TUBERSOL 5 [iU]/.1mL
Tuberculin Purified Protein Derivative · INJECTION, SOLUTION · A-S Medication Solutions
TUBERSOL is a injection, solution containing tuberculin purified protein derivative at 5 [iU]/.1mL, taken intradermal. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- TUBERSOL
- Generic Name
- Tuberculin Purified Protein Derivative
- NDC Code (Product)
50090-1668- Manufacturer
- A-S Medication Solutions
- Strength
- 5 [iU]/.1mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRADERMAL
- Marketing Status
- Application #
- BLA103941
- Drug Class
- Skin Test Antigen [EPC]; Tuberculosis Skin Test [EPC]
- Marketing Start
- 08/15/1956
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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. (8)
Dosage & Administration
DOSAGE AND ADMINISTRATION Dosage Five (5) 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 . If subcutaneous injection occurs, the test cannot be interpreted. Inspect for extraneous particulate matter and/or discoloration before use. If these conditions exist, do not administer the product. Use a separate syringe and needle for each injection. (12) The following procedure is recommended for performing the Mantoux test: The preferred site of the test is the volar aspect of the forearm. Avoid areas on the skin that are red or swollen. Avoid visible veins. Clean the skin site with a suitable germicide and allow the site to dry prior to injection of the antigen. Administer the test dose (0.1 mL) of TUBERSOL with a 1 mL syringe calibrated in tenths and fitted with a short, one-quarter to one-half inch, 26 or 27 gauge needle. Wipe the stopper of the vial with a suitable germicide and allow to dry before needle insertion. Then insert the needle gently through the stopper and draw 0.1 mL …
Warnings
WARNINGS Hypersensitivity Allergic reactions may occur following the use of TUBERSOL even in persons with no prior history of hypersensitivity to the product components. (10) 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.
Contraindications
CONTRAINDICATIONS 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, (9) Persons with extensive burns or eczema.
Drug Interactions
Drug Interactions Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents. (7) Reactivity to TUBERSOL may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). If a parenteral live attenuated virus vaccine has been administered recently, tuberculin testing should be delayed for >1 month after vaccination. (7)(11) (See Interpretation of the Test .) When tuberculin screening is required at the same time as a measles-containing vaccine or other parenteral live attenuated virus vaccine, simultaneous administration of TUBERSOL and the vaccine at separate sites is the preferred option.
Adverse Reactions
ADVERSE REACTIONS 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. Injection site erythema or injection site rash (without induration) occurring within 12 hours of testing. These reactions do not indicate TB infection. Injection site hemorrhage and injection site hematoma up to three days after the administration of the test. Injection site vesicles, injection site ulcer or injection site necrosis in highly sensitive persons. Injection site scar as a result of strongly positive reactions. Pyrexia Immune system disorders Hypersensitivity, including anaphylaxis/anaphylactic reactions, angioedema, urticaria Respiratory, thoracic, and mediastinal disorders Stridor, dyspnea Skin and subcutaneous tissue disorders Rash, generalized rash Nervous system disorders Presyncope, syncope (including syncope associated with tonic-clonic movements and othe…
Frequently Asked Questions
What is TUBERSOL used for?
TUBERSOL contains Tuberculin Purified Protein Derivative. It is a injection, solution taken intradermal. Consult your doctor for specific uses.
Is TUBERSOL a controlled substance?
TUBERSOL is not classified as a controlled substance by the DEA.
What is the generic name for TUBERSOL?
The generic name for TUBERSOL is Tuberculin Purified Protein Derivative. There are 9 other brand versions of Tuberculin Purified Protein Derivative.
What is the NDC code for TUBERSOL 5 [iU]/.1mL?
The NDC (National Drug Code) for TUBERSOL 5 [iU]/.1mL is 50090-1668, listed by A-S Medication Solutions.
Other TUBERSOL Dosages
Other Tuberculin Brands
See all →- Tuberculinum15 [hp_C]/15[hp_C]0220-7945
- Tuberculinum10 [hp_M]/10[hp_M]0220-7949
- Tuberculinum8 [hp_X]/10220-7935
- Tuberculinum1 [hp_M]/[hp_M]0220-7948
- Aplisol5 [iU]/.1mL42023-104
- Tuberculinum12 [hp_C]/12[hp_C]0220-7944
- Tuberculinum200 [kp_C]/200[kp_C]0220-7947
- APLISOL5 [iU]/.1mL50090-1336
- Tuberculinum30 [hp_C]/30[hp_C]0220-7946
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)