Indication: Active booster immunization for the prevention of tetanus, diphtheria, and pertussis (whooping cough) in individuals 4 years of age and older.
Use: Can be used for tetanus prophylaxis in wound management. Recommended for those who have had tetanus, diphtheria, or pertussis previously, as these infections do not always confer immunity.
Contraindications
Hypersensitivity: Known systemic hypersensitivity reaction to any component of ADACEL® or a life-threatening reaction after previous administration of the vaccine or a vaccine containing similar components.
Neurological Disorders: Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause.
Warnings and Precautions
General: Health-care providers should inform recipients or their guardians about the benefits and risks of immunization and review the recipient’s history for possible hypersensitivity, recent health status, and presence of any contraindications.
Administration: Should be administered intramuscularly, preferably in the deltoid muscle, and not by intravascular, intradermal, or subcutaneous routes.
Acute Disease: Vaccination should be postponed in cases of acute or febrile disease.
Hematologic: Caution in individuals with bleeding disorders or on anticoagulant therapy; intramuscular injections can cause injection site hematomas.
Immune: May not achieve the expected immune response in immunocompromised persons; vaccination of persons with chronic immunodeficiency is recommended even if the immune response might be limited.
Adverse Reactions
Common: Pain at the injection site, tiredness, headache, myalgia, and fever. Most reactions were mild and transient.
Serious: Rare cases of severe migraine with unilateral facial paralysis and nerve compression in the neck and arm, both resolving spontaneously or with treatment.
Post-Marketing: Reports of hypersensitivity reactions (anaphylaxis), Guillain-Barré syndrome, brachial neuritis, myocarditis, and extensive limb swelling.
Drug Interactions
Concomitant Administration: Can be administered concurrently with trivalent inactivated influenza vaccine and hepatitis B vaccine using separate injection sites and syringes.
Dosage and Administration
Dose: 0.5 mL intramuscularly as a booster injection. Re-dosing can boost immunity at 5- to 10-year intervals.
Reconstitution: Shake the vial well until a uniform, cloudy suspension is obtained. Administer immediately and do not mix with other vaccines in the same syringe.
Storage and Stability
Storage: Store at 2° to 8°C (35° to 46°F). Do not freeze. Stable up to 25°C for a maximum of 3 days (72 hours).
