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Aplisol (Tuberculin) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

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

Teratogenic effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Aplisol. It is also not known whether Aplisol can cause fetal harm when administered to a pregnant woman or can affect the reproduction capacity. Aplisol should be given to a pregnant woman only if clearly needed. However, the risk of unrecognized tuberculosis and the postpartum contact between a mother with active disease and an infant leaves the infant in grave danger of tuberculosis and complications such as tuberculous meningitis. Although there have not been any reported adverse effects upon the fetus recognized as being due to tuberculosis skin testing, the prescribing physician will want to 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.

Tuberculin skin testing is considered valid and safe throughout pregnancy.3

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.

REFERENCES

  • 1Seibert, F.B. The isolation and properties of the purified protein derivative of tuberculin: Am Rev Tuberc 1934; 30:713.
  • 2Seibert, F.B., and Glenn, J.T. Tuberculin purified protein derivative. Preparation and analyses of a large quantity for standard. Am Rev Tuberc 1941; 44:9-25.
  • 3Centers for Disease Control and Prevention (CDC). Essential components of a tuberculosis prevention and control program; and 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):1-34.
  • 4Centers for Disease Control and Prevention (CDC). Prevention and control of tuberculosis in correctional facilities: recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR 1996;45(RR-8):1-27.
  • 5Huebner RE, Shein MF, Bass JB. The Tuberculin Skin Test. Clin Infect Dis 1993;17:968–75.
  • 6AHFS Drug Information, 1997, 36:84 pp 1962–1968.
  • 7American Thoracic Society: Diagnostic Standards and classification of tuberculosis in Adults and Children. Am J Respir Crit Care Med 2000 Apr; 161:1376-95.
  • 8Am Rev Respir Dis 1985;886.
  • 9Brickman HF et.Al. The Timing of Tuberculin Tests in Relation to Immunization with Live Viral Vaccines. Pediatrics 1975;55:392.
  • 10Nakayama K, Monma M, Fukushima T, Ohrui T, Sasaki H. Tuberculin responses and risk of pneumonia in immobile elderly patients. Thorax 2000 Oct;55(10):867-9.
  • 11Fukushima T, Nakayama K, Monma M, Sekizawa K, Sasaki H. Depression of T helper-1 and the tuberculin responses in older bed-bound patients. J Am Geriatri Soc 1999 Feb;47(2):259-260.
  • 12American Academy of Pediatrics. Tuberculosis. In: Pickering LK, CJ Baker, Long SS, McMillan JA, eds. Red Book: 2006 Report of the Committee on Infectious Diseases, 27th ed. Elk Grove Village, IL: American Academy of Pediatrics 2006: 678-698.
  • 13Landi S, Held HR. Stability of a dilute solution of tuberculin purified derivative at extreme temperatures. J Biol Stand 1981; 9:195.
  • 14Centers For Disease Control and Prevention (CDC). Diagnosis of TB Infection and TB Disease, March 21,1996, Doc# 2250102.
  • 15Sewell, E.M., O'Hare, D., and Kendig, E.L., Jr. The Tuberculin Test. Pediatrics Vol. 54, No. 5, Nov.1974.
  • 16Centers for Disease Control and Prevention(CDC). Prevention and control of tuberculosis in facilities providing long-term care to the elderly. Recommendations of the Advisory Committee of Elimination of Tuberculosis (ACET): MMWR 1990, 39(RR-10): 7–20.
  • 17Centers for Disease Control and Prevention(CDC). The use of preventative therapy for tuberculosis infection in the United States, Recommendations of the Advisory Committee of Elimination of Tuberculosis (ACET), MMWR 1990 39(RR-8):9–12.
  • 18Centers for Disease Control and Prevention(CDC). Screening for tuberculosis and tuberculosis infection in high risk populations. Recommendations of the Advisory Committee of Elimination of Tuberculosis (ACET), MMWR 1990, 39(RR-8): 1-7.
  • 19Centers for Disease Control and Prevention (CDC). Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection. MMWR, 2000. 49(RR-6): 1-51.
  • 20Pediatrics: Screening for Tuberculosis in Infants and Children, 1994. 93: 131-134.
  • 21Centers for Disease Control and Prevention (CDC). Controlling Tuberculosis in the United States. MMWR 2005. 54 (RR-12).

Rx only.

Prescribing Information as of Nov 2008.

Manufactured and Distributed by:
JHP Pharmaceuticals, LLC
Rochester, MI 48307

3003008

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