Adacel Intramuscular

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.

Pediatric

Boostrix® and Adacel® are not used in children younger than 10 years of age.

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

Geriatric

Adacel® is not used in adults 65 years of age and older.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Boostrix® in the elderly.

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.

Interactions with 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

Interactions with Food/Tobacco/Alcohol

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:

• Brachial neuritis (nerve problem) or
• Epilepsy (seizures or convulsions), uncontrolled or
• Guillain-Barré syndrome (nerve disorder with paralysis), history of after a vaccine with tetanus or
• Infection, severe or
• Progressive encephalopathy (a brain disease) or
• Stroke, active—Your doctor will decide if you or your child should receive this vaccine.

• Encephalopathy (a brain disease), history of after a vaccine with pertussis—Should not be used in patients with this condition.

• Immunodeficiency disorder (weak immune system)—May not work as well in patients with this condition.

It is very important that you call the doctor right away if you or your child have any unwanted effects after receiving 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.

Fainting may occur after you receive this vaccine. You may also have vision changes, numbness or tingling in your arms, hands, or feet, or jerky movements of the arms and legs. Call the doctor right away if you or your child have any of these symptoms.

It is very important to tell the doctor if you or your child are allergic to rubber. The syringes may contain dry natural latex rubber. This may cause an allergic reaction if you have a latex allergy.

This vaccine will not treat an active infection. If you or your child have a diphtheria, tetanus, or pertussis infection, you will need medicine to treat the infection.

Adacel (diphtheria, tetanus acellular, and pertussis adult vaccine - also called Tdap) is used to help prevent tetanus, diphtheria, and pertussis in people who are at least 10 years old. Most people in this age group require only one Tdap shot for protection against these diseases.

Tetanus, diphtheria, and pertussis are serious diseases caused by bacteria.

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

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.

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

Adacel is especially important for healthcare workers or people who have close contact with a baby younger than 12 months old.

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

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

In most cases,Adacel is given in only one dose. Follow your doctor's instructions about receiving a booster dose if needed.

You can still receive the Adacel vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving Adacel.

You should not receive Adacel if you have ever had had a life-threatening allergic reaction to a tetanus, diphtheria, or pertussis vaccine. You also should not receive this vaccine if you had a neurologic disorder affecting your brain within 7 days after having a previous pertussis vaccine.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the Adacel vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Follow your doctor's instructions about any restrictions on food, beverages, or activity after receiving Adacel.

Before receiving Adacel, tell your doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine;

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

• medicines to treat or prevent organ transplant rejection.

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete. Other drugs may interact with Adacel, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Data not available

There are no data on the excretion of diphtheria/pertussis, acellular/tetanus in human milk. The manufacturer recommends that caution be used when administering diphtheria/pertussis, acellular/tetanus to nursing women.