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Daptacel

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Daptacel

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Management Of Acute Allergic Reactions

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.

Adverse Reactions Following Prior Pertussis Vaccination

If any of the following events occur within the specified period after administration of a whole-cell pertussis vaccine or a vaccine containing an acellular pertussis component, the decision to administer DAPTACEL vaccine should be based on careful consideration of potential benefits and possible risks. [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.
  • Seizures with or without fever within 3 days.

Guillain-Barre Syndrome And Brachial Neuritis

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome. (1) If Guillain-Barre syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barre syndrome may be increased following DAPTACEL vaccine.

Infants And Children With A History Of Previous Seizures

For infants or children with a history of previous seizures, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing an acellular pertussis component (including DAPTACEL vaccine) and for the following 24 hours, to reduce the possibility of post-vaccination fever.

Limitations Of Vaccine Effectiveness

Vaccination with DAPTACEL vaccine may not protect all individuals.

Altered Immunocompetence

If DAPTACEL vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Immunosuppressive Treatments]

Apnea In Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including DAPTACEL, to an infant born prematurely should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

Syncope

Syncope (fainting) has been reported following vaccination with DAPTACEL. Procedures should be in place to prevent falling injury and manage syncopal reactions.

Non-Clinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

DAPTACEL vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with DAPTACEL vaccine. It is also not known whether DAPTACEL vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

Pediatric Use

DAPTACEL vaccine is not indicated for infants below 6 weeks of age or children 7 years of age or older. Safety and effectiveness of DAPTACEL vaccine in these age groups have not been established.

Last reviewed on RxList: 8/18/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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