How does this medication work? What will it do for me?

This medication belongs to a group of medications known as vaccines. It is used to prevent tetanus, diphtheria, pertussis (whooping cough), polio, and infections (such as meningitis, lung infections, and heart infections) caused by the bacterium Hemophilus influenzae B (Hib) in infants and children ages 6 weeks to 2 years.

It works by increasing a child’s defenses against the bacteria and viruses that cause these infections, by stimulating the production of the child's own antibodies. These antibodies remain in the body until needed to fight off the viruses and bacteria causing these infections if the child is exposed to them.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why your child is being given this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Pediacel is supplied as a sterile, uniform, cloudy, white-to-off-white suspension in a vial. Each single dose (0.5 mL) contains diphtheria toxoid 15 Lf; tetanus toxoid 5 Lf; acellular pertussis: pertussis toxoid (PT) 20 µg, filamentous haemagglutinin (FHA) 20 µg, pertactin (PRN) 3 µg, fimbriae types 2 and 3 (FIM) 5 µg; inactivated poliomyelitis vaccine: type 1 (Mahoney) 40 D-antigen units (*or the equivalent antigen quantity, determined by suitable immunochemical method), type 2 (MEF1) 8 D-antigen units*, type 3 (Saukett) 32 D-antigen units*; purified polyribosylribitol phosphate capsular polysaccharide (PRP) of H. influenzae type b covalently bound to 20 µg of tetanus protein 10 µg. Nonmedicinal ingredients: aluminum phosphate (adjuvant) 1.5 mg, 2-phenoxyethanol 0.6% v/v, polysorbate 80 ≤0.1% w/v (by calculation). Manufacturing process residuals: bovine serum albumin, neomycin, polymyxin B, streptomycin, formaldehyde, and glutaraldehyde are present in trace amounts.

How should I use this medication?

This medication is given as an injection into a muscle (either the thigh for smaller children or the upper arm for bigger children), usually in a doctor's office. When used for primary immunization of infants, the usual immunization schedule is one dose given at 2, 4, and 6 months of age. A booster dose is recommended at least 6 months after the last dose and before 24 months of age. It is very important this medication be given on a regular schedule exactly as recommended by the doctor. If you miss an appointment for your child to receive a dose of this medication, contact your child's doctor as soon as possible to reschedule your appointment. Your child may not be fully protected against these illnesses if doses are missed.  Add all vaccines to your immunization record.

This medication should be kept in the fridge, not frozen and protected from light.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Your child should not receive this medication if they:

  • are allergic to diphtheria, tetanus, pertussis, hepatitis B, poliovirus, or Haemophilus influenzae type b vaccines, or any ingredients of this medication
  • are allergic to neomycin, or polymyxin
  • have previously had encephalopathy (abnormal brain function) within 7 days of receiving a pertussis-containing vaccine
  • are currently experiencing a fever or severe, acute illness

Do not give this medication to children 5 years of age and older.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if your child experiences these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • fever (usually lasts less than 48 hours)
  • irritability
  • loss of appetite
  • pain, soreness, redness, swelling, or a lump at the place of injection
  • restlessness
  • sleepiness
  • unusual crying
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • bleeding or bruising more easily
  • cough
  • slowed breathing
  • swollen glands
  • symptoms of a cold, sinus, or ear infection
  • temporary breathing interruptions (more likely to occur with children born at 28 weeks of pregnancy or less)
  • wheezing

Stop your child from receiving the medication and seek immediate medical attention if any of the following occur:

  • collapse
  • periods of unconsciousness or lack of awareness
  • seizures
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Be sure to mention any side effect to your doctor, as it may mean that your child is allergic to the vaccine. If so, it would not be safe for them to have more doses of the same type of vaccine.

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while your child is taking this medication.

Are there any other precautions or warnings for this medication?

Before your child receives this medication, be sure to inform your child's doctor of any medical conditions or allergies they may have, any medications your child is taking, and any other significant facts about your child's health. These factors may affect how your child should receive this medication.

Allergic reactions: In rare cases, this vaccine may cause severe allergic reactions. For this reason, doctors often ask people to stay in the office for about 30 minutes after having the vaccine so they can receive medical care if an allergic reaction occurs. If you notice signs of a severe allergic reaction in your child (hives; trouble breathing or swallowing; or swelling of the lips, face, throat, or tongue), get medical attention immediately.

Bleeding disorders: If you or your child have a bleeding disorder or are taking medications that make you more likely to bleed (i.e., warfarin, acetylsalicylic acid [ASA]) tell the person giving the injection. There is a risk of excessive bleeding where the injection is given if it is not done carefully.

Immune system: As with any vaccine, this vaccine may not be as effective for people with a weakened immune system (such as those on chemotherapy, people who have had an organ transplant, or people who have HIV).

If your child has a weakened immune system, for any reason, discuss with your doctor how this medication may affect your child's medical condition, how your child's medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection or fever: This vaccine should not be given to anyone who has an active infection or an illness associated with fever, unless the doctor decides that the benefits outweigh the risks.

Seizures: People who have a history of seizures or seizure disorders may be at an increased risk of experiencing seizures with this vaccine. Your child's doctor may suggest that you give your child a dose of medication to prevent fever. If your child has a history of seizures, discuss with their doctor whether any special precautions are needed.

Vaccine protection: As with any vaccine, this vaccine may not protect all people who receive it and may not prevent infection in those people already infected with the bacteria or virus.

Pregnancy and breast-feeding: Studies have not been conducted with this vaccine during pregnancy or breast-feeding. This vaccine is not recommended for anyone 5 years of age or older.

Children: Very premature children are at an increased risk of breathing problems as a result of receiving this vaccine. However, the benefit of receiving the vaccination is greater than the risk of side effects, and the vaccine should be given as scheduled, based on the baby's age. If you have concerns, speak with your child's doctor.

This vaccine should not be administered to infants younger than 2 months or children 5 years of age or older.

What other drugs could interact with this medication?

There may be an interaction between this vaccine and any of the following:

  • acetaminophen
  • belimumab
  • fingolimod
  • immunosuppressants (medications used to treat cancer or autoimmune disease, or prevent organ rejection)
    • azathioprine
    • corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone)
    • cyclosporine
    • hydroxyurea
    • infliximab
    • medications to treat cancer (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine)
    • mycophenolate
    • rituximab
    • tacrolimus
  • meningococcal polysaccharide (Groups A/C/Y and W-135) tetanus toxoid conjugate vaccine
  • warfarin

If your child is taking any of these medications, speak with your doctor or pharmacist. Depending on the specific circumstances, your doctor may want your child to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how they are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that your child must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications your child is taking. Also tell them about any supplements your child takes. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if your child uses them.