Pediatric Clinical Pharmacology

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Questions and Answers

A neonate requires a medication that is primarily metabolized by the CYP3A4 enzyme. Considering the physiological differences in neonates compared to adults, what is the most likely outcome if the neonate is given a standard adult dose?

  • The drug will be metabolized more rapidly, leading to a subtherapeutic effect.
  • The drug will accumulate in the neonate's system, potentially leading to toxicity. (correct)
  • The drug's metabolism will be unaffected, but the drug's distribution will be altered due to higher body water content.
  • The drug will be metabolized at the same rate as in adults, resulting in the expected therapeutic effect.

A drug is known to bind extensively to albumin in the bloodstream. If this drug is administered to a neonate, what potential alteration in drug effect should clinicians anticipate due to the neonate's physiology?

  • Decreased drug efficacy due to increased binding to fetal albumin.
  • Prolonged drug half-life due to decreased renal clearance.
  • No significant change in drug effect, as albumin binding is consistent across all age groups.
  • Increased risk of toxicity due to a higher concentration of free, unbound drug. (correct)

A medication is most effective when administered in an environment with a low (acidic) pH in the stomach. Considering differences in gastric physiology between neonates and older children, which route of administration or formulation adjustment would likely be most appropriate for a neonate to ensure optimal drug absorption?

  • Administer the drug via the intramuscular route to avoid gastric absorption.
  • Administer the drug intravenously to bypass gastric pH considerations. (correct)
  • Administer the drug with an antacid to neutralize the neonate's stomach pH.
  • Use a higher dose of the oral medication to compensate for reduced absorption in the basic stomach environment.

A clinical trial is designed to test a new drug in both adults and pediatric patients. If the drug is primarily eliminated through glomerular filtration, what adjustment should be made to the dosing regimen for neonates compared to adults to account for age-related differences in renal function?

<p>Decrease the dose and increase the interval between doses to account for reduced GFR, active tubular secretion, active tubular reabsorption, and active drug excretion. (D)</p> Signup and view all the answers

A drug is known to undergo significant first-pass metabolism in the liver. How would you expect the bioavailability of this drug to differ between a neonate and an adult, assuming both are given the same oral dose per kilogram of body weight?

<p>Bioavailability would be higher in the neonate due to immature hepatic enzyme systems. (A)</p> Signup and view all the answers

A neonate requires an aminoglycoside antibiotic for a severe infection. Aminoglycosides are known for their potential nephrotoxic effects and are primarily eliminated through the kidneys. What specific consideration regarding renal function should guide dosage adjustments in this patient population?

<p>Reduce the dose and/or increase the dosing interval to account for reduced active tubular secretion, active tubular reabsorption, reduced glomerular filtration rate, and active drug excretion. (A)</p> Signup and view all the answers

Which statement best integrates physiological differences in infants with the principles of pharmacokinetics to predict drug response?

<p>Infant's reduced hepatic enzyme activity increases the risk of toxicity from drugs primarily cleared by the liver. (C)</p> Signup and view all the answers

A researcher is developing a new oral medication for use in pediatric patients. Given the physiological changes that occur from infancy to childhood, which factor would be most critical to consider when designing age-appropriate dosing guidelines?

<p>Changes in gastric pH, gut microbiota, and enzyme activity affecting drug absorption as the child matures. (C)</p> Signup and view all the answers

An infant requires both an opioid analgesic and a sedative medication. Both drugs are metabolized by the same CYP450 enzyme in the liver. What adjustment to the typical adult dosing needs to occur?

<p>Administer each medication at reduced doses and monitor closely for excessive sedation or respiratory depression. (B)</p> Signup and view all the answers

A medication is known to undergo enterohepatic recirculation. How might this phenomenon affect drug exposure in a neonate compared to an adult?

<p>Entrohepatic recirculation is increased in a neonate resulting in prolongation of drugs in the system. (C)</p> Signup and view all the answers

Flashcards

Babies vs. Adults

Babies' organ systems are not fully developed, requiring different drug dosing than adults.

Pharmacokinetics

What the body does to the drug, including absorption, distribution, metabolism, and excretion.

Pharmacodynamics

What the drug does to the body, including therapeutic effects and toxicity.

Cytochrome P450

Reduced activity of these enzymes in neonates leads to slower drug metabolism.

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Neonatal Gastric Function

Irregular emptying and more basic pH affect drug solubility and absorption in newborns.

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Plasma Albumin

Reduced levels in neonates increase free drug concentration, raising toxicity risk.

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Renal Function

Reduced function in neonates prolongs drug half-life.

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Hepatic metabolism

Reduced in neonates, leading to slower metabolism and potentially increased drug levels.

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Pharmacogenomics

Genetic differences influence drug metabolism rates, affecting drug efficacy and toxicity.

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Study Notes

  • Babies are not simply smaller versions of adults
  • Immature organ systems require tailored drug dosing in pediatric populations

Key Considerations

  • Drug dosing and disposition vary widely in pediatric populations due to underdeveloped organ systems and metabolic pathways
  • Hepatic and cytochrome systems are not fully developed in babies
  • Administering adult doses to babies can lead to increased drug levels, prolonged effects, and potential toxicity due to slower metabolism and elimination

Clinical Pharmacology

  • Pharmacokinetics: What the body does to the drug (absorption, distribution, metabolism, excretion)
  • Pharmacodynamics: What the drug does to the body (drug concentration vs. response)
  • Pharmacogenomics: How genes affect individual responses to drugs

Pharmacokinetics in Pediatrics

  • Affected by delayed gastric emptying, higher water content, immature liver enzymes, and reduced kidney function

Pharmacodynamics in Pediatrics

  • Focuses on the relationship between drug concentration and its effects
  • Important to balance desired therapeutic effects with the risk of unwanted toxicity or lack of effect due to underdosing

Pharmacogenomics and Drug Metabolism

  • Genetic variations influence drug metabolism
  • Individuals with slower metabolism may experience prolonged drug effects and increased risk of toxicity.

Physiological Changes Impacting Drug Disposition

  • Gastric Function:

    • Neonates have irregular and reduced gastric emptying and a more basic stomach pH
    • Infants and children have normalized gastric emptying and a more acidic pH

  • Hepatic Metabolism:

    • Cytochrome P450 enzyme activity is reduced in neonates
    • This leads to slower metabolism and prolonged drug effects or toxicity

  • Oral absorption is erratic in neonates, increased in infants, and near adult in children

  • Intramuscular (IM) Absorption:

    • Neonates have lower muscle mass and blood flow, leading to poor IM drug absorption
    • IM absorption is variable in neonates
    • Infants have increased IM absorption
    • Children have near-adult muscle function, improving IM drug uptake

  • Percutaneous absorption is increased in neonates and infants, and near adult in children

  • Rectal absorption is very efficient in neonates, efficient in infants, and near adult in children

  • Plasma Albumin & Drug Binding:

    • Neonates have reduced albumin levels, resulting in less drug binding
    • Increased free drug concentration, which raises the risk of toxicity

  • Renal Function & Drug Elimination:

    • Neonatal kidneys have reduced function (lower glomerular filtration rate "GFR")
    • Drugs eliminated via the kidneys have prolonged half-lives in neonates
    • Infants have a normal glomerular filtration by one year of age

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