1 What is Pediarix?

Brand: Pediarix

Generic: Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B and Polio Vaccine

Pediarix is a combination immunizing agent used to prevent illness caused by diphtheria, tetanus, pertussis (a whooping cough), hepatitis B and poliovirus. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. The vaccine is given only to infants and children who are 6 weeks to 6 years of age and is given before the child’s 7th birthday.

This vaccine combines 5 agents into 1 vaccine. In order to complete the series, you must get three injections of this vaccine at separate intervals. As there are so many different diseases you need to be vaccinated against, be sure to follow your doctor’s orders about your vaccination schedule.

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia and possibly death. The risk of serious complications is greater in very young children and the elderly.

Tetanus is a very serious illness that causes convulsions and severe muscle spasms that can be strong enough to cause spine fractures. Tetanus causes death in 30%-40% of cases. The disease continues to occur almost exclusively in people who do not get vaccinated.

Pertussis (a whooping cough) is a serious disease that causes severe coughing fits that can limit breathing. Pertussis may also cause pneumonia, long-lasting bronchitis, seizures, brain damage and death.

Hepatitis B is a major cause of serious liver diseases, including liver cancer. This injection is transmitted through exposure to infected body fluids such as saliva and blood. Pregnant women who have or are carriers of hepatitis B can give the disease to their babies when they are born. These babies often suffer serious long-term illnesses from the disease. People who have the virus can give it to others without knowing it.

Polio is a very serious illness that causes muscle paralysis, including the muscles you use to walk and breathe. A polio infection may leave a person unable to breathe without the help of a breathing machine. It may also leave a person unable to walk without leg braces or being confined to a wheelchair. There is no cure for polio.

This medication is only to be administered by or under the supervision of your doctor or health care professional. This product is available in the following forms:

  • Suspension

2 What to Know Before Using

Before using Pediarix, you must know all about the risks and complications associated with it. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

Allergies: Inform your doctor if you have ever had an allergic reaction to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric: Up-to-date Pediatric Appropriate studies have not indicated any problems that would limit the use of this medication in children 6 years of age or younger.

No appropriate studies have been performed on the relationship of age to the effects of this medication in children 7 years of age and older. Safety and efficacy have not been established.

Geriatric: This medication is not recommended for use in adult patients.

Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions.

When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive.

Using this medication with any of the following medications may increase your risk of side effects. However, using both medications may be the best treatment for you.

If both medications are prescribed together, your doctor may change the dose or how often you take one or both medications:

Other Interactions: Certain medications should not be used while eating, or while eating certain foods in the case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other Medical Problems: Pre-existing medical problems may affect the use of this medication.

Be sure to tell your doctor if you have any other medical problems, especially:

  • Encephalopathy (a brain disease) after a vaccine with pertussis - Should not be used in patients with this condition.
  • Fever, high
  • Moderate or severe illness, with or without fever - This vaccine may make these conditions worse or may increase the chance of side effects.
  • Guillain-Barre syndrome (nerve disease that causes paralysis) - If your child had this condition after getting a vaccine with tetanus in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine.
  • Immunodeficiency disorder - If you have an immune system disorder, this vaccine may not work well for you.
  • Previous side effects after a vaccine with pertussis - If your child has had certain side effects to this vaccine or another vaccine with pertussis in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine. Some serious reactions include being less responsive than normal, crying continuously without stopping for 3 hours or more, having a seizure with or without a fever, or having a fever that is 105 degrees F or higher.
  • Progressive neurologic disorders - This includes infantile spasms, progressive brain disease, or uncontrolled epilepsy (seizures). This vaccine should not be given until these conditions are under control.

3 Proper Usage

Proper usage of Pediarix requires strict adherence to your doctor’s orders. A nurse or other trained health professional will give your child this vaccine. It is given as a shot into one of the muscles (intramuscular), normally in the shoulder or thighs.

This vaccine is given as 3 shots. The first dose may be given as early as 6 weeks of age. You will need another dose at 4 and 6 months after the first dose unless your doctor directs you otherwise.

Your child may receive other vaccines at the same time as this one but in a different area of the body. You should receive information sheets about all the vaccines your child receives. Be sure you understand all the information.

Your child may also receive a medication to help prevent or treat some of the minor side effects of the vaccine, such as fever and soreness.

It is important that your child receives all the doses in this series. Keep all of your scheduled appointments. If you child misses a dose of this medication, make another appointment as soon as you are able to.

4 Precautions to Take

Before using Pediarix, there are some precautions you must take. It is very important that your child returns for the second and third doses of this medication. Be sure to notify the child’s doctor of any side effects.

If your child develops a skin rash, hives or any allergic reaction after receiving this medication, inform their doctor immediately.

Inform your child’s doctor of all the other vaccines you child has had, especially if those vaccines were part of a series. This vaccine may be used to finish a series of vaccines.

Be sure you doctor knows if your child has a latex allergy. One of the pre-filled syringes for this vaccines contains dry natural latex rubber. This may cause an allergic reaction in children who are sensitive to latex.

This vaccine may cause apnea (breathing problem) in some premature infants. The doctor will decide if your child should receive this vaccine.

This vaccine will not treat an active infection. If your child has an infection of diphtheria, tetanus, pertussis, hepatitis B or polio, you will need medication to treat your child.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Pediarix. Although not all of these side-effects may occur, if they do occur they may need medical attention.

It is very important to tell your child’s doctor if they have any side effects, even if the side effect goes away without treatment. Some side effects mean that the child should not receive any more doses of this vaccine.

Check with your doctor immediately if you experience any of the following side-effects:

More common:

  • Bleeding
  • Blistering
  • Burning
  • Coldness
  • Discoloration of the skin
  • Fussiness
  • Feeling of pressure
  • Infection
  • Inflammation
  • Lumps
  • Numbness
  • Pain
  • Restlessness
  • Scarring
  • Sleeping more than usual (hypersomnia)
  • Soreness
  • Stinging
  • Tenderness
  • Tingling
  • Ulceration
  • Unusual cry
  • Warmth on the skin

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects. Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.