Diphtheria/Tetanus/Pertussis/Hepatitis B/Polio Vaccine, Injection dif-THEER-ee-a TET-a-nus TOKS-oyds ay-SEL-yoo-lar per-TUSS-sis hep-a-TY-tis bee in-AK-ti-vay-ted POH-lee-oh-VY-rus vak-SEEN

What are other names for this medicine?

Type of medicine: vaccine

Generic and brand names: diphtheria/tetanus toxoids/acellular pertussis adsorbed/hepatitis b/inactivated poliovirus vaccine, injection; Pediarix

What is this medicine used for?

This vaccine is given by injection (shots) to immunize children against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio.

What should the healthcare provider know before someone receives this medicine?

Before receiving this medicine, tell the healthcare provider if the person getting the shot has ever had:

• an allergic reaction to any medicine or vaccine
• an allergic reaction to latex or to yeast
• a bleeding disorder
• a neurologic or brain disease
• Guillain-Barré syndrome
• seizures

Tell your healthcare provider if the person currently has a fever or infection. Also talk with the provider if the person has a weakened immune system from diseases such as HIV/AIDS or from cancer chemotherapy, radiation therapy, or steroid medicine.

Tell your provider if the person who is to receive the vaccine has ever had a high fever (over 105°), cried non-stop for 3 or more hours, had a seizure, collapsed, or had any other serious reaction after getting a vaccine.

Females of childbearing age: This medicine is not usually given to pregnant women. Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while receiving this medicine without your healthcare provider's approval.

How do I use it?

This vaccine is given by a healthcare provider. Several shots are usually given over a period of time. Get all the shots on schedule to provide complete protection. Keep a record of when each vaccine was last given. If a shot is missed, contact your healthcare provider right away and schedule another appointment for the shot.

What should I watch out for?

It is very important to get all shots on schedule to provide protection from these serious diseases. Keep all appointments for injections and check-ups.

There may be temporary redness, tenderness, and swelling where the shot was given. Also, this medicine may cause a mild fever of 100 to 102°F within 4 days after a vaccination. If the fever continues or gets worse, contact your healthcare provider. Acetaminophen (Tylenol) may help reduce the fever and discomfort caused by the vaccine. Talk with your healthcare provider about this.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as the body adjusts to the medicine. Tell your healthcare provider if any side effects continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of the lips, tongue, and throat).

Serious (report these to your healthcare provider right away): High fever (over 105°); seizures; collapse; fainting; loss of alertness; crying or screaming for more than 3 hours.

Other: Drowsiness; irritability; restlessness; decreased appetite; mild fever (100-102°); nausea; vomiting; diarrhea; temporary redness, tenderness, and swelling where the shot was given; headache; tiredness; sore joints; body aches.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• arthritis medicines such as adalimumab (Humira), anakinra (Kineret), etanercept (Enbrel), or infliximab (Remicade)
• medicine that reduces the chance of blood clots forming such as warfarin (Coumadin)
• cancer medicines such as vincristine (Vincasar) and vinorelbine (Navelbine)
• corticosteroids such as betamethasone (Celestone), cortisone, dexamethasone, fludrocortisone (Florinef), hydrocortisone (Cortef), methylprednisolone (Medrol), prednisone, and prednisolone
• immunosuppressants such as azathioprine (Imuran), cyclosporine (Sandimmune, Gengraf, Neoral), mycophenolate mofetil (CellCept), sirolimus (Rapamune), and tacrolimus (Prograf, Protopic)
• other vaccines
• radiation treatment or chemotherapy (this vaccine may not be effective)

Keep a record of all vaccines received and when your child received them.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you or your child about all products taken.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.