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Related Concept Videos

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

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Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
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Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

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Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
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Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

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In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
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Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

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Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
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Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

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In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Ferric Maltol: Pediatric First Approval.

Susan J Keam1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand. pdd@adis.com.

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|March 30, 2026
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Summary
This summary is machine-generated.

Ferric maltol, an oral iron replacement, is now approved for pediatric patients aged 10 years and older in the USA for