Adacel Intramuscular

Name: Adacel Intramuscular

What happens if I miss a dose?

Since Adacel vaccine is usually given only once, you are not likely to miss a dose.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

For the Consumer

Applies to diphtheria toxoid / pertussis, acellular / tetanus toxoid: intramuscular suspension

Along with its needed effects, diphtheria toxoid / pertussis, acellular / tetanus toxoid 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 or nurse immediately if any of the following side effects occur while taking diphtheria toxoid / pertussis, acellular / tetanus toxoid:

Less common
  • Crying for 3 or more hours
  • fainting
Rare
  • Confusion
  • convulsions (seizures)
  • difficulty with breathing or swallowing
  • fever of 102.2 degrees 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
  • sleepiness (unusual and continuing)
  • swelling of the eyes, face, or inside of the nose
  • unusual tiredness or 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
  • cough
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast heartbeat
  • flushed, dry skin
  • fruit-like breath odor
  • inability to move the arms and legs
  • increased hunger
  • increased thirst
  • increased urination
  • large, flat, blue or purplish patches on the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of consciousness
  • muscle pain or spasm
  • nausea
  • painful knees and ankles
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness and swelling on the skin, buttocks, legs, or ankles
  • skin rash
  • stiff neck
  • stomach pain
  • sudden numbness and weakness in the arms and legs
  • sweating
  • tightness in the chest
  • trouble breathing
  • unexplained weight loss
  • unusual tiredness or weakness

Some side effects of diphtheria toxoid / pertussis, acellular / tetanus toxoid 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
  • Body aches
  • diarrhea
  • fever of 99.5 degrees F or more
  • headache
  • redness, swelling, tenderness, pain, or a lump at the place of injection
  • tiredness
Incidence not known
  • Back pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • injection site bruising
  • muscle or joint pain
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • weakness of the muscles in the face
  • welts on the skin

For Healthcare Professionals

Applies to diphtheria toxoid / pertussis, acellular / tetanus toxoid: intramuscular suspension

Local

Local side effects have included injection site pain, swelling, and erythema.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, and vomiting.[Ref]

Musculoskeletal

Musculoskeletal side effects have included sore and swollen joints, body aches, muscle weakness, and lymph node swelling.[Ref]

General

General side effects have included headache, fever, chills, and tiredness.[Ref]

Dermatologic

Dermatologic side effects have included rash, pruritus, and urticaria.[Ref]

Some side effects of Adacel (Tdap) may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Tetanus Prophylaxis

Booster Immunization (ADACEL):

18 to 64 years: 0.5 mL IM once. Individuals who have completed a primary series against tetanus and who sustain wounds which are minor and uncomplicated, should receive a booster dose of a tetanus toxoid containing vaccine only if they have not received a tetanus toxoid within the preceding 10 years. For tetanus prone wounds, a booster is appropriate if the patient has not received a tetanus toxoid containing preparation within the preceding 5 years.

Booster Immunization (BOOSTRIX):
18 years or older: 0.5 mL IM once. Individuals who have completed a primary series against tetanus and who sustain wounds which are minor and uncomplicated, should receive a booster dose of a tetanus toxoid containing vaccine only if they have not received a tetanus toxoid within the preceding 10 years. For tetanus prone wounds, a booster is appropriate if the patient has not received a tetanus toxoid containing preparation within the preceding 5 years.

Liver Dose Adjustments

Data not available

Precautions

Diphtheria/pertussis, acellular/tetanus is contraindicated if encephalopathy not attributable to another cause developed within 7 days of administration of previous dose.

If a progressive neurologic disorder, uncontrolled epilepsy, or progressive encephalopathy is present, do not administer vaccine until a treatment regimen has been established, the condition stabilized, and the benefit clearly outweighs the risk.

Because intramuscular injections can cause injection site hematoma, diphtheria/pertussis, acellular/tetanus vaccine should not be given to patients with any bleeding disorder, such as thrombocytopenia or hemophilia, or on anticoagulation therapy unless the potential benefit clearly outweighs the risk of administration.

Caution should be exercised when administering diphtheria/pertussis, acellular/tetanus to patients who presented the following symptoms after receiving a previous dose of pertussis vaccine: fever of greater than 40.5 degrees Celsius occurring within 48 hours; collapse or shocklike state (i.e., hypnotic hyporesponsive episode) occurring within 48 hours; persistent, inconsolable crying lasting 3 or more hours occurring within 48 hours, or: seizures with or without fever occurring within 3 days

Epinephrine injection 1:1000 must be immediately available should an acute anaphylactic reaction occur due to any component of the vaccine.

Do not administer this product intravenously or subcutaneously.

Other Comments

Administer the vaccine intramuscularly.

Common adverse reactions and all serious reactions that occur during administration in the U.S. should be reported to the U.S. Department of Health and Human Services Vaccine Adverse Event Reporting System. Reporting forms and information regarding the completion of the form can be obtained at 1-800-822-7967.

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