DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

BCG Vaccine (Bacillus Calmette-Guerin) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

BCG VACCINE has not been evaluated for carcinogenic, mutagenic potentials or impairment of fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with BCG VACCINE. It is also not known whether BCG VACCINE can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Although no harmful effects to the fetus have been associated with BCG VACCINE, its use is not recommended during pregnancy.3

OVERDOSAGE

Accidental overdosages if treated immediately with anti-tuberculous drugs have not led to complications.22 If the vaccination response is allowed to progress it can still be treated successfully with anti-tuberculous drugs but complications can include regional adenitis, lupus vulgaris, subcutaneous cold abscesses, ocular lesions, and others.23

CONTRAINDICATIONS

BCG VACCINE for prevention of tuberculosis should not be given to persons (a) whose immunologic responses are impaired because of HIV infections, congenital immunodeficiency such as chronic granulomatous disease or interferon gamma receptor deficiency, leukemia, lymphoma, or generalized malignancy or (b) whose immunologic responses have been suppressed by steroids, alkylating agents, antimetabolites, or radiation.3 BCG VACCINE should not be administered to HIV-infected or immunocompromised infants, children, or adults.

Prior to administration, the possibility of allergic reactions should be assessed. Allergy to any component of BCG VACCINE or an anaphylactic or allergic reaction to a previous dose of BCG VACCINE are contraindications for vaccination.

BCG VACCINE is not a vaccine for the treatment of active tuberculosis.

BCG VACCINE should not be used in infants, children, or adults with severe immune deficiency syndromes. Children with a family history of immune deficiency disease should not be vaccinated; if they are, an infectious disease specialist should be consulted and anti-tuberculous therapy administered if clinically indicated.18

REFERENCES

  1. Guerin C: The history of BCG. In: Rosenthal SR (ed): BCG VACCINE: Tuberculosis-Cancer. Littleton, MA, PSG Publishing Co., Inc. 1980; pp. 35—43.
  2. Enarson, D, Murray, JF. Global Epidemiology of Tuberculosis. In: Rom, WN, Garay, SM (eds.); Tuberculosis. Boston, Little Brown and Company; 1996; pp. 57—76.
  3. Centers for Disease Control and Prevention. The Role of BCG VACCINE in the Prevention and Control of Tuberculosis in the United States. MMWR 45(RR-4):1—18, 1996.
  4. Centers for Disease Control and Prevention. Tuberculosis Morbidity — United States, 1998. MMWR 47(13):253—257.
  5. Moore M, Ornarato IM, McCray E, Castro KG. Trends in Drug-Resistant Tuberculosis in the United States, 1993—1996. JAMA 1997;278:833—837.
  6. Gordin FM, Matts JP, Miller C, Brown LS, Hafner R, John SL, et al: A Controlled Trial of Isoniazid in Persons with Anergy and Human Immunodeficiency Virus Infection Who are at High Risk for Tuberculosis. NEJM 1997;337:315—320.
  7. Comstock, GW. Field trials of tuberculosis vaccines: How could we have done better? Controlled Clinical Trials 1994;15:247—276.
  8. Colditz GA, Brewer TF, Berkey CS et al. Efficacy of BCG VACCINE in the prevention of tuberculosis. Metaanalysis of the published literature. JAMA 1994;271:698—709.
  9. Centers for Disease Control and Prevention. Use of BCG VACCINE in the Control of Tuberculosis. MMWR 43:663—675, 1988.
  10. Romanus V: Tuberculosis in bacillus Calmette-Guerin immunized and unimmunized children in Sweden: a ten-year evaluation following the cessation of general bacillus Calmette-Guerin immunization of the newborn in 1975. Pediatr Infect Dis 1987;6:272—280.
  11. Smith PG: Case-control studies of the efficacy of BCG against tuberculosis. In: International union against tuberculosis, Proceeding of the XXVIth IUAT World Conference on Tuberculosis and Respiratory Diseases, Singapore. Professional Postgraduate Services, International, Japan, 1987:73—79.
  12. Padungchan S, Konjanart S, Kasiratta S, et al: The effectiveness of BCG vaccination of the newborn against childhood tuberculosis in Bangkok. Bull WHO 1986;64:247—258.
  13. Tidjani O, Amedone A, ten Dam HG: The protective effect of BCG vaccination of the newborn against childhood tuberculosis in an African community. Tubercle 1986;67:269—281.
  14. Young TK, Hershfield ES: A case-control study to evaluate the effectiveness of mass neonatal BCG vaccination among Canadian Indians. Am J Public Health 1986;76:783—786.
  15. Shapiro C, Cook N, Evans D, et al.: A case-control study of BCG and childhood tuberculosis in Cali, Columbia. Int J Epidemiol 1985;14:441—446.
  16. Rosenthal SR, Loewinsohn E, Graham ML, Liveright D, Throne MG, Johnson V, Baston HC. BCG Vaccination Against Tuberculous in Chicago: a Twenty-year Study Statistically Analyzed. Pediatrics 1961;28:622—641.
  17. Data on file, Organon Teknika Corporation LLC, Durham, NC.
  18. Lorin MI, Hsu KHK, Jacob SC: Treatment of tuberculosis in children. In: Symposium on anti-infective therapy. Pediatric Clinics of North America 1983;30:333—348.
  19. Stone MM, Vannier AM, Storch SK, et al.: Brief report: meningitis due to iatrogenic BCG infection in two immunocompromised children. Lancet 1995;333:561—563.
  20. Centers for Disease Control and Prevention. Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities. MMWR 43:1—38, 1994.
  21. Report of the Committee on the Control of Infectious Diseases. American Academy of Pediatrics 1988; 21st Edition.
  22. Griffith AH: Ten cases of BCG overdose treated with isoniazid. Tubercle 1963;44:247—250.
  23. Watkins SM: Unusual complications of BCG vaccination. Brit Med J 1971;1:442.
  24. Lotte A, Wazs-Hockert O, Poisson N, Dumitrescu N, Verron M, Couvet E: BCG Complications. Adv Tuberc Res 1984;21:107—193.
  25. Mande R: BCG Vaccination. Dawson of Pall Mall, London, UK, 1968, pp. 112—265.

Manufactured for: Organon USA Inc.
Roseland, NJ 07068

Manufactured by: Organon Teknika Corporation LLC
100 Rodolphe Street
Building 1300
Durham, NC 27712

U.S. License No. 1747

TICE® is a registered trademark owned by the University of Illinois and licensed to Organon Teknika Corporation LLC.

RM122.6
Dec. 2006

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017