Drug: DTP

Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed USP (For Pediatric Use) combines diphtheria and tetanus toxoids adsorbed with pertussis vaccine, for intramuscular use, in a sterile isotonic sodium chloride solution containing sodium phosphate buffer to control pH. The vaccine, after shaking, is a turbid liquid, whitish-gray in color. When used to reconstitute Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), ActHIB ® or OmniHIB, the combined vaccines appear whitish 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. Both toxins are detoxified with formaldehyde. The detoxified materials are separately purified by serial ammonium sulfate fractionation and diafiltration. The pertussis vaccine component is derived from Bordetella pertussis cultures grown on blood-free Bordet Gengou media. The pertussis organisms are harvested and inactivated with thimerosal and resuspended in physiological saline and thimerosal. The toxoids are adsorbed to aluminum potassium sulfate (alum). The adsorbed diphtheria and tetanus toxoids are combined with pertussis vaccine concentrate, and diluted to a final volume using sterile phosphate-buffered physiological saline. Each 0.5 mL dose contains, by assay, not more than 0.17 mg of aluminum and not more than 100 µg (0.02%) of residual formaldehyde. Thimerosal (mercury derivative) 1:10,000 is added as a preservative. Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test). The total human immunizing dose (the first three 0.5 mL doses administered) contains an estimate of 12 units of pertussis vaccine (4 protective units per single dose). 2 The potency of the pertussis component of each lot of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) is tested in a mouse protection test. At the time when Connaught Laboratories, Inc. (CLI) DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB, each single dose of the 0.5 mL mixture is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, an estimate of 4 protective units of pertussis vaccine, 10 µg of purified capsular polysaccharide conjugated to 24 µg of inactivated tetanus toxoid, and 8.5% of sucrose. NOTE: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB ® is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) OmniHIB (distributed by SmithKline Beecham Pharmaceuticals); both products are manufactured by Pasteur Mérieux Sérums & Vaccins S. A.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Adverse reactions associated with the use of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) include local redness, warmth, edema, induration with or without tenderness, as well as urticaria and rash. Some data suggest that febrile reactions are more likely to occur in those who have experienced such responses after prior doses. 6 The frequency of local reactions and fever following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccination is significantly higher with increasing numbers of doses of D.P. while other mild to moderate systemic reactions (e. g., fretfulness, vomiting) are significantly less frequent. 19 If local redness 2.5 cm occurs, the likelihood of recurrence after another DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) dose increases significantly. 6 Evidence does not indicate a causal relation between DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine and SIDS. Studies showing a temporal relation between these events are consistent with the expected occurrence of SIDS over the age range in which DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) immunization typically occurs. 13 Deaths due to causes other than SIDS, including deaths due to serious infections, have occurred in infants following the administration of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) . No association has been shown for hospitalizations due to infectious disease and receipt of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) . 20 Approximate rates for adverse events following receipt of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine (regardless of dose number in the series) are indicated in TABLE 1. 2 TABLE 1 2 ADVERSE EVENTS OCCURRING WITHIN 48 HOURS OF DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) VACCINATIONS Event Frequency* Local   Redness 1/3 doses Swelling 2/5 doses Pain 1/2 doses Systemic   Fever > 38°C (> 100.4° F) 1/2 doses Drowsiness 1/3 doses Fretfulness 1/2 doses Vomiting 1/15 doses Anorexia 1/5 doses Persistent, inconsolable crying (duration > 3 hours) 1/100 doses Fever ³ 40.5°C (³ 105° F) 1/330 doses Nervous System   Collapse (hypotonic-hyporesponsive episode) 1/1,750 doses Convulsions (with or without fever) 1/1,750 doses
