Pentacel is a vaccine used to improve immunity against diphtheria, haemophilus influenzae type B, pertussis, polio, and tetanus, all serious diseases caused by bacteria or viruses.

Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.

Haemophilus B bacteria can infect the lungs or throat, and can also spread to the blood, bones, joints, brain, or spinal cord. It can cause breathing problems or meningitis, and these infections can be fatal.

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.

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.

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.

Diphtheria, haemophilus B, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

Pentacel vaccine is used to help prevent these diseases in children who are ages 6 weeks through 4 years (before the 5th birthday).

Pentacel works by exposing your child to a small dose of the virus, bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. Pentacel will not treat an active infection that has already developed in the body.

Like any vaccine, the Pentacel may not provide protection from disease in every person

Pentacel vaccine 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, 6 months, and 15 to 18 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 Pentacel. 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 a vaccine 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 Pentacel.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Your child should not receive a Pentacel vaccine if he or she has a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine).

Becoming infected with diphtheria, haemophilus influenzae, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, Pentacel can cause side effects, but the risk of serious side effects is extremely low.

Pentacel is given as an injection (shot) into a muscle.

Pentacel 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, 6 months, and 15 to 18 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.

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 for Haemophilus influenzae Prophylaxis:

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age.

Usual Pediatric Dose for Poliomyelitis Prophylaxis:

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age.

Usual Pediatric Dose for Diphtheria Prophylaxis:

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age.

Usual Pediatric Dose for Pertussis Prophylaxis:

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age..

Usual Pediatric Dose for Tetanus Prophylaxis:

0.5 mL intramuscularly at 2, 4, 6, and 15 to 18 months of age

Comments:
-The first dose may be given as early as 6 weeks of age.
-Four doses constitute a primary vaccination course against pertussis.
-Three doses constitute a primary vaccination course against diphtheria, tetanus, Haemophilus b, and poliomyelitis, with the fourth dose considered a booster against these diseases.
-Pentacel may be used to complete the first 4 doses of the 5 dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [DTaP] series in infants who have received 1 or more DTaP doses and are also scheduled to receive the other antigens in Pentacel, but safety and immunogenicity of these mixed sequences have not been established.
-Pentacel may be used in infants/children who have received 1 or more doses of another inactivated polio vaccine (IPV) or a Haemophilus b Conjugate vaccine (individual or combination vaccination) and are scheduled to receive the other antigens in Pentacel, but safety and immunogenicity of these mixed sequences have not been established.
-When Pentacel is administered at the recommended ages, the Advisory Committee on Immunization Practices (ACIP) recommends an additional IPV booster dose at 4 to 6 years old, resulting in a 5 dose IPV series.

Your child should not receive Pentacel if he or she has:

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

• 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 Pentacel 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.

To make sure Pentacel is safe to administer, 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; or

• if the child was born prematurely.

Your child can still receive a Pentacel 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 Pentacel.

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

An overdose of Pentacel 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 Pentacel: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Your child should not receive a 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, haemophilus B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving Pentacel. However, like any medicine, Pentacel can cause side effects but the risk of serious side effects is low.

Call your doctor at once if the child has:

• irritability, crying for an hour or longer;

• very high fever; or

• extreme drowsiness, fainting.

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 Pentacel side effects may include:

• low fever, mild fussiness; or

• redness, pain, tenderness, or swelling where the shot was given.

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.

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