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Drug overview for TUBERSOL (tuberculin, purified protein derivative):
Generic name: TUBERCULIN, PURIFIED PROTEIN DERIVATIVE
Drug class:
Therapeutic class: Diagnostic Agents
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).
No enhanced Uses information available for this drug.
Generic name: TUBERCULIN, PURIFIED PROTEIN DERIVATIVE
Drug class:
Therapeutic class: Diagnostic Agents
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).
No enhanced Uses information available for this drug.
DRUG IMAGES
TUBERSOL 5T UNIT/0.1 ML VIAL
The following indications for TUBERSOL (tuberculin, purified protein derivative) have been approved by the FDA:
Indications:
Delayed hypersensitivity skin test for tuberculin purified protein derivative- PPD
Professional Synonyms:
Diagnostic test for TB exposure
Mantoux test
PPD skin test
PPD test
Purified protein derivative test
Tuberculin skin test
Indications:
Delayed hypersensitivity skin test for tuberculin purified protein derivative- PPD
Professional Synonyms:
Diagnostic test for TB exposure
Mantoux test
PPD skin test
PPD test
Purified protein derivative test
Tuberculin skin test
The following dosing information is available for TUBERSOL (tuberculin, purified protein derivative):
No enhanced Dosing information available for this drug.
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.
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 available.
No generic dosing information available.
The following drug interaction information is available for TUBERSOL (tuberculin, purified protein derivative):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
ACAM2000 (NATIONAL STOCKPILE), ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, BCG VACCINE (TICE STRAIN), DENGVAXIA, ERVEBO (NATIONAL STOCKPILE), FLUMIST TRIVALENT 2024-2025, IXCHIQ, M-M-R II VACCINE, PRIORIX, PROQUAD, ROTARIX, ROTATEQ, STAMARIL, VARIVAX VACCINE, VAXCHORA ACTIVE COMPONENT, VAXCHORA VACCINE, VIVOTIF, YF-VAX |
There are 0 moderate interactions.
The following contraindication information is available for TUBERSOL (tuberculin, purified protein derivative):
Drug contraindication overview.
*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.
*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 0 contraindications.
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for TUBERSOL (tuberculin, purified protein derivative):
Adverse reaction overview.
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.
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.
There are 7 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Dermal necrosis Dyspnea Skin rash Skin ulcer Urticaria |
There are 5 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Injection site sequelae Pain Pruritus of skin |
| Rare/Very Rare |
|---|
|
Fever Stridor |
The following precautions are available for TUBERSOL (tuberculin, purified protein derivative):
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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
The following prioritized warning is available for TUBERSOL (tuberculin, purified protein derivative):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for TUBERSOL (tuberculin, purified protein derivative)'s list of indications:
| Delayed hypersensitivity skin test for tuberculin PPD | |
| Z11.1 | Encounter for screening for respiratory tuberculosis |
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