*Rate per total number of doses regardless of dose number in DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) series. Body System as a Whole Mild systemic reactions such as fever, drowsiness, fretfulness, and anorexia, occur quite frequently. These reactions are significantly more common following administration of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) than following DT, are usually self-limited, and need no therapy other than symptomatic treatment such as acetaminophen. 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, tetanus, and/or pertussis antigens. 2 Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection), may follow receipt of tetanus toxoid. 2 Moderate to severe systemic events, include high fever (i. e., temperature of >40.5° C [> 105° F]) and persistent, inconsolable crying lasting > 3 hours. These events occur infrequently and appear to be without sequelae. 2 Occasionally, a nodule may be palpable at the injection site of adsorbed products for several weeks. Sterile abscesses at the site of injection have been reported (6 to 10 per million doses). 2 Nervous System The following neurologic illnesses have been reported as temporally associated with vaccine containing tetanus toxoid: neurological complications 21,22 including cochlear lesion, 23 brachial plexus neuropathies, 23,24 paralysis of the radial nerve, 25 paralysis of the recurrent nerve, 23 accommodation paresis, and EEG disturbances with encephalopathy. 19 The report from the IOM suggests that there is a causal relation between Guillain-Barré syndrome (GBS) and vaccines containing tetanus toxoid. 26 In the differential diagnosis of polyradiculoneuropathies following administration of a vaccine containing tetanus toxoid should be considered as a possible etiology. 19,27 Short-lived convulsions (usually febrile), or collapse (hypotonic-hyporesponsive episode) occur infrequently and appear to be without sequelae. 2 More severe neurologic events, such as a prolonged convulsion, or encephalopathy, although rare, have been reported in temporal association with DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) administration. An analysis of these data failed to show any cause and effect association. 2 In the National Childhood Encephalopathy Study (NCES), a large, case-control study in England, children 2 to 35 months of age with serious, acute neurologic disorders such as encephalopathy or complicated convulsion( s), were more likely to have received DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) in the 7 days preceding onset than their age-, sex-, and neighborhood-matched controls. Among children known to be neurologically normal before entering the study, the relative risk (estimated by odds ratio) of a neurologic illness occurring within the 7-day period following receipt of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) dose, compared to children not receiving DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) in the 7-day period before onset of their illness, was 3.3 (p < 0.001). 2 Within this 7-day period, the risk was significantly increased for immunized children only within 3 days of vaccination (relative risk 4.2, p < 0.001). The relative risk for illnesses occurring 4 to 7 days after vaccination was 2.1 (p < 0.1). Serious neurologic illnesses requiring hospitalization attributable to pertussis vaccine are rare. Final analysis of a comprehensive case-control study has estimated that the attributable risk of such illnesses is 1 in 140,000 doses administered. An earlier analysis had estimated this risk at 1/110,000 doses. In contrast, final analysis of the case-control study found that the risk of serious neurologic illness following pertussis disease was 1/11,000 pertussis cases. Repeated evaluations have shown that the benefits of vaccine outweigh the risks. 2,9 The methods and results of the NCES have been thoroughly scrutinized since publication of the study. This reassessment by multiple groups has determined that the number of patients was too small and their classification subject to enough uncertainty to preclude drawing valid conclusions about whether a causal relation exists between pertussis vaccine and permanent neurologic damage. Preliminary data from a 10-year follow-up study of some of the children studied in the original NCES study also suggested a relation between symptoms following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccination and permanent neurologic disability. However, details are not available to evaluate this study adequately, and the same concerns remain about DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine precipitating initial manifestations of pre-existing neurologic disorders. 2 An IOM report by the Committee to review the adverse consequences of pertussis and rubella vaccines concluded that evidence is consistent with a causal relation between DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine and acute encephalopathy, defined in the controlled studies reviewed as encephalopathy, encephalitis, or encephalomyelitis. On the basis of a review of the evidence bearing on this relation, the Committee concludes that the range of excess risk of acute encephalopathy following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) immunization is consistent with that estimated for the NCES: 0.0 to 10.5 per million immunizations. The report also states that there is insufficient evidence to indicate a causal relation between DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine and permanent neurologic damage. 13 Onset of infantile spasms has occurred in infants who have recently received DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or DT. Analysis of data from the NCES on children with infantile spasms showed that receipt of DT or DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was not causally related to infantile spasms. 