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Pediarix (Diphtheria Toxoid / Tetanus Toxoid / Acellular Pertussis / Hepatitis B Recombinant Vaccine / Inactivated Poliovirus Vaccine) - Drug Interactions, Contraindications, Overdosage, etc

Pediarix Rx
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DRUG INTERACTIONS

PEDIARIX drug label information in our database does not contain a dedicated section on drug interactions. Please check subsections of WARNINGS AND PRECAUTIONS as well as other sources.

CONTRAINDICATIONS

Hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B, is a contraindication (see DESCRIPTION).

It is a contraindication to use this vaccine after a serious allergic reaction (e.g., anaphylaxis) temporally associated with a previous dose of this vaccine or with any components of this vaccine. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. 1

In addition, the following events are contraindications to administration of any pertussis-containing vaccine, including PEDIARIX: 10

  • Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause;
  • Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.

PEDIARIX is not contraindicated for use in individuals with HIV infection.10,37

REFERENCES

  1. Centers for Disease Control. Diphtheria, tetanus, and pertussis: Recommendations for vaccine use and other preventive measures -- Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28.
  2. Centers for Disease Control and Prevention. Diphtheria. In: Atkinson W and Wolfe C, eds. Epidemiology and prevention of vaccine-preventable diseases. 7th ed. Atlanta, GA: Public Health Foundation; 2002:39-48.
  3. Bisgard KM, Hardy I, Popovic T, et al. Respiratory diphtheria in the United States, 1980 through 1995. Am J Public Health 1998;88(5):787-791.
  4. Centers for Disease Control and Prevention. Toxigenic Corynebacterium diphtheriae -- Northern Plains Indian community, August-October 1996. MMWR 1997;46(22):506-510.
  5. Mortimer EA and Wharton M. Diphtheria Toxoid. In: Plotkin SA and Orenstein WA, eds. Vaccines. 3rd ed. Philadelphia, PA: W.B. Saunders Company; 1999:140-157.
  6. Centers for Disease Control and Prevention. Tetanus -- Puerto Rico, 2002. MMWR 2002;51(28):613-615.
  7. Centers for Disease Control and Prevention. Tetanus surveillance -- United States, 1995-1997. MMWR 1998;47(SS-2):1-13.
  8. Wassilak SGF, Orenstein WA, and Sutter RW. Tetanus Toxoid. In: Plotkin SA and Orenstein WA, eds. Vaccines. 3rd ed. Philadelphia, PA: W.B. Saunders Company; 1999:441-474.
  9. Department of Health and Human Services, Food and Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review; Proposed rule. Federal Register December 13, 1985;50(240):51002-51117.
  10. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.
  11. Long SS. Pertussis (Bordetella pertussis and B. parapertussis). In: Behrman RE, Kliegman RM, Jenson HB, eds. Nelson Textbook of Pediatrics. 16th ed. Philadelphia, PA: W.B. Saunders; 2000:838-842.
  12. Centers for Disease Control and Prevention. Pertussis -- United States, 1997-2000. MMWR 2002;51(4):73-76.
  13. Nennig ME, Shinefield HR, Edwards KM, et al. Prevalence and incidence of adult pertussis in an urban population. JAMA 1996;275(21):1672-1674.
  14. Güris D, Strebel PM, Bardenheier B, et al. Changing epidemiology of pertussis in the United States: Increasing reported incidence among adolescents and adults, 1990-1996. Clin Infect Dis 1999;28:1230-1237.
  15. Greco D, Salmaso S, Mastrantonio P, et al. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. N Engl J Med 1996;334(6):341-348.
  16. Schmitt H-J, von König CHW, Neiss A, et al. Efficacy of acellular pertussis vaccine in early childhood after household exposure. JAMA 1996;275(1):37-41.
  17. Salmaso S, Mastrantonio P, Tozzi AE, et al. Sustained efficacy during the first 6 years of life of 3-component acellular pertussis vaccines administered in infancy: The Italian experience. Pediatrics 2001;108(5):E81.
  18. Centers for Disease Control. Recommendations for protection against viral hepatitis: Recommendation of the Immunization Practices Advisory Committee (ACIP). MMWR 1985;34(22):313-324.
  19. Centers for Disease Control and Prevention. Hepatitis B. In: Atkinson W and Wolfe C, eds. Epidemiology and prevention of vaccine-preventable diseases. 7th ed. Atlanta, GA: Public Health Foundation; 2002:169-189.
  20. Lee WM. Hepatitis B virus infection. N Engl J Med 1997;337(24):1733-1745.
  21. Centers for Disease Control. Protection against viral hepatitis: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1990;39(RR-2):1-26.
  22. Ambrosch F, Frisch-Niggemeyer W, Kremsner P, et al. Persistence of vaccine-induced antibodies to hepatitis B surface antigen and the need for booster vaccination in adult subjects. Postgrad Med J 1987;63(Suppl. 2):129-135.
  23. Andre FE and Safary A. Clinical experience with a yeast-derived hepatitis B vaccine. In: Zuckerman AJ, ed. Viral hepatitis and liver disease. New York, NY: Alan R Liss, Inc.; 1988:1025-1030.
