"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Avoid injecting TUBERSOL (tuberculin purified protein) ® subcutaneously.If this occurs, no local reaction will develop and the test cannot be interpreted.
Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test. A large number of factors has been reported to cause a decreased ability to respond to the tuberculin test in the presence of tuberculous infection including viral infections (measles, mumps, chickenpox and HIV), live virus vaccinations (measles, mumps, rubella, oral polio and yellow fever), overwhelming tuberculosis, other bacterial infections, drugs (corticosteroids and many other immunosuppressive agents), and malignancy.11,12
Anything that impairs or attenuates cell mediated immunity (CMI) potentially can cause a false negative tuberculin reaction (viral infections, particularly HIV, live virus vaccines, severe protein malnutrition, lymphoma, leukemia, sarcoidosis, use of glucocorticosteroids and other immunosuppressant drugs).
Because in HIV-infected individuals, tuberculin skin-test results are less reliable as CD4 counts decline, screening should be completed as early as possible after HIV-infection occurs. Those HIV-infected patients at high risk for continuing exposure to patients who have TB should be screened periodically for TB infection.If they have TB symptoms or if they are exposed to a patient who has pulmonary TB, HIV-infected persons should be evaluated promptly for TB. Because active disease can develop rapidly in HIV-infected persons, the highest priority for contact investigation should be given to persons potentially coinfected with HIV and TB.13
TUBERSOL (tuberculin purified protein) ® should be administered with caution, or not at all, in persons with documented active tuberculosis or documented treatment in the past because of the severity of reactions (e.g. vesiculation, ulceration or necrosis) that may occur at the test site.
Effective use of tuberculin testing requires an understanding of the characteristics inherent to the test and extrinsic factors relating that have influence on interpertation of the results. The utility of the tuberculin test depends on the prevalance of infection with M. tuberculosis and the relative prevalence of cross-reaction with nontuberculous mycobacteria.16,19
A separate, sterilesyringe and needle, or a sterile disposable unit, must be used for each patient to prevent the transmission of infectious agents from one person to another. There have been case reports of transmission of HIV and hepatitis by failure to scrupulously observe sterile technique. In particular, the same needle must never be used to re-enter a multidose vial even when it is to be used on the same patient. This may lead to the contamination of the vial contents and infection of patients who subsequently receive product from the vial.20
Special care should be taken to ensure the product is given intradermally and on the volar aspect of the forearm. Do not administer intravenously, intramuscularly or subcutaneously.
Needles should not be recapped and should be disposed of according to applicable biohazard waste guidelines.
Epinephrine Hydrochloride Solution (1:1,000) and other appropriate agents should be readily available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Before using this product, all appropriate precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible hypersensitivity to the product, determination of previous use of Tuberculin Purified Protein Derivative (Mantoux) - TUBERSOL (tuberculin purified protein) ®, and the presence of any contraindications to the test.
Failure to store and handle TUBERSOL (tuberculin purified protein) ® as recommended will result in a loss of potency and potentially inaccurate test results.21,22,23
Reactivity to the test may be depressed or suppressed for as long as 5 to 6 weeks in individuals who have received recent immunization with certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella), who have had viral infections (rubeola, influenza, mumps and probably others)11,12 or who are receiving corticosteroids or immunosuppressive agents.
Tuberculin reactivity may indicate prior infection and/or disease with M. tuberculosis and does not necessarily indicate the presence of active tuberculous disease. Individuals showing tuberculin reactions considered positive by current public health guidelines should be evaluated by other diagnostic procedures, such as x-ray examination of the chest and microbiological examination of the sputum.13
Carcinogenesis, Mutagenesis, Impairment of Fertility
TUBERSOL (tuberculin purified protein) ® has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility.
The product should not be used for extended treatment over a long period of time.
Pregnancy Category C (Tuberculin)
Animal reproduction studies have not been conducted with TUBERSOL (tuberculin purified protein) ®. However, the Advisory Council for Elimination of Tuberculosis states: Tuberculin skin testing is considered valid and safe throughout pregnancy. No teratogenic effects of testing during pregnancy have been documented.13
The risk of unrecognized tuberculosis and the close post partum contact between a mother with active disease and an infant leaves the infant in grave danger of tuberculosis and complications such as tuberculous meningitis. Therefore, the prescribing physician should consider if the potential benefits outweigh the possible risks for performing the tuberculin test on a pregnant woman or a woman of childbearing age, particularly in certain high risk populations.13,26
There is no age contraindication to tuberculin skin testing of infants. Because their immune systems are immature, many infants < 6 weeks of age who are infected with M. tuberculosis do not react to tuberculin tests. Older infants and children develop tuberculin sensitivity 6 weeks or more after initial infection. Very young children are at increased risk for active tuberculosis once infected; therefore, during contact investigations, priority with regard to skin testing and evaluation for preventive therapy should be given to infants and young children who have been exposed to persons with active tuberculosis. These children should receive preventive therapy if their reactions to a tuberculin skin test measure ≥ 5 mm.A cutoff of 10 mm is appropriate for children where tuberculosis case rates are high. A cutoff of 15 mm is used for children with minimal risk exposure to tuberculosis.16
11. Mori and Shiozawa.Suppression of tuberculin hypersensitivity caused by rubella infection.Am Rev Respir Dis 1985;886-890.
12. Brickman HF,et al.The timing of tuberculin tests in relation to immunization with live viral vaccines. Pediatrics:1975;55:392-396.
13. Screening for tuberculosis and tuberculosis infection in high-risk populations. Recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR 1995;44,RR-11.
16. The tuberculin skin test.Clin Infect Dis 1993;17:968-975.
19. CDC Core Curriculum on Tuberculosis, Third Edition, 1994.
20. Plott RT, et al. Iatrogenic contamination of multidose vials in simulated use. Arch Dermatol 1990;126:1441-1444.
21. Landi S, et al.Stability of dilute solution of tuberculin purified protein derivative at extreme temperatures. J Biol Stand 1981;9:195-199.
22. Landi S, et al.Effect of light on tuberculin purified protein derivative solutions. Am Rev Respir Dis 1975; 111:52-61.
23. Landi S, et al.Effect of oxidation on the stability of tuberculin purified protein derivative (PPD) In: International Symposium on Tuberculins and BCG Vaccine. Basel: International Association of Biological Standardization,1983.Dev Biol Stand 1986; 58:545-552.
24. APIC Guidelines Committee. APIC position paper: responsibility for interpretation of the PPD tuberculin skin test. Am J Infect Control 1999;27:56-58.
26. Tuberculosis among pregnant women-New York City, 1985-1992. MMWR 1993;42:605. 27. Data on file; Aventis Pasteur Inc.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/30/2009
Additional Tubersol Information
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