28 The incidence of onset of infantile spasms increases at 3 to 9 months of age, the time period in which the second and third doses of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) are generally given. Therefore, some cases of infantile spasms can be expected to be related by chance alone to recent receipt of D.P. 2 A bulging fontanelle associated with increased intracranial pressure which occurred within 24 hours following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) immunization has been reported. A causal relationship has not been established. 29,30,31 Cardiovascular System An infant who developed myocarditis several hours after immunization has been reported. 32 Respiratory System Respiratory difficulties, including apnea, have been observed. Local Rash and allergic reactions have been observed. Sudden Infant Death Syndrome (SIDS) has temporally occurred in infants following administration of D.P. A large case-control study of SIDE in the United States showed that receipt of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was not causally related to SIDS. 33,34,35 It should be recognized that the first three primary immunizing doses of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) are usually administered to infants 2 to 6 months of age and that approximately 85% of SIDS cases occur at ages 1 to 6 months, with the peak incidence occurring at 6 weeks to 4 months of age. By chance alone, some SIDE victims can be expected to have recently received D.P. 33,34,35 When CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was administered concomitantly (at separate sites with separate syringes) with ActHIB ® or OmniHIB, the systemic adverse experience profile was not different from that seen when CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine was administered alone. 10,11 (Refer to ActHIB ® package insert.) In general, the rates of minor systemic reactions after DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was used to reconstitute ActHIB ® or OmniHIB were comparable to those usually reported after DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine alone. 6,19,36 When CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) was used to reconstitute ActHIB ® or OmniHIB and administered to infants at 2, 4, and 6 months of age, the systemic adverse experience profile was comparable to that observed when the two vaccines were given separately. An increase in the rate of local reactions was observed in some instances within the 24- hour period after immunization. 10,11 (Refer to ActHIB ® package insert.) Reporting of Adverse Events Reporting by parents or guardians of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by health-care providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967. 16,17,18 Health-care providers also should report these events to the Director of Medical Affairs, Connaught Laboratories, Inc., a Pasteur Mérieux Connaught Company, Route 611, PO Box 187, Swiftwater, PA 18370 or call 1-800-822-2463. Read the DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

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. Vaccine contains a bacterial suspension. Vigorous agitation is required to resuspend the contents of the vial. Discard if vaccine cannot be resuspended. For Administration of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) Vaccine Only The primary series for children less than 7 years of age is four doses of 0.5 mL each given intramuscularly. The customary age for the first dose is 2 months of age but may be given as young as 6 weeks of age and up to the seventh birthday. 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 use of reduced volume (fractional doses) is not recommended. The effect of such practices on the frequency of serious adverse events and on protection against disease has not been determined. Do NOT administer this product subcutaneously. Special care should be taken to ensure that the injection does not enter a blood vessel. 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. The primary series consists of four doses. For infants 6 weeks through 12 months of age, administer three 0.5 mL doses intramuscularly at least 4 to 8 weeks apart. The fourth dose is administered 6 to 12 months after the third injection. 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 DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) just before entering kindergarten or elementary school. This booster dose is not necessary if the fourth dose in the primary series was administered after the fourth birthday. Thereafter, routine booster immunizations should be with Td, at intervals of 10 years. PERSONS 7 YEARS OF AGE AND OLDER SHOULD NOT BE IMMUNIZED WITH DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS VACCINE ADSORBED USP (FOR PEDIATRIC USE) (DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) ). TABLE 2 2 ROUTINE DIPHTHERIA, TETANUS, AND PERTUSSIS VACCINATION SCHEDULE Summary For Children < 7 Years Old United States, 1991 Dose Customary Age Age/Interval † Product Primary 1 2 Months 6 weeks old or older DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) † Primary 2 4 Months 4-8 weeks after first dose* DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) † Primary 3 6 Months 4-8 weeks after second dose* DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) † Primary 4 15 Months 6-12 months after third dose* DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) † Booster 4-6 years old, before entering kindergarten or elementary school (not necessary if fourth primary vaccinating dose administered after fourth birthday) DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) † Additional Boosters Every 10 years after last dose Td
