diphtheria, hepatitis B, pertussis (acellular), polio, and tetanus vaccine

Generic Name: diphtheria, hepatitis B, pertussis (acellular), polio, and tetanus vaccine (dif THEER ee a, hep a TYE tis B, per TUS iss, POE lee oh, and TET a nus)
Brand Name: Pediarix

What is diphtheria, hepatitis B, pertussis, polio, and tetanus vaccine?

Diphtheria, pertussis, and tetanus are serious diseases caused by bacteria. Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death. Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death. Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Hepatitis B and polio are serious diseases caused by viruses. Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when the mother is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death. Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.

Diphtheria, hepatitis B, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, hepatitis B, acellular pertussis, polio, and tetanus vaccine is used to help prevent these diseases in children who are ages 6 weeks to 6 years old, before the child has reached his or her 7th birthday.

This vaccine works by exposing your child to a small dose of the bacteria or virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

Your child should not receive this vaccine if he or she has a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine).

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Keep track of any and all side effects your child has after receiving this vaccine. Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

What should I discuss with my healthcare provider before receiving this vaccine?

A hepatitis B vaccine will not protect your child against infection with hepatitis A, C, and E, or other viruses that affect the liver. It may also not protect the child from hepatitis B if he or she is already infected with the virus, even if the child does not yet show symptoms.

Your child should not receive this vaccine if the child is allergic to yeast, neomycin, or polymyxin B, or if:

  • the child has a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine); or

  • the child has ever had a life-threatening allergic reaction to any vaccine containing diphtheria, hepatitis B, pertussis, polio, or tetanus.

Your child may not be able to receive this vaccine if he or she has ever received a similar vaccine that caused any of the following:

  • a very high fever (over 104 degrees);

  • excessive crying for 3 hours or longer;

  • fainting or going into shock;

  • Guillain-Barré syndrome (within 6 weeks after receiving a vaccine);

  • seizure (convulsions); or

  • a severe skin reaction.

If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

  • a bleeding or blood clotting disorder such as hemophilia or easy bruising;

  • a history of seizures,

  • an allergy to latex rubber;

  • a weak immune system caused by disease or by taking certain medicines or receiving cancer treatments;

  • if the child is taking a blood thinner such as warfarin (Coumadin); or

  • if it has been less than 6 weeks since the child last received a vaccine.

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

How is this vaccine given?

This vaccine is injected into a muscle. You will receive this injection in a doctor's office or clinic setting.

This vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months and 6 months of age. Your child's booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Your doctor may recommend treating fever and pain with an aspirin free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

What happens if I miss a dose?

Contact your doctor if you miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

This vaccine side effects

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Call your doctor at once if the child has:

  • extreme drowsiness, fainting;

  • slow breathing with long pauses between breaths;

  • fussiness, irritability, crying for an hour or longer;

  • seizure (black-out or convulsions); or

  • high fever (can occur for up to 4 days after the vaccine).

Common side effects include:

  • redness, pain, or swelling where the shot was given;

  • mild fever;

  • mild fussiness or crying;

  • drowsiness; or

  • loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

See also: Side effects (in more detail)

Diphtheria, hepatitis B, pertussis (acellular), polio, and tetanus vaccine dosing information

Usual Pediatric Dose for Poliomyelitis Prophylaxis:

Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3:
6 months to 5 years:
3 doses of 0.5 mL, given intramuscularly, at 6- to 8-week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age. The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response.

Modified Schedules:
Children Previously Vaccinated With One or More Doses of Hepatitis B Vaccine: Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered 3 doses of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) according to the recommended schedule.

Children Previously Vaccinated With One or More Doses of INFANRIX (diphtheria/tetanus/pertussis,acel): diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of INFANRIX and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Children Previously Vaccinated With One or More Doses of Poliovirus vaccine, inactivated (IPV):
diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Usual Pediatric Dose for Diphtheria Prophylaxis:

Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3:
6 months to 5 years:
3 doses of 0.5 mL, given intramuscularly, at 6- to 8-week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age. The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response.

Modified Schedules:
Children Previously Vaccinated With One or More Doses of Hepatitis B Vaccine: Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered 3 doses of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) according to the recommended schedule.

Children Previously Vaccinated With One or More Doses of INFANRIX (diphtheria/tetanus/pertussis,acel): diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of INFANRIX and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Children Previously Vaccinated With One or More Doses of Poliovirus vaccine, inactivated (IPV):
diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Usual Pediatric Dose for Pertussis Prophylaxis:

Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3:
6 months to 5 years:
3 doses of 0.5 mL, given intramuscularly, at 6- to 8-week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age. The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response.

Modified Schedules:
Children Previously Vaccinated With One or More Doses of Hepatitis B Vaccine: Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered 3 doses of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) according to the recommended schedule.

Children Previously Vaccinated With One or More Doses of INFANRIX (diphtheria/tetanus/pertussis,acel): diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of INFANRIX and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Children Previously Vaccinated With One or More Doses of Poliovirus vaccine, inactivated (IPV):
diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Usual Pediatric Dose for Tetanus Prophylaxis:

Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3:
6 months to 5 years:
3 doses of 0.5 mL, given intramuscularly, at 6- to 8-week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age. The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response.

Modified Schedules:
Children Previously Vaccinated With One or More Doses of Hepatitis B Vaccine: Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered 3 doses of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) according to the recommended schedule.

Children Previously Vaccinated With One or More Doses of INFANRIX (diphtheria/tetanus/pertussis,acel): diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of INFANRIX and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Children Previously Vaccinated With One or More Doses of Poliovirus vaccine, inactivated (IPV):
diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Usual Pediatric Dose for Hepatitis B Prophylaxis:

Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3:
6 months to 5 years:
3 doses of 0.5 mL, given intramuscularly, at 6- to 8-week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age. The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response.

Modified Schedules:
Children Previously Vaccinated With One or More Doses of Hepatitis B Vaccine: Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered 3 doses of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) according to the recommended schedule.

Children Previously Vaccinated With One or More Doses of INFANRIX (diphtheria/tetanus/pertussis,acel): diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of INFANRIX and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

Children Previously Vaccinated With One or More Doses of Poliovirus vaccine, inactivated (IPV):
diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX) may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and are also scheduled to receive the other vaccine components of diphtheria/hepB/pertussis,acel/polio/tetanus vaccine (PEDIARIX).

What other drugs will affect diphtheria, hepatitis B, pertussis, polio, and tetanus vaccine?

Before your child receives this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has received drugs or treatments in the past 2 weeks that can weaken the immune system. If your child is using any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished:

  • an oral, nasal, inhaled, or injectable steroid medicine;

  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

  • medicines to treat or prevent organ transplant rejection.

This list is not complete. Other drugs may interact with this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-07-17, 9:32:59 PM.

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