Diptheria and Tetanus
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In 2013, the US Food and Drug Administration (FDA) grant"...
Diphtheria and Tetanus
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).
DOSAGE AND ADMINISTRATION
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
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.
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
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
Store between 2° - 8°C (35° - 46°F).DO NOT FREEZE.
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
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
Additional Diphtheria and Tetanus Information
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