*Use DT if pertussis vaccine is contraindicated. If the child is ³ 1 year of age at the time that primary dose three is due, a third dose 6 to 12 months after the second dose completes primary vaccination with DT. †Prolonging the interval does not require restarting series. Preterm infants should be vaccinated according to their chronological age from birth. 2,9 Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity achieved with D.P. There is no need to start the series over again, regardless of the time elapsed between doses. Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) can be interchangeably used with DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) for the fourth and fifth doses. However ActHIB ® cannot be reconstituted with DTaP. The simultaneous administration of D.P. oral poliovirus 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 with separate syringes) with D.P. MMR, OPV, or inactivated poliovirus vaccine (IPV), and Haemophilus b conjugate vaccine (HbCV) is also acceptable. 2 The ACIP recommends the simultaneous administration, at separate sites with separate syringes, of all vaccines appropriate to the age and previous vaccination status of the recipients including the special circumstance of simultaneous administration of D.P. OPV, HbCV, and MMR at ³15 months of age. 2 If passive immunization is needed for tetanus, TIG 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 for wounds of average severity is 250 units intramuscularly. When tetanus toxoid and TIG are administered concurrently, separate syringes and separate sites should be used. The ACIP recommends the use of only adsorbed toxoid in this situation. 2 WHEN RECONSTITUTING HAEMOPHILUS b CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE), ActHIB ® or OmniHIB NOTE: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB ® is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) OmniHIB (distributed by SmithKline Beecham Pharmaceuticals); both products are manufactured by Pasteur Mérieux Sérums & Vaccins S. A. CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine also can be used for reconstitution of ActHIB ® or OmniHIB. Cleanse both the DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) and ActHIB ® or OmniHIB vaccine vial rubber barriers with a suitable germicide prior to reconstitution. Thoroughly agitate the vial of CLI wholecell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine, then withdraw a 0.6 mL dose and inject into the vial of lyophilized ActHIB ® or OmniHIB. After reconstitution and thorough agitation, ActHIB ® or OmniHIBwill appear whitish in color. Withdraw and administer 0.5 mL dose of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /ActHIB ® or OmniHIBvaccines. When CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB, administer intramuscularly only. Vaccine should be used within 24 hours after reconstitution. After reconstitution, each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, an estimate of 4 protective units of pertussis vaccine, 10 mg of purified capsular polysaccharide conjugated to 24 mg of inactivated tetanus toxoid, and 8.5% of sucrose. (Refer to ActHIB ® package insert.) Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel. Each dose of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /ActHIB ® or OmniHIBvaccines is administered intramuscularly in the outer aspect of the vastus lateralis (midthigh) or deltoid. The vaccine should not be injected into the gluteal area or areas where there may be a nerve trunk. During the course of primary immunizations, injections should not be made more than once at the same site. When CLI DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB, the combined vaccines are indicated for infants and children 2 months through 5 years of age for intramuscular administration in accordance with the schedule indicated in Table 3. 10 TABLE 3 10 RECOMMENDED IMMUNIZATION SCHEDULE For Previously Unvaccinated Children DOSE AGE IMMUNIZATION First, Second and Third At 2, 4 and 6 months DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /ActHIB® or DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /OmniHIBTM Fourth At 15 to 18 months DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /ActHIB® or DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /OmniHIB TM or Acellular Pertussis (DTaP)* Fifth At 4 to 6 years DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or Acellular Pertussis (DTaP)*
