negative reaction, including aging.
ICD codes
| Code | Type | Description |
|---|---|---|
| Delayed hypersensitivity skin test for tuberculin purified protein derivative- PPD | ||
| Z11.1 | ICD10CM | Encounter for screening for respiratory tuberculosis |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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