Aplisol®

Frequently Asked Questions


Q: How is Aplisol® supplied?

Aplisol® is available in the following presentations:

  • NDC 42023-104-01: 1mL (10 tests) Multiple Dose Vial
  • NDC 42026-104-05: 5mL (50 tests) Multiple Dose Vial

Q: Does Aplisol® have special storage considerations?

A: Yes. Aplisol® should be stored at 2° - 8°C (36° - 46°F) and protected from light (do not freeze Aplisol®).

Q: Does Aplisol® need to be diluted?

A: No. Aplisol® is ready for immediate use without further dilution.

Q: What dose of Aplisol® is used in a tuberculin skin test?

A: Exactly 0.1 mL of Aplisol®, which is clinically bioequivalent to the standard PPD-S (5 TU/0.1 mL). It is the same dose for pediatric patients as well as adults.

Q: How long can I use an opened vial of Aplisol®?

A: Up to 30 days. Vials in use for more than 30 days should be discarded due to possible oxidation and degradation which may affect potency.

Q: Who can receive Aplisol®?

A: Most persons can receive Aplisol®. It is not contraindicated in infants, children, pregnant women, breastfeeding women, persons who are HIV-infected or persons who have been vaccinated with BCG.1

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.2

Q: What is a false-positive tuberculin skin test reaction?

A: A reaction to a tuberculin skin test classified as positive even though the person is not infected with Mycobacterium tuberculosis. Some of the causes include: infection with nontuberculosis mycobacteria, previous BCG vaccination, incorrect method of administration, incorrect interpretation of the reaction, incorrect bottle of antigen used.1

Q: What is a false-negative tuberculin skin test reaction?

A: A reaction that does not occur after a tuberculin skin test even though the person is infected with Mycobacterium tuberculosis. Some of the causes include: cutaneous anergy, recent TB infection (within 8-10 weeks of exposure), very old TB infection (many years), very young age (< 6 months old), recent live-virus vaccination, overwhelming TB disease, some viral illnesses, incorrect method of administration, incorrect interpretation of the reaction.1

Q: What is erythema? Do I include erythema in the interpretation of a tuberculin skin test reaction?

A: Erythema is redness of the skin. It can occur around the injection site after administration of a tuberculin skin test. The size of the erythema should not be included in the measurement for interpretation of a tuberculin skin test. Only an induration (palpable, raised and hardened area) should be measured for interpretation.1

1 CDC. TB elimination tuberculin skin testing http://www.cdc.gov/tb/publications/factsheets/testing/skintesting.pdf. October 2011. Accessed April 23, 2015.

2Aplisol [package insert]. Spring Valley, NY: Par Pharmaceutical Companies; 2014.

Important Safety Information

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 to tuberculin purified protein derivative (e.g., vesiculation, ulceration, or necrosis) because of the severity of reaction that may occur at the test site. Strongly positive test reactions may result in scarring at the test site. Immediate erythematous or other reactions may occur at the injection site. Systemic allergic reactions including anaphylaxis/anaphylactoid reactions have been reported to occur in association with the use of Aplisol®. Several factors, such as certain types of infections, corticosteroids and immunosuppressants, malnutrition, and other various disease states and conditions have been reported to alter the ability to respond to the tuberculin test. A review of the patient's history with respect to possible immediate type hypersensitivity to the product, determination of previous use of Aplisol®, the presence of any contraindication, as well as potential factors that may alter results should be thoroughly conducted.

View the full Prescribing Information for Aplisol®

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