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Daptacel (Diphtheria Toxoid / Tetanus Toxoid / Acellular Pertussis Vaccine) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

As with other intramuscular (I.M.) injections, use with caution in patients on anticoagulant therapy.

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines. Although no specific studies with pertussis vaccine are available, if immunosuppressive therapy is to be soon discontinued, it seems reasonable to defer immunization until the patient has been off therapy for one month; otherwise, the patient should be vaccinated while still on therapy.4

If DAPTACEL® is administered to persons with an immunodeficiency disorder, on immunosuppressive therapy or after a recent injection of immune globulin, an adequate immunologic response may not occur.

For information regarding simultaneous administration with other vaccines refer to DOSAGE AND ADMINISTRATION.

If passive immunization is needed for tetanus or diphtheria prophylaxis, Tetanus Immune Globulin (Human) (TIG), or Diphtheria Antitoxin, if used, should be given in a separate site, with a separate needle and syringe.18

CONTRAINDICATIONS

This vaccine is contraindicated in children and adults seven years of age and older.

Hypersensitivity to any component of the vaccine is a contraindication to further administration. 5

The following events after receipt of DAPTACEL® are contraindications to further administration of any pertussis-containing vaccine:5

  • An immediate anaphylactic reaction. Because of uncertainty as to which component of the vaccine may be responsible, no further vaccination with diphtheria, tetanus or pertussis components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.
  • Encephalopathy not attributable to another identifiable cause (e.g., an acute, severe central nervous system disorder occurring within 7 days after vaccination and consisting of major alterations in consciousness, unresponsiveness or generalized or focal seizures that persist more than a few hours, without recovery within 24 hours). In such cases, DT vaccine should be administered for the remaining doses in the vaccination schedule.

The decision to administer or delay vaccination because of a current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. According to the ACIP, all vaccines can be administered to persons with mild illness such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness.17,18 However, children with moderate or serious illness should not be immunized until recovered. 4

Elective immunization procedures should be deferred during an outbreak of poliomyelitis because of the risk of provoking paralysis.19,20,21

