diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/hepatitis b vaccine (Pediarix, DTaP/ IPV/ HepB, DTaP/hepatitis B/inactivated poliovirus vaccine)

Dosing and uses of Pediarix, DTaP/ IPV/ HepB (diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/hepatitis b vaccine)

• Adult
• Pediatric

 

Adult dosage forms and strengths

Safety & efficacy not established

 

Pediatric dosage forms and strengths

Lf = limits of flocculation

(diphtheria toxoid/tetanus toxoid/inactivated pertussis toxin (PT)/ filamentous hemagglutinin (FHA)/pertactin/hepatitis B surface antigen (HBsAg)/type 1 poliovirus/type 2 poliovirus/type 3 poliovirus)/0.5 mL.

 

Injection Suspension

(25 Lf/10 Lf/25 mcg/25 mcg/8 mcg/10 mcg/40 D-antigen units/8 D-antigen units/32 D-antigen units)/0.5 mL.

 

Immunization

Diphtheria, tetanus, pertussis, hepatitis B, & polio (poliovirus types 1, 2, 3)

<6 weeks: Not recommended

6 weeks-7 years: 0.5 mL IM x 3 doses starting at 6-8 weeks old, then 4 months and last dose at 6 months

Administer no sooner than every 4 weeks

 

Administration

< 1 years: Anterolateral thigh

>1 years: Deltoid muscle

 

Pediarix, DTaP/ IPV/ HepB (diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/hepatitis b vaccine) adverse (side) effects

Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

 

>10%

Irritability/fussiness (61-65%)

Drowsiness (41-57%)

Fever (28-39%)

Loss of appetite (26-31%)

Swelling (17-29%)

 

1-10%

Fever (≤1%)

 

<1%

Anorexia

Apnea

Erythema

Decreased consciousness

Diarrhea

Hypotonia

Encephalitis

Brachial neuritis

Erythema

Peripheral neuropathy

Cough

Lethargy

Limb pain

Liver function test abnormalities

Rash

Restlessness

 

Warnings

Contraindications

Hypersensitivity to any component (including yeast, neomycin, polymyxin B)

History of Arthus reaction to prior tetanus vaccination (unless 10 yr have elapsed)

History of encephalopathy (within 7 days of administration not attributable to other causes), progressive neurologic disorder with pertussis-containing vaccine

 

Progressive neurologic disorder

Infantile spasms, uncontrolled epilepsy, progressive encephalopathy

Do not administer pertussis vaccine until neurologic status is stabilized

 

Cautions

Associated with higher rates of fever than separately administered vaccines

Apnea reported in premature infants following IM vaccine administration

Tetanus toxoid carries risk for brachial neuritis, Guillain-Barre syndrome and anaphylaxis

Caution in Guillain-Barre syndrome within 6 wk of prior tetanus toxoid vaccine

Syncope accompanied by transient disturbances, tonic-clonic movements, or weakness reported

Consider postponing administration iin patients with moderate or severe acute illness (with or without fever)

Use caution in patients with a history of bleeding disorders (including thrombocytopenia) and or patients on anticoagulants

Use caution in severely immunocompromised patients

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Not indicated for women of childbearing age

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Pediarix, DTaP/ IPV/ HepB (diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/hepatitis b vaccine)

Mechanism of action

Production of specific antibodies to tetanus, diphtheria, and pertusis (active immunity)

Conveys active immunity via stimulation of production of endogenously produced antibodies