Overview
DESCRIPTION Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative.
Mechanism of Action
CLINICAL PHARMACOLOGY In the United States, the prevalence of Mycobacterium tuberculosis infection and active disease varies for different segments of the population; however, the risk for M. tuberculosis infection in the overall population is low. Tuberculosis (TB) case rates declined steadily for decades in the United States. However, in 1985 the TB case rate stabilized and subsequently increased through 1992, accompanied by a 14% increase in the TB mortality rate in 1988. This has been attributed to several complex social and medical factors, including the human immunodeficiency virus (HIV) epidemic, the occurrence of TB in foreign-born persons from countries that have a high prevalence of TB, the emergence of drug-resistant strains of TB, and the transmission of M.
Indications
- INDICATIONS AND USAGE Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis . The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD. 7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.
Common Doses
- 0.1 mL
- 1.0 mL
- 15 mg
Dosage
DOSAGE AND ADMINISTRATION Aplisol vials should be inspected visually for both particulate matter and discoloration prior to administration and discarded if either is seen. Vials in use for more than 30 days should be discarded. The 0.1 mL dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 tuberculin units (TU) dose of Tuberculin PPD, which is the standard strength used for intradermal Mantoux testing. Standard Method (Mantoux Test) The Mantoux test is performed by intradermally injecting, on the volar aspect of the forearm, with a syringe and needle, exactly 0.1 mL of Aplisol.
Contraindications
- CONTRAINDICATIONS 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.
Side Effects
- ADVERSE REACTIONS In highly sensitive individuals, strongly positive reactions including vesiculation, ulceration or necrosis may occur at the test site. Cold packs or topical steroid preparations may be employed for symptomatic relief of the associated pain, pruritus and discomfort. Strongly positive test reactions may result in scarring at the test site. Immediate erythematous or other reactions may occur at the injection site. Local hypersensitivity reactions may occur at the injection site including erythema, pruritus, edema, urticaria and rash.
Interactions
- Drug Interactions In patients who are receiving corticosteroids or immunosuppressive agents, reactivity to the test may be depressed or suppressed. This reduced reactivity may be present for as long as 5–6 weeks after discontinuation of therapy (see PRECAUTIONS – General ). 9 The reactivity to PPD may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella).