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Diptheria and Tetanus

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Diphtheria and Tetanus

Warnings
Precautions

WARNINGS

This product contains dry natural latex rubber as follows: The stopper to the vial contains dry natural latex rubber.

Persons who experienced Arthus-type hypersensitivity reactions or a temperature of > 103°F (> 39.4°C) following a prior dose of tetanus toxoid usually have high serum tetanus antitoxin levels and should not be given even emergency doses of Td more frequently than every 10 years, even if they have a wound that is neither clean nor minor.2

Intramuscular injections should be given with great care in patients suffering from thrombocytopenia or other coagulation disorders.2

This vaccine is not to be administered to persons 7 years of age and older, since adverse reactions to the quantity of diphtheria toxoid contained in DT may be more severe in this age group than in young children.

Deaths have been reported in temporal association with the administration of DT vaccine; however, no causal relationship was proven9 (see ADVERSE REACTIONS section).

PRECAUTIONS

GENERAL

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

EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE.

There is an increased incidence of local and systemic reactions to booster doses of tetanus toxoid when given to previously immunized persons.(Refer to DOSAGE AND ADMINISTRATION section for timing of recall injections.) Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This should include a review of the patient's history with respect to possible sensitivity and any previous adverse reactions (see CONTRAINDICATIONS section) to the vaccine or similar vaccines and to possible sensitivity to dry natural latex rubber, and a current knowledge of the literature concerning the use of the vaccine under consideration.

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

Immunosuppressive therapies including radiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic drugs may reduce the immune response to vaccines. Therefore, routine vaccination should be deferred, if possible, while patients are receiving such therapy.2 If DT has been administered to persons receiving immunosuppressive therapy, or having an immunodeficiency disorder, an adequate antibody response may not be obtained.2 When possible, immunosuppressive treatment should be interrupted when immunization is required due to a tetanus-prone wound.

Administration of DT is not contraindicated in individuals with HIV infection.10

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

CARCINOGENESIS,MUTAGENESIS,IMPAIRMENT OF FERTILITY

No studies have been performed to evaluate carcinogenicity, mutagenic potential, or impact on fertility.

PREGNANCY

THIS VACCINE IS NOT RECOMMENDED FOR PERSONS 7 YEARS OF AGE AND OLDER.

PEDIATRIC USE

SAFETY AND EFFECTIVENESS OF DT VACCINE IN INFANTS BELOW THE AGE OF SIX WEEKS HAVE NOT BEEN ESTABLISHED.

This vaccine is recommended for immunizing children 6 weeks of age through 6 years of age (up to the seventh birthday). Diphtheria and Tetanus (diphtheria and tetanus (diphtheria and tetanus toxoids) toxoids) Toxoids and Acellular Pertussis Vaccine (DTaP) TripediaÒ, or DTP are the preferred vaccines in this age group, but in those situations where an absolute contraindication to pertussis vaccination exists, or where in the opinion of the physician the pertussis vaccine should not be administered, DT is the appropriate alternative.

REFERENCES

2. Recommendations of the Advisory Committee on Immunization Practices (ACIP).Diphtheria, Tetanus, and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR 40:No.RR10, 1991

9. Stratton KR, et al. Adverse events associated with childhood vaccines. Evidence Bearing on Causality. National Academy Press, Washington,DC,1994

10. ACIP.General recommendations on immunization. MMWR 38:205-227,1989

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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