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Tetanus Toxoid Adsorbed

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Tetanus Toxoid Adsorbed

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 Tetanus Toxoid Adsorbed more frequently than every 10 years, even if they have a wound that is neither clean nor minor.1

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

A routine booster should not be given more frequently than every ten years. (This guideline should not preclude wound management considerations.)

Deaths have been reported in temporal association with the administration of Tetanus Toxoid Adsorbed vaccine; however, no causal relationship was proven6 (see ADVERSE REACTIONS section).

PRECAUTIONS

General

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

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 booster 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.1 If Tetanus Toxoid Adsorbed vaccine has been administered to persons receiving immunosuppressive therapy, or having an immunodeficiency disorder, an adequate antibody response may not be obtained.1 When possible, immunosuppressive treatment should be interrupted when immunization is required due to a tetanus-prone wound.

Administration of Tetanus Toxoid Adsorbed vaccine is not contraindicated in individuals with HIV infection.7

It is advisable to use DT (For Pediatric Use – under 7 years of age) or Td (For Adult Use – 7 years of age and older) in wound prophylaxis instead of tetanus toxoid alone in order to maintain adequate levels of diphtheria immunity.1

A separate, sterile syringe and needle or a sterile disposable unit must 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

Reproductive Studies – Pregnancy Category C

Animal reproduction studies have not been conducted with Tetanus Toxoid Adsorbed vaccine. It is also not known whether Tetanus Toxoid Adsorbed vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tetanus Toxoid Adsorbed vaccine should be given to a pregnant woman only if clearly needed.

Adequate immunization by routine boosters in non-pregnant women of child-bearing age can obviate the need to vaccinate women during pregnancy (see DOSAGE AND ADMINISTRATION section).

Physicians generally avoid prescribing unnecessary drugs and biologics for pregnant women.

However, the ACIP recommends the following: A previously unvaccinated pregnant woman whose child might be born under unhygienic circumstances (without sterile technique) should receive two doses of Td 4 to 8 weeks apart before delivery, preferably during the last two trimesters. Pregnant women in similar circumstances who have not had a complete vaccination series should complete the three-dose series. Those vaccinated more than 10 years previously should have a booster dose. No evidence exists to indicate that tetanus and diphtheria toxoids administered during pregnancy are teratogenic.1

It has been reported that tetanus toxoid administered to pregnant women prevents neonatal tetanus in newborns.11,12 However, the data reported on the safety of tetanus toxoid when so used is inconclusive because the incidence of neonatal deaths in New Guinea was significantly higher than in the United States.11 A prospective study in the United States has not been done to confirm these reports.

Pediatric Use

SAFETY AND EFFECTIVENESS OF TETANUS TOXOID ADSORBED VACCINE IN INFANTS BELOW THE AGE OF SIX WEEKS HAVE NOT BEEN ESTABLISHED. HOWEVER, THIS VACCINE IS NOT INDICATED FOR CHILDREN UNDER 7 YEARS OF AGE.

Tetanus Toxoid Adsorbed vaccine is suitable for tetanus immunization in the pediatric age group. However, for children under 7 years of age DT (For Pediatric Use) is preferred to tetanus toxoid alone if the pertussis component is contraindicated. For children 7 years of age and older, Td (For Adult Use) is preferred to tetanus toxoid alone.1

REFERENCES

1. Recommendations of the Immunization Practices Advisory Committee (ACIP). Diphtheria, Tetanus, and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR 40: No. RR-10, 1991

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

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

11. MacLennan R, et al. Immunization against neonatal tetanus in New Guinea. Antitoxin response of pregnant women to adjuvant and plain toxoids. Bull WHO 32: 683-697, 1965

12. Newell KW, et al. The use of toxoid for the prevention of tetanus neonatorium. Bull WHO 35: 863-871, 1966

Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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