Uses of This Medicine:

Diphtheria and Tetanus Toxoids (also known as DT and Td) is a combination immunizing agent given by injection to prevent diphtheria and tetanus.

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia, and possibly death. The risk of serious complications and death is greatest in very young children and in the elderly.

Tetanus (also known as lockjaw) 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 with diphtheria and tetanus toxoids for pediatric use (DT) is recommended for infants and children from 6 weeks of age (8 weeks in Canada) up until their 7th birthday

Children 7 years of age and older and adults should be immunized with tetanus and diphtheria toxoids for adult use (Td). In addition, these children and adults should receive booster doses of Td every 10 years for the rest of their lives.

Diphtheria and tetanus are serious diseases that can cause life-threatening illnesses. Although some serious side effects can occur after a dose of DT or Td, these are rare. The chance of your child catching one of these diseases and being permanently injured or dying as a result is much greater than the chance of your child getting a serious side effect from the DT or Td vaccine.

Before Using This Medicine:

In deciding to receive 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 these vaccines, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

For infants up to 6 weeks of age, use of DT or Td is not recommended.

For infants and children 6 weeks up to 7 years of age, Td is not recommended. DT is used instead.

For children 7 years of age and older, DT is not recommended. Td is used instead.

Older adults

DT is not recommended. Td is used instead. Td is not expected to cause different side effects or problems in older people than it does in younger adults. However, Td may be slightly less effective in older people than in younger adults.

Pregnancy

This vaccine has not been shown to cause birth defects or other problems in humans. Immunization of a pregnant woman can prevent her newborn baby from getting tetanus at birth.

Breast-feeding

This vaccine has not been shown to cause problems in nursing babies.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 vaccines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Fever or
• Infection or illness (severe) Use of DT or Td may make the condition worse or may increase the chance of side effects.

Proper Use of This Medicine:

Dosing

The dose medicines in this class 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 these medicines. 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 form:
  • For prevention of diphtheria and tetanus:
    • Adults and children 7 years of age and over Use is not recommended. Td should be used instead.
    • Children 1 to 7 years of age One dose is given at the first visit to the doctor, followed by a second dose four to eight weeks later. A third dose is given six to twelve months after the second dose. A booster (fourth) dose is given when the child is four to six years of age. The booster (fourth dose) is given only if the third dose was given before the child's fourth birthday. The doses are injected into a muscle.
    • Children 6 weeks to 1 year of age One dose is given every four to eight weeks for a total of three doses. A fourth dose is given six to twelve months after the third dose. A booster (fifth) dose is given when the child is four to six years of age. The booster (fifth) dose is given only if the fourth dose was given before the child's fourth birthday. The doses are injected into a muscle.
    • Children up to 6 weeks of age Use is not recommended.

• For injection dosage form:
  • For prevention of diphtheria and tetanus:
    • Adults and children 7 years of age and over One dose is given at the first visit to the doctor, followed by a second dose four to eight weeks later. A third dose is given six to twelve months after the second dose. You should receive a booster dose every ten years. 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 five years since your last booster dose. The doses are injected into a muscle.
    • Children up to 7 years of age Use is not recommended. DT should be used instead.

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.

It is very important that you tell your doctor about any side effect that occurs after a dose of DT or Td, even if the side effect has gone away without treatment. Some types of side effects may mean that you should not receive any more doses of DT or Td.

Check with your doctor immediately if any of the following side effects occur:

Rare

(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)

excessive sleepiness

fever over 39.4 °C (103 °F)

headache or vomiting (severe or continuing)

hives

itching

joint aches or pain

skin rash

swelling, blistering, pain, or other severe reaction at the place of injection (generally starts within 2 to 8 hours after the injection)

unusual irritability

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

(For DT and Td)

Redness or hard lump at the place of injection (this may last for a few days; however, less often, the hard lump may last for a few weeks)

More common

(For DT only)

Fever under 39.4 °C (103 °F)

swelling, pain, or tenderness at the place of injection (this may last for a few days)

Less common

(For DT and Td)

Dent or indentation at the place of injection

Less common

(For DT only)

Crying (continuing)

drowsiness

fretfulness

loss of appetite

vomiting

Less common

(For Td only)

Chills

fast heartbeat

fever under 39.4 °C (103 °F)

general feeling of discomfort or illness

headache

muscle aches

swelling of glands in armpit

unusual tiredness or weakness

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.