Medically reviewed by Drugs.com. Last updated on Feb 25, 2021.
Generic name: CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15[Lf] in 0.5mL, CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5[Lf] in 0.5mL, BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 20ug in 0.5mL, BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 20ug in 0.5mL, BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3ug in 0.5mL, BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5ug in 0.5mL, POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40[D'ag'U] in 0.5mL, POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 8[D'ag'U] in 0.5mL, POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 32[D'ag'U] in 0.5mL; HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10ug in 0.5mL
Dosage form: injection
Pentacel is to be administered as a 4 dose series at 2, 4, 6 and 15-18 months of age. The first dose may be given as early as 6 weeks of age. Four doses of Pentacel constitute a primary immunization course against pertussis. Three doses of Pentacel constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis; the fourth dose is a booster for diphtheria, tetanus, H. influenzae type b invasive disease, and poliomyelitis immunizations. [See 14 Clinical Studies (14.1, 14.2, 14.3, 14.4, 14.5).]
Mixed Sequences of Pentacel and DTaP Vaccine
While Pentacel and DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [DTaP], Sanofi Pasteur Limited) vaccines contain the same pertussis antigens, manufactured by the same process, Pentacel contains twice the amount of detoxified pertussis toxin (PT) and four times the amount of filamentous hemagglutinin (FHA) as DAPTACEL. Pentacel may be used to complete the first 4 doses of the 5-dose DTaP series in infants and children who have received 1 or more doses of DAPTACEL and are also scheduled to receive the other antigens of Pentacel. However, data are not available on the safety and immunogenicity of such mixed sequences of Pentacel and DAPTACEL for successive doses of the primary DTaP series. Children who have completed a 4-dose series with Pentacel should receive a fifth dose of DTaP vaccine using DAPTACEL at 4-6 years of age. (1)
Data are not available on the safety and effectiveness of using mixed sequences of Pentacel and DTaP vaccine from different manufacturers.
Mixed Sequences of Pentacel and IPV Vaccine
Pentacel may be used in infants and children who have received 1 or more doses of another licensed IPV vaccine and are scheduled to receive the antigens of Pentacel. However, data are not available on the safety and immunogenicity of Pentacel in such infants and children.
The Advisory Committee on Immunization Practices (ACIP) recommends that the final dose in the 4-dose IPV series be administered at age ≥4 years. (2) When Pentacel is administered at ages 2, 4, 6, and 15-18 months, an additional booster dose of IPV vaccine should be administered at age 4-6 years, resulting in a 5-dose IPV series. (2)
Mixed Sequences of Pentacel and Haemophilus b Conjugate Vaccine
Pentacel may be used to complete the vaccination series in infants and children previously vaccinated with one or more doses of Haemophilus b Conjugate Vaccine (either separately administered or as part of another combination vaccine), who are also scheduled to receive the other antigens of Pentacel. However, data are not available on the safety and immunogenicity of Pentacel in such infants and children. If different brands of Haemophilus b Conjugate Vaccines are administered to complete the series, three primary immunizing doses are needed, followed by a booster dose.
The package contains a vial of the DTaP-IPV component and a vial of lyophilized ActHIB vaccine component.
After removing the "flip-off" caps, cleanse the DTaP-IPV and ActHIB vial stoppers with a suitable germicide. Do not remove the vial stoppers or metal seals holding them in place. Just before use, thoroughly but gently shake the vial of DTaP-IPV component, withdraw the entire liquid content and inject into the vial of the lyophilized ActHIB vaccine component. Gently swirl the vial now containing Pentacel until a cloudy, uniform, white to off-white (yellow tinge) suspension results.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, Pentacel should not be administered.
Using a sterile needle and syringe and aseptic technique, withdraw and administer a single 0.5 mL dose of Pentacel intramuscularly. Use a separate sterile needle and syringe for each injection. Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Pentacel should be used immediately after reconstitution. Discard unused portion. Refer to Figures 1, 2, 3, 4 and 5.
Pentacel: Instructions for Reconstitution of ActHIB Vaccine Component with DTaP-IPV Component
In infants younger than 1 year, the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection. In older children, the deltoid muscle is usually large enough for injection. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this product intravenously or subcutaneously.
Pentacel should not be mixed in the same syringe with other parenteral products.
More about Pentacel (diphtheria toxoid / haemophilus b conjugate (prp-t) vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid)
- Side Effects
- During Pregnancy
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: vaccine combinations
- FDA Approval History
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