Adacel

What is Adacel?

• Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) is a vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis.

What are the uses of this medicine?

• Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) is a vaccine that helps protect against tetanus, diphtheria, and pertussis diseases in people who are 10 through 64 years of age. It cannot cause tetanus, diphtheria, or pertussis.
• Adacel vaccine may not protect all people getting the vaccine.

Tetanus:

• Tetanus, also called "lockjaw", can cause severe muscle spasms making it difficult for a person to open their mouth or swallow.
• You can get tetanus through a cut or wound.

Diphtheria:

• Diphtheria can cause throat, lung and skin infections leading to severe complications that affect the lungs, heart and nervous system.

Pertussis:

• Pertussis, also called "whooping cough," causes coughing fits that can affect breathing.
• Diphtheria and pertussis are spread from person to person.

How does this medicine work?

• Tetanus is a disease manifested primarily by neuromuscular dysfunction caused by a potent exotoxin released by C tetani.
• Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assay is considered the minimum protective level.

• Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C diphtheriae. Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally regarded as protective.

• Pertussis (whooping cough) is a respiratory disease caused by B pertussis. This Gram-negative coccobacillus produces a variety of biologically active components, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• had a severe allergic reaction to a previous tetanus vaccine, diphtheria vaccine, pertussis vaccine, or any component of Adacel vaccine.
• were told you have an "encephalopathy", which is a kind of brain disease or malfunction, after receiving a previous dose of a pertussis vaccine.
• are younger than 10 years old or older than 64 years of age.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention if you are taking any of the following:

• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids.

• Adacel should not be mixed with any other vaccine in the same syringe or vial.

Is this medicine FDA approved?

• Initial U.S. Approval: 2005

How should this medicine be used?

Recommended dosage:

• Each dose of Adacel is administered as a 0.5 mL injection.
• For routine booster vaccination, a first dose of Adacel is administered 5 years or more after the last dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) series or 5 years or more after vaccination with Tetanus and Diphtheria Toxoids Adsorbed (Td).
• A second dose of Adacel may be administered 8 years or more after the first dose with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap).
• Adacel may be administered for tetanus prophylaxis for wound management.
• For management of a tetanus prone wound, a booster dose of Adacel may be administered if at least 5 years have elapsed since previous receipt of a tetanus toxoid containing vaccine.

Administration:

• For intramuscular injection only.
• Adacel is a single shot that is given into the muscle of the upper arm.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-dose vials and prefilled syringes containing a 0.5 mL suspension for injection.

This medicine is available in fallowing brand namesː

• Adacel; Boostrix

What side effects can this medication cause?

The most common side effects of this medicine include:

• pain, redness and swelling where you got the shot
• headache
• body ache
• tiredness
• fever

What special precautions should I follow?

• Epinephrine hydrochloride solution and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.
• If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following a dose of Adacel.
• Administration of Adacel to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.
• Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last dose of a tetanus toxoid containing vaccine.
• If Adacel is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.
• Fainting can occur around the time of vaccination with Adacel or other vaccines. Tell your healthcare provider if you or your child has fainted in connection with any previous vaccination.
• People with minor illnesses, such as a cold, may be vaccinated. People who are moderately or severely ill should usually wait until they recover before getting Tdap vaccine.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available data suggest the rates of major birth defects and miscarriage in women who receive Adacel within 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Adacel during pregnancy. Women who receive Adacel during pregnancy are encouraged to contact directly, or have their healthcare professional contact, Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE).

Can this medicine be used in children?

• Adacel is not approved for individuals less than 10 years of age.
• Safety and effectiveness of Adacel in persons less than 10 years of age in the U.S. have not been established.

What are the active and inactive ingredients in this medicine?

• Adacel vaccine contains noninfectious tetanus, diphtheria, and pertussis proteins, aluminum phosphate, 2-phenoxyethanol, and residual amounts of formaldehyde and glutaraldehyde.

Who manufactures and distributes this medicine?

Manufactured by:

• Sanofi Pasteur Limited
• Toronto Ontario Canada

Distributed by:

• Sanofi Pasteur Inc.
• Swiftwater PA USA

What should I know about storage and disposal of this medication?

• Adacel should be stored at 2°C to 8°C (35°F to 46°F).
• DO NOT FREEZE.
• Product which has been exposed to freezing should not be used.
• Do not use after expiration date shown on the label.

• Dailymed label info on Adacel
• FDA Adacel

Adacel Resources
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