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Tetanus Toxoid (Systemic)


VA CLASSIFICATION
Primary: IM200



Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Immunizing agent (active)—

Indications

Accepted

Tetanus (prophylaxis)—Tetanus toxoid is indicated for immunization against tetanus. The main objectives of tetanus immunization are to prevent tetanus infection {01} and the severe complications, including death, that arise from the toxins produced by Clostridium tetani {01}. Although the spores of tetanus are ubiquitous, naturally acquired immunity to tetanus does not occur in the U.S., and primary immunization and booster injections are essential to protect persons in all age groups {02}.
—Unless otherwise contraindicated, all infants 6 to 8 weeks of age and older, all children, and all adults should be immunized against tetanus with the primary series of tetanus toxoid and a booster injection every 10 years throughout their lives, including {02} {03} {04} {05} {06} {07} {08}:    • Adults, especially those 50 years of age and older. In recent years, approximately two-thirds of persons contracting tetanus have been in this age group {02}.
   • Persons with uncertain histories of a complete primary series with tetanus toxoid or immunizing agents containing tetanus toxoid {09}.
   • Travelers {10} {11}.
   • Persons at increased risk of receiving lacerations and abrasions through their occupation or recreation {02} {07}.
   • Persons with known sensitivity to horse serum or with asthma or other allergies. This is to minimize the possible need for passive immunization with tetanus antitoxin (TAT) of animal origin (usually horse) if a wound is received. Although human tetanus immune globulin (TIG) is usually used for passive immunization, TAT of animal origin still may be used in certain areas of the world and has the potential of causing adverse reactions in hypersensitive patients {02} {07}.
   • Pregnant women who are unimmunized or inadequately immunized and who may deliver their infants under unhygienic conditions, thereby exposing their infants to neonatal tetanus.
   • Those recovering from tetanus {03}. Since a tetanus infection does {09} not confer immunity, especially in the U.S. {02}, immunization with tetanus toxoid should be initiated or continued at the time of recovery from the illness.

—In addition, persons who are injured may require emergency tetanus prophylaxis depending on the number of primary immunizations, the timing of any boosters, and/or the type of wound received {11} {07} {08}.
—It is recommended that infants and children 6 weeks up {09} to 7 years of age receive tetanus toxoid as part of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP) immunization according to the DTP immunization schedule. In those cases where the pertussis vaccine is contraindicated, it is recommended that Diphtheria and Tetanus Toxoids for pediatric use (DT) be administered instead, according to the DT immunization schedule {02}.
—It is recommended that children 7 years of age and older and all adults receive tetanus toxoid as part of Tetanus and Diphtheria Toxoids for adult use (Td) both for the primary series and for the booster doses every 10 years {02} {05}.
—When the single-entity vaccine is used, tetanus toxoid adsorbed is the vaccine of choice for primary immunization because greater antigenic stimulation and longer lasting immunity are achieved than with the tetanus toxoid (fluid) {05} {07} {08} {11}. Most {01} experts feel that tetanus toxoid adsorbed should be used for booster doses as well {07} {08}; others feel that either tetanus toxoid adsorbed or tetanus toxoid (fluid) may be used for booster doses with equal results {05} {11}. Either tetanus toxoid adsorbed or tetanus toxoid (fluid) may be used for emergency tetanus prophylaxis for wounds {11}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Tetanus toxoid adsorbed and fluid are prepared by growing the tetanus bacilli Clostridium tetani on a protein-free, semi-synthetic medium {08} {09} {12}. The tetanus toxin produced by these bacilli is detoxified by using formaldehyde and forms the tetanus toxoid {04} {08} {11} {12}. Thimerosal is added as a preservative {02} {04} {05} {07} {08}. In addition, for tetanus toxoid adsorbed, aluminum phosphate {04} {05} {11} or aluminum potassium sulfate {02} is used as a mineral adjuvant to adsorb the tetanus antigens. This prolongs and enhances the antigenic properties by retarding the rate of absorption of the injected toxoid into the body {02}.

Mechanism of action/Effect:

Following intramuscular injection of tetanus toxoid adsorbed or either intramuscular or subcutaneous injection of tetanus toxoid (fluid), an antigenic response is induced in the immunized patient, causing the formation of tetanus antibodies {08} {09}.


Protective effect

Tetanus toxoid adsorbed—Most {01} persons possess protective levels of antitoxin to tetanus after two doses {02}. The remaining persons usually obtain protective levels following the third dose of the primary series {01}, which is given approximately one year later {02}.

Tetanus toxoid (fluid)—Does not produce as great an antigenic stimulation as does tetanus toxoid adsorbed, but does provide protective levels {05} {07} {08} {11}.


