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Allergic reactions may occur following the use of TUBERSOL even in persons with no prior history of hypersensitivity to the product components. (11) Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available.
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.
Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
TUBERSOL has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility.
Pregnancy Category C
Animal reproduction studies have not been conducted with TUBERSOL. It is also not known whether TUBERSOL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TUBERSOL should be given to a pregnant woman only if clearly needed.
It is not known whether TUBERSOL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TUBERSOL is administered to a nursing woman.
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. (13) (See Interpretation of the Test)
Clinical studies of TUBERSOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
8 American Thoracic Society: Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Crit Care Med 2000;161:1376-1395.
11 Froeschle JE, et al. Immediate hypersensitivity reactions after use of tuberculin skin testing. Clin Infect Dis 2002;34:e12-13.
12 Brickman HF, et al. The timing of tuberculin tests in relation to immunization with live viral vaccines. Pediatrics: 1975;55:392-396.
13 Huebner RE, et al. Tuberculosis commentary: the tuberculin skin test. Clin Infect Dis 1993;17:968-75.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/5/2016
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