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Tripedia

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Tripedia

Warnings
Precautions

WARNINGS

The stopper of the vial contains dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.

If any of the following events occurs in temporal relation with the receipt of either whole-cell pertussis DTP vaccine or a vaccine containing an acellular pertussis component, the decision to administer subsequent doses of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine or any vaccine containing a pertussis component should be based on careful consideration of potential benefits and possible risks.15,23

1. Temperature of ≥40.5°C (105°F) within 48 hours, not attributable to another identifiable cause.

2. Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.

3. Persistent crying lasting ≥3 hours within 48 hours.

4. Convulsions with or without fever, occurring within 3 days.

When a decision is made to withhold the pertussis component, immunization with DT vaccine should be continued.3

If Guillain-Barré syndrome occurs within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give subsequent doses of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.11

Because of the risk of hemorrhage, Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine should not be given to infants or children with any coagulation disorder, including thrombocytopenia, that would contraindicate intramuscular injection, or to those on anticoagulant therapy, unless the potential benefit clearly outweighs the risk of administration. If the decision is made to administer Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine in such infants or children, it should be given with caution, with steps taken to avoid the risk of bleeding and hematoma formation following injection.

A family history of seizures or other central nervous system disorders is not a contraindication to pertussis vaccine.3,11,15,23

For infants or children at higher risk for seizures than the general population, an appropriate antipyretic may be administered at the time of vaccination with a vaccine containing an acellular pertussis component (including Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine) and for the ensuing 24 hours according to the respective prescribing information recommended dosage to reduce the possibility of post-vaccination fever.11,15

A committee of the Institute of Medicine (IOM) has concluded that evidence is consistent with a causal relationship between whole-cell pertussis DTP vaccine and acute neurologic illness, and under special circumstances, between whole-cell pertussis DTP vaccine and chronic neurologic disease in the context of the National Childhood Encephalopathy Study (NCES) report.24,25 However, the IOM committee concluded that the evidence was insufficient to indicate whether or not whole-cell pertussis DTP vaccine increased the overall risk of chronic neurologic disease.25

The decision to administer a pertussis-containing vaccine to children with stable central nervous system disorders must be made by the physician on an individual basis, with consideration of all relevant factors, and assessment of potential risks and benefits for that individual. The Advisory Committee on Immunization Practices (ACIP) and the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) have issued guidelines for such children.15,22,23 The parent or guardian should be advised of the potential increased risk involved (see PRECAUTIONS, Information for Vaccine Recipients and Parents or Guardians section).

The ACIP has published guidelines for vaccination of persons with recent or acute illness.11

Except for reconstitution of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine with ActHIB vaccine for administration of the fourth dose to children 15-18 months of age, Tripedia vaccine should not be combined through reconstitution with any vaccine (see PRECAUTIONS section, Drug Interactions subsection).

PRECAUTIONS

General

Care is to be taken by the health-care provider for the safe and effective use of this vaccine.

EPINEPHRINE INJECTION (1: 1, 000), AND OTHER APPROPRIATE AGENTS AND EQUIPMENT MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE.

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. The physician should have a current knowledge of the literature concerning the use of the vaccine under consideration, including the nature of the adverse reactions that may follow its use. The patients medical history should be reviewed with respect to possible sensitivity and any previous adverse reactions to the vaccine or similar vaccines, possible sensitivity to dry natural latex rubber (see WARNINGS section), previous immunization history, and current health status (see CONTRAINDICATIONS section).

The expected immune response to Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine may not be obtained in immunosuppressed persons. Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is not contraindicated for use in individuals with HIV infection.11,26

Special care should be taken to ensure that the injection does not enter a blood vessel.

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of blood borne infectious agents from person to person. Needles should not be recapped but should be disposed of according to biohazard waste guidelines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility.

Pregnancy

Reproductive Studies Pregnancy Category C

Animal reproduction studies have not been conducted with Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine. It is not known whether Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is NOT indicated for women of child-bearing age.

Pediatric Use

SAFETY AND EFFECTIVENESS OF TRIPEDIA VACCINE IN INFANTS BELOW SIX WEEKS OF AGE HAVE NOT BEEN ESTABLISHED. (SEE DOSAGE AND ADMINISTRATION SECTION.)

THIS VACCINE IS NOT RECOMMENDED FOR PERSONS 7 YEARS OF AGE AND OLDER. Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) vaccine is to be used in individuals 7 years of age or older.

Geriatric Use

Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is NOT indicated for adults.

REFERENCES

3. Centers for Disease Control and Prevention (CDC). 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.

11. CDC. General recommendations on immunization: Recommendations of the ACIP and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2): 1-35.

15. CDC. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children. Recommendations of the ACIP. MMWR 1997;46(RR-7): 1-25.

22. American Academy of Pediatrics. In: Pickering LK, ed. 2000 Red Book: Report of the Committee of Infectious Diseases. 26th Ed. Elk Grove Village, IL: American Academy of Pediatrics 2003.

23. CDC. Update: vaccine side effects, adverse reactions, contraindications, and precautions. Recommendations of the ACIP. MMWR 1996;45 (RR-12): 1-35.

24. Institute of Medicine (IOM). Adverse effects of pertussis and rubella vaccines. Howson CP, et al, Editors. Washington: National Academy Press 1991;154-157.

25. IOM. DTP Vaccine and chronic nervous system dysfunction: a new analysis. National Academy Press, Washington, DC 1994;Supplement: 1-17.

26. CDC. Use of vaccines and immune globulins in persons with altered immunocompetence. Recommendations of the ACIP. MMWR 1993;42(RR-4).

Last reviewed on RxList: 6/8/2006
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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