Duration of protective effect

Duration of immunity is unknown, but is generally believed to persist for 10 or more years following a primary series or a booster dose of tetanus toxoid {02} {11}. Tetanus toxoid adsorbed causes greater antigenic stimulation and longer lasting immunity than does the tetanus toxoid (fluid) {05} {07} {08} {11}.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients allergic to thimerosal may be allergic to the tetanus toxoid available in the U.S. and Canada because it may contain a small amount of thimerosal {03} {13} {14} {15} {16} {17}.

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans; however, problems in humans have not been documented {02} {03}.

Immune pregnant women confer protection to their infants through transplacental maternal antibody. Pregnant women who are inadequately immunized or unimmunized and who may deliver their infants under unhygienic conditions may expose their infants to neonatal tetanus. For inadequately immunized or unimmunized pregnant women, it is recommended that immunization with tetanus toxoid be initiated or continued during the last two trimesters. Unimmunized women should receive the first two doses of the primary series before childbirth {03} {06} {07}.

Studies have not been done in animals {02}.

FDA Pregnancy Category C {02}.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Infants up to 6 weeks of age—Use is not recommended.

Infants and children 6 weeks of age and older—Pediatrics-specific problems that would limit the usefulness of this vaccine in children in this age group are not expected {11}.


Geriatrics


Although appropriate studies on the relationship of age to the effects of tetanus toxoid have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of tetanus toxoid in the elderly. However, the immune response in the elderly may be slightly diminished {01}.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Immunosuppressants or
Radiation therapy    (because normal defense mechanisms are suppressed, the patient's antibody response to tetanus toxoid may be decreased. The precaution does not apply to corticosteroids used as replacement therapy, for short-term [less than 2 weeks] systemic therapy, or by other routes of administration that do not cause immunosuppression. Where possible, immunosuppressive therapy should be interrupted when immunization is required because of a tetanus-prone wound {02} {03} {04} {05} {06} {07} {08} {11} {18})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:
» Febrile illness, severe or
» Respiratory disease, acute    (routine primary or booster immunization should not be administered until the acute symptoms of the patient's illness have abated; however, emergency tetanus prophylaxis for wounds should be administered as usual. Minor illnesses, such as upper respiratory infection, do not preclude administration of tetanus toxoid {02} {03} {04} {05} {06} {07} {08} {11})


» Tetanus infection    (tetanus toxoid should not be used to treat a tetanus infection; tetanus antitoxin, preferably tetanus immune globulin (TIG), should be used instead; after recovery, tetanus toxoid should be initiated or continued, since a tetanus infection does not confer immunity {02} {07} {09})


Risk-benefit should be considered when the following medical problem exists
Sensitivity to tetanus vaccine


Side/Adverse Effects

Note: If an arthus-type hypersensitivity reaction or a fever greater than 39.4 °C (103 °F) occurs following a dose of tetanus toxoid, the patient usually has very high serum tetanus antitoxin levels and no additional doses of tetanus toxoid should be given for any reason, including wounds, more frequently than every 10 years {03}.
If a systemic allergic {02} {07} or neurologic {02} {09} reaction occurs following a dose of tetanus toxoid, the person should not be further immunized using tetanus toxoid {03}; instead, passive immunization using tetanus immune globulin (TIG) should be used when other than a clean, minor wound is sustained {02} {03}. Neurological reactions, such as peripheral neuropathies, have been temporally related to tetanus toxoid administration {02} {05} {06} {07}; however, no causal relationship has been established.
Booster doses of tetanus toxoid administered more frequently than every 10 years have been reported to result in an increased occurrence and severity of adverse reactions {03}.
Generally, a history of hypersensitivity reactions other than anaphylaxis, such as delayed-type, cell-mediated {01} allergic reaction (contact dermatitis), does not preclude immunization.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Anaphylactic reaction {05}{06}{11}(difficulty in breathing or swallowing; hives; itching, especially of soles or palms; reddening of skin, especially around ears; swelling of eyes, face, or inside of nose; sudden and severe unusual tiredness or weakness)
    
neurologic reaction {09}(confusion; fever over 39.4 °C [103 °F]; severe or continuing headache; seizures; excessive sleepiness; unusual irritability; severe or continuing vomiting)



Additional side/adverse effects that may occur because of very high serum tetanus antitoxin levels and indicating need for medical attention
Incidence rare
    
Fever over 39.4 °C (103 °F)
    
lymphadenopathy {04}{08}(swelling of glands in armpit)
    
swelling, blistering, or pain at injection site, which may be severe and extensive{04}{06}{08}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Redness or hard lump at injection site —may persist for a few days{04}{08}

