Drug: Diphtheria and Tetanus

Diphtheria and Tetanus Toxoids Adsorbed USP (For Pediatric Use) (DT), for intramuscular use, is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color. Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.1 Clostridium tetani cultures are grown in a peptone-based medium containing bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration. The 1 dose vial of vaccine is formulated without preservatives but contains a trace amount of thimerosal (a mercury [Hg] containing compound) from the manufacturing process (≤0.3 mg Hg/0.5 mL dose).The multidose (5 mL) vial of vaccine contains the preservative thimerosal (25 mg Hg/0.5 mL dose). Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid,5 Lf of tetanus toxoid, and not more than 0.17 mg of aluminum. The residual formaldehyde content, by assay, is less than 0.02%.Both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test. REFERENCES 1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40:21-32,1941

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BODY SYSTEM AS A WHOLE Adverse reactions may be local and include redness, warmth, edema, induration, with or without tenderness, as well as urticaria, and rash. Malaise, transient fever, pain, hypotension, nausea and arthralgia may develop in some patients after the injection. Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection) may occur, particularly in persons who have received multiple prior boosters.2 Rarely, an anaphylactic reaction (i.e., hives, swelling of the mouth, difficulty breathing, hypotension, or shock) and death have been reported after receiving preparations containing diphtheria and tetanus antigens.2 The vaccine was well tolerated clinically. No local or systemic reactions were observed in approximately half of the infants and only mild or moderate reactions were observed in the remainder of the study group (Table 3).3 TABLE 33 SUMMARY OF CLINICAL REACTIONS   Category of Reactions

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DOSAGE AND ADMINISTRATION2 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 0.5 mL intramuscularly only. The preferred injection sites are the anterolateral aspect of the thigh and the deltoid muscle of the upper arm. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk. During the course of primary immunizations, injections should not be made more than once at the same site. The following guidelines are derived from the Advisory Committee on Immunization Practices (ACIP).2 PRIMARY IMMUNIZATION This vaccine is recommended for children 6 weeks through 6 years (up to the seventh birthday),ideally beginning when the infant is 6 weeks to 2 months of age. For infants 6 weeks through 12 months, the primary series consists of 4 doses: administer three 0.5 mL doses intramuscularly 4 to 8 weeks apart. A reinforcing dose is given 6 to 12 months after the third injection. For children 1 year through 6 years (up to the seventh birthday), the primary series consists of 3 doses: administer two 0.5 mL doses intramuscularly 4 to 8 weeks apart. A reinforcing dose is given 6 to 12 months after the second injection. In the event the final immunizing dose would be given after the seventh birthday, use Tetanus and Diphtheria Toxoids Adsorbed for Adult Use. BOOSTER IMMUNIZATION For children between 4 and 6 years of age (preferably at time of kindergarten or elementary school entrance), a booster of 0.5 mL should be administered intramuscularly. Those who receive all four primary immunizing doses before their fourth birthday should receive a single dose of DT just before entering kindergarten or elementary school. This booster dose is not necessary if the fourth dose in the primary series was given after the fourth birthday. Thereafter, routine booster immunizations should be with Tetanus and Diphtheria Toxoids Adsorbed for Adult Use, at intervals of 10 years. PERSONS 7 YEARS OF AGE AND OLDER SHOULD NOT BE IMMUNIZED WITH DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (FOR PEDIATRIC USE). Preterm infants should be vaccinated according to their chronological age from birth.2 Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity achieved with DT. There is no need to start the series over again, regardless of the time elapsed between doses. The simultaneous administration of DT, oral polio virus vaccine (OPV), and measles-mumps-rubella vaccine (MMR) has resulted in seroconversion rates and rates of side effects similar to those observed when the vaccines are administered separately. Simultaneous vaccination (at separate sites and separate syringes) with DT, MMR, OPV, or inactivated poliovirus vaccine (IPV), and Haemophilus b Conjugate Vaccine (HbCV) is also acceptable. The ACIP recommends the simultaneous administration, at separate sites and separate syringes, of all vaccines appropriate to the age and previous vaccination status of the recipients including the special circumstance of simultaneous administration of DT, OPV, HbCV, and MMR at ≥15 months of age.2 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.2

