Professional Drug Information > Td

Diphtheria and Tetanus Toxoids (Systemic)

This monograph includes information on the following:

1) Diphtheria and Tetanus Toxoids for Pediatric Use (DT)
2) Tetanus and Diphtheria Toxoids for Adult Use (Td)

Note: There are some differences in terminology with respect to the use of the terms “primary” and “reinforcing” in some of the manufacturers" labeling used for this monograph ^{{02} {06} {08} {12} {13}}. In this monograph, the term “primary immunizing series” will be used to denote the initial doses that are usually given 4 to 8 weeks apart as well as the “reinforcing” dose that is usually given 6 to 12 months thereafter. The dose usually given at 4 to 6 years of age and the doses given every 10 years will be called booster doses ^{{01} {03} {07} {18}}.


VA CLASSIFICATION
Primary: IM200



Other commonly used names are:
DT—Diphtheria and Tetanus Toxoids
Td— Tetanus and Diphtheria Toxoids

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



Category:


Immunizing agent (active)—

Indications

Accepted

Diphtheria and tetanus (prophylaxis)—Diphtheria and tetanus toxoid combination is indicated for immunization against diphtheria and tetanus ^{{01} {07}}.
—Diphtheria and tetanus toxoids for pediatric use (DT) is indicated for immunization of infants and children 6 weeks up to 7 years of age who, because of a contraindication to pertussis vaccine, cannot receive diphtheria and tetanus toxoids and pertussis vaccine (DTP) combination. If there is no contraindication to pertussis vaccine, DTP is the vaccine of choice for this age group ^{{01} {18}}.
—Tetanus and diphtheria toxoids for adult use (Td) is indicated for immunization of adults and children 7 years of age and older ^{{07} {08}}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Diphtheria toxoid is prepared by first cultivating a suitable strain of Corynebacterium diphtheriae . Tetanus toxoid is prepared by first cultivating a suitable strain of Clostridium tetani The resulting toxins are detoxified with formaldehyde. The detoxified toxins (toxoids) are adsorbed onto an aluminum salt. This prolongs and enhances the antigenic properties by retarding the rate of absorption of the injected toxoid in the body ^{{01} {02} {07} {08} {15} {18} {36}}.

Mechanism of action/Effect:

Following intramuscular injection, diphtheria toxoid and tetanus toxoid induce the formation of diphtheria antitoxin and tetanus antitoxin, respectively ^{{01} {08}}.


Protective effect


Diphtheria antitoxin:

The protective level in serum is 0.01 unit per mL ^{{03} {10}}.



Tetanus antitoxin:

The protective level in serum is 0.01 unit per mL ^{{03} {10}}.



Time to protective effect


For diphtheria and tetanus toxoids for pediatric use (DT)

In a study of 20 children under 1 year of age, protective levels of diphtheria and tetanus antitoxins were detected in 100% of the children after administration of 3 doses of DT. In addition, protective levels of diphtheria and tetanus antitoxins were detected in 100% of the children after administration of 2 doses of DT, but maternal antibody may have contributed to the total neutralizing antibody in some of these children ^{03}.



For tetanus and diphtheria toxoids for adult use (Td)


Response to primary immunization—

Diphtheria—In a study of 10 adults who had less than 0.001 unit per mL of diphtheria antitoxin in pre-immunization serum, protective levels of diphtheria antitoxin were detected in 50% of the adults after administration of 2 doses of Td, each containing 2 Lf units of diphtheria toxoid. In a similar study of 6 adults, protective levels of diphtheria antitoxin were detected in 100% of the adults after administration of 3 doses of Td ^{{10} {36}}.

Tetanus—In a study of 20 adults who had less than 0.0025 unit per mL of tetanus antitoxin in pre-immunization serum, protective levels of tetanus antitoxin were detected in 70% of the adults after administration of 2 doses, and in 100% of the adults after administration of 3 doses, of Td, each containing 2 Lf units of tetanus toxoid ^{{10} {36}}.