Incidence less frequent
    
Allergic reaction, delayed-type, cell-mediated (pain, tenderness, itching, or swelling at injection site{02}{05}{06}{07}{11})
    
chills, fever, irritability, or unusual tiredness{02}{05}{06}{07}{11}
    
nodule or sterile abscess at injection site —probably{01}{09} from the aluminum content of tetanus toxoid adsorbed; may persist for a few weeks{02}{04}{05}{09}
    
skin rash{02}{07}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Tetanus Toxoid (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this vaccine
»   Conditions affecting use, especially:





Use in children—Not recommended for infants up to 6 weeks of age

Other medical problems, especially severe febrile illness, acute respiratory disease, or tetanus infection

Proper use of this vaccine

» Proper dosing


Side/adverse effects
Signs of potential side effects, especially anaphylactic reaction; neurologic reaction; fever over 39.4 °C (103 °F); lymphadenopathy; or swelling, blistering, or pain at injection site


General Dosing Information
It is recommended that infants and children 6 weeks up to 7 years of age receive tetanus toxoid as part of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP) immunization according to the DTP immunization schedule. In those cases where the pertussis vaccine is contraindicated, it is recommended that Diphtheria and Tetanus Toxoids for pediatric use (DT) be administered instead, according to the DT immunization schedule {02} {03} {09}.

It is recommended that children 7 years of age and older and all adults receive tetanus toxoid as part of Tetanus and Diphtheria Toxoids for adult use (Td), both for the primary series and for the booster doses every 10 years {02} {03} {05} {09}.

The dosage of tetanus toxoid is the same for all persons: infants, children, and adults {02} {07}.

A primary series of tetanus toxoid adsorbed consists of 3 doses; a primary series of tetanus toxoid (fluid) consists of 4 doses. If a combination of tetanus toxoid adsorbed and tetanus toxoid (fluid) is used, a total of 4 doses constitutes a primary series. These primary series include a reinforcing dose administered 6 to 12 months after the first 2 doses of tetanus toxoid adsorbed or after the first 3 doses of tetanus toxoid (fluid) or a combination of both. Basic immunization cannot be considered complete until all of these doses are administered {04} {08}.

Prolonging the interval between the primary immunizing doses probably does not interfere with the final immunity. Any dose of tetanus toxoid, including an emergency prophylactic dose, a person has received during the last 10 years may be counted as one of his immunizing injections {04} {08}.

Persons infected with human immunodeficiency virus (HIV) may receive tetanus toxoid whether they have asymptomatic {19} {20} or symptomatic {20} HIV infection.

Tetanus toxoid can be administered concurrently with the following, using separate body sites, separate syringes, and the precautions that apply to each immunizing agent:    • Tetanus immune globulin (human) or tetanus antitoxin (animal).
   • Polysaccharide vaccines, such as haemophilus b polysaccharide vaccine, haemophilus b conjugate vaccine, meningococcal polysaccharide vaccine, or pneumococcal polyvalent vaccine.
   • Influenza vaccine, whole or split virus.
   • Diphtheria toxoid and/or pertussis vaccine.
   • Live virus vaccines, such as measles, mumps, and/or rubella vaccines.
   • Poliovirus vaccines (oral [OPV], inactivated [IPV], or enhanced-potency inactivated [enhanced-potency IPV]).
   • Immune globulin and disease-specific immune globulins.
   • Hepatitis B recombinant or plasma-derived vaccine, or other inactivated vaccines, except cholera, typhoid, and plague. It is recommended that cholera, typhoid, and plague vaccines be administered on separate occasions because of these vaccines' propensity to cause side/adverse effects.


For tetanus toxoid (fluid) only
Tetanus toxoid (fluid) is administered subcutaneously or intramuscularly into the area of the midlateral muscles (vastus lateralis) of the thigh or into the deltoid {06} {07}. The vaccine should not be injected intravenously.

For tetanus toxoid adsorbed only
Tetanus toxoid adsorbed is administered intramuscularly into the area of the midlateral muscles (vastus lateralis) of the thigh or into the deltoid {02} {04} {05}. The same muscle site should not be used more than once during the course of the primary immunization {04}. The vaccine should not be injected intravenously.

Emergency tetanus prophylaxis of wounds
Examples of wounds that are not clean, minor wounds are: wounds contaminated with dirt, feces, soil, or saliva; puncture wounds; wounds caused by tearing; and wounds resulting from missiles, crushing, burns, or frostbite.

Patients who were unimmunized or inadequately immunized prior to injury should complete their primary immunization schedule as soon as possible {11}.

