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USP DI Vol. II - DIPHTHERIAAND TETANUS TOXOIDS AND PERTUSSIS VACCINE ADSORBED (Systemic)

DIPHTHERIAAND TETANUS TOXOIDS AND PERTUSSIS VACCINE ADSORBED (Systemic)


Some commonly used brand names are:

In the U.S.?

  • ADACEL
  • Boostrix
  • Infanrix
  • Tripedia

In Canada?

  • ADACEL
  • TRIPACEL

Generic name product may be available in the U.S. and Canada.

Other commonly used names are acellularDTP, DTaP, DTP, DTwP, whole-cell DTP, Tdap.


Category

  • Immunizing agent, active

Description

Diphtheria and tetanus toxoidsand pertussis (dif-THEER-ee-a and TET-n-usand per-TUS-iss) vaccine (also known as DTP) is a combinationimmunizing agent given by injection to prevent diphtheria, tetanus, and pertussis.

Diphtheria is a serious illness that can cause breathing difficulties,heart problems, nerve damage, pneumonia, and possibly death. The risk of seriouscomplications and death is greater in very young children and in the elderly.

Tetanus (also known as lockjaw) is a serious illness that causes convulsions(seizures) and severe muscle spasms that can be strong enough to cause bonefractures of the spine. Tetanus causes death in 30 to 40 percent of cases.

Pertussis (also known as whooping cough) is a serious disease that causessevere spells of coughing that can interfere with breathing. Pertussis alsocan cause pneumonia, long-lasting bronchitis, seizures, brain damage, anddeath.

Immunization against diphtheria, tetanus, and pertussis is recommendedfor all infants and children from 2 months of age up to their 7th birthday.Children 10 years of age and older and adults may need an additional immunizationagainst diphtheria, tetanus, and pertussis. Adults and teenagersshould receive DTP to instead of the diphtheria and tetanus injection if ithas been 10 years or more since their last diphtheria and tetanus vaccination.DTP vaccination is recommended for adults who are in close contact with ababy who is less than a year old and adults who work in the healthcare field.

Diphtheria, tetanus, and pertussis are serious diseases that can causelife-threatening illnesses. Although some serious side effects can occur aftera dose of DTP (usually from the pertussis vaccine in DTP), this rarely happens.The chance of your child catching one of these diseases and being permanentlyinjured or dying as a result is much greater than the chance of your childgetting a serious side effect from the DTP vaccine.

DTP is available in the following dosage form:

    Parenteral
  • Injection (U.S. and Canada)


Before Receiving This Vaccine

In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For DTP, the following should be considered:

Allergies?Tell your doctor if you or your child has ever hadany unusual or allergic reaction to diphtheria toxoid, tetanus toxoid, pertussisvaccine, or DTP. Also tell your health care professional if your child isallergic to any other substances, such as preservatives.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals. Before receiving this vaccine, make sure yourdoctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether DPT passes into breastmilk. Although most medicines pass into breast milk in small amounts, manyof them may be used safely while breast-feeding. Mothers who receive thisvaccine and who wish to breast-feed should discuss this with their doctor.

Children?Use is not recommended for infants up to 2 monthsof age.

The Advisory Committee on Immunization Practices (ACIP) has recommendedthat teenagers be given a DTP vaccination instead of the tetanus-diphtheria(Td) vaccination. The committee is also encouraging all teenagers, even thosewho have already received Td, to get a DTP booster to help protect againstpertussis (e.g., whooping cough). If you have questions about whether yourteenager should receive DTP, contact your doctor.

Older adults?Use is not recommended for persons older than 64years of age.

Other medicines?Although certain medicines should not be used togetherat all, in other cases two different medicines may be used together even ifan interaction might occur. In these cases, your doctor may want to changethe dose, or other precautions may be necessary. When you receive this vaccine,it is especially important that your health care professional knows if youare taking any of the following:

  • Anticoagulant therapy (medicines that prevent blood clots) (warfarin[e.g., Coumadin])?Caution should be used to prevent blood clots at theinjection site.

