Trade Names:Pediarix- Injection diphtheria toxoid (DT) 25 Lf, tetanus toxoid 10 Lf, inactivated pertussis toxin (PT) 25 mcg, filamentous hemagglutinin (FHA) 25 mcg, pertactin 8 mcg, hepatitis B surface antigen (HBsAg) 10 mcg, type 1 poliovirus 40 D-antigen units (DU), type 2 poliovirus 8 DU, and type 3 poliovirus 32 DU per 0.5 mL
Diphtheria and tetanus toxoids induce antibodies against toxins made by Corynebacterium diphtheriae and Clostridium tetani ; pertussis vaccine protects against Bordetella pertussis ; hepatitis B vaccine induces specific antibodies against hepatitis B virus (HBV); poliovirus vaccine induces protective antipoliovirus antibodies, reducing pharyngeal excretion of poliovirus types 1, 2, and 3.
Active immunization against diphtheria, tetanus, pertussis, all known types of HBV, and poliomyelitis (caused by types 1, 2, and 3).
Use of this vaccine after a serious allergic reaction temporally associated with a previous dose of the vaccine or with any components of this vaccine; encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause; progressive neurologic disorder (including infantile spasms, progressive encephalopathy, or uncontrolled epilepsy) until a treatment regimen has been established and the condition has stabilized; hypersensitivity to any component of the vaccine (including neomycin, polymyxin B, and yeast).
IM 3 doses of 0.5 mL at 6- to 8-wk intervals (preferably 8 wk); customary age for the first dose is 2 mo.Children Previously Vaccinated With Hepatitis B VaccineChildren born of HBsAg-negative mothers who have received a dose of hepatitis B at or shortly after birth
IM 3 doses of 0.5 mL according to the recommended schedule.Children Previously Vaccinated With Inactivated Poliovirus Vaccine (IPV)Children
IM Pediarix may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and who are also scheduled to receive the other vaccine components of Pediarix .Children Previously Vaccinated With InfanrixChildren
IM Pediarix may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of Infanrix and also are scheduled to receive the other vaccine components of Pediarix .Interchangeability of Licensed DTaP, IPV, or Recombinant Hepatitis B Vaccines and Pediarix
It is recommended that Pediarix be given for all 3 doses because data are limited regarding the safety and efficacy of using acellular pertussis vaccines from different manufacturers for successive doses of the pertussis vaccination series. Because of a lack of data, Pediarix is not recommended for completion of a DTaP vaccination series initiated with a DTaP vaccine from a different manufacturer. However, Pediarix may be used to complete hepatitis B vaccination series initiated with a licensed hepatitis B (recombinant) vaccine from a different manufacturer and may be used complete the first 3 doses of the IPV vaccination series initiated with IPV from a different manufacturer.
Store vials in refrigerator (36° to 46°F). Do not freeze. Discard if vaccine has been frozen.
Children may not respond optimally to active immunization.Other vaccines
Do not mix another vaccine in the same syringe or vial.
None well documented.
Cyanosis, pallor, petechiae (postmarketing).
Irritability/fussiness (65%); drowsiness (57%); brachial neuritis; cranial and peripheral mononeuropathy; demyelinating diseases of the CNS; bulging fontanelle, convulsions, crying, depressed consciousness, fatigue, febrile convulsions, hypotonia, hypotonic-hyporesponsive episode, insomnia, irritability, lethargy, nervousness, pyrexia, restlessness, screaming, somnolence, unusual crying (postmarketing).
Angioedema, erythema, rash, urticaria (postmarketing).
Loss of appetite (31%); diarrhea, vomiting (postmarketing).
Anaphylactic reactions (ie, difficulty breathing, hives, hypotension, shock, swelling of the mouth); arthus-type hypersensitivity reactions characterized by severe local reactions; anaphylactoid reactions (postmarketing).
Abnormal LFTs (postmarketing).
Redness (40%); pain (36%); swelling (29%); injection-site cellulitis, induration, itching, nodules/lumps, and warmth (postmarketing).
Limb pain (postmarketing).
Apnea, dyspnea, upper respiratory tract infection (postmarketing).
Fever (39%); Guillain-Barré syndrome, limb swelling, sudden infant death syndrome (postmarketing).
When child returns for next dose in series, question child's parent or guardian about serious adverse reactions with previous dose. Note any adverse reactions that would contraindicate additional pertussis vaccine. Continue immunization series with DT, hepatitis B, and IPV vaccines to complete series.
Category C .
Safety and efficacy not established in children younger than 6 wk of age. Pediarix is not recommended for persons 7 yr of age and older.
Not recommended for use in the adult population.
Use with caution and consider the benefits and risks in the following conditions: temperature of 105°F within 48 h not attributable to an identifiable cause; collapse or shock-like state within 48 h; persistent, inconsolable crying lasting at least 3 h and occurring with 48 h; seizures with or without fever occurring within 3 days.
Consider delaying immunization during course of moderate or severe acute febrile illness.
Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case of occurrence of an anaphylactic or acute hypersensitivity reaction.
Use with caution in children with bleeding disorders (eg, hemophilia, thrombocytopenia); take steps to avoid the risk of hematoma following the injection.
If Guillain-Barré syndrome occurred within 6 wk of receiving a prior vaccine containing tetanus toxoid, base the decision to give Pediarix vaccine or any vaccine containing tetanus toxoid on careful consideration of potential benefits and possible risks.
The expected immune response may not be obtained.
The tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals.
For infants and children at risk of seizures, an appropriate antipyretic may be administered at the time of vaccination and for the following 24 h to reduce possible postvaccination fever.
Copyright © 2009 Wolters Kluwer Health.