If only tetanus toxoid adsorbed has been used for the primary doses—Patients who receive an emergency prophylactic dose of tetanus toxoid adsorbed after their second primary dose should count the prophylactic dose as their third (last) primary dose if the prophylactic dose is administered at least 6 months after the second primary dose {04}.

If either tetanus toxoid (fluid) or a combination of both toxoids has been used for the primary doses—Patients who receive an emergency prophylactic dose of either tetanus toxoid (fluid) or tetanus toxoid adsorbed after their third primary dose should count the prophylactic dose as their fourth (last) primary dose if the prophylactic dose is administered at least 6 months after the third primary dose {08}.

The decision to administer concomitant passive immunization by using tetanus immune globulin (human) or tetanus antitoxin (animal) {09} depends on such factors as location, type, and severity of the wound; degree and kind of contamination; and the time elapsed since the injury {01} {11}. Some experts feel that tetanus toxoid adsorbed should be used with the selected antitoxin {02} {07}; others feel that either tetanus toxoid adsorbed or tetanus toxoid (fluid) may be used {11}.

For treatment of adverse effects
Recommended treatment includes

   • For mild hypersensitivity reaction—Administering antihistamines and, if necessary, corticosteroids {03}.
   • For severe hypersensitivity or anaphylactic reaction—Administering epinephrine. Antihistamines or corticosteroids may also be administered as required {03}.


Parenteral Dosage Forms

TETANUS TOXOID (FLUID) INJECTION USP

Usual adult and adolescent dose
Tetanus (prophylaxis)—Intramuscular or subcutaneous, 0.5 mL (U.S.) or 1 mL (Canada—Connaught) {06} {16} {02} {17} :


First dose:
At initial visit {06} {08} {11} {16}.



Second dose:
4 to 8 weeks after the first dose {06} {08} {11} {16}.



Third dose:
4 to 8 weeks after the second dose {06} {08} {11} {16}.



Fourth dose:
6 to 12 months after the third dose {06} {07} {08} {11} {16}.



Booster doses:
Every 10 years {06} {16}.



Emergency tetanus prophylaxis of wounds:


U.S.—
If less than the 4 primary doses have been administered—As soon as possible following any wound. For other than clean, minor wounds, tetanus immune globulin (human) (preferred) {01} or tetanus antitoxin (animal) {09} should also be administered.

If 4 or more doses have been administered—For a clean, minor wound, as soon as possible if more than 10 years have passed since the last dose. For all other wounds, as soon as possible if more than 5 years have passed since the last dose. {16} No tetanus immune globulin (human) {16} {01} or tetanus antitoxin (animal) {09} is required in either case.



Canada—
If less than 2 primary doses have been administered—As soon as possible following any wound. For other than clean, minor wounds, tetanus immune globulin (human) (preferred) {01} or tetanus antitoxin (animal) {09} should also be administered.

If 2 primary doses have been administered—As soon as possible following any wound. For other than clean, minor wounds, tetanus immune globulin (human) (preferred) {01} or tetanus antitoxin (animal) {09} should also be administered if more than 24 hours have elapsed since the injury.

If 3 or more doses have been administered—For a clean, minor wound, as soon as possible if more than 10 years have passed since the last dose. For all other wounds, as soon as possible if more than 5 years have passed since the last dose. No tetanus immune globulin (human) {01} or tetanus antitoxin (animal) {09} is required in either case.




Usual pediatric dose
See Usual adult and adolescent dose .

Note: For infants, the first dose is usually administered at 6 to 8 weeks of age.


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


4 Lf per 0.5 mL (Rx)[Generic](may contain thimerosal){07}{12}{16}

Canada—


10 Lf per 1 mL (Rx)[Generic](may contain thimerosal){06}{16}

Note: Lf is the quantity of toxoid as assessed by flocculation.


Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F). Do not freeze {07} {08}.

Stability:
The vaccine should not be used if exposed to freezing {05} or if cloudy or turbid {06}.

Auxiliary labeling:
   • Shake well {07}.
   • Do not freeze {07} {08}.


TETANUS TOXOID ADSORBED (INJECTION) USP

Usual adult and adolescent dose
Tetanus (prophylaxis)—Intramuscular, 0.5 mL:


First dose:
At initial visit {02} {03} {04} {05} {11}.



Second dose:
4 to 8 weeks after the first dose {02} {03} {04} {05} {11}.



Third dose:
6 to 12 months after the second dose {02} {03} {04} {05} {11}.



Booster doses:
Every 10 years {03}.



