Diphtheria, tetanus, acellular pertussis, hepatitis b, and polio vaccine (Intramuscular)

Diphtheria and tetanus toxoids and pertussis vaccine (also known as DTP vaccine) combined with hepatitis B and poliovirus vaccine (also known as HepB and IPV) is a combination immunizing agent used to prevent illnesses caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, and poliovirus. The vaccine helps the body produce its own protection (antibodies) against these diseases. This vaccine is given only to infants and children who are 6 weeks to 6 years old, and must be given before the child’s 7th birthday.

This vaccine combines five agents into one. To complete the vaccination series, you must receive three injections of this vaccine at different times. Because there are several diseases you need to be vaccinated against, make sure to follow your doctor's instructions regarding your vaccination schedule.

Diphtheria is a serious illness that can lead to breathing problems, heart issues, nerve damage, pneumonia, and even death. The risk of serious complications is higher for very young children and older adults.

Tetanus (also known as lockjaw) is a very serious condition that can cause convulsions (seizures) and severe muscle spasms, which may be strong enough to fracture the spine. Tetanus results in death in 30% to 40% of cases. The disease mainly affects people who do not get vaccinated or do not have enough protection from previous vaccinations.

Pertussis (also known as whooping cough) is a serious disease that leads to severe coughing spells that can make breathing difficult. Pertussis can also result in pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Hepatitis B infection is a leading cause of severe liver diseases, including liver cancer. You can get hepatitis B by being exposed to someone else's body fluids. Pregnant women with hepatitis B infection or who carry the hepatitis B virus can pass the disease to their babies at birth. These babies often face serious long-term health issues. People with the virus can transmit it to others without knowing.

Polio is a very serious infection that can cause paralysis of the muscles, including those needed for walking and breathing. A polio infection may leave a person unable to breathe without a breathing machine. It may also result in being unable to walk without leg braces or being confined to a wheelchair. There is no cure for polio.

This vaccine must be given only by or under the direct supervision of your doctor.

It is very important for your child to return to the doctor's office for the second and third dose of this vaccine. Be sure to inform your doctor or clinic of any side effects that may happen after your child has received the vaccine.

If your child develops a skin rash, hives, or any allergic reaction after getting this vaccine, tell your child's doctor immediately.

Inform your child’s doctor about all other vaccines your child has received, especially if they were part of a series. This vaccine might be used to complete a series of vaccines.

Make sure your doctor knows if your child is allergic to latex rubber. One of the prefilled syringes for this vaccine contains dry natural latex rubber, which may cause an allergic reaction in children who are sensitive to latex.

This vaccine may cause apnea (breathing problems) in some premature infants. The doctor will determine if your child should receive this vaccine.

This vaccine will not treat an active infection. If your child has a diphtheria, tetanus, pertussis, hepatitis B, or polio infection, you will need medication to treat the infection.

Be sure to tell your child’s doctor about any serious side effects that happen after your child receives the vaccine. This may include fainting, seizures, a high fever, crying that does not stop, or severe redness or swelling at the injection site.

In deciding to use this vaccine, you and your doctor need to consider the risks and benefits. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this vaccine or any other vaccines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how this vaccine affects infants younger than 6 weeks or children 7 years of age and older. Its safety and effectiveness in these groups have not been established.

Geriatric

This vaccine is not recommended for adult patients.

Interactions with Medicines

Some medicines should never be used together, while others may be used together with caution. If you are receiving this vaccine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below are significant but may not include all possible interactions.

It is usually not recommended to receive this vaccine with any of the following medicines, but it may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about the use of this vaccine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this vaccine. Be sure to tell your doctor about any medical problems you have, especially:

• Encephalopathy (a brain disease), history of after a vaccine with pertussis—This vaccine should not be used in patients with this condition.

• Fever, high or
• Moderate or severe illness, with or without fever—This vaccine may worsen these conditions or increase the risk of side effects.