Response to booster doses—

Booster doses of Td given as long as 25 to 30 years after primary immunization series have produced rapid and significant increases in the levels of both tetanus and diphtheria antitoxins ^{32}.

Diphtheria—In a study of 140 adolescent males, protective levels of diphtheria antitoxin were detected in 100% of the males after administration of a single booster dose of Td containing 1 Lf unit of diphtheria toxoid ^{{10} {36}}.

Tetanus—In a study of 36 adults, protective levels of tetanus antitoxin were detected in 100% of the adults after administration of a single booster dose of Td containing 1 Lf unit of tetanus toxoid ^{{10} {36}}.




Duration of protective effect

At least 10 years for both diphtheria toxoid and tetanus toxoid following a completed primary immunizing series of injections ^{{01} {07} {08} {18}}.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to diphtheria toxoid or tetanus toxoid may be sensitive to diphtheria and tetanus toxoids for pediatric use (DT) or tetanus and diphtheria toxoids for adult use (Td) also ^{{01} {07}}.

Carcinogenicity/Mutagenicity

Studies have not been done ^{08}.

Pregnancy/Reproduction
Fertility—
Studies have not been done ^{08}.

Pregnancy—
There is no evidence that diphtheria and tetanus toxoid combination is teratogenic.

For DT: Use of DT is not recommended in females of child-bearing age.

For Td: Unimmunized pregnant women should receive 2 properly spaced doses of Td before delivery, preferably during the last 2 trimesters. Incompletely immunized pregnant women should complete the primary immunizing series of Td. Those fully immunized more than 10 years ago should receive a booster dose of Td.

Studies have not been done in animals.

FDA Pregnancy Category C ^{{01} {07} {08} {18} {19} {32}}.

Breast-feeding

Diphtheria and tetanus toxoids have not been isolated from breast milk.

For DT—Use of DT is not recommended in females of child-bearing age.

For Td—There is no evidence that breast milk from women who have received Td is harmful to infants ^{08}.

Pediatrics


For DT:

Infants up to 6 weeks of age: Use of DT is not recommended ^{01}.

Infants and children up to 7 years of age: Pediatrics-specific problems that would limit the usefulness of DT in these children are not expected ^{{01} {07} {08}}.

Children 7 years of age and older: Use of DT is not recommended in this age group ^{{01} {07}}.



For Td:

Infants and children up to 7 years of age: Use of Td is not recommended in this age group ^{{01} {07} {08}}.

Children 7 years of age and older: Pediatrics-specific problems that would limit the usefulness of Td in these children are not expected ^{{01} {07}}.



Geriatrics


For DT—Use of DT is not recommended in this age group.

For Td—Although appropriate studies on the relationship of age to the effects of Td have not been performed in the geriatric population, geriatrics-specific problems are not expected to limit the usefulness of Td in the elderly. However, the immune response in the elderly may be slightly diminished ^{{01} {16} {21} {32}}.

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 DT or Td may be decreased during therapy and deferral of routine DT or Td administration may be considered. 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 ^{{01} {03} {07} {08} {22} {34}})


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 or
» Infection, 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. A minor afebrile illness, such as an upper respiratory infection, usually does not preclude administration of DT or Td ^{{01} {03} {07} {08} {30} {31}})


» Sensitivity to DT or Td^{01}{07}
» Tetanus infection    (products containing tetanus toxoid should not be used to treat a tetanus infection; tetanus antitoxin, preferably tetanus immune globulin [TIG], should be used instead; after recovery, the primary immunizing series should be initiated or continued, since a tetanus infection does not confer immunity ^{{01} {07}})


Risk-benefit should be considered when the following medical problem exists
» Sensitivity to thimerosal^{{01}{07}{08}{35}}


