Pronunciation:

TET-a-nus TOX-oyd

Brand Names:

• TE Anatoxal Berna
• Tetanus Toxoid Adsorbed

Uses of This Medicine:

Tetanus Toxoid is used to prevent tetanus (also known as lockjaw). Tetanus 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.

Immunization against tetanus is recommended for all infants 6 to 8 weeks of age and older, all children, and all adults. Immunization against tetanus consists first of a series of either 3 or 4 injections, depending on which type of tetanus toxoid you receive. In addition, it is very important that you get a booster injection every 10 years for the rest of your life. Also, if you get a wound that is unclean or hard to clean, you may need an emergency booster injection if it has been more than 5 years since your last booster. In recent years, two-thirds of all tetanus cases have been in persons 50 years of age and older. A tetanus infection in the past does not make you immune to tetanus in the future.

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 medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

In deciding to receive this vaccine, the risks of receiving the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For tetanus toxoid, 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—

Use is not recommended for infants up to 6 weeks of age. For infants and children 6 weeks of age and older, tetanus toxoid is not expected to cause different side effects or problems than it does in adults.

Older adults—

This vaccine is not expected to cause different side effects or problems in older people than it does in younger adults. However, the vaccine may be slightly less effective in older persons than in younger adults.

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. When you are taking this medicine, 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.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ocrelizumab

Using this medicine 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.

• Chloramphenicol

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• A severe reaction or a fever greater than 103 °F (39.4 °C) following a previous dose of tetanus toxoid—May increase the chance of side effects with future doses of tetanus toxoid; be sure your doctor knows about this before you receive the next dose of tetanus toxoid

• Bronchitis, pneumonia, or other illness involving lungs or bronchial tubes, or
• Severe illness with fever—Possible side effects from tetanus toxoid may be confused with the symptoms of the condition

Proper Use of This Medicine:

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 forms:
  • For prevention of tetanus (lockjaw):
    • Adults, children, and infants 6 weeks of age and older—One dose is given at your first visit, then a second dose is given four to eight weeks later. Depending on the product given, you may receive a third dose four to eight weeks after the second dose, and a fourth dose six to twelve months after that; or you may receive a third dose six to twelve months after the second dose. Everyone should receive a booster dose every ten years. The doses are injected under the skin or into a muscle. In addition, if you get a wound that is unclean or hard to clean, you may need an emergency booster injection if it has been more than 5 years since your last booster dose.

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:

Symptoms of allergic reaction

Difficulty in breathing or swallowing

hives

itching, especially of feet or hands

reddening of skin, especially around ears

swelling of eyes, face, or inside of nose

unusual tiredness or weakness (sudden and severe)

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Confusion

convulsions (seizures)

fever over 103 °F (39.4 °C)

headache (severe or continuing)

sleepiness (excessive)

swelling, blistering, or pain at place of injection (severe or continuing)

swelling of glands in armpit

unusual irritability

vomiting (severe or continuing)

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

Redness or hard lump at place of injection

Less common

Chills, fever, irritability, or unusual tiredness

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

skin rash

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.