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If passive immunization for tetanus is needed, TIG (Human) is the product of choice for tetanus.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.2 Diphtheria Antitoxin (equine) is available for treatment of the acute phases of diphtheria. When DT and Diphtheria Antitoxin are used together, they must be given at different sites using separate needles and syringes. As with other intramuscular injections, use with caution in patients on anticoagulant therapy. Immunosuppressive therapies may reduce the response to vaccines (see PRECAUTIONS GENERAL section). 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.RR-10,1991
3. Pichichero ME, et al. Pediatric diphtheria and tetanus (diphtheria and tetanus (diphtheria and tetanus toxoids) toxoids) toxoids-adsorbed vaccine: Immune response to the first booster following the diphtheria and tetanus (diphtheria and tetanus (diphtheria and tetanus toxoids) toxoids) toxoids vaccine primary series. Pediatr Infec Dis 5:428-430,1986
9. Stratton KR, et al. Adverse events associated with childhood vaccines. Evidence Bearing on Causality. National Academy Press, Washington,DC,1994
11.CDC.Vaccine Adverse Event Reporting System United States. MMWR 39:730-733,1990
12.CDC. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37:197-200,1988
13.Food and Drug Administration. New reporting requirements for vaccine adverse events. FDA Drug Bull 18 (2),16-18,1988
14.Rutledge SL, et al .Neurological complications of immunizations. J Pediatr 109:917-924,1986
15.Wilson GS. The Hazards of Immunization. Allergic manifestations: Post-vaccinal neuritis. pp 153-156,1967
16.Tsairis P, et al. Natural history of brachial plexus neuropathy.Arch Neurol 27:109-117,1972
17.Blumstein GI, et al. Peripheral neuropathy following Tetanus toxoid administration. JAMA 198:1030-1031,1966
18.Cody CL, et al. Nature and rates of adverse reactions associated with DTP and DT immunizations in infants and children. Pediatr 68:650-660,1981
19.Pollard JD, et al. Relapsing neuropathy due to tetanus toxoid: report of a case. J Neurol Sci 37:112-125,1978Last reviewed on RxList: 6/8/2006
This monograph has been modified to include the generic and brand name in many instances.

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Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT) is indicated for active immunization of children up to age 7 years against diphtheria and tetanus. Diphtheria and Tetanus (diphtheria and tetanus (diphtheria and tetanus toxoids) toxoids) Toxoids and Acellular Pertussis Vaccine (DTaP) TripediaÒ,or DTP is recommended for primary immunization of infants and persons up to 7 years of age. However, in instances where the pertussis vaccine component is contraindicated, or where the physician decides that pertussis vaccine is not to be administered, DT should be used.2 Immunization should be started at 6 weeks to 2 months of age and be completed before the seventh birthday. Immunization always should be started at once if diphtheria is present in the community. This vaccine is NOT to be used for the treatment of diphtheria or tetanus infection. This vaccine should NOT be used for immunizing persons 7 years of age and older. For persons 7 years of age and older, the recommended vaccine is Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td). As with any vaccine, vaccination with DT may not protect 100% of susceptible individuals. If passive immunization is required, Tetanus Immune Globulin (Human) (TIG) and/or equine Diphtheria Antitoxin are the products of choice for tetanus and diphtheria, respectively (see DRUG INTERACTIONS and DOSAGE AND ADMINISTRATION sections).

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HYPERSENSITIVITY TO ANY COMPONENT OF THE VACCINE,INCLUDING THIMEROSAL, A MERCURY DERIVATIVE,IS A CONTRAINDICATION FOR FURTHER USE OF THIS VACCINE. It is a contraindication to use this or any other related vaccine after an immediate anaphylactic reaction associated with a previous dose. A history of systemic allergic or neurologic reactions following a previous dose of DT is an absolute contraindication for further use.2 If a contraindication to using tetanus toxoid-containing preparations exists in a person who has not completed a primary immunizing course of tetanus toxoid and other than a clean, minor wound is sustained, only passive immunization should be given using TIG (Human).2 Immunization should be deferred during the course of an acute illness. Vaccination of infants and children with severe, febrile illness should generally be deferred until these persons have recovered. However, the presence of minor illnesses such as mild upper respiratory infections with or without low grade fever should not preclude vaccination.2 Elective immunization procedures should be deferred during an outbreak of poliomyelitis.8 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.RR-10,1991
8. Wilson GS. The Hazards of Immunization. Provocation poliomyelitis.270-274,1967Last reviewed on RxList: 6/8/2006
This monograph has been modified to include the generic and brand name in many instances.

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No information provided..

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Vial,1 Dose (contains NO preservative) (10 per package) Product No.49281-278-10 Vial,10 Dose (5 mL) (contains preservative) Product No.49281-275-10 STORAGE Store between 2° - 8°C (35° - 46°F).DO NOT FREEZE. 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.RR-10,1991 Manufactured by:
Aventis Pasteur Inc.
Swiftwater PA 18370 USA
Product information as of October 2001
Printed in USA
FDA revision date: 10/01 Last reviewed on RxList: 6/8/2006
This monograph has been modified to include the generic and brand name in many instances.

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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.

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