TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST).
From the U.S. FDA-approved label for Tuberculin, purified protein derivative (PPD). Full label: DailyMed.
TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST). Current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm. Previous BCG vaccination is not a contraindication to tuberculin testing. The skin-test results of BCG vaccinated persons can be used to support or exclude the diagnosis of TB infection. However, an FDA-approved interferon gamma release assay is preferred over tuberculin skin test for persons 5 years of age and older who were previously vaccinated with BCG.
From the U.S. FDA-approved label for Tuberculin, purified protein derivative (PPD). Full label: DailyMed.
Dosage Five tuberculin units (TU) per test dose of 0.1 mL is the standard strength used for intradermal (Mantoux) testing. Method of Administration TUBERSOL is indicated for intradermal injection only. Do not inject intravenously, intramuscularly, or subcutaneously.
Directions from the U.S. FDA-approved label — your doctor or pharmacist may advise differently.
Allergy to any component of TUBERSOL or an anaphylactic or other allergic reaction to a previous test of tuberculin PPD is a contraindication to the use of TUBERSOL. (See DESCRIPTION and HOW SUPPLIED.) TUBERSOL should not be administered to: Persons who have had a severe reaction (e.g., necrosis, blistering, anaphylactic shock, or ulcerations) to a previous TST, Persons with documented active tuberculosis or a clear history of treatment for TB infection or disease, Persons with extensive burns or eczema.
Excerpt from the U.S. FDA-approved label. Talk to a pharmacist or doctor before use.
Hypersensitivity Allergic reactions may occur following the use of TUBERSOL even in persons with no prior history of hypersensitivity to the product components. Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available. Syncope Syncope (fainting) can occur in association with administration of injectable medicines, including TUBERSOL. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
Warnings and precautions excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor before use.
Induration at the TUBERSOL injection site is the expected reaction for a positive skin test. (See Interpretation of the Test.) The information pertaining to adverse events has been compiled from historical clinical studies and post-marketing experience with TUBERSOL. General disorders and administration site conditions Injection site pain, injection site pruritus and injection site discomfort.
Excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor about side effects.
This page is information only and is not medical advice. Medicine details come from the sources listed above and may change — always confirm the medicine, strength and dose with a pharmacist or doctor before use. NLEM listing does not guarantee that a medicine is in stock at any pharmacy.
