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Diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine

Generic Name: diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine (dif-THEER-ee-a/TET-a-nus/aye-SELL-yoo-ler per-TUS-is/hep-a-TYE-tis/POE-lee-oh-VYE-rus)
Brand Name: Pediarix

Diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine is used for:

Preventing diphtheria, tetanus, pertussis, hepatitis B, and polio infections in infants and children.

Diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine is a vaccine for diphtheria, tetanus, pertussis, hepatitis B, and polio. It works by helping the immune system to protect against these infections.

Do NOT use diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine if:

  • the patient is allergic to any ingredient in diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine or to latex, yeast, neomycin, or polymyxin B
  • the patient has had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) or other severe reaction (eg, coma, prolonged seizure) to a previous dose of diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine or a similar vaccine
  • the patient has untreated nervous system problems (eg, infantile spasms, uncontrolled seizures, coma)

Contact the patient's doctor or health care provider right away if any of these apply.

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Before using diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine:

Some medical conditions may interact with diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine. Tell the patient's doctor or pharmacist if the patient has any medical conditions, especially if any of the following apply:

  • 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 has developed any of the following within 48 hours after a previous pertussis-containing vaccine: high fever (greater than 105 degrees F [40.5 degrees C]) from an unknown cause, coma, or persistent crying (for more than 3 hours)
  • if the patient has a history of seizures (with or without fever) within 3 days of a previous pertussis-containing vaccine
  • if the patient has a fever, infection, or other current illness; has cancer; receives chemotherapy or radiation therapy; is very ill or weakened; or takes medicine that may weaken the immune system, such as immunosuppressants (eg, cyclosporine) or corticosteroids (eg, prednisone)
  • if the patient has a history of nervous system problems (eg, seizures, infantile spasms, multiple sclerosis), Guillain-Barre syndrome, poor health, a weakened immune system (eg, HIV infection, AIDS), or bleeding problems (eg, hemophilia, low platelets)

Some MEDICINES MAY INTERACT with diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine. Tell the patient's health care provider if the patient is taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
  • Corticosteroids (eg, prednisone), immunosuppressants (eg, cyclosporine), medicines that may weaken the immune system, or medicines to treat cancer because they may decrease diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine's effectiveness

This may not be a complete list of all interactions that may occur. Ask the patient's health care provider if diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine may interact with other medicines that the patient takes. Check with the patient's health care provider before you start, stop, or change the dose of any medicine.

How to use diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine:

Use diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine as directed by the patient's doctor. Check the label on the medicine for exact dosing instructions.

  • Diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine is usually given as an injection at the patient's doctor's office, hospital, or clinic.
  • Do not use diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine if it contains particles or a gel-like substance, is cloudy or discolored, or if the container is cracked or damaged.
  • 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 diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine, contact the patient's doctor right away.

Ask the patient's health care provider any questions you may have about how to use diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine.

Important safety information:

  • Tell the patient's doctor or dentist that the patient has received diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine before the patient receives any medical or dental care, emergency care, or surgery.
  • Tell the patient's doctor if the patient will be receiving other vaccines.
  • Diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine may not protect everyone who receives it from diphtheria, tetanus, pertussis, hepatitis, or polio. Discuss any questions or concerns with the patient's doctor.
  • Diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine should not be used in INFANTS younger than 6 weeks of age or in CHILDREN who are 7 years of age or older; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine is not approved for use in adults. It is not known if diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine while you are pregnant. It is not known if diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine is found in breast milk. If you are or will be breast-feeding and use diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine:

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:

Decreased appetite; drowsiness; fever; irritability or fussiness; minor 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); burning, numbness, or tingling; fainting; joint pain or stiffness; red, swollen, or blistered skin; seizures; severe or persistent fever, diarrhea, unusual drowsiness, stomach pain, or vomiting; severe or persistent irritability (eg, unusual crying, screaming, restlessness); shortness of breath; unresponsiveness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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 diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine:

Diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine is usually handled and stored by a health care provider. If you are using diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine at home, store diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine as directed by your pharmacist or health care provider. Protect from light. Keep diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine out of the reach of children and away from pets.

General information:

  • If you have any questions about diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine, please talk with your doctor, pharmacist, or other health care provider.
  • Diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using diphtheria and tetanus toxoids, acellular pertussis, hepatitis b (recombinant), and inactivated poliovirus vaccine.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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