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Tuberculin Purified Protein Derivative
Overview
What is Aplisol?
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.
This product is ready for immediate use without further dilution.
The purified protein fraction is isolated from culture media filtrates of a human strain of
by the method of F.B. Seibert.
Tuberculin PPD, diluted, is prepared from Tuberculin PPD which is clinically bioequivalent in potency to the standard PPD-S
(5 TU
per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control.
The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs.
What does Aplisol look like?
What are the available doses of Aplisol?
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What should I talk to my health care provider before I take Aplisol?
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How should I use Aplisol?
Tuberculin PPD is indicated as an aid in the detection of infection with
. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.
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
infections.
HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.
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.
What interacts with Aplisol?
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.
What are the warnings of Aplisol?
Itraconazole Capsules and Itraconazole Oral Solution should not be used interchangeably. This is because drug exposure is greater with the Oral Solution than with the Capsules when the same dose of drug is given. In addition, the topical effects of mucosal exposure may be different between the two formulations. Only the Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis.
Aplisol should not be administered to persons who previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site (see
).
Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test. A number of factors have been reported to cause a decreased ability to respond to the tuberculin test, such as the presence of infections, viral infections (measles, mumps, chickenpox, HIV), live virus vaccinations (measles, mumps, rubella and other live vaccines), bacterial infections (typhoid fever, brucellosis, typhus, leprosy, pertussis, overwhelming tuberculosis, tuberculous pleurisy), fungal infections (South American blastomycosis), drugs (corticosteroids and other immunosuppressive agents), metabolic derangements (chronic renal failure), low protein states (severe protein depletion, afibrinogenemia), age (newborns, elderly patients with waned sensitivity), stress (surgery, burns, mental illness, graft-versus-host reactions), diseases affecting lymphoid organs (Hodgkin's disease, lymphoma, chronic leukemia, sarcoidosis), and malignancy.
Any condition that impairs or attenuates cell mediated immunity potentially can cause a false negative reaction, including aging.
Tuberculin skin test results are less reliable in HIV-infected individuals as CD4 counts decline (see
).
Avoid injecting tuberculin subcutaneously. If this occurs, no local reaction develops, but a general febrile reaction and/or acute inflammation around old tuberculous lesions may occur in highly sensitive individuals.
What are the precautions of Aplisol?
General
The predictive value of the tuberculin skin test depends on the prevalence of infection with
and the relative prevalence of cross-reactions with nontuberculous mycobacteria.
A separate, sterile, single-use disposable syringe and needle should be used for each individual patient to prevent possible transmission of serum hepatitis virus and other infectious agents from one person to another. Special care should be taken to ensure that the product is injected intradermally and not into a blood vessel.
Before administration of Aplisol, a review of the patient's history with respect to possible immediate-type hypersensitivity to the product, determination of previous use of Aplisol and the presence of any contraindication to the test should be made (see
).
As with any biological product, epinephrine should be immediately available in case an anaphylactoid or acute hypersensitivity reaction occurs.
Failure to store and handle Aplisol as recommended may result in a loss of potency and inaccurate test results.
Reactivity to the test may be depressed or suppressed for as long as 5–6 weeks in individuals following immunization with certain live viral vaccines, viral infections or discontinuation of corticosteroids or immunosuppressive agents.
Information to Patients
Patients should be instructed to report adverse events such as vesiculation, ulceration or necrosis which may occur at the test site in highly sensitive individuals. Patients should be informed that pain, pruritus and discomfort may occur at injection site.
Patients should be informed of the need to return to their physician or health care provider for the reading of the test and of the need to keep and maintain a personal immunization record.
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
).
The reactivity to PPD may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). Therefore, if a tuberculin test is to be performed, it should be administered either before the live vaccine or given simultaneously, but at a separate site than the live vaccine, or testing should be postponed for 4–6 weeks.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term studies have been conducted in animals or in humans to evaluate carcinogenic or mutagenic potential or effects on fertility with Aplisol.
Pregnancy
Geriatric Use
Once acquired, tuberculin sensitivity tends to persist, although it often wanes with time and advancing age. In geriatric patients or in patients receiving a tuberculin skin test for the first time, the reaction may develop more slowly and may not be maximal until after 72 hours.
(see
). Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test. A number of factors have been reported to cause a decreased ability to respond to the tuberculin test, such as elderly patients with waned sensitivity.
Any condition that impairs or attenuates cell mediated immunity potentially can cause a false negative reaction, including aging
(see
). An induration of >10 mm is classified as positive in all persons who do not meet any of the criteria listed under an induration of >5 mm, but who belong to one or more of the following groups at high risk for TB, including residents and employees of high risk congregate settings, such as nursing homes and other long-term facilities for the elderly.
The negative tuberculin skin test should never be used to exclude the possibility of active tuberculosis among person for whom the diagnosis is being considered (symptoms compatible with tuberculosis) (see
).
Pediatric Use
Because their immune systems are immature, many neonates and infants <6 weeks of age, who are infected with
, may not have a delayed hypersensitivity reaction to a tuberculin test (see
). Older infants and children develop tuberculin sensitivity 3-6 weeks, and up to 3 months, after initial infection.
