DTP

DRUG DESCRIPTION

Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed USP (For Pediatric Use) combines diphtheria and tetanus toxoids adsorbed with pertussis vaccine, for intramuscular use, in a sterile isotonic sodium chloride solution containing sodium phosphate buffer to control pH. The vaccine, after shaking, is a turbid liquid, whitish-gray in color. When used to reconstitute Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), ActHIB ^® or OmniHIB, the combined vaccines appear whitish in color.

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium. ¹ Clostridium tetani cultures are grown in a peptone- based medium. Both toxins are detoxified with formaldehyde. The detoxified materials are separately purified by serial ammonium sulfate fractionation and diafiltration.

The pertussis vaccine component is derived from Bordetella pertussis cultures grown on blood-free Bordet Gengou media. The pertussis organisms are harvested and inactivated with thimerosal and resuspended in physiological saline and thimerosal.

The toxoids are adsorbed to aluminum potassium sulfate (alum). The adsorbed diphtheria and tetanus toxoids are combined with pertussis vaccine concentrate, and diluted to a final volume using sterile phosphate-buffered physiological saline. Each 0.5 mL dose contains, by assay, not more than 0.17 mg of aluminum and not more than 100 µg (0.02%) of residual formaldehyde. Thimerosal (mercury derivative) 1:10,000 is added as a preservative.

Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test).

The total human immunizing dose (the first three 0.5 mL doses administered) contains an estimate of 12 units of pertussis vaccine (4 protective units per single dose). ² The potency of the pertussis component of each lot of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) is tested in a mouse protection test.

At the time when Connaught Laboratories, Inc. (CLI) DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ^® or OmniHIB, each single dose of the 0.5 mL mixture is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, an estimate of 4 protective units of pertussis vaccine, 10 µg of purified capsular polysaccharide conjugated to 24 µg of inactivated tetanus toxoid, and 8.5% of sucrose.

NOTE: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB ^® is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) OmniHIB (distributed by SmithKline Beecham Pharmaceuticals); both products are manufactured by Pasteur Mérieux Sérums & Vaccins S. A.

What are the precautions when taking diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp (DTP)?

Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if your child has certain medical conditions. Before using this medicine, consult the doctor or pharmacist if your child has: history of severe reaction to vaccine (e.g., paralysis, encephalopathy), uncontrolled seizures or other nervous system disorder (e.g., unresponsiveness).

Before using this medication, tell your doctor or pharmacist your child's medical history, especially of: bleeding disorders (e.g.,...

Read All Potential Precautions of DTP »

DTP Consumer (continued)

SIDE EFFECTS: Mild fever, irritability, vomiting, loss of appetite, sleepiness, diarrhea, or pain/swelling/redness at the injection site may occur. Acetaminophen may be used to reduce these effects. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor immediately if any of these rare but very serious side effects occur: high fever (105 degrees F/40 degrees C or higher), persistent crying (beginning within 48 hours of the injection and lasting longer than 3 hours), seizure, listlessness/unresponsiveness, numbness/tingling, muscle weakness/floppy muscles.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, severe dizziness, trouble breathing, itching/swelling (especially of the face/tongue/throat).

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before your child receives this vaccination, tell the doctor or pharmacist if your child is allergic to it; or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if your child has certain medical conditions. Before using this medicine, consult the doctor or pharmacist if your child has: history of severe reaction to vaccine (e.g., paralysis, encephalopathy), uncontrolled seizures or other nervous system disorder (e.g., unresponsiveness).

Before using this medication, tell your doctor or pharmacist your child's medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of Guillain-Barre syndrome, immune system disorders (e.g., autoimmune disorders, radiation treatment), illness/infection, seizures (e.g., epilepsy controlled by medication, febrile seizures), other nervous system disorders (e.g., paralysis, numbness/tingling, extreme drowsiness, confusion), previous reactions to any vaccine (e.g., high fever, seizures).

This vaccine is usually not used in adults or children 7 years or older. Therefore, no information on pregnancy or breast-feeding is included. Vaccines for this age group are available. Consult your health care professional.