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DTP

Warnings
Precautions

WARNINGS

If any of the following events occur in temporal relation to receipt of D.P. the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks, particularly since these events are not associated with permanent sequelae. 2

THE FOLLOWING EVENTS WERE PREVIOUSLY CONSIDERED CONTRAINDICATIONS AND ARE NOW CONSIDERED

WARNINGS

: 2

1. Temperature of ³ 40.5° C (105° F) within 48 hours not due to another identifiable cause: Such a temperature is considered a warning because of the likelihood that fever following a subsequent dose of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine also will be high. Because such febrile reactions are usually attributed to the pertussis component, vaccination with DT should not be discontinued. 2

2. Collapse or shock-like state (hypotonic- hyporesponsive episode) within 48 hours: Although these uncommon events have not been recognized to cause death nor to induce permanent neurological sequelae, it is prudent to continue vaccination with DT, omitting the pertussis component. 2

3. Persistent, inconsolable crying lasting ³3 hours, occurring within 48 hours: Follow-up of infants who have cried inconsolably following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccination has indicated that this reaction, though unpleasant, is without long-term sequelae and not associated with other reactions of greater significance. 2 Evidence is insufficient to indicate whether pertussis vaccine-associated protracted, inconsolable, or high-pitched crying or screaming does, or does not, lead to chronic neurologic damage. 13 Inconsolable crying occurs most frequently following the first dose and is less frequently reported following subsequent doses of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine. However, crying for > 30 minutes following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccination can be a predictor of increased likelihood of recurrence of persistent crying following subsequent doses. Children with persistent crying have had a higher rate of local reactions than children who had other DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) -associated reactions (including high fever, seizures, and hypotonic-hyporesponsive episodes), suggesting that prolonged crying was really a pain reaction. 2

4. Convulsions with or without fever occurring within three days: Short-lived convulsions, with or without fever, have not been shown to cause permanent sequelae. Furthermore, the occurrence of prolonged febrile seizures (i. e., status epilepticus any seizure lasting > 30 minutes or recurrent seizures lasting a total of 30 minutes without the child fully regaining consciousness), irrespective of their cause, involving an otherwise normal child does not substantially increase the risk for subsequent febrile (brief or prolonged) or afebrile seizures. The risk is significantly increased (p = 0.018) only among those children who are neurologically abnormal before their episode of status epilepticus. 2 Accordingly, although a convulsion following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccination has previously been considered a contraindication to further doses, under certain circumstances subsequent doses may be indicated, particularly if the risk of pertussis in the community is high. If a child has a seizure following the first or second dose of D.P. it is desirable to delay subsequent doses until the childs neurologic status is better defined. By the end of the first year of life, the presence of an underlying neurologic disorder has usually been determined, and appropriate treatment instituted. DT vaccine should not be administered before a decision has been made about whether to continue the DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) series. Regardless of which vaccine is given, it is prudent also to administer acetaminophen, 2 15 mg/kg of body weight, at the time of vaccination and every 4 hours subsequently for 24 hours.

Persons who experienced Arthus-type hypersensitivity reactions or a temperature of > 103° F (39.4° C) following a prior dose of tetanus toxoid usually have high serum tetanus antitoxin levels and should not be given even emergency doses of Td more frequently than every 10 years, even if they have a wound that is neither clean nor minor. 2

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) should not be given to children with any coagulation disorder, including thrombocytopenia, that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.

Recent studies suggest that infants and children with a history of convulsions in first-degree family members (i. e., siblings and parents) have a 3.2- fold increased risk for neurologic events compared with those without such histories. 14 However, the ACIP has concluded that a family history of convulsions in parents and siblings is not a contraindication to pertussis vaccination and that children with such family histories should receive pertussis vaccine according to the recommended schedule. 2

A recent review of all available data by the IOM found evidence is consistent with a causal relation between DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccination and acute encephalopathy, but 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

Infants and children with recognized possible or potential underlying neurologic conditions seem to be at enhanced risk for the appearance of manifestations of the underlying neurologic disorder within two or three days following vaccination. 2 Whether to administer DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) to children with proven or suspected underlying neurologic disorders must be decided on an individual basis. Important considerations include the current local incidence of pertussis, the near absence of diphtheria in the United States and the low risk of infection with C. tetani. 2

Although these events were considered absolute contraindications in previous ACIP recommendations, there may be circumstances, such as a high incidence of pertussis, in which the potential benefits outweigh possible risks, particularly because these events are not associated with permanent sequelae. 2

The administration of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) to children with proven or suspected underlying neurologic disorders that are not actively evolving must be decided on an individual basis.

Only full doses (0.5 mL) of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine should be given; if a specific contraindication to DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) exists, the vaccine should not be given. 2 Controversy regarding the safety of pertussis vaccine during the 1970s led to several studies of the benefits and risks of this vaccination during the 1980s. These epidemiologic analyses clearly indicate that the benefits of pertussis vaccination outweigh any risks and have not shown a cause and effect with neurologic illness. 2,9

Deaths have been reported in temporal association with the administration of DTP vaccine (see ADVERSE REACTIONS section). When CLI DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used alone or to reconstitute ActHIB ® or OmniHIB and administered to immunosuppressed persons or persons receiving immunosuppressive therapy, the expected antibody responses may not be obtained. This includes patients with severe combined immunodeficiency, hypogammaglobulinemia, or agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized malignancy; or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation. 15

Administration of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) and/or Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) is not contraindicated in individuals with HIV infection. 11

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.

PRECAUTIONS

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.

Warnings
Precautions
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