pharmacopeia

Tuberculin

Tuberculosis diagnosticsUS-FDASourced from openFDA
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Indications

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  • Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis . The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.ICD-10: A15.9

Contraindications

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  • Aplisol is contraindicated in patients with known hypersensitivity or allergy to Aplisol or any of its components. Aplisol should not be administered to persons who have previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site.contraindicated

Dosage & administration

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Aplisol vials should be inspected visually for both particulate matter and discoloration prior to administration and discarded if either is seen. Vials in use for more than 30 days should be discarded. The 0.1 mL dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 tuberculin units (TU) dose of Tuberculin PPD, which is the standard strength used for intradermal Mantoux testing. Standard Method (Mantoux Test) The Mantoux test is performed by intradermally injecting, on the volar aspect of the forearm, with a syringe and needle, exactly 0.1 mL of Aplisol. The result is read 48 to 72 hours later and palpable induration only is considered in interpreting the test . Induration is a hard, raised area with clearly defined margins at and around the injection site (see Interpretation of Tuberculin Reaction ). Erythema may develop at the injection site but has no diagnostic value. The standard test is performed as follows: The site of the test is usually the volar or dorsal surface of the forearm about 4" below the elbow. Other skin sites may be used, but the volar surface of the forearm is preferred. The use of a skin area free of lesions and away from any veins is recommended. 7 The skin at the injection site is cleansed with 70% alcohol and allowed to dry. The test material is administered with a tuberculin syringe (0.5 or 1.0 mL) fitted with a short (1/4 to 1/2") 27 gauge needle. A separate, sterile, single-use disposable syringe and needle should be used for each individual patient. The diaphragm of the vial-stopper should be wiped with 70% alcohol.

Warnings & precautions

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Aplisol should not be administered to persons who previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site (see CONTRAINDICATIONS ). Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test. A number of factors have been reported to cause a decreased ability to respond to the tuberculin test, such as the presence of infections, viral infections (measles, mumps, chickenpox, HIV), live virus vaccinations (measles, mumps, rubella and other live vaccines), bacterial infections (typhoid fever, brucellosis, typhus, leprosy, pertussis, overwhelming tuberculosis, tuberculous pleurisy), fungal infections (South American blastomycosis), drugs (corticosteroids and other immunosuppressive agents), metabolic derangements (chronic renal failure), low protein states (severe protein depletion, afibrinogenemia), age (newborns, elderly patients with waned sensitivity), stress (surgery, burns, mental illness, graft-versus-host reactions), diseases affecting lymphoid organs (Hodgkin's disease, lymphoma, chronic leukemia, sarcoidosis), and malignancy. 7,8,9 Any condition that impairs or attenuates cell mediated immunity potentially can cause a false negative reaction, including aging. 10,11 Tuberculin skin test results are less reliable in HIV-infected individuals as CD4 counts decline (see CLINICAL PHARMACOLOGY ). 3 Avoid injecting tuberculin subcutaneously.

Adverse reactions

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In highly sensitive individuals, strongly positive reactions including vesiculation, ulceration or necrosis may occur at the test site. Cold packs or topical steroid preparations may be employed for symptomatic relief of the associated pain, pruritus and discomfort. Strongly positive test reactions may result in scarring at the test site. Immediate erythematous or other reactions may occur at the injection site. Local hypersensitivity reactions may occur at the injection site including erythema, pruritus, edema, urticaria and rash. Systemic allergic reactions including anaphylaxis/anaphylactoid reactions have been reported to occur in association with the use of Aplisol. The reactions, including anaphylaxis, generally occurred within 24 hours of exposure and manifestations included rash, urticaria, edema/angioedema and pruritus. To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Use in specific populations

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Pregnancy Teratogenic effects: Pregnancy Category C Animal reproduction studies have not been conducted with Aplisol. It is also not known whether Aplisol can cause fetal harm when administered to a pregnant woman or can affect the reproduction capacity. Aplisol should be given to a pregnant woman only if clearly needed. However, the risk of unrecognized tuberculosis and the postpartum contact between a mother with active disease and an infant leaves the infant in grave danger of tuberculosis and complications such as tuberculous meningitis. Although there have not been any reported adverse effects upon the fetus recognized as being due to tuberculosis skin testing, the prescribing physician will want to consider if the potential benefits outweigh the possible risks for performing the tuberculin test on a pregnant woman or a woman of childbearing age, particularly in certain high risk populations. Tuberculin skin testing is considered valid and safe throughout pregnancy. 3

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,560 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Poor Quality Product Administered39515%
  2. 2Product Storage Error32313%
  3. 3Injection Site Erythema2419.4%
  4. 4Expired Product Administered1485.8%
  5. 5Erythema1295.0%
  6. 6Pruritus1264.9%
  7. 7Injection Site Pruritus1214.7%
  8. 8Injection Site Induration1144.5%
  9. 9No Adverse Event1144.5%
  10. 10Product Quality Issue1094.3%
  11. 11False Positive Tuberculosis Test1064.1%
  12. 12Dyspnoea1044.1%
  13. 13Tuberculin Test False Positive1034.0%
  14. 14Wrong Product Administered953.7%
  15. 15Injection Site Pain923.6%

Literature

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Recent PubMed references pinned to Tuberculin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 138 ClinicalTrials.gov registrations naming Tuberculin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Tuberculin used for?
According to FDA labeling, Tuberculin carries indications including: Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis . The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tuberculin?
Tuberculin is classified as Tuberculosis diagnostics.
What are the contraindications for Tuberculin?
Tuberculin labeling lists contraindications including: Aplisol is contraindicated in patients with known hypersensitivity or allergy to Aplisol or any of its components. Aplisol should not be administered to persons who have previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site.. Always consult the full prescribing information and a clinician.
Note. Data for tuberculin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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