Pediarix

FDA label, GlaxoSmithKline Biologicals SA, intramuscular, effective 2010-02-12. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Inactivated Bordetella Pertussis Vaccine, Inactivated Clostridium Tetani Vaccine, Inactivated Corynebacterium Diphtheriae Vaccine, Inactivated Poliovirus Vaccine

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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DOSAGE AND ADMINISTRATION Preparation for Administration PEDIARIX contains an adjuvant; therefore shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Drug interactions

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  • Pediarix
Label text (1 paragraph)

Drug Interactions For information regarding concomitant administration with other vaccines, refer to DOSAGE AND ADMINISTRATION. PEDIARIX should not be mixed with any other vaccine in the same syringe or vial. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines. The ACIP has published guidelines for vaccination of persons on such therapies (www.cdc.gov/vaccines). 21

Contraindications

Hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B, is a contraindication (see DESCRIPTION). It is a contraindication to use this vaccine after a serious allergic reaction (e.g., anaphylaxis) temporally associated with a previous dose of this vaccine or with any components of this vaccine. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered.

2 In addition, the following events are contraindications to administration of any pertussis-containing vaccine, including PEDIARIX: 5 Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause; Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy. Pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for pediarix. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Pregnancy Category C: PEDIARIX is not indicated for women of child-bearing age. Animal reproduction studies have not been conducted with PEDIARIX. It is not known whether PEDIARIX can cause fetal harm when administered to a pregnant woman or if PEDIARIX can affect reproductive capacity.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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