Infants and children who have been exposed to persons with active tuberculosis should be considered positive when reaction to the tuberculin skin test measures ≥ 5 mm. Those children younger than 4 years of age who are exposed to persons at increased risk to acquire tuberculosis are considered positive when reaction measures ≥10 mm. Children with minimal risk exposure to tuberculosis would be considered positive when reaction measures ≥15 mm.
Other criteria for positive tuberculin reactions that are applicable to both pediatric and adult patients are provided in
.
What are the side effects of Aplisol?
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.
Systemic allergic reactions including anaphylaxis/anaphylactoid reactions have been reported to occur in association with the use of Aplisol. The reactions, including anaphylaxis, generally occurred within 24 hours of exposure and manifestations included rash, urticaria, edema/angioedema and pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-888-INFO-FDA (1-888-463-6332) or www.fda.gov/medwatch/.
What should I look out for while using Aplisol?
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.
Aplisol should not be administered to persons who previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site (see
).
Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test. A number of factors have been reported to cause a decreased ability to respond to the tuberculin test, such as the presence of infections, viral infections (measles, mumps, chickenpox, HIV), live virus vaccinations (measles, mumps, rubella and other live vaccines), bacterial infections (typhoid fever, brucellosis, typhus, leprosy, pertussis, overwhelming tuberculosis, tuberculous pleurisy), fungal infections (South American blastomycosis), drugs (corticosteroids and other immunosuppressive agents), metabolic derangements (chronic renal failure), low protein states (severe protein depletion, afibrinogenemia), age (newborns, elderly patients with waned sensitivity), stress (surgery, burns, mental illness, graft-versus-host reactions), diseases affecting lymphoid organs (Hodgkin's disease, lymphoma, chronic leukemia, sarcoidosis), and malignancy.
Any condition that impairs or attenuates cell mediated immunity potentially can cause a false negative reaction, including aging.
Tuberculin skin test results are less reliable in HIV-infected individuals as CD4 counts decline (see
).
Avoid injecting tuberculin subcutaneously. If this occurs, no local reaction develops, but a general febrile reaction and/or acute inflammation around old tuberculous lesions may occur in highly sensitive individuals.
What might happen if I take too much Aplisol?
Sorry No Records found
How should I store and handle Aplisol?
Store in a refrigerator 2° to 8°C (36° to 46°F).Tuberculin PPD-Aplisol bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is available in the following presentations: 1 mL (10 tests) – multiple dose vial 5 mL (50 tests) – multiple dose vialThis product is ready for use without further dilution.Tuberculin PPD-Aplisol bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is available in the following presentations: 1 mL (10 tests) – multiple dose vial 5 mL (50 tests) – multiple dose vialThis product is ready for use without further dilution.Tuberculin PPD-Aplisol bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is available in the following presentations: 1 mL (10 tests) – multiple dose vial 5 mL (50 tests) – multiple dose vialThis product is ready for use without further dilution.Tuberculin PPD-Aplisol bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is available in the following presentations: 1 mL (10 tests) – multiple dose vial 5 mL (50 tests) – multiple dose vialThis product is ready for use without further dilution.Tuberculin PPD-Aplisol bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is available in the following presentations: 1 mL (10 tests) – multiple dose vial 5 mL (50 tests) – multiple dose vialThis product is ready for use without further dilution.Tuberculin PPD-Aplisol bioequivalent to 5 US units (TU) PPD-S per test dose (0.1 mL) is available in the following presentations: 1 mL (10 tests) – multiple dose vial 5 mL (50 tests) – multiple dose vialThis product is ready for use without further dilution.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
In the United States, the prevalence of
infection and active disease varies for different segments of the population; however, the risk for
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
in congregate settings (e.g., health-care facilities, correctional facilities, drug-treatment centers, and homeless shelters). Because the overall risk of acquiring
is low for the total U.S. population, the primary strategy for preventing and controlling TB in the United States is to minimize the risk of transmission by the early identification and treatment of patients who have active infectious TB, finding and screening persons who have been in contact with active infectious TB patients and screening high risk populations.
Tuberculin PPD is indicated as an aid in the detection of infection with
.
After a person becomes infected with mycobacteria, T lymphocytes proliferate and become sensitized. These sensitized T cells enter the bloodstream and circulate for months or years. This sensitization process occurs principally in the regional lymph nodes and may take 2–10 weeks to develop following infection. Once acquired, tuberculin sensitivity tends to persist, although it often wanes with time and advancing age. The injection of tuberculin into the skin stimulates the lymphocytes and activates the series of events leading to a delayed-type hypersensitivity (DTH) response. This response is called "delayed" because the reaction becomes evident hours after injection. Dermal reactivity involves vasodilation, edema, and the infiltration of lymphocytes, basophils, monocytes, and neutrophils into the site of antigen injection. Antigen-specific T lymphocytes proliferate and release lymphokines, which mediate the accumulation of other cells at the site. The area of induration reflects DTH activity.
