Tuberculin purified protein derivative

Tuberculin purified protein derivative is used as an aid in the detection of infection with Mycobacterium tuberculosis. 

• Tuberculin purified protein derivative is available under the following different brand names: Aplisol, Mantoux, PPD, Sclavo PPD Soln, Tubersol

Common side effects of Tuberculin purified protein derivative include:

• Injection site reactions (redness, ulceration of the skin, skin rash, pain, discomfort, or itching),
• Fever,
• Shortness of breath,
• Generalized rash,
• Lightheadedness, and
• Fainting

Serious side effects of Tuberculin purified protein derivative include:

• Difficulty breathing,
• Hives,
• Rash,
• Burning in the eyes,
• Swelling of the face or tongue, and
• Fainting

Rare side effects of Tuberculin purified protein derivative include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Intradermal solution

• 5 Units/0.1mL

Tuberculosis

• Adult and pediatric dosage and geriatric dosage
• Diagnosis: Mantoux test, inject 0.1 mL (5 tuberculin units) intradermally; the result is read 48 to 72 hours after administration
• Positive if 10 mm induration
• Use 1 TU in sensitized patients, 250 TU if no response to 5 TU

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Tuberculin purified protein derivatives have no noted severe interactions with any other drugs.
• Tuberculin purified protein derivatives have no noted serious interactions with any other drugs.
• Tuberculin purified protein derivatives have no noted moderate interactions with any other drugs.
• Tuberculin purified protein derivatives have no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Previous positive tuberculin skin test responsiveness suppressed within 6 weeks of viral infection, inactive TB

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tuberculin purified protein Derivatives?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tuberculin purified protein Derivatives?”

Cautions

• Contains soluble growth products from tubercle bacillus
• Old tuberculin (OT) is culture filtrate of uniform potency
• PPD is more refined and is the preferred product
• Multiple puncture devices (Aplitest, SclavoTest-PPD, Tine Test PPD) are not as sensitive
• Several factors were 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
• Any condition that impairs or attenuates cell-mediated immunity potentially can cause a false negative reaction, including aging.
• Test results are less reliable in HIV-infected individuals as CD4 counts decline
• Avoid injecting tuberculin subcutaneously; if this occurs, no local reaction develops, but a general febrile reaction and/or acute inflammation around old tuberculous lesions may occur in highly sensitive individuals.
• The predictive value of the tuberculin skin test depends on the prevalence of infection with M. tuberculosis and the relative prevalence of cross-reactions with nontuberculous mycobacteria
• A separate, sterile, single-use disposable syringe and needle should be used for each patient to prevent possible transmission of serum hepatitis virus and other infectious agents from one person to another; special care should be taken to ensure that the product is injected intradermally and not into a blood vessel
• Before administration of Aplisol, review the patient’s history concerning possible immediate-type hypersensitivity to the product, determination of previous use of the agent, and the presence of any contraindication to the test
• As with any biological product, epinephrine should be immediately available in case an anaphylactoid or acute hypersensitivity reaction occurs.
• Failure to store and handle the drug as recommended may result in a loss of potency and inaccurate test results
• Reactivity to the test may be depressed or suppressed for as long as 5–6 weeks in individuals following immunization with certain live viral vaccines, viral infections, or discontinuation of corticosteroids or immunosuppressive agents

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy.

Lactation

• Not known if excreted in breast milk