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Diphtheria, tetanus, acellular pertussis, polio, hib vaccine (Intramuscular route)

Pronunciation:

dif-THEER-ee-a TOX-oyd, ad-SORBD, TET-a-nus TOX-oyd, per-TUS-iss VAX-een, a-SELL-yoo-lar, POE-lee-oh VYE-rus VAX-een, in-AK-ti-vated, hee-MOF-i-lus B KON-joo-gate VAX-een

Brand Names:

  • Pentacel

Dosage Forms:

  • Suspension
  • Powder for Suspension

Uses of This Medicine:

Diphtheria, tetanus, and acellular pertussis vaccine (also known as DTaP) combined with inactivated poliovirus and Haemophilus B conjugate vaccine (also known as IPV and Hib) is a combination vaccine that is given to protect against infections caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), poliovirus, and Haemophilus influenzae type b. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. This vaccine is only given to infants and children who are 6 weeks to 4 years of age, and is given before the child's 5th birthday.

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 (also known as lockjaw) is a very serious illness that causes seizures and severe muscle spasms that can be strong enough to cause bone fractures of the spine. The disease continues to occur almost exclusively among people who do not get vaccinated or do not have enough protection from previous vaccines.

Pertussis (also known as whooping cough) is a serious disease that causes severe spells of coughing that can interfere with breathing. Pertussis can also cause pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Polio is a very serious infection that causes paralysis of the muscles, including the muscles that enable you 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 influenzae type b (Hib) 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; pneumonia, which affects the lungs; and septic arthritis, which affects the bones and joints.

This vaccine is to be administered only by or under the supervision of your child's doctor or other authorized health care professional.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of this vaccine in infants younger than 6 weeks of age and in children 5 years of age and older. Safety and efficacy have not been established.

Make sure your doctor knows if your child was born prematurely. This vaccine may cause breathing problems (such as apnea) to infants born prematurely.

Older adults—

No information is available on the relationship of age to the effects of this vaccine in geriatric patients.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Meningococcal Vaccine, Tetanus Toxoid Conjugate Quadrivalent

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Brain disease (e.g., 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), history of—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 or
  • 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.

Proper Use of This Medicine:

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot into one of your child's muscles.

This vaccine is usually given as a series of 4 shots. It is important that your child receive all of the shots in this series. Try to keep all scheduled appointments. If your child must miss a shot, make another appointment with the doctor as soon as possible.

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

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

Precautions While Using This Medicine:

It is very important that the doctor check your child at regular visits to make sure this vaccine is working properly and to check for unwanted effects. It is very important that you return to your child's doctor for the next dose in the series.

Tell your child’s doctor about all other vaccines your child has had, especially if those vaccines were part of a series. This vaccine might be used to finish a series of vaccines.

This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, pertussis, polio, or Haemophilus influenzae type b, your child will need medicines to treat these infections. .

Be sure to tell your child's doctor about any side effects that occur after your child receives the vaccine. This may include fainting, seizures, a high fever, crying that will not stop, or severe redness or swelling where the shot was given.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Abdominal or stomach pain
chest pain
confusion
coughing or shortness of breath
crying, persistent and inconsolable, occurring within 48 hours and lasting 3 or more hours
decreased urination
diarrhea
dizziness
dry mouth
fainting
fever
increase in heart rate
lightheadedness
loss of appetite
nausea
noisy breathing
rapid breathing
shortness of breath
sneezing
sore throat
sunken eyes
thirst
tightness in the chest
unusual tiredness or weakness
wrinkled skin
Incidence not known
Bluish color of the fingernails, lips, skin, palms, or nail beds
chills
cold or flu-like symptoms
drowsiness
fast heartbeat
general feeling of illness
hives
hoarseness
irritation
itching
joint pain, stiffness, or swelling
rash
redness of the skin
runny nose
severe headache
slow breathing
sneezing
stiff neck or back
stuffy nose
swelling of the eyelids, face, lips, hands, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Irritability
tenderness at the injection site
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known
Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
change in skin color at the injection site
paleness of the skin
sleepiness or unusual drowsiness
vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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