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INTRODUCTION

This section provides a description of medications used in the contemporary care of sick newborn infants.1 It is not intended to be an exhaustive list of all drugs available for infants, nor is it intended to be an in-depth source of information about neonatal pharmacology. Readers are encouraged to consult with their institutional pharmacists regarding issues of pharmacokinetics, drug interactions, drug elimination and metabolism, and monitoring drug serum levels. Many of these medications may not have formal US Food and Drug Administration (FDA) approval for use in neonates but have become commonly used in this population. The chapter does not provide detailed information about the medication but rather focuses on the use in neonatal population. Information on medications and breast feeding and pregnancy can be found in Chapter 156.

When the designations of neonate/newborn or infant are used for medication doses, it refers to the following:

  • Neonate/Newborn: Birth to 28 days postnatal age (PNA).

  • Infant: >28 days (1 month) to 1 year of age.

1 Edited Black Box “Warnings” are provided for select medications. Readers should review the entire package insert for each medication. Selected common brand names are provided in addition to the generic name. Many of these drugs are available as generic medications.

ACETAMINOPHEN (APAP) (LIQUIPRIN, TEMPRA, TYLENOL)

  • INDICATIONS AND USE: Analgesic, antipyretic.

  • ACTIONS: Analgesic effect—inhibition of prostaglandin synthesis in the central nervous system (CNS) and peripherally, blocking pain impulse generation. Antipyretic effect—inhibition of hypothalamic heat-regulating center.

  • DOSAGE: oral (PO), per rectum (PR), intravenous (IV).

    • Preterm infants 28 to 32 weeks: 10 to 12 mg/kg/dose PO every 6 to 8 hours or 20 mg/kg/dose PR every 12 hours. Maximum daily dose: 40 mg/kg. IV: 20 mg/kg IV loading dose; then 7.5 to 10 mg/kg/dose IV every 12 hours. Maximum daily dose: 22.5 mg/kg.

    • Preterm infants 33 to 37 weeks; term neonates <10 days: 10 to 15 mg/kg/dose PO every 6 hours or 30 mg/kg PR loading dose; then 15 mg/kg/dose every 8 hours. Maximum daily dose: 60 mg/kg. IV: 20 mg/kg IV loading dose; then 7.5 to 10 mg/kg/dose IV every 8 hours. Maximum daily dose: 40 mg/kg.

    • Term infants ≥10 days: 10 to 15 mg/kg/dose PO every 4 to 6 hours or 30 mg/kg PR loading dose; then 20 mg/kg/dose every 6 to 8 hours. Do not exceed 5 doses in 24 hours. Maximum daily dose: 75 mg/kg. IV: 20 mg/kg IV loading dose; then 10 mg/kg/dose IV every 6 hours. Maximum daily dose: 40 mg/kg.

  • ADVERSE EFFECTS: Rash, blood dyscrasias (neutropenia, leukopenia, and thrombocytopenia), and hepatic necrosis with overdose; renal injury may occur with chronic use.

  • PHARMACOLOGY: Extensively metabolized by the liver primarily by sulfonation, and by glucuronidation to a much lesser extent. Excretion by the kidney with elimination half-life: term infants—approximately 3 hours, preterm infants >32 weeks—5 hours, and in premature infants <32 weeks—up to 11 hours. ...

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