*Acellular Pertussis (DTaP) should NOT be used to reconstitute ActHIB®/OmniHIB. When administering DTaP for the fourth dose, Haemophilus influenzae type b vaccine also should be administered at this time in a separate syringe at a different site. For Previously Unvaccinated Children Immunization schedules should be considered on an individual basis for children not vaccinated according to the recommended schedule. Three doses of a product containing D.P. given at approximately 2-month intervals, are required followed by a fourth dose of a product containing DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or DTaP approximately 12 months later and a fifth dose of a product containing DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or DTaP at 4 to 6 years of age. If the fourth dose of a pertussis-containing vaccine is not given until after the fourth birthday, no further doses of a pertussis-containing vaccine are necessary. The number of doses of a product containing H influenzae type b conjugate vaccine indicated depends on the age that immunization is begun. A child 7 to 11 months of age should receive 3 doses of a product containing H influenzae type b conjugate vaccine. A child 12 to 14 months of age should receive 2 doses of a product containing H influenzae type b conjugate vaccine. A child 15 to 59 months of age should receive 1 dose of a product containing H influenzae type b conjugate vaccine. Preterm infants should be vaccinated according to their chronological age from birth. 9
Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved when CLI DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB. There is no need to start the series over again, regardless of the time elapsed between doses. It is recommended that the same conjugate vaccine be used throughout each immunization schedule, consistent with the data supporting approval and licensure of the vaccine. Since ActHIB ® or OmniHIB are the same vaccine, these may be used interchangeably. DO NOT INJECT INTRAVENOUSLY

Source: http://www.rxlist.com

If DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) and TIG or Diphtheria Antitoxin are administered concurrently, separate syringes and separate sites should be used. As with other intramuscular injections, use with caution in patients on anticoagulant therapy. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines. Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Although no specific studies with pertussis vaccine are available, if immunosuppressive therapy will be discontinued shortly, it is reasonable to defer vaccination until the patient has been off therapy for one month; otherwise, the patient should be vaccinated while still on therapy. 2 If DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) has been administered to persons receiving immunosuppressive therapy, a recent injection of immunoglobulin or having an immunodeficiency disorder, an adequate immunologic response may not be obtained. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed USP (For Pediatric Use) is recommended for active immunization of children up to age 7 years against diphtheria, tetanus, and pertussis (whooping cough) simultaneously. 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. Immunization should be started at 6 weeks to 2 months of age and be completed before the seventh birthday. 2,9 Persons recovering from confirmed pertussis do not need additional doses of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) but should receive additional doses of DT to complete the series. 2 Available data indicate that the appropriate age for institution of immunizations in prematurely born infants is the usual chronological age of 2 months. Vaccine doses should not be reduced for preterm infants. 2,9 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 DOSAGE AND ADMINISTRATION section). When CLI DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB, the combined vaccines are indicated for the active immunization of infants and children 2 months through 5 years of age for the prevention of invasive diseases caused by diphtheria, tetanus, pertussis and H influenzae type b. 10,11 (Refer to ActHIB ® package insert.) A single injection containing diphtheria, tetanus, pertussis and Haemophilus b conjugate antigens may be more acceptable to parents and may increase compliance with vaccination programs. Therefore, in those situations where, in the judgment of the physician, it is of benefit to administer a single injection of whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine and Haemophilus b conjugate vaccine concomitantly, only CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine may be used for reconstitution of lyophilized ActHIB ® or OmniHIB. Antibody levels associated with protection may not be achieved earlier than two weeks following the last recommended dose. (See section.) As with any vaccine, vaccination with DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or combined vaccines CLI DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) and ActHIB ® or OmniHIB may not protect 100% of susceptible individuals. NOTE: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB ® is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) OmniHIB (distributed by SmithKline Beecham Pharmaceuticals); both products are manufactured by Pasteur Mérieux Sérums & Vaccins S. A. This vaccine is NOT to be used for the treatment of diphtheria, tetanus, pertussis or H influenzae type b infection. This vaccine should NOT be used for immunizing persons 7 years of age and older.

