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Generic Name: Diphtheria, Tetanus Toxoids, Acellular Pertussis, Hepatitis B (Recombinant), and Inactivated Poliovirus Vaccine (dif-THEER-ee-ah/TET-ah-nus/aye-SELL-yoo-ler purr-TUSS-uss/hep-a-TYE-tis/POE-lee-o-vye-rus)
Brand Name: Pediarix

Pediarix is used for:

Immunizing children 7 years of age and younger against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and poliomyelitis.

Pediarix is a vaccine. It works by providing long-term protection against diphtheria, tetanus, pertussis, hepatitis B, and polio myelitis by stimulating the body to produce antibodies to these diseases.

Do NOT use Pediarix if:

  • the patient is allergic to any ingredient in Pediarix , including yeast, neomycin, and polymyxin
  • the patient has had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) or neurologic reaction to any previous dose of this or a similar vaccine
  • the patient has ever experienced unusual or severe drowsiness, prolonged seizures, or coma within 7 days after receiving any pertussis-containing vaccine
  • the patient has certain nervous system problems (eg, infantile spasms, uncontrolled seizures) or is in a coma

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pediarix :

Some medical conditions may interact with Pediarix . Tell your doctor or pharmacist if the patient has any medical conditions, especially if any of the following apply to you:

  • if the patient is taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if the patient has allergies to medicines, foods, or other substances
  • if the patient is allergic to latex
  • if the patient has experienced seizures within 3 days of receiving a vaccine containing diphtheria, tetanus, or pertussis
  • if the patient has experienced collapse, shock, persistent crying for 3 hours or more, or a fever of 105 degrees F (40.5 degrees C) or more within 48 hours of receiving a vaccine containing diphtheria, tetanus, or pertussis
  • if the patient has experienced Guillain-Barre syndrome (eg, numbness, tingling, and weakness of the legs) within 6 weeks of receiving a vaccine containing tetanus toxoid
  • if the patient has a fever, infection, or other acute illness; brain or nervous system problems; heart or lung problems; bleeding problems (eg, hemophilia, low blood platelet levels); a weakened immune system; cancer; multiple sclerosis; hepatitis B; or a history of seizures
  • if the patient is undergoing chemotherapy or radiation therapy, or if the patient has been very ill or weakened
  • if the patient"s mother has hepatitis B antigens or if it is unknown whether the patient"s mother has hepatitis B antigens

Some MEDICINES MAY INTERACT with Pediarix . Tell your health care provider if the patient is taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because the risk of a blood clot at the injection site may be increased
  • Immunosuppressive therapies including corticosteroids (eg, prednisone), antimetabolites (eg, methotrexate), alkylating agents (eg, cyclophosphamide), or cytotoxic drugs (eg, dactinomycin) because they may decrease Pediarix "s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pediarix may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pediarix :

Use Pediarix as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Pediarix is usually administered as an injection at the doctor"s office, hospital, or a clinic. The injection is only given intramuscularly (IM, into a muscle), usually in the upper arm or upper thigh. This vaccine is administered as indicated in the recommended immunization schedule for infants and children. The vaccine schedule is usually started in infants between 6 weeks and 2 months of age. Ask the doctor or pharmacist any questions that you may have about Pediarix .
  • It is very important to receive each vaccine as scheduled. Be sure to make a note of when each vaccine was given for the child"s medical record.
  • If the patient misses a dose of the vaccine series, contact your doctor immediately to reschedule the vaccine appointment.

Ask your health care provider any questions you may have about how to use Pediarix .

Important safety information:

  • If the patient has a fever or infection, the doctor may delay giving the vaccine. Discuss the risks and benefits of vaccination with the doctor.
  • There are various combinations of vaccines available. Based on previous reactions to vaccines, the doctor will determine the most appropriate ones to use.
  • Keep all doctor and lab appointments while using Pediarix .
  • This vaccine is not recommended for patients older than 7 years of age or in INFANTS younger than 6 weeks of age. Safety and effectiveness in these age groups have not been confirmed.
  • PREGNANCY and BREASTFEEDING: Pediarix is not recommended for use in patients older than 7 years of age.

Possible side effects of Pediarix :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; fever; fussiness; irritability; loss of appetite; pain, swelling, or redness at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); high or persistent fever; seizures; severe drowsiness; shortness of breath; weakness, numbness, or tingling of the legs.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (, or emergency room immediately.

Proper storage of Pediarix :

Store Pediarix in the refrigerator, between 35 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Pediarix out of the reach of children and away from pets.

General information:

  • If you have any questions about Pediarix , please talk with your doctor, pharmacist, or other health care provider.
  • Pediarix is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If the patient"s symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pediarix . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition
Copyright © 2006 Wolters Kluwer Health, Inc.

Where can I get more information about Pediarix ? We recommend to use

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