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.

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.

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 Pediarix to protect against these diseases. Like any medicine, Pediarix can cause side effects, but the risk of serious side effects is extremely low.

Pediarix vaccine 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.

Usual Pediatric Dose of Pediarix for Poliomyelitis Prophylaxis:

0.5 mL intramuscularly at 2, 4, and 6 months of age.

Usual Pediatric Dose of Pediarix for Diphtheria Prophylaxis:

0.5 mL intramuscularly at 2, 4, and 6 months of age.

Usual Pediatric Doseof Pediarix for Pertussis Prophylaxis:

0.5 mL intramuscularly at 2, 4, and 6 months of age.

Usual Pediatric Dose of Pediarix for Tetanus Prophylaxis:

0.5 mL intramuscularly at 2, 4, and 6 months of age.

Usual Pediatric Dose of Pediarix for Hepatitis B Prophylaxis:

0.5 mL intramuscularly at 2, 4, and 6 months of age

Comments:
-Administer at 6- to 8-week intervals, preferably 8 weeks.
-First dose may be given as early as 6 weeks of age.
-Three doses of Pediarix constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and the complete immunization course for hepatitis B.

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 Pediarix if he or she has:

• an allergy to yeast, neomycin, or polymyxin B;

• a history of life-threatening allergic reaction to a vaccine containing diphtheria, hepatitis B, pertussis, polio, or tetanus;

• a history of decreased consciousness, seizures, or coma within 7 days after receiving a pertussis vaccine; or

• a progressive or untreated nervous system problem or brain disorder (such as infantile spasms or uncontrolled epilepsy).

Your child may not be able to receive Pediarix if he or she has ever received a pertussis vaccine that caused:

• within 48 hours after the vaccine - a very high fever (over 104 degrees), excessive crying for 3 hours or longer, fainting or going into shock; or

• within 3 days after the vaccine - a seizure.

Tell the vaccination provider if your child has ever had:

• seizures;

• chemotherapy or radiation;

• a weak immune system (caused by disease or by using certain medicine);

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

• an allergy to latex rubber; or

• if the child was born prematurely.

Your child can still receive a Pediarix 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.

Contact your doctor if you will miss a Pediarix 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, or the child may not be fully protected against disease.

An overdose of Pediarix is unlikely to occur.

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

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

Your child should not receive a Pediarix booster vaccine if he or she had a life threatening allergic reaction after the first shot. Keep track of all side effects your child has. If the child receives a booster dose, tell the vaccination provider 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. However, like any medicine, Pediarix can cause side effects but the risk of serious side effects is low.

Call your doctor at once if the child has:

• extreme drowsiness, fainting;

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

• a seizure; or

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

You may be able to treat fever or pain with an over-the-counter pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others). Follow the label directions or your vaccination provider's instructions.

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

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.

The vaccine may not work as well if your child receives drugs or treatments that can weaken the immune system, including:

• steroid medicine;

• cancer treatments;

• medicine 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 affect Pediarix, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.