Pediarix

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 Names: Pediarix

What is Pediarix?

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

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.

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

Like any vaccine, Pediarix vaccine may not provide protection from disease in every person.

Important information

Pediarix 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 individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

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

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

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

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

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

Before receiving Pediarix

Pediarix 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 Pediarix 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 Pediarix 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, Pediarix 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 Pediarix.

How is Pediarix given?

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

Pediarix 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 Pediarix. 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 Pediarix is unlikely to occur.

What should I avoid?

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

Pediarix side effects

Get emergency medical help if your child has any of these signs of an allergic reaction to Pediarix: 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 Pediarix 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 Pediarix 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)

What other drugs will affect Pediarix?

Before your child receives Pediarix, 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 Pediarix, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

More about Pediarix (diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid)

Consumer resources

Professional resources

Related treatment guides

Where can I get more information?

  • Your doctor or pharmacist may have information about Pediarix 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 Pediarix vaccine only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-07-17, 9:32:59 PM.

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