Allina Health

Pronunciation:

ree-DOOST dif-THEER-ee-a TOX-oyd, TET-n-us TOX-oyd, per-TUS-iss VAX-een, a-SELL-yoo-lar

Brand Names:

• Adacel
• Boostrix

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Diphtheria, tetanus, and acellular pertussis booster vaccine (also known as Tdap) is a combination immunizing agent given by injection to protect against infections caused by diphtheria, tetanus (lockjaw), and pertussis (whooping cough). This vaccine is given to children 10 years of age and older, and to adults who have already been given this vaccine in the past. The vaccine will "boost" or increase the protection that the child or adult had from the earlier dose.

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia, and possibly death. The risk of serious complications and death is greater in very young children and in the elderly.

Tetanus (also known as lockjaw) is a serious illness that causes convulsions (seizures) and severe muscle spasms that can be strong enough to cause bone fractures of the spine. Tetanus causes death in 30 to 40 percent of cases.

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

Children 10 years of age and older, and adults, may need an additional immunization called a booster against diphtheria, tetanus, and pertussis. Adults and teenagers should receive Tdap instead of the tetanus-diphtheria (Td) injection if it has been 10 years or more since their last tetanus-diphtheria vaccination. Tdap vaccination is recommended for adults who are in close contact with a baby who is less than a year old and for adults who work in the healthcare field.

Diphtheria, tetanus, and pertussis are serious diseases that can cause life-threatening illnesses. Although some serious side effects can occur after a dose of Tdap (usually from the pertussis vaccine part), this rarely happens. The chance of your child catching one of these diseases, and being permanently injured or dying as a result, is much greater than the chance of your child getting a serious side effect from the Tdap vaccine.

This vaccine is to be administered only by or under the supervision of your doctor or other 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—

Boostrix® is not used in children younger than 10 years of age. Adacel™ is not used in children younger than 11 years of age.

The Advisory Committee on Immunization Practices (ACIP) has recommended that teenagers be given a Tdap vaccination instead of the tetanus-diphtheria (Td) vaccination. The committee is also encouraging all teenagers, even those who have already received Td, to get a Tdap booster to help protect against pertussis (e.g., whooping cough). If you have questions about whether your teenager should receive Tdap, contact your doctor.

Older adults—

Adacel™ and Boostrix® are not recommended for adults 65 years of age and older.

Pregnancy—

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Allergic reaction to a previous dose of Tdap or
• Brain disease (decreased level of consciousness, uncontrolled seizures) or
• Fever—May make these conditions worse or increase the chance of side effects.

• Bleeding disorders (hemophilia, thrombocytopenia)—Should not use in patients with this condition.

• Epilepsy (seizures or convulsions), history of or
• Guillain-Barré syndrome (nervous system disorder that causes paralysis), history of or
• Nervous system disorder—Your doctor will decide if you should receive this vaccine.

• Weakened immune system—This vaccine may not work as well in patients with this condition.

Proper Use of This Medicine:

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

The Adacel™ brand of Tdap vaccine should only be given to adults, teenagers, and children 11 to 64 years of age.

The Boostrix® brand of Tdap vaccine should only be given to adults, teenagers, and children 10 to 64 years of age.

At the time of the Tdap injection, your doctor may give your child a dose of acetaminophen (Tylenol®) or another medicine that prevents fever. This is to help prevent some of the side effects of Tdap. Your doctor may also want your child to take this medicine every 4 hours for the 24 hours after your child receives the vaccine. Check with your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For prevention of diphtheria, tetanus, and pertussis:
    • Adults and children 11 to 64 years of age—One single dose of Adacel™ brand vaccine.
    • Adults and children 10 to 64 years of age—One single dose of Boostrix® brand vaccine.
    • Children up to 10 years of age—Contact your child's doctor. Your infant or child should receive a different diphtheria, tetanus, and pertussis vaccine called DTaP.

Precautions While Using This Medicine:

It is very important to tell the doctor if you or your child are allergic to rubber. The syringes of the Boostrix® brand of Tdap vaccine contain dry natural latex rubber, which may cause an allergic reaction if you or your child has a latex allergy.

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, 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:

Less common

Collapse

crying for 3 or more hours

Rare

Confusion

convulsions (seizures)

difficulty with breathing or swallowing

fever of 102.2 °F or more

headache (severe or continuing)

hives

itching, especially of the feet or hands

low blood pressure

reddening of the skin, especially around the ears

seizures (convulsions)

shock-like state

sleepiness (unusual and continuing)

swelling of the eyes, face, or inside of the nose

unusual tiredness, weakness (sudden and severe)

vomiting (severe or continuing)

Incidence not known

Blood in the urine

bloody or black, tarry stools

blurred vision

chest pain or discomfort

chills

dry mouth

fast heartbeat

fatigue

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

large, flat, blue or purplish patches on the skin

loss of consciousness

nausea

painful knees and ankles

raised red swellings on the skin, buttocks, legs or ankles

stiff neck

stomach pain

stomachache

sweating

unexplained weight loss

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

Diarrhea

fever of 99.5 °F or more

lump at place of injection (may be present for a few weeks after injection)

redness, swelling, tenderness, or pain at place of injection

Less common

Fever between 102.2 °F and 104 °F

Rare

Skin rash

swollen glands on the side of the neck after Tdap injection into the arm

Incidence not known

Back pain

burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings

injection site bruising

itching skin

muscle or joint pain

redness of the skin

swollen, painful, or tender lymph glands in the neck, armpit, or groin

weakness of the muscles in the face

welts

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.