REFERENCES

  1. Stainer DW, Scholte MJ. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1970;63:211-220.
  2. Stainer DW. Production of diphtheria toxin. In: Manclark CR, ed. Proceeding of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda, MD. DHHS Publication No. (FDA) 91-1174. 1991:7-11.
  3. Mueller JH, Miller PA. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67:271-277.
  4. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Diphtheria, Tetanus, and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR 1991;40(RR-10):1-28.
  5. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Pertussis vaccination: Use of acellular pertussis vaccines among infants and young children. MMWR 1997;46(RR-7):1-25.
  6. Plotkin SA, et al. Vaccines. 3rd ed. Philadelphia, W. B. Saunders Company. 1999:140-157,293-344,441-474.
  7. Centers for Disease Control and Prevention (CDC). Notice to readers: Final 2000 reports of notifiable diseases. MMWR 2001;50(33):1-10.
  8. Atkinson W, et al, editors. Epidemiology and Prevention of Vaccine-Preventable Diseases. 6th ed. Centers for Disease Control and Prevention (CDC); Public Health Foundation. 2000:51-72.
  9. American Public Health Association (APHA). Control of Communicable Diseases Manual. 2000;(17):166-167.
  10. Hardy IRB, et al. Current situation and control strategies for resurgence of diphtheria in newly independent states of the former Soviet Union. Lancet 1996;347:1739-1744.
  11. Bedson SP, et al. The prevention of whooping-cough by vaccination. A Medical Research Council Investigation. Br Med J 1951;1:1463-1471.
  12. Centers for Disease Control and Prevention (CDC). Pertussis-United States,1997-2000. MMWR 2002;51(4):1-92.
  13. Güris D, 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.
  14. Gustafsson L, et al. A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine. N Engl J Med 1996;6:349-355.
  15. Aventis Pasteur Limited: Data on File.
  16. Department of Health and Human Services, Food and Drug Administration. Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Proposed Rule. Federal Register 1985; 50(240):51002-51117.
  17. American Academy of Pediatrics. In: Pickering LK, ed. 2000 Red Book: Report on the Committee of Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics 2000:17,31-35,51-53,54,65,68,440-445,759-765.
  18. Recommendations of the Advisory Committee on Immunization Practices (ACIP). General recommendations on immunization. MMWR 1994;43(RR-1):1-38.
  19. Expanded programme on immunization, injection and paralytic poliomyelitis. Wkly Epidem Rec 1980;5:38-40.
  20. Sutter RW, et al. Attributable risk of DTP (diphtheria and tetanus toxoids and pertussis vaccine) injection in provoking paralytic poliomyelitis during a large outbreak in Oman. J Infect Dis 1992;165:444-449.
  21. Christie AB. Infectious diseases: Epidemiology and Clinical Practice. 4th ed. Edinburgh, Churchill Livingstone. 1987;2:817-825.
  22. Livengood JR, et al. Family history of convulsion and use of pertussis vaccine. J Pediatr 1989;115(4):527-531.
  23. Howson CP, et al. Adverse Effects of Pertussis and Rubella Vaccines, Pertussis Vaccines and CNS Disorders. Institute of Medicine (IOM). National Academy Press, Washington, DC, 1991:7-169.
  24. Institute of Medicine (IOM). DTP vaccine and chronic nervous system dysfunction: A new analysis. National Academy Press, Washington, DC, 1994;Supplement:1-17.
  25. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Update: Vaccine side effects, adverse reactions, contraindications, and precautions. MMWR 1996;45(RR-12):1-35.
  26. National Advisory Committee on Immunization (NACI): Canadian Immunization Guide, 5th ed. Minister of Public Works and Government Services Canada. 1998:9-13,133-139.
  27. Edwards KM, et al. Comparison of 13 acellular pertussis vaccines: Overview and serologic response. American Academy of Pediatrics 1995;Supplement:548-557.
  28. Decker MD, et al. Comparison of 13 acellular pertussis vaccines: Adverse reactions. Pediatr 1995;96:557-566.
  29. Halperin SA, et al. Adverse reactions and antibody response to four doses of acellular or whole-cell pertussis combined with diphtheria and tetanus toxoids in the first 19 months of life. Vaccine 1996;14(18):767-772.
  30. Halperin SA, et al. Safety and immunogenicity of two acellular pertussis vaccines with different pertussis toxoid and filamentous hemagglutinin content in infants 2-6 months old. Scand J Infect Dis 1995;27:279-287.
  31. Halperin SA, et al. Acellular pertussis vaccine as a booster dose for seventeen- to nineteen-month-old children immunized with either whole cell acellular pertussis vaccine at two, four and six months of age. Pediatr Infect Dis J 1995;14:792-797.
  32. Fawcett HA, Smith NP. Injection-site granuloma due to aluminum. Arch Dermatol 1984;120:1318-1322.
  33. Blumstein GI, et al. Peripheral neuropathy following tetanus toxoid administration. JAMA 1966;198(9):1030-1031.
  34. Institute of Medicine (U.S.). Adverse Effects of Pertussis and Rubella Vaccines. Howson CP, et al, editors. Washington: National Academy Press. 1991:154-157.
  35. Rutledge SL, et al. Neurological complications of immunizations. J Pediatr 1986;109:917-924.
  36. Walker AM, et al. Neurologic events following diphtheria-tetanus-pertussis immunization. Pediatr 1988;81: 345-349.
  37. Tsairis P, et al. Natural history of brachial plexus neuropathy. Arch Neurol 1972;27:109-117.
  38. Cody CL, et al. Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children. Pediatr 1981;68(5):650-660.
  39. Schlenska GK. Unusual neurological complications following tetanus toxoid administration. J Neurol 1977;215:299-302.
  40. Alderslade R, et al. The National Childhood Encephalopathy Study: a report on 1000 cases of serious neurological disorders in infants and young children from the NCES Research Team. In: Department of Health and Social Security. Whooping cough: reports from the Committee on the Safety of Medicines and the Joint Committee on Vaccination and Immunization. London: Her Majesty's Stationery Office 1981:79-169.
  41. Olin P, et al. Randomized controlled trial of two-component, three-component, and five-component acellular pertussis vaccines compared with whole-cell pertussis vaccine. Lancet 1997:1569-1577.
  42. Griffin MR, et al. Risk of sudden infant death syndrome after immunization with the diphtheria-tetanus-pertussis vaccine. N Engl J Med 1988:618-623.
  43. Hoffman HJ, et al. Diphtheria-tetanus-pertussis immunization and sudden infant death: Results of the National Institute of Child Health and Human Development cooperative epidemiological study of sudden infant death syndrome risk factors. Pediatr 1987;79(4):598-611.
  44. Miller D, et al. Pertussis Immunisation and Serious Acute Neurological Illnesses in Children. Academic Department of Public Health, St. Mary's Hospital Medical School, University of London, 1993.
  45. Jacob J, et al. Increased intracranial pressure after diphtheria, tetanus and pertussis immunization. Am J Dis Child 1979;133:217-218.
  46. Mathur R, et al. Bulging fontanel following triple vaccine. Indian Pediatr 1981;18(6):417-418.
  47. Shendurnikar N, et al. Bulging fontanel following DTP vaccine. Indian Pediatr 1986;23(11):960.
  48. Centers for Disease Control and Prevention (CDC). National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37(13):197-200.
  49. Center for Disease Control and Prevention (CDC). Vaccine Adverse Event Reporting System—United States. MMWR 1990;39:730-733.
  50. Pichichero MD, et al. Safety and immunogenicity of six acellular pertussis vaccines and one whole-cell pertussis vaccine given as a fifth dose in four six-year-old children. Pediatr 2000;105(1),e11:1-8.

Manufactured by:

Aventis Pasteur Limited

Toronto Ontario Canada

Distributed by:

Aventis Pasteur Inc.

Swiftwater PA 18370 USA

US Patents: 4500639, 4687738, 4784589, 4997915, 5444159, 5667787, 5877298.

Product information

as of January 2003.

R2-0103 USA

4825

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