Other medical problems?The presence of other medicalproblems may affect the use of DTP. Make sure you tell your doctor if youor your child has any other medical problems, especially:

  • Allergic reaction to a previous dose of DTP or
  • Brain disease or
  • Fever?Use of DTP may make the condition worse or may increasethe chance of side effects.
  • Bleeding disorders?This vaccine should not be given to anyonewho has a bleeding disorder.
  • Brain disorders or
  • Epilepsy (seizure disorder) or
  • Guillain-Barre syndrome (inflammatory disorder which causes paralysis)or
  • Nervous system disorder?Your doctor will decide if you shouldreceive this vaccine.

Proper Use of This Vaccine

Dosing?Only the ADACELbrand of DTaP vaccine should be given to adults and teenagers 11 to 64 yearsof age.

Only the Boostrix brand of DTaP vaccine shouldbe given to children and teenagers 10 to 18 years of age.

The dose of DTP will be different for different patients. The followinginformation includes only the average doses of DTP.

  • For injection dosage form:
    • For prevention of diphtheria, tetanus, and pertussis:
      • Adults and children 11 years of age and older?One single doseof ADACEL brand vaccine
      • Teenagers and children 10 to 18 years of age?One single doseof Boostrix brand vaccine
      • Children 2 months to 7 years of age?One dose every four toeight weeks for a total of three doses, then a fourth dose six to twelve monthsafter the third dose. A booster dose should be given at 4, 5, or 6 years ofage. (The booster dose is given only if the fourth dose was given before thechild's 4th birthday.)


Precautions After Receiving This Vaccine

At the time of the DTP injection, your doctor may give your child a doseof acetaminophen (or another medicine that helps prevent fever). This is tohelp prevent some of the side effects of DTP. Your doctor may also want yourchild to take this medicine every 4 hours for 24 hours after your child receivesthe DTP injection. Check with your doctor if you have any questions.


Side Effects of This Vaccine

Along with its needed effects, a vaccine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention. Itis very important that you tell your doctor about any side effect that occursafter a dose of DTP, even though the side effect may have gone awaywithout treatment. Some types of side effects may mean that your child shouldnot receive any more doses of DTP.

Get emergency help immediately if any of the followingside effects occur:

    Less frequent

      Collapse; crying for 3 or more hours

    Rare

      Confusion; convulsions (seizures); difficulty in breathing or swallowing; fever of 105 ?F (40.5 ?C) or more; headache(severe or continuing); hives; irritability (unusual); itching, especially of feetor hands; periods of unconsciousness or lack of awareness; reddening of skin, especially around ears; sleepiness (unusual and continuing); swelling of eyes, face, or inside of nose; unusualtiredness, weakness (sudden and severe); vomiting(severe or continuing)

Other side effects may occur that usually do not need medicalattention. These side effects may go away as your child's body adjusts tothe vaccine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

    More common

      Fever between 100.4 and 102.2 ?F (38 and 39 ?C) (mayoccur with fretfulness, drowsiness, vomiting, and loss of appetite); lump at place of injection (may be present for a few weeks afterinjection); redness, swelling, tenderness, or painat place of injection

    Less common

      Fever between 102.2 and 104 ?F (39 and 40 ?C) (may occurwith fretfulness, drowsiness, vomiting, and loss of appetite)

    Rare

      Fever between 104 and 105 ?F (40 and 40.5 ?C) (may occurwith fretfulness, drowsiness, vomiting, and loss of appetite); skin rash; swollen glands on side ofneck (following DTP injection into arm)

    Incidence not known

      Injection site bruising; itching skin; redness of skin; welts

Other side effects notlisted above may also occur in some patients. If you notice any other effects,check with your doctor.


Revised: 05/10/2006