In most tuberculin-sensitive individuals, the delayed hypersensitivity reaction is evident 5–6 hours after administration of a tuberculin skin test and is maximal 48–72 hours. In geriatric patients or in patients receiving a tuberculin skin test for the first time, the reaction may develop more slowly and may not be maximal until after 72 hours.
Because their immune systems are immature, many neonates and infants <6 weeks of age, who are infected with
, do not react at all to tuberculin tests.
Immediate erythematous or other hypersensitivity reactions to tuberculin or the constituents of the diluent may occur at the injection site.
A possible decrease in responsiveness to skin testing may occur in the presence of infections, viral infections (measles, mumps, chickenpox, HIV), live virus vaccinations (measles, mumps, rubella, oral polio, varicella, yellow fever), bacterial infections (typhoid fever, brucellosis, typhus, leprosy, pertussis, overwhelming tuberculosis, tuberculous pleurisy), fungal infections (South American blastomycosis), drugs (corticosteroids and other immunosuppressive agents), metabolic derangements (chronic renal failure), low protein states (severe protein depletion, afibrinogenemia), age (newborns, elderly patients with waned sensitivity), stress (surgery, burns, mental illness, graft-versus-host reactions), diseases affecting lymphoid organs (Hodgkin's disease, lymphoma, chronic leukemia, sarcoidosis) and malignancy (see
).
Tuberculin skin-test results are also less reliable as CD4 counts decline in HIV infected individuals.
The 5TU dose of Tuberculin PPD intradermally (Mantoux) is indicated as an aid in the detection of infection with
. Reactions to the Mantoux test are interpreted on the basis of a quantitative measurement of the response to a specific dose (5 TU PPD-S or equivalent) of Tuberculin PPD.
To determine that the Tuberculin PPD is clinically bioequivalent in potency to standard 5TU PPD-S
, 3 dose-response studies were conducted in the following populations (1) persons with a history of bacteriologically confirmed TB; (2) healthy volunteers; and (3) volunteers with active or previously active nontuberculosis mycobacterial lung disease.
Non-Clinical Toxicology
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.Aplisol should not be administered to persons who previously experienced a severe reaction (e.g., vesiculation, ulceration, or necrosis) because of the severity of reactions that may occur at the test site (see ).
Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test. A number of factors have been reported to cause a decreased ability to respond to the tuberculin test, such as the presence of infections, viral infections (measles, mumps, chickenpox, HIV), live virus vaccinations (measles, mumps, rubella and other live vaccines), bacterial infections (typhoid fever, brucellosis, typhus, leprosy, pertussis, overwhelming tuberculosis, tuberculous pleurisy), fungal infections (South American blastomycosis), drugs (corticosteroids and other immunosuppressive agents), metabolic derangements (chronic renal failure), low protein states (severe protein depletion, afibrinogenemia), age (newborns, elderly patients with waned sensitivity), stress (surgery, burns, mental illness, graft-versus-host reactions), diseases affecting lymphoid organs (Hodgkin's disease, lymphoma, chronic leukemia, sarcoidosis), and malignancy.
Any condition that impairs or attenuates cell mediated immunity potentially can cause a false negative reaction, including aging.
Tuberculin skin test results are less reliable in HIV-infected individuals as CD4 counts decline (see ).
Avoid injecting tuberculin subcutaneously. If this occurs, no local reaction develops, but a general febrile reaction and/or acute inflammation around old tuberculous lesions may occur in highly sensitive individuals.
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 ).
The reactivity to PPD may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). Therefore, if a tuberculin test is to be performed, it should be administered either before the live vaccine or given simultaneously, but at a separate site than the live vaccine, or testing should be postponed for 4–6 weeks.
The predictive value of the tuberculin skin test depends on the prevalence of infection with and the relative prevalence of cross-reactions with nontuberculous mycobacteria.
A separate, sterile, single-use disposable syringe and needle should be used for each individual patient to prevent possible transmission of serum hepatitis virus and other infectious agents from one person to another. Special care should be taken to ensure that the product is injected intradermally and not into a blood vessel.
Before administration of Aplisol, a review of the patient's history with respect to possible immediate-type hypersensitivity to the product, determination of previous use of Aplisol and the presence of any contraindication to the test should be made (see ).
As with any biological product, epinephrine should be immediately available in case an anaphylactoid or acute hypersensitivity reaction occurs.
Failure to store and handle Aplisol as recommended may result in a loss of potency and inaccurate test results.
Reactivity to the test may be depressed or suppressed for as long as 5–6 weeks in individuals following immunization with certain live viral vaccines, viral infections or discontinuation of corticosteroids or immunosuppressive agents.
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.
Systemic allergic reactions including anaphylaxis/anaphylactoid reactions have been reported to occur in association with the use of Aplisol. The reactions, including anaphylaxis, generally occurred within 24 hours of exposure and manifestations included rash, urticaria, edema/angioedema and pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-888-INFO-FDA (1-888-463-6332) or www.fda.gov/medwatch/.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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