• Guillain-Barre syndrome (nerve disease causing paralysis), history of—If your child had this condition after a vaccine containing tetanus, discuss the potential benefits and risks of this vaccine with your doctor.

• Immunodeficiency disorder—If you have an immune system disorder, this vaccine may not work properly for you.

• Previous side effects, history of after a vaccine with pertussis—If your child has experienced certain side effects from this vaccine or another vaccine containing pertussis, talk to your doctor about the potential benefits and risks of this vaccine. Serious reactions may include being less responsive than usual, continuous crying for 3 hours or more, having a seizure with or without a fever, or having a fever of 105 degrees F or higher.

• Progressive neurologic disorders—This includes infantile spasms, progressive brain disease, or uncontrolled epilepsy (seizures). This vaccine should not be given until these conditions are managed.

Along with the benefits of a vaccine, there may be some unwanted effects. Not all of these side effects will happen, but if they do, you may need to seek medical help. It is very important to inform your doctor about any side effect that occurs after a dose of DTaP-HepB-IPV vaccine, even if the side effect goes away on its own. Some side effects may indicate that your child should not receive any more doses of DTaP-HepB-IPV vaccine.

Check with your doctor or nurse right away if any of the following side effects happen:

Incidence not known

• Abdominal or stomach pain
• agitation
• back pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• chills
• clay colored stools
• collapse or shock-like state
• coma
• confusion
• cough
• dark urine
• diarrhea
• difficulty with swallowing
• dizziness
• drowsiness
• fast heartbeat
• fever
• hallucinations
• headache
• heavier menstrual periods
• hives or hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• hoarseness
• irritability
• irritation
• itchiness, puffiness or swelling of the eyelids or around the eyes, face, lips, tongue, hands, or feet
• itching
• joint pain
• loosening of the skin
• mood or mental changes
• nausea
• pain or cramping in the abdomen or stomach
• pinpoint red spots on the skin
• redness of the skin
• red, irritated eyes
• seizures
• shortness of breath
• skin rash
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stiff neck
• stiffness or swelling
• Sudden Infant Death Syndrome (SIDS)
• swelling
• tightness in the chest
• troubled breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting or vomiting of blood
• weight loss
• wheezing
• yellow eyes or skin

Some side effects may occur that usually do not require medical attention. These side effects may go away as your body adjusts to the vaccine. Your healthcare provider may also be able to suggest ways to prevent or lessen some of these side effects. Check with your healthcare provider if any of the following side effects continue or are bothersome, or if you have any questions about them:

More common

• Bleeding
• blistering
• burning
• coldness
• discoloration of the skin
• fussiness
• feeling of pressure
• infection
• inflammation
• lumps
• numbness
• pain
• restlessness
• scarring
• sleeping more than usual
• soreness
• stinging
• tenderness
• tingling
• ulceration
• unusual cry
• warmth on the skin

Incidence not known

• Arm or leg swelling
• difficulty with moving
• dullness, tiredness, weakness, or feeling of sluggishness
• feeling of warmth
• general feeling of discomfort or illness
• hair loss
• itching skin
• lack or loss of strength
• loss of appetite
• loss of strength or energy
• muscle pain, weakness, or stiffness
• pain in the joints
• paleness of the skin
• redness of the face, neck, arms, and occasionally, upper chest
• sneezing
• sores, ulcers, or white spots in the mouth or on the lips
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• thinning of the hair

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

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Pediarix

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot into one of your child’s muscles, usually in the shoulder muscle or thighs.

This vaccine is usually given as three shots. The first dose may be given as early as 6 weeks of age. You will need another dose at 4 and 6 months after the first dose, unless your doctor tells you otherwise.

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, such as fever and soreness.

It is important that your child receive all of the doses of vaccine in this series. Try to keep all of your scheduled appointments. If your child does miss a dose of this vaccine, make another appointment as soon as possible.