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Pediarix Generic Name & Formulations
Legal Class
Rx
General Description
Diphtheria and tetanus toxoids, acellular pertussis vaccine, aluminum hydroxide adsorbed; hepatitis B vaccine (recombinant), aluminum phosphate adsorbed; inactivated polio vaccine; susp for IM inj; preservative-free; contains traces of formaldehyde, yeast protein, neomycin, polymyxin B, polysorbate 80.
Pharmacological Class
DTaP + HB + IPV.
How Supplied
Single-dose vials—10; Single-dose prefilled syringes—5
Manufacturer
Pediarix Indications
Indications
Immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliovirus (types 1, 2, and 3) in infants age 6 weeks up to 7yrs (before 7th birthday) born of HBsAg-negative mothers.
Pediarix Dosage and Administration
Adult
Not recommended.
Children
Each dose is 0.5mL IM in deltoid or anterolateral thigh. Give 1st dose preferably at 2 months of age (may give as early as 6 weeks of age); then give 2nd dose 6–8 weeks later; then give 3rd dose 6–8 weeks later (preferably 8 weeks between doses). Previously vaccinated with one or more doses of individual components: see literature. Not for use as booster dose.
Pediarix Contraindications
Contraindications
Anaphylaxis associated with previous dose. Encephalopathy within 7 days after previous pertussis-containing vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).
Pediarix Boxed Warnings
Not Applicable
Pediarix Warnings/Precautions
Warnings/Precautions
Guillain-Barre syndrome within 6 weeks of previous tetanus toxoid-containing vaccine. Fever (≥105°F within 48hrs), persistent inconsolable crying (≥3hrs within 48hrs), shock (within 48hrs), or seizures (within 3 days) after previous DTaP or DTwP vaccine: see literature. Seizure risk (may give antipyretic). Bleeding disorders. Have epinephrine available. Latex allergy (syringes). Immunodeficiency. Pregnancy (Cat.C).
Pediarix Pharmacokinetics
See Literature
Pediarix Interactions
Interactions
Concomitant vaccines: see literature. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.
Pediarix Adverse Reactions
Adverse Reactions
Local reactions (pain, redness, swelling), irritability/fussiness, fever, crying, drowsiness, loss of appetite; rare: seizure, anaphylaxis.
Pediarix Clinical Trials
See Literature
Pediarix Note
Not Applicable
Pediarix Patient Counseling
See Literature
