Diphtheria, Tetanus, And Acellular Pertussis Vaccine (Intramuscular Route)

Diphtheria, tetanus, and acellular pertussis vaccine (also known as DTaP) is a combination immunizing agent given by injection to protect against infections caused by diphtheria, tetanus (lockjaw), and pertussis (whooping cough). This vaccine is given only to children 6 weeks through 6 years of age (before the child's 7th birthday).

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 greater 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.

Pertussis (also known as whooping cough) is a serious disease that causes severe spells of coughing that can interfere with breathing. Pertussis also can cause pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Diphtheria, tetanus, and pertussis are serious diseases that can cause life-threatening illnesses. Although some serious side effects can occur after a dose of DTaP (usually from the pertussis vaccine part), this rarely happens. 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 DTaP vaccine.

This vaccine is to be administered only by or under the supervision of your child's doctor or other health care professional.

This product is available in the following dosage forms:

• Suspension

Before Using

In deciding to use 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 this vaccine, 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diphtheria, tetanus, and acellular pertussis vaccine in children younger than 6 weeks of age and in children 7 years of age and older. Safety and efficacy have not been established.

Geriatric

Diphtheria, tetanus, and acellular pertussis vaccine is not recommended for use in adult populations.

No information is available on the relationship of age to the effects of Daptacel® in geriatric patients.

Pregnancy

Information about this diphtheria-tetanus-and-acellular-pertussis-vaccine-intramuscular-route

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

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.

Drug Interactions

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 receiving this vaccine, 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.

Receiving this vaccine 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.

• Meningococcal Vaccine, Tetanus Toxoid Conjugate Quadrivalent

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

• Bleeding disorders (eg, hemophilia, thrombocytopenia)—Should not use in patients with this condition.

• Brain disease (eg, encephalopathy)—This includes a coma, a decreased level of consciousness, or seizures lasting a long time. Children who have these symptoms within 7 days of receiving a vaccine with pertussis should not get this vaccine.

• Guillain-Barré syndrome (nerve disease that causes paralysis), history of—If your child had this condition after getting a vaccine with tetanus toxoid in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine.

• Immunodeficiency disorder or
• Weakened immune system—This vaccine may not work as well in children with this condition.

• Previous serious reaction to a vaccine—If your child had a serious reaction to this vaccine or another vaccine with pertussis in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine. Some serious reactions include being less responsive than normal, crying continuously without stopping for 3 hours or more, having a seizure with or without a fever, or having a fever that was 105 degrees F or higher.

• Progressive neurologic disorder—This includes infantile spasms, progressive brain disease, or uncontrolled seizures. This vaccine should not be given until these conditions are treated and under control.

Proper Use

A nurse or other trained health professional will give your child this vaccine. The vaccine is given as a shot into one of your child's muscles.

This vaccine is usually given as a series of 4 or 5 shots. It is important that your child receive all of the shots in this series. Try to keep all scheduled appointments. If your child must miss a shot, make another appointment with the child's doctor as soon as possible.

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.

Your child may also receive a medicine to help prevent or treat some of the minor side effects of the vaccine, like fever and soreness.

Precautions

It is very important that the doctor check your child at regular visits to make sure this vaccine is working properly and to check for unwanted effects. It is very important that you return to your child's doctor for the next dose in the series.

Contact your doctor immediately if your child has sudden weakness in the arms and legs. This could be a sign of a serious condition called Guillain-Barré syndrome.

It is very important to tell the doctor if your child is allergic to rubber. The vial and syringes may contain dry natural latex rubber, which may cause an allergic reaction if your child has a latex allergy.

This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, or pertussis, your child will need medicines to treat these infections.

Syncope (fainting) may occur after receiving this vaccine. Your doctor may want your child to be observed after receiving the injection to prevent and manage fainting.

Be sure to tell your child's doctor about any side effects that occur after your child receives the vaccine. This may include seizures, fever, crying that will not stop, or severe redness or swelling where the shot was given.

This vaccine may cause apnea (breathing stops for short periods) in some premature infants. Discuss this with your child's doctor if you are concerned.

Make sure your doctor knows if you are using medicines that weaken your immune system such as cancer medicines, radiation treatment, or steroids.

Side Effects

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 or nurse immediately if any of the following side effects occur:

Less common

1. Collapse or shock-like state
2. crying for 3 hours or more
3. fever over 102.2 °F
4. redness or swelling of 4 inches or more at the injection site
5. seizures (convulsions)
6. severe pain at the injection site

Incidence not known

1. Agitation
2. back pain
3. black, tarry stools
4. bleeding gums
5. bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
6. blood in the urine or stools
7. bloody nose
8. bluish color of the fingernails, lips, skin, palms, or nail beds
9. blurred vision
10. confusion
11. cough
12. diarrhea
13. difficulty with swallowing
14. dizziness
15. drowsiness
16. fast heartbeat
17. hallucinations
18. headache
19. hoarseness
20. irritability
21. irritation
22. joint pain, stiffness, or swelling
23. loss of bladder control
24. loss of consciousness
25. loss of strength or energy
26. muscle pain or weakness
27. nausea and vomiting
28. pain or cramping in the abdomen or stomach
29. pinpoint red spots on the skin
30. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
31. rash with flat lesions or small raised lesions on the skin
32. screaming
33. shortness of breath
34. sleepiness or unusual drowsiness
35. sneezing
36. sore throat
37. stiff neck
38. swollen, painful, or tender lymph glands in the neck, armpit, or groin
39. tightness in the chest
40. total body jerking
41. unusual bleeding or bruising
42. unusual tiredness or weakness (sudden and severe)

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

1. Fever of 99.5 °F or more
2. fussiness
3. loss of appetite
4. mild pain, redness, swelling, or tenderness at the injection site
5. restlessness
6. weight loss

Incidence not known

1. Crying
2. ear pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.