Source: http://www.rxlist.com

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. It is a contraindication to administer this vaccine in the presence of any evolving neurological condition. Encephalopathy after a previous dose is a contraindication to further use. 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 are not contraindications to further use. 2 Elective immunization procedures should be deferred during an outbreak of poliomyelitis. 12 Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided.

Source: http://www.rxlist.com

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) Vial, 7.5 mL Product No. 49281-280-84 One 7.5 mL vial of Connaught Laboratories, Inc. Diphtheria and Tetanus Toxoids and Pertussis Vaccine as Diluent packaged with Vial, 1 Dose lyophilized Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (10 x 1 Dose vials per package) Product No. 49281-549-10 Administer vaccine within 24 hours after reconstitution. Storage Store between 2° 8° C (35° 46° F). DO NOT FREEZE. Temperature extremes may adversely affect resuspendability of this vaccine. Store lyophilized vaccine packaged with vial containing Diphtheria and Tetanus Toxoids and Pertussis vaccine and reconstituted vaccine, when not in use, between 2° 8° C (35° 46° F). DO NOT FREEZE. Discard vaccine within 24 hours after reconstitution. 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 2. 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 (NOTE: Articles relevant to reference cited are listed in the MMWR publication.) 3. C.C. Summary of Notifiable Diseases, United States 1992. MMWR 41: No. 55, 1993 4. Department of Health and Human Services, Food and Drug Administration. Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Proposed Rule. Federal Register Vol 50 No. 240, pp 51002- 51117, 1985 5. Pichichero ME, et al. Pediatric diphtheria and tetanus toxoids- adsorbed vaccine: Immune response to the first booster following the diphtheria and tetanus toxoids vaccine primary series. Pediatr Infec Dis 5: 428- 430, 1986 6. Barkin RM, et al. Pediatric diphtheria and tetanus toxoids (DT) vaccine: Clinical and immunologic response when administered as the primary series. J Pediatr 106: 779- 781, 1985 7. Baraff L, et al. DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) associated reactions: An analysis by injection site, manufacturer, prior reactions and dose. Pediatr 73: 31-36, 1984 8. Centers for Disease Control and Prevention (CDC). Tetanus Surveillance United States, 1989- 1990. Pertussis Surveillance United States, 1989- 1991. MMWR 41: No. SS- 8, 1992 9. American Academy of Pediatrics. In: Peter G, ed. 1994 Red Book: Report of the Committee on Infectious Diseases. 23rd ed. Elk Grove Village, IL 1994 10. Data on file, Pasteur Mérieux Sérums & Vaccins S. A. 11. Data on file, Connaught Laboratories, Inc. 12. Wilson GS. The Hazards of Immunization. Provocation poliomyelitis. 270- 274, 1967 13. Howson CP, et al. Adverse Effects of Pertussis and Rubella Vaccines. National Academy Press, Washington, DC, 1991 14. ACIP. Pertussis immunization: Family history of convulsions and use of antipyretics supplementary ACIP statement. MMWR 36: 281- 282, 1987 15. ACIP. General recommendations on immunization. MMWR 38: 205- 227, 1989 16. C.C. Vaccine Adverse Event Reporting System United States. MMWR 39: 730- 733, 1990 17. C.C. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197- 200, 1988 18. Food and Drug Administration. New reporting requirements for vaccine adverse events. FDA Drug Bull 18 (2), 16- 18, 1988 19. Cody CL, et al. Nature and rates of adverse reactions associated with DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) and DT immunizations in infants and children. Pediatr 68: 650- 660, 1981 20. Joffe LS, et al. Diphtheria-tetanus toxoids-pertussis vaccination does not increase the risk of hospitalization with an infectious illness. Pediatr Infect Dis J 11: 730- 735, 1992 21. Rutledge SL, et al. Neurological complications of immunization. J Pediatr 109: 917- 924, 1986 22. Walker AM, et al. Neurologic events following Diphtheria-Tetanus-Pertussis immunization. Pediatr 81: 345- 349, 1988 23. Wilson GS. The Hazards of Immunization. Allergic manifestations: Post- vaccinal neuritis. pp 153- 156, 1967 24. Tsairis P, et al. Natural history of brachial plexus neuropathy. Arch Neurol 27: 109- 117, 1972 25. Blumstein GI, et al. Peripheral neuropathy following tetanus toxoid administration. JAMA 198: 1030- 1031, 1966 26. Stratton KR, et al. