July 30, 2016
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Tubersol

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Tubersol

Warnings
Precautions

WARNINGS

Hypersensitivity

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

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.

PRECAUTIONS

General

Diagnostic Limitations

False positive or false negative tuberculin skin test reactions may occur in some individuals. (See Interpretation of the Test)

False positive tuberculin reaction tests occur in individuals who have been infected with other mycobacteria, including vaccination with BCG.

Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test.

Many factors have been reported to cause a decreased ability to respond to the tuberculin test in the presence of tuberculous infection. (See Interpretation of the Test)

Carcinogenesis, Mutagenesis, Impairment Of Fertility

TUBERSOL has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility.

Pregnancy

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.

Nursing Mothers

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.

Pediatric Use

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)

Geriatric Use

Clinical studies of TUBERSOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

REFERENCES

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

Warnings
Precautions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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