Side/Adverse Effects

Note: Although both the diphtheria toxoid and the tetanus toxoid components may evoke local and systemic allergic responses, it has been suggested that the tetanus toxoid component may be the more common cause ^{02}.
If an Arthus-type hypersensitivity reaction or a fever over 39.4 °C (103 °F) occurs following a dose of diphtheria and tetanus toxoid combination, the patient usually has a very high serum tetanus antitoxin level and no additional doses of tetanus toxoid should be given for any reason, including wound management, more frequently than every 10 years ^{{06} {07} {08} {12} {18}}.
Neurological reactions, such as convulsions, encephalopathy, and various mono- and polyneuropathies, have been reported following administration of preparations containing diphtheria toxoid and/or tetanus toxoid ^{{01} {07}}. Pallor, coldness, and hyporesponsiveness were reported in 1 child ^{01}. In the differential diagnosis of polyradiculoneuropathies, previous administration of tetanus toxoid should be considered as a possible cause ^{03}. If a neurologic reaction or a severe systemic allergic reaction occurs following a dose of diphtheria and tetanus toxoids for pediatric use (DT) or tetanus and diphtheria toxoids for adult use (Td), the person should not be further immunized with DT or Td ^{{01} {07} {08} {18} {36}}.
Booster doses of tetanus toxoid administered more frequently than every 10 years have been reported to result in increased occurrence and severity of adverse reactions ^{{07} {08} {36}}.
Generally, a history of hypersensitivity reactions other than anaphylaxis, such as delayed-type, cell-mediated allergic reaction (contact dermatitis), does not preclude immunization ^{18}.
Sterile abscesses have been reported rarely following administration of DT or Td. These are thought to be caused by inadvertent subcutaneous injection of the aluminum adjuvant in the product ^{{01} {07} {08} {12}}.
Use of jet injectors, which deposit some toxoid in the subcutaneous tissue, has been associated with a higher frequency of local reactions than has intramuscular injection by needle ^{08}.

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
For DT and Td
    
Anaphylactic reaction ^{{01}{07}{08}{12}{29}}(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; unusual tiredness or weakness, sudden and severe)
    
arthralgias ^{01}{07}{08}(joint aches or pain)
    
neurologic reaction ^{{01}{07}{08}{25}}(confusion; excessive sleepiness; fever over 39.4 °C [103 °F]; headache, severe or continuing; seizures; unusual irritability; vomiting, severe or continuing)
    
pruritus ^{08}(itching)
    
skin rash^{01}{07}
    
urticaria ^{{01}{07}{08}{12}}(hives)


Additional side/adverse effects that may occur because of very high serum tetanus antitoxin levels and may indicate a need for medical attention ^{{07} {08} {18}}
Incidence rare
    
Arthus-type reaction ^{{03}{07}{08}{18}}(swelling, blistering, pain, or other severe local reaction at injection site)
    
fever over 39.4 °C (103 °F)^{07}{18}
Note: Arthus-type reaction and fever over 39.4 °C usually occur only in patients old enough to receive Td, i.e., persons old enough to have received multiple booster doses of a tetanus toxoid–containing product ^{{03} {06} {07} {08} {12} {18} {33}}. An Arthus-type reaction generally starts within 2 to 8 hours after the injection and may be severe and extensive ^{{03} {07} {08} {18}}.






Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
For DT and Td
    
Redness or hard lump at injection site —may persist for a few days^{{01}{03}{07}{12}{28}}

For DT only
    
Fever under 39.4 °C (103 °F)^{01}{03}
    
swelling, pain, or tenderness at injection site —may persist for a few days^{01}{03}


Incidence less frequent
For DT and Td
    
Nodule^{{01}{03}{07}{08}} (hard lump) at injection site
    
subcutaneous atrophy (dent or indentation) at injection site^{01}{07}{08}
Note: Nodule ^{{01} {03} {07} {08}} (hard lump) at injection site probably is caused by the aluminum content of the toxoids ^{{06} {12}} and may persist for a few weeks ^{08}.



