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Pentacel

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Pentacel

Pentacel

WARNINGS

If any of the following events occur within the specified period after administration of a whole-cell pertussis or acellular pertussis-containing vaccine, the decision to administer Pentacel (tetanus toxoid conjugate) vaccine or any pertussis-containing vaccine should be based on careful consideration of potential benefits and possible risks. (19) (See DOSAGE AND ADMINISTRATION.)

  • Temperature of ≥ 40.5°C ( ≥ 105°F) within 48 hours, not attributable to another identifiable cause.
  • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours.
  • Persistent, inconsolable crying lasting 3 hours within 48 hours.
  • Seizure with or without fever within ≥ 3 days.

A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and brachial neuritis, Guillain-Barré syndrome and anaphylaxis. (20) If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give Pentacel (tetanus toxoid conjugate) vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. (19)

Vaccination with Pentacel (tetanus toxoid conjugate) vaccine may not protect all individuals.

PRECAUTIONS

General

Before administration of Pentacel (tetanus toxoid conjugate) vaccine, the patient's current health status and medical history should be reviewed in order to determine whether any contraindications exist and to assess the benefits and risks of vaccination. (See CONTRAINDICATIONS and WARNINGS).

Epinephrine Hydrochloride Solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

For infants or children at higher risk for seizures than the general population, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with an acellular pertussis-containing vaccine (including Pentacel (tetanus toxoid conjugate) vaccine) and for the following 24 hours, to reduce the possibility of post-vaccination fever. (19)

If Pentacel (tetanus toxoid conjugate) vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been performed with Pentacel (tetanus toxoid conjugate) vaccine to evaluate carcinogenicity, mutagenic potential, or impairment of fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Pentacel (tetanus toxoid conjugate) vaccine. It is not known whether Pentacel (tetanus toxoid conjugate) vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentacel (tetanus toxoid conjugate) vaccineis not approved for use in women of childbearing age.

Pediatric Use

The safety and effectiveness of Pentacel (tetanus toxoid conjugate) vaccine was established in the age group 6 weeks through 18 months on the basis of clinical studies. (See ADVERSE REACTIONS and CLINICAL PHARMACOLOGY.) The safety and effectiveness of Pentacel (tetanus toxoid conjugate) vaccine in the age group 19 months through 4 years is supported by evidence in children 6 weeks through 18 months. The safety and effectiveness of Pentacel (tetanus toxoid conjugate) vaccine in infants less than 6 weeks of age and in children 5 to 16 years of age have not been established.

Pentacel (tetanus toxoid conjugate) vaccineis not approved for use in persons 5 years of age or older.

Geriatric Use

Pentacel (tetanus toxoid conjugate) vaccine is not approved for use in adult populations.

REFERENCES

19. CDC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.

20. Stratton KR, et al. editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington, DC: National Academy Press; 1994. p. 67-117.

Last reviewed on RxList: 7/25/2008
This monograph has been modified to include the generic and brand name in many instances.

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