  24. Poovorawan Y, Sanpavat S, Pongpunlert W, et al. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers. JAMA 1989;261(22):3278-3281.
  25. Centers for Disease Control and Prevention. Proposed vaccine information materials for hepatitis B, Haemophilus influenza type B (Hib), varicella (chickenpox), and measles, mumps, rubella (MMR) vaccines. Federal Register September 3, 1998;63(171): 47026-47031.
  26. Chang MH, Chen CJ, Lai MS. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. N Engl J Med 1997;336:1855-1859.
  27. Lee MS, Kim DH, Kim H, et al. Hepatitis B vaccination and reduced risk of primary liver cancer among male adults: A cohort study in Korea. Int J Epidemiol 1998;27(2):316-319.
  28. Centers for Disease Control and Prevention. Poliomyelitis. In: Atkinson W and Wolfe C, eds. Epidemiology and prevention of vaccine-preventable diseases. 7th ed. Atlanta, GA: Public Health Foundation; 2002:71-82.
  29. Centers for Disease Control and Prevention. Poliomyelitis prevention in the United States: Introduction of a sequential vaccination schedule of inactivated poliovirus vaccine followed by oral poliovirus vaccine -- Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997;46(RR-3):1-25.
  30. Kim-Farley RJ, Bart KJ, Schonberger LP, et al. Poliomyelitis in the USA: Virtual elimination of disease caused by wild virus. Lancet 1984;2:1315-1317.
  31. Nathanson N, Martin JR. The epidemiology of poliomyelitis: Enigmas surrounding its appearance, epidemiology, and disappearance. Am J Epidemiol 1979;110(6):672-692.
  32. Centers for Disease Control and Prevention. Summary of notifiable diseases, United States, 2000. MMWR 2000;49(53):83.
  33. Centers for Disease Control and Prevention. Poliomyelitis prevention in the United States: Updated recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2000;49(RR-5):1-22.
  34. Sutter RW, Pallansch MA, Sawyer LA, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, Goldenthal KL, Burns DL, Lewis Jr BP, eds. Combined vaccines and simultaneous administration. Current issues and perspectives. New York, NY: The New York Academy of Sciences; 1995:289-299.
  35. Yeh SH, Ward JI, Partridge S, et al. Safety and immunogenicity of a pentavalent diphtheria, tetanus, pertussis, hepatitis B and polio combination vaccine in infants. Pediatr Infect Dis J 2001;20:973-980.
  36. Centers for Disease Control and Prevention. Recommended childhood immunization schedule -- United States, 2002. MMWR 2002;51(2):31-33.
  37. Centers for Disease Control and Prevention. Use of vaccines and immune globulins in persons with altered immunocompetence: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1993;42(RR-4):1-18.
  38. Centers for Disease Control and Prevention. Pertussis vaccination: Use of acellular pertussis vaccines among infants and young children -- Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1997;46(RR-7):1-25.
  39. Centers for Disease Control and Prevention. Update: Vaccine side effects, adverse reactions, contraindications, and precautions -- Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(RR-12):1-35.
  40. Institute of Medicine (IOM). Howson CP, Howe CJ, Fineberg HV, eds. Adverse effects of pertussis and rubella vaccines. Washington, DC: National Academy Press; 1991.
  41. Institute of Medicine (IOM). Stratton KR, Howe CJ, Johnston RB, eds. DPT vaccine and chronic nervous dysfunction: A new analysis. Washington, DC: National Academy Press; 1994.
  42. American Academy of Pediatrics. Pertussis. In: Pickering LK, ed. 2000 Red Book: Report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:442-448.
  43. Zepp F, Schuind A, Meyer C, et al. Safety and reactogenicity of a novel DTPa-HBV-IPV combined vaccine given along with commercial Hib vaccines in comparison with separate concomitant administration of DTPa, Hib, and OPV vaccines in infants. Pediatrics 2002;109(4):E58.
  44. Poets CF. Plötzlicher Säuglingstod. Neue Erkenntnisse. Pädiat prax 2001;60:285-292.
  45. Centers for Disease Control and Prevention. Sudden Infant Death Syndrome -- United States, 1983-94. MMWR 1996;45(40):859-863.
  46. Institute of Medicine (IOM). Stratton KR, Howe CJ, Johnston RB, eds. Adverse events associated with childhood vaccines. Evidence bearing on causality. Washington, DC: National Academy Press; 1994.
  47. Centers for Disease Control. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37(13):197-200.
  48. National Vaccine Injury Compensation Program: Vaccine injury table. www.hrsa.gov/osp/vicp/table.htm. Accessed April 29, 2002.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, US License 1617, and

Chiron Behring GmbH & Co

Marburg, Germany, US License 0097

Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709

PEDIARIX is a trademark and TIP-LOK, INFANRIX, and ENGERIX-B are registered trademarks of GlaxoSmithKline.

SAFETYGLIDE is a trademark of Becton, Dickinson and Company.

©2003, GlaxoSmithKline. All rights reserved.

August 2003/PE:L2

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