For DT only
    
Anorexia (loss of appetite)^{01}
    
drowsiness^{01}
    
fretfulness^{01}
    
persistent crying^{01}
    
vomiting^{01}

For Td only
    
Axillary lymphadenopathy (swelling of glands in armpit)^{08}
    
chills^{07}{12}
    
fever under 39.4 °C (103 °F)^{07}{08}{12}
    
headache^{07}
    
hypotension (unusual tiredness or weakness)^{08}
    
malaise (general feeling of discomfort or illness)^{08}
    
muscle aches^{07}{08}
    
tachycardia (fast heartbeat)^{08}






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

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

Before receiving this vaccine
»   Conditions affecting use, especially:
Sensitivity to diphtheria toxoid, tetanus toxoid, or thimerosal





Use in children—Not recommended for infants up to 6 weeks of age; only diphtheria and tetanus toxoids for pediatric use (DT) is recommended for infants and children 6 weeks to 7 years of age; only tetanus and diphtheria toxoids for adult use (Td) is recommended for children 7 years of age and older






Use in the elderly—Only tetanus and diphtheria toxoids for adult use (Td) is recommended; the immune response in the elderly may be slightly diminished
Other medical problems, especially acute infection, febrile illness, or tetanus infection

Proper use of this vaccine

» Proper dosing


Side/adverse effects
Notifying physician of any side effect that occurs after a dose of DT or Td, even if the side effect has gone away without treatment

Signs of potential side effects, especially anaphylactic reaction; arthralgias; neurologic reaction; pruritus; skin rash; urticaria; Arthus-type reaction; and fever over 39.4 °C (103 °F)


General Dosing Information
Diphtheria and tetanus toxoid combination is administered by deep intramuscular injection into the deltoid (for adults and older children) or into the area of the midlateral muscles (vastus lateralis) of the thigh (for infants and younger children). The same muscle site should not be used more than once during the course of the primary immunizing series. The vaccine should not be injected subcutaneously or intravenously ^{{01} {03} {07} {08}}.

Before each additional dose of diphtheria and tetanus toxoids for pediatric use (DT) or tetanus and diphtheria toxoids for adult use (Td), the health status of the patient should be assessed. In addition, information should be obtained regarding any symptom and/or sign of an adverse reaction that occurred after the previous dose ^{{01} {03} {07}}.

Routine immunization of adults and children over 6 months of age should be deferred during an outbreak of poliomyelitis in the community, unless there is also an outbreak of diphtheria. In either case, emergency tetanus prophylaxis for wounds should be administered as usual ^{{03} {06} {07} {08}}.

Persons with impaired immune response may be immunized, but may have reduced antibody response to DT or Td. Persons infected with human immunodeficiency virus (HIV) may receive DT or Td whether they have asymptomatic or symptomatic HIV infection ^{{01} {03} {07} {17} {23} {24}}.

Diphtheria infection may not (and tetanus infection does not) confer immunity; therefore, initiation or completion of active immunization with DT or Td is indicated at the time of recovery from either of these infections ^{{01} {02} {07} {08} {18}}.

Interruption of the recommended schedule for the primary immunizing series of DT or Td by a delay between doses does not interfere with the final immunity achieved and does not necessitate starting the series over again, regardless of the length of time that elapsed between doses ^{{01} {07} {18}}.

Emergency tetanus prophylaxis of wounds
Patients who were unimmunized or inadequately immunized with a tetanus toxoid–containing product prior to a wound should complete their primary immunizing series as soon as possible ^{{01} {07}}.

For routine wound management in children under 7 years of age who have not received the primary immunizing series against tetanus, DT (or DTP, if appropriate) should be used instead of single-antigen tetanus toxoid. In addition, children whose wounds are considered to be prone to tetanus infection and who have had fewer than 3 doses (or an unknown number of doses) of a tetanus toxoid–containing product also should be administered tetanus antitoxin, preferably tetanus immune globulin (TIG). A separate syringe and site of administration should be used for DT and TIG ^{{01} {32} {36}}.