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. National Academy Press, Washington, DC, 1993 27. Schlenska GK. Unusual neurological complications following tetanus toxoid administration. J Neurol 215: 299- 302, 1977 28. Bellman MH, et al. Infantile spasms and pertussis immunization. Lancet, i: 1031- 1034, 1983 29. Jacob J, et al. Increased intracranial pressure after diphtheria, tetanus and pertussis immunization. Am J Dis Child Vol 133: 217- 218, 1979 30. Mathur R, et al. Bulging fontanel following triple vaccine. Indian Pediatr 18 (6): 417- 418, 1981 31. Shendurnikar N, et al. Bulging fontanel following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine. Indian Pediatr 23 (11): 960, 1986 32. C.C. Adverse events following immunization. Surveillance Report No. 3, 1985- 1986, Issued February 1989 33. Griffin MR, et al. Risk of sudden infant death syndrome after immunization with the Diphtheria-Tetanus-Pertussis Vaccine. N Engl J Med 618- 623, 1988 34. Hoffman HJ, et al. Diphtheria-Tetanus-Pertussis immunization and sudden infant death: Results of the National Institute of Child Health and Human Development Cooperative Epidemiological Study of Sudden Infant Death Syndrome Risk Factors. Pediatr 79: 598- 611, 1987 35. Walker AM, et al. Diphtheria-Tetanus-Pertussis immunization and sudden infant death syndrome. Am J Public Health 77: 945-951, 1987 36. Long SS, et al. Longitudinal study of adverse reactions following diphtheria- tetanus- pertussis vaccine in infancy. Pediatr 85: 294- 302, 1990 Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Care is to be taken by the health-care provider for the safe and effective use of D.P. Epinephrine Injection (1:1000) must be immediately available should an acute anaphylactic reaction occur due to any component of the vaccine. Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patients history with respect to possible sensitivity and any previous adverse reactions to the vaccine or similar vaccines, previous immunization history, current health status (see CONTRAINDICATIONS; WARNINGS sections), and a current knowledge of the literature concerning the use of the vaccine under consideration. Immunosuppressed patients may not respond. Prior to administration of D.P. health-care personnel should inform the parent or guardian of the patient the benefits and risks of immunization, and also inquire about the recent health status of the patient to be injected. Special care should be taken to ensure that the injection does not enter a blood vessel. 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 properly disposed. 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 DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) VACCINE OR AT THE TIME WHEN DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) VACCINE IS USED TO RECONSTITUTE ActHIB ® OR OmniHIB IN INFANTS BELOW THE AGE OF SIX WEEKS HAVE NOT BEEN ESTABLISHED. (See DOSAGE AND ADMINISTRATION section.) This vaccine is recommended for immunizing children 6 weeks of age through 6 years of age (up to the seventh birthday). DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) is the preferred vaccine in this age group, but in those situations where an absolute contraindicationto pertussis vaccination exists, or where in the opinion of the physician the pertussis vaccine should not be administered, DT is the appropriate alternative. Full protection is achieved upon completion of primary immunization with either four doses of D.P. or three doses of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) followed by a dose of an approved acellular D.P. A fifth dose of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or an approved acellular DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) is required. THIS VACCINE IS NOT RECOMMENDED FOR 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). Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Health Services in

Drug Database Online

Welcome to Vaccine Health Center an online drug guide and dictionary, here you can get drug information and definitaions for most popular pharmaceutical and medicinal drugs, and specifically DTP. Find what medications you are taking today.