Emergency tetanus prophylaxis of wounds:


U.S.—
If less than the 3 primary doses have been administered—As soon as possible following any wound {03} For other than clean, minor wounds, tetanus immune globulin (human) (preferred) {01} {03} or tetanus antitoxin (animal) {09} should also be administered.

If 3 or more doses have been administered—For a clean, minor wound, as soon as possible if more than 10 years have passed since the last dose {03}. For all other wounds, as soon as possible if more than 5 years have passed since the last dose {03}. Generally {11}, no tetanus immune globulin (human) {01} or tetanus antitoxin (animal) {09} is required in either case.



Canada—
If less than 2 primary doses have been administered—As soon as possible following any wound. For other than clean, minor wounds, tetanus immune globulin (human) (preferred) {01} or tetanus antitoxin (animal) {09} should also be administered.

If 2 primary doses have been administered—As soon as possible following any wound. For other than clean, minor wounds, tetanus immune globulin (human) (preferred) {01} or tetanus antitoxin (animal) {09} should also be administered if more than 24 hours have elapsed since the injury.

If 3 or more doses have been administered—For a clean, minor wound, as soon as possible if more than 10 years have passed since the last dose. For all other wounds, as soon as possible if more than 5 years have passed since the last dose. No tetanus immune globulin (human) {01} or tetanus antitoxin (animal) {09} is required in either case.




Usual pediatric dose
See Usual adult and adolescent dose .

Note: For infants, the first dose is usually administered at 6 to 8 weeks of age {11}.


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


5 Lf per 0.5 mL (Rx)[Generic](may contain thimerosal){02}{03}{12}{13}


10 Lf per 0.5 mL (Rx)[Generic](may contain thimerosal){12}{14}

Canada—


5 Lf per 0.5 mL (Rx)[Generic](may contain thimerosal){12}{15}

Note: Lf is the quantity of toxoid as assessed by flocculation.


Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F). Do not freeze {02} {03} {04} {05}.

Stability:
The vaccine should not be used if exposed to freezing {05}.

Auxiliary labeling:
   • Shake well {03} {04} {05}.
   • Do not freeze {02} {03} {04} {05}.



Revised: 07/12/1994



References
  1. Reviewer comments, 9/90.
  1. Tetanus Toxoid Adsorbed, generic, package insert (Connaught—US), Rev 12/85, Rec 3/88.
  1. Tetanus Toxoid Adsorbed, generic (Lederle). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 1191.
  1. Tetanus Toxoid Adsorbed, generic, package insert (Wyeth—US), Rev 11/86, Rec 3/87.
  1. Tetanus Toxoid Adsorbed, generic (Connaught). In: Krogh CME, editor. Compendium of pharmaceuticals and specialties. 22nd ed. Ottawa: Canadian Pharmaceutical Association, 1987: 858.
  1. Tetanus Toxoid (fluid), generic (Connaught). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 22nd ed. Ottawa: Canadian Pharmaceutical Association, 1987: 857.
  1. Tetanus Toxoid (fluid), generic, package insert (Connaught—US), Rev 8/81, Rec 3/88.
  1. Tetanus Toxoid (fluid), generic, package insert (Wyeth—US), Rev 8/86, Rec 12/87.
  1. Panel comments, 4/15/88.
  1. ABC of healthy travel: Immunisation—II. Br Med J 1983 Feb 26; 286.
  1. Tetanus Toxoid Adsorbed and Tetanus Toxoid (fluid), generic, package insert (Lederle—US), Rev 10/85, Rec12/87.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc., 1985 Oct: 469.
  1. Tetanus Toxoid Adsorbed, generic, package insert (Connaught—US), Rev 12/85, Rec 7/93.
  1. Te Anatoxal Berna (Tetanus Toxoid Adsorbed), package insert (Berna—US), Rev 1/91, Rec 6/93.
  1. Tetanus Toxoid Adsorbed, generic, package insert (IAF Biovac—Canada), Rev 8/91, Rec 7/93.
  1. Tetanus Toxoid (fluid), generic, package insert (Connaught—US), Rev 8/81, Rec 7/93.
  1. Tetanus Toxoid (fluid), generic, package insert (IAF Biovac—Canada), Rev 4/91, Rec 7/93.
  1. Tetanus panel ballot, 6/17/88.
  1. Centers for Disease Control and Prevention. ACIP: Immunization of children infected with HTLV-III/LAV lymphadenopathy-associated virus. MMWR 1986 Sep 26; 35: 595-606.
  1. Centers for Disease Control and Prevention. ACIP: Immunization of children infected with human immunodeficiency virus (HIV). Supplementary statement of the Immunization Practices Advisory Committee. MMWR 1988 Apr 1; 37: 181-3.
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