The decision to administer Td for wound management with or without concomitant passive immunization using tetanus immune globulin (TIG) depends on the condition of the wound and the patient's immunization history. 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. Tetanus has rarely occurred in persons who have received a documented primary immunizing series of a tetanus toxoid–containing product. Persons who have received the primary immunizing series and whose wounds are minor and uncontaminated should receive a booster dose of a tetanus toxoid–containing product, such as Td, only if they have not received a tetanus toxoid booster dose within the past 10 years. Persons who have received the primary immunizing series and who have wounds that are not minor and uncontaminated should receive a booster dose of a tetanus toxoid–containing product, such as Td, only if they have not received a tetanus toxoid booster dose within the past 5 years. Persons who have not received the primary immunizing series against tetanus (or whose immunization history is unknown) should be immunized with a tetanus toxoid–containing product, such as Td. If persons who have not received the primary immunizing series against tetanus (or whose immunization history is unknown) have wounds that are considered to be prone to tetanus infection, tetanus antitoxin (preferably TIG) should be administered in addition to Td. A separate syringe and site of administration should be used for Td and TIG ^{{07} {36}}.

Emergency diphtheria prophylaxis
Immunization with diphtheria toxoid reduces the risk of developing diphtheria and lessens the severity of clinical illness. However, it does not eliminate Corynebacterium diphtheriae from the pharynx or the skin ^{{01} {07} {08} {36}}.

Household and other close contacts of persons with diphtheria infection who have received fewer than 3 doses of a diphtheria toxoid–containing product should receive an immediate dose of a diphtheria toxoid–containing product, such as DT or Td (according to their age requirement), and should complete the primary immunizing series according to schedule. Household and other close contacts who have received 3 or more doses of a diphtheria toxoid–containing product and who have not received an additional dose within 5 years should receive a booster dose of a diphtheria toxoid–containing product, such as DT or Td (according to their age requirement) ^{{01} {07} {18}}.

For treatment of adverse effects ^{{01} {03} {07}}
Recommended treatment includes:

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

DIPHTHERIA AND TETANUS TOXOIDS (DT)
Summary of Differences
Indications: Diphtheria and tetanus toxoids for pediatric use (DT) is indicated for immunization of infants and children 6 weeks up to 7 years of age ^{01}.

Strength(s) usually available: DT contains 6.6 to 25 Lf units of diphtheria toxoid and 5 to 10 Lf units of tetanus toxoid, per dose ^{{01} {02} {03} {04} {05} {06} {36}}.


Additional Dosing Information
Diphtheria toxoid of the strength used in DT is not recommended for adults and children 7 years of age and older, because of the increased risk of side/adverse effects associated with the use of higher doses of diphtheria toxoid in this age group ^{{01} {06}}.

It is recommended that infants and children up to 7 years of age receive diphtheria and tetanus toxoids as part of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP). In those cases in which the pertussis vaccine is contraindicated, it is recommended that DT be administered instead ^{01}.

The primary immunizing series of DT consists of 4 doses (3 initial and 1 reinforcing) for children 6 weeks up to 1 year of age (in Canada, 2 months up to 7 years of age) or 3 doses (2 initial and 1 reinforcing) for children 1 to 7 years of age ^{{01} {06}}.

Preterm infants should be immunized according to their chronological age from birth ^{{18} {30}}.

DT can be administered concurrently with the following, using separate body sites and separate syringes (for parenterals), and the precautions that apply to each immunizing agent:
   • Hepatitis B recombinant or plasma-derived vaccine ^{{27} {31}}.
   • Polysaccharide vaccines, such as haemophilus b polysaccharide vaccine, haemophilus b conjugate vaccine, or pneumococcal polyvalent vaccine ^{{18} {26} {27} {31}}.
   • Live virus vaccines, such as measles, mumps, and rubella (MMR) or oral polio vaccine (OPV) ^{{18} {26} {27} {31}}.
   • Inactivated poliovirus vaccine (IPV) or enhanced-potency inactivated vaccine (enhanced-potency IPV) ^{{18} {27} {31}}.


