Tubersol (Intradermal)

Tuberculin purified protein derivative (PPD) is used in a skin test to help diagnose tuberculosis (TB) infection in people who are at higher risk of developing active disease.

The tuberculin skin test is performed by injecting tuberculin PPD into the top layer of the skin. If the test is positive, you will see a reaction at and around the injection or puncture site. If the test is done with an injection, the reaction usually appears as a hard, raised area with clear edges. If the test is done with puncture devices, the reaction usually looks like a swollen area at the puncture site. The size of the reaction is measured and recorded, and the results of the test are reviewed after 48 to 72 hours.

This medicine should only be given by or under the supervision of a doctor.

This medicine may lead to serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Call your doctor right away if you experience a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after getting this medicine.

Fainting might happen after receiving this test. It may come with other symptoms such as lightheadedness, muscle weakness, or seizures.

Some patients may experience false positive or negative reactions to the tuberculin skin test. This can happen if you have been vaccinated against tuberculosis (for example, BCG) or if you have been around other mycobacteria.

Make sure your doctor is aware if you are taking a medicine that weakens your immune system, like a steroid or cancer treatment.

The tuberculin skin test should not be given within 1 month to patients who have had live vaccines. These vaccines include measles, mumps, rubella, oral polio, yellow fever, and varicella.

In deciding to use a diagnostic test, you and your doctor need to consider any risks of the test against the benefits it will provide. Other factors may also affect test results. For this test, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also tell your healthcare professional about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies conducted so far have not shown any specific problems that would limit the use of tuberculin injection in children.

Geriatric

While studies on the effects of tuberculin injection in older adults have not been done, no specific problems related to age have been documented so far.

Breast Feeding

Research in women indicates that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might occur. In these situations, your doctor may adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this diagnostic test. Be sure to tell your doctor if you have any other medical issues, especially:

• Extensive skin burns or eczema (skin disease) or
• Tuberculosis, whether active or a past history—Should not be given to patients with these conditions.

• HIV infection or AIDS or
• History of organ transplant or
• Weak immune system—May increase your risk of developing active tuberculosis.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Incidence not known

• Bleeding at the injection site (occurring up to 3 days after the skin test)
• Blistering, crusting, or scabbing at the injection site
• Cough
• Deep, dark purple bruise at the injection site (occurring up to 3 days after the skin test)
• Difficult or labored breathing
• Dizziness
• Fainting
• Fast heartbeat
• Fever
• Hard lump at the injection site
• Hives
• Itching, pain, redness, or swelling at the injection site
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Noisy breathing
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Scar at the injection site
• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Pain, discomfort, or itching at the injection site
• Redness or rash at the injection site (occurring within 12 hours after skin test)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Aplisol
• Tubersol

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Tuberculin

A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is injected into the skin on your forearm.

Your skin may become red and swollen in the area where the medicine was given.

You must return to your doctor's office 2 or 3 days after receiving tuberculin. This is to check at the way your skin has reacted to the medicine.