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Tetanus Toxoid Adsorbed

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Tetanus Toxoid Adsorbed

Tetanus Toxoid Adsorbed

INDICATIONS

Tetanus Toxoid Adsorbed vaccine is indicated for active immunization of children 7 years of age or older, and adults, against tetanus, wherever combined antigen preparations are not indicated.1

This vaccine should not be used for immunizing children below 7 years of age. In children below 7 years of age, either Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) - Tripedia®, or Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed USP (For Pediatric Use) (DTP) is recommended. If a contraindication to pertussis immunization exists, the recommended vaccine is Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT).1

For the prevention of neonatal tetanus in infants born of unvaccinated pregnant women, see Pregnancy section.1

This vaccine is NOT to be used for the treatment of tetanus infection.

As with any vaccine, vaccination with Tetanus Toxoid Adsorbed may not protect 100% of susceptible individuals.

If passive immunization is required, Tetanus Immune Globulin (Human) (TIG) should be used (see DRUG INTERACTIONS and DOSAGE AND ADMINISTRATION sections).

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration whenever solution and container permit. If these conditions exist, the vaccine should not be administered.

SHAKE VIAL WELL before withdrawing each dose. Discard vial of vaccine if it cannot be resuspended.

Inject intramuscularly in the area of the vastus lateralis (mid-thigh laterally) or deltoid. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

The following guidelines are derived from the Advisory Committee on Immunization Practices (ACIP).1

Primary Immunization for Persons 7 Years of Age and Older

A series of three doses of 0.5 mL each, of Tetanus Toxoid Adsorbed vaccine should be given intramuscularly; the second dose of 0.5 mL is given 4 to 8 weeks after the first dose; and the third dose of 0.5 mL is given 6 to 12 months after the second dose.

Children who remain incompletely immunized after their seventh birthday should be counted as having prior exposure to tetanus and diphtheria toxoids (e.g., a child who previously received two doses of DTaP or DTP needs only one dose of Tetanus Toxoid Adsorbed vaccine to complete the primary series for tetanus).

Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity achieved with Tetanus Toxoid Adsorbed vaccine. There is no need to start the series over again, regardless of the time elapsed between doses.

Routine Booster Injections

To maintain adequate protection, a booster dose of 0.5 mL of Td (For Adult Use) vaccine or Tetanus Toxoid Adsorbed vaccine every 10 years thereafter is recommended.

Booster Injection After Injury

A thorough attempt must be made to determine whether a patient has completed primary immunization. Patients with unknown or uncertain previous immunization histories should be considered to have no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose. Although most people in the military since 1941 may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement (Table 1).1

Available evidence indicates that complete primary vaccination with tetanus toxoid provides long-lasting protection ≥ 10 years for most recipients. Consequently, after complete primary tetanus vaccination, boosters, even for wound management, need to be given only every 10 years when wounds are minor and uncontaminated. For other wounds, a booster is appropriate if the patient has not received tetanus toxoid within the preceding five years. Persons who have received at least two doses of tetanus toxoid develop antitoxin antibodies.1

Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) is the preferred vaccine for active tetanus immunization in wound management of patients ≥ 7 years of age. Because a large proportion of adults are susceptible to diphtheria, this vaccine enhances diphtheria protection. Thus, by taking advantage of acute health-care visits, such as for wound management, some patients can be protected who otherwise would remain susceptible. For inadequately vaccinated patients of all ages, completion of primary vaccination at the time of discharge or at follow-up visits should be ensured.1

TABLE 11: Guide to Tetanus Prophylaxis in Routine Wound Management*

History of Adsorbed Tetanus Toxoid (Doses) Clean, Minor Wounds All Other Wounds**
Td TIG Td TIG
Unknown or < three Yes No Yes Yes
≥ Three No No No§ No
* Important details are in the text of the insert. **Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite.
Yes, if > 10 years since last dose.
§Yes, if > 5 years since last dose. (More frequent boosters are not needed and can accentuate side effects.)

If passive immunization for tetanus is needed, TIG (Human) is the product of choice. It provides longer protection than antitoxin of animal origin and causes few adverse reactions. The currently recommended prophylactic dose of TIG (Human) for wounds of average severity is 250 units intramuscularly. When tetanus toxoid and TIG (Human) are given concurrently, separate syringes and separate sites should be used. The ACIP recommends the use of only adsorbed toxoid in this situation.1

HOW SUPPLIED

Vial, 5 mL – Product No. 49281-800-83

Storage

Store between 2° – 8°C (35° – 46°F). DO NOT FREEZE.

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

Manufactured by: Aventis Pasteur Inc. Swiftwater PA 18370 USA Product information as of April 1999. FDA Rev date: n/a

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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