1 What is Pentacel?

Brand: Pentacel

Generic: Diphtheria, Tetanus, Acellular Pertussis, Polio, Hib Vaccine

Pentacel is a combination vaccine used to protect against infections caused by diphtheria, tetanus, pertussis (a whooping cough), Haemophilus influenza type 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 6 weeks to 4 years of age and is given before the child’s 5th birthday.

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.

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.

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.

Infection by Haemophilus influenza type B bacteria can cause life-threatening illnesses, such as meningitis, which affects the brain, epiglottitis, which affects the throat and can cause death by suffocation, pericarditis, which affects the heart and septic arthritis, which affects the bones and joints.

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
  • Powder for suspension

2 What to Know Before Using

Before using Pentacel, 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 weeks of age to 4 years of age.

No appropriate studies have been performed on the relationship of age to the effects of this medication in children under 6 weeks of age and 5 years of age and older. Safety and efficacy have not been established.

Geriatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in elderly patients. Safety and efficacy have not been established.

Pregnancy: This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.

Breastfeeding: There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

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:

  • Brain disease (i.e. encephalopathy) - This includes a coma, a decreased level of consciousness, or seizures lasting a long time. Children who have these symptoms within 7 days of receiving a vaccine with pertussis should not get this vaccine.
  • Guillain-Barré 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.
  • Weakened immune system - This vaccine may not work as well in children with these conditions.
  • Previous serious reaction to a vaccine - If your child had a serious reaction 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 was 105 degrees F or higher.
  • Progressive neurologic disorder - This includes infantile spasms, progressive brain disease, or uncontrolled seizures. This vaccine should not be given until these conditions are treated and under control.

3 Proper Usage

Proper usage of Pentacel 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).

This vaccine is given as 4 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.

4 Precautions to Take

Before using Pentacel, 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.

This vaccine will not treat an active infection. If your child has an infection of diphtheria, tetanus, pertussis, Haemophilus influenza type 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 Pentacel. Although not all of these side-effects may occur, if they do occur they may need medical attention.

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

More common:

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More common:

  • Irritability
  • Tenderness at the injection site
  • Unusual drowsiness, dullness, fatigue, weakness or lethargy

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.