Parenteral Dosage Forms

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (DT) (FOR PEDIATRIC USE) USP

Note: DT is indicated for immunization of infants and children 6 weeks up to 7 years of age who cannot receive diphtheria and tetanus toxoids and pertussis vaccine (DTP) combination, because of a contraindication to pertussis vaccine. If there is no contraindication to pertussis vaccine, DTP is the vaccine of choice for this age group ^{01}.


Usual adult and adolescent dose
Use is not recommended. Tetanus and diphtheria toxoids for adult use (Td) should be administered instead ^{{01} {07}}.

Usual pediatric dose
Diphtheria and tetanus (prophylaxis)
Intramuscular, preferably into the deltoid or the midlateral muscles of the thigh.


U.S.:
Children 6 weeks to 1 year of age: 0.5 mL at four- to eight-week intervals for a total of three doses. A fourth dose of 0.5 mL is administered six to twelve months after the third dose. A booster (fifth) dose of 0.5 mL is usually administered at four through six years of age (i.e., preferably prior to school entry); however, if the fourth dose of the primary immunizing series was administered after the fourth birthday, a booster (fifth) dose is not necessary ^{{01} {18}}.

Children 1 to 7 years of age: 0.5 mL followed by 0.5 mL four to eight weeks later for a total of two doses. A third dose of 0.5 mL is administered six to twelve months after the second dose. A booster (fourth) dose of 0.5 mL is usually administered at four through six years of age (i.e., preferably prior to school entry); however, if the third dose of the primary immunizing series was administered after the fourth birthday, a booster (fourth) dose is not necessary ^{01}.

Children 7 years of age and older: Use is not recommended. Td should be administered instead ^{{01} {07}}.



Canada:
Children 2 months to 7 years of age: 0.5 mL at eight-week intervals for a total of three doses. A fourth dose of 0.5 mL is administered twelve months after the third dose. A booster (fifth) dose of 0.5 mL is usually administered at four through six years of age (i.e., preferably prior to school entry); however, if the fourth dose of the primary immunizing series was administered after the fourth birthday, a booster (fifth) dose is not necessary ^{06}.

Children 7 years of age and older: Use is not recommended. Td should be administered instead. ^{06}



Strength(s) usually available
U.S.—


6.6 Lf units of diphtheria toxoid and 5 Lf units of tetanus toxoid per 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{03}


7.5 Lf units of diphtheria toxoid and 7.5 Lf units of tetanus toxoid per 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{04}


10 Lf units of diphtheria toxoid and 5 Lf units of tetanus toxoid per 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{02}


12.5 Lf units of diphtheria toxoid and 5 Lf units of tetanus toxoid per 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{01}


15 Lf units of diphtheria toxoid and 10 Lf units of tetanus toxoid per 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{05}

Canada—


25 Lf units of diphtheria toxoid and 5 Lf units of tetanus toxoid in each 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{06}

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


Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F), unless otherwise specified by manufacturer. Store away from the freezer compartment. Protect from freezing ^{{01} {32}}.

Stability:
Freezing destroys activity. The product should not be used if it has been exposed to freezing ^{{12} {32}}. In addition, the product should not be left out at room temperature (e.g., between patients) ^{37}.

Auxiliary labeling:
   • Shake the vial vigorously immediately before each dose is withdrawn in order to resuspend the contents ^{{01} {12}}.
   • Protect from freezing ^{{01} {12} {32}}.


TETANUS AND DIPHTHERIA TOXOIDS (Td)
Summary of Differences
Indications: Tetanus and diphtheria toxoids for adult use (Td) is indicated for immunization of adults and children 7 years of age and older ^{{07} {08}}.

Side/adverse effects: Arthus-type reaction and fever over 39.4 °C usually occur only in patients old enough to receive Td, i.e., persons old enough to have received multiple booster doses of a tetanus toxoid–containing product ^{{03} {06} {07} {08} {12} {18} {33}}.

Strength(s) usually available: Td contains 2 Lf units of diphtheria toxoid and 2 to 10 Lf units of tetanus toxoid, per dose ^{{07} {08} {09} {10} {11} {12} {13} {36}}.


Additional Dosing Information
The concentration of diphtheria toxoid in Td, which is intended for use in persons 7 years of age and older, is lower than that of the concentration of diphtheria toxoid in diphtheria and tetanus toxoids for pediatric use (DT) ^{07}.

It is recommended that adults and children 7 years of age and older receive Td rather than the single-entity tetanus toxoid for the primary immunizing series, all booster doses, and active tetanus immunization in wound management. This is to help ensure protection against diphtheria infection, since a large proportion of adults is susceptible to diphtheria infection ^{07}.

The primary immunizing series of Td consists of 3 doses (2 initial and 1 reinforcing) for adults and children 7 years of age and older ^{07}.


Parenteral Dosage Forms

TETANUS AND DIPHTHERIA TOXOIDS ADSORBED FOR ADULT USE (Td) USP

Usual adult and adolescent dose
Diphtheria and tetanus (prophylaxis)—Intramuscular, preferably into the deltoid: 0.5 mL followed by 0.5 mL four to eight weeks later (in Canada, eight weeks later) for a total of two doses. A third dose of 0.5 mL is administered six to twelve months after the second dose. A booster dose of 0.5 mL is administered every ten years thereafter ^{{07} {12} {13}}.

Note: If a booster dose of Td is administered less than ten years after the previous booster dose (e.g., as part of wound management or after exposure to diphtheria), the next booster dose should be administered ten years after the interim dose ^{07}.


Usual pediatric dose
Diphtheria and tetanus (prophylaxis)—Intramuscular, preferably into the deltoid or the midlateral muscles of the thigh.
Children up to 7 years of age—Use is not recommended. Diphtheria and tetanus toxoids for pediatric use (DT) should be administered instead ^{{01} {07}}.

Children 7 years of age and older—See Usual adult and adolescent dose ^{{07} {12} {13}}.


Strength(s) usually available
U.S.—


2 Lf units of tetanus toxoid and 2 Lf units of diphtheria toxoid per 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{10}


5 Lf units of tetanus toxoid and 2 Lf units of diphtheria toxoid per 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{07}{08}{09}


10 Lf units of tetanus toxoid and 2 Lf units of diphtheria toxoid per 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{11}

Canada—


5 Lf units of tetanus toxoid and 2 Lf units of diphtheria toxoid per 0.5 mL dose (Rx)[Generic](may contain thimerosal)^{12}{13}

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


Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F), unless otherwise specified by manufacturer. Store away from the freezer compartment. Protect from freezing ^{{07} {12} {32}}.

Stability:
Freezing destroys activity. The product should not be used if it has been exposed to freezing ^{07}. In addition, the product should not be left out at room temperature (e.g., between patients) ^{37}.

Auxiliary labeling:
   • Shake the vial vigorously immediately before each dose is withdrawn in order to resuspend the contents ^{{07} {12}}.
   • Protect from freezing ^{{07} {12} {32}}.

Developed: 04/26/1995

References

1. Diphtheria and Tetanus Toxoids Adsorbed (Lederle). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 1158.
   

2. Diphtheria and Tetanus Toxoids Adsorbed package insert (Wyeth-Ayerst— US), Rev 4/94, Rec 11/94.
   

3. Diphtheria and Tetanus Toxoids Adsorbed package insert (Connaught— US), Rev 4/84, Rec 10/94.
   

4. Diphtheria and Tetanus Toxoids Adsorbed package insert (Massachusetts Public Health Biologic Labs), Rev 8/92, Rec 11/94.
   

5. Diphtheria and Tetanus Toxoids Adsorbed (Biocine Sclavo). In: Tatro DS, editor. Drug interaction facts. St Louis: Facts and Comparisons, 1990: 470b (7/93).
   

6. Diphtheria and Tetanus Toxoids Adsorbed (Connaught). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 388.
   

7. Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Lederle). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 1189.
   

8. Tetanus and Diphtheria Toxoids Adsorbed for Adult Use package insert (Wyeth-Ayerst—US), Rev 2/94, Rec 10/94.
   

9. Tetanus and Diphtheria Toxoids Adsorbed for Adult Use package insert (Connaught—US), Rev 12/85, Rec 10/94.
   

10. Tetanus and Diphtheria Toxoids Adsorbed for Adult Use package insert (Massachusetts Public Health Biologic Labs), Rev 9/94, Rec 11/94.
    

11. Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Biocine Sclavo). In: Tatro DS, editor. Drug interaction facts. St Louis: Facts and Comparisons, 1990: 470b (7/93).
    

12. Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (IAF BioVac). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 389.
    

13. Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Connaught). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 1300.
    

14. The United States pharmacopeia. The national formulary. USP 23rd revision (January 1, 1995). NF 18th ed (January 1, 1995). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1995: 538, 1503.
    

15. Tetanus Toxoid Adsorbed (Wyeth-Ayerst). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 2609.
    

16. Bentley DW. Vaccinations. Clin Geriatr Med 1992 Nov; 8(4): 745-60.
    

17. Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR 1993 Apr 9; 42(RR-4): 1-18.
    

18. Centers for Disease Control and Prevention. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991 Aug 8; 40(RR-10): 1-28.
    

19. Centers for Disease Control and Prevention. Update on adult immunization: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991 Nov 15; 40(RR-12): 1-94.
    

20. Tetanus Toxoid Adsorbed package insert (Te Anatoxal Berna, Berna—US), Rev 1/91, Rec 6/93.
    

21. Reviewer comment to Tetanus Toxoid monograph, 9/90.
    

22. Tetanus Toxoid Adsorbed package insert (Connaught—US), Rev 12/85, Rec 7/93.
    

23. 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.
    

24. 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.
    

25. Reviewer comment to Tetanus Toxoid monograph, 4/15/88.
    

26. Grabenstein JD. Drug interactions involving immunologic agents. Part I. Vaccine-vaccine, vaccine-immunoglobulin, and vaccine-drug interactions. Drug Intell Clin Pharm 1990 Jan; 24: 67-81.
    

27. Centers for Disease Control and Prevention. Pertussis vaccination: acellular pertussis vaccine for reinforcing and booster use—supplementary ACIP statement. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1992 Feb 7; 41(RR-1): 1-10.
    

28. Harcus AW, Ward AE, Roberts J, et al. An evaluation of diphtheria-tetanus (adult) vaccine in unselected human volunteers. J Int Med Res 1989; 17: 262-7.
    

29. Stratton KR, Johnson Howe C, Johnston RB Jr. Adverse events associated with childhood vaccines other than pertussis and rubella: summary of a report from the Institute of Medicine. JAMA 1994 May; 271: 1602-5.
    

30. Centers for Disease Control and Prevention. Standards for pediatric immunization practices. Recommended by the National Vaccine Advisory Committee. MMWR 1993 Apr 23; 42 (RR-5): 12.
    

31. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1994 Jan 28; 43 (RR-1): 13.
    

32. ACP Task Force on Adult Immunization and Infectious Diseases Society of America. Guide for Adult Immunization. 2nd ed. Philadelphia: American College of Physicians, 1990: 2, 17, 22, 37, 110-1.
    

33. Centers for Disease Control and Prevention. Health information for international travel 1994. Washington, D.C.: U.S. Government Printing Office, 1994: 94.
    

34. Ridgway D, Wolff LJ, Deforest A. Immunization response varies with intensity of acute lymphoblastic leukemia therapy. Am J Dis Child 1991 Aug; 145(8): 887-91.
    

35. Reviewers' consensus on monograph revision of 9/23/94.
    

36. Panel comment, 9/23/94.
    

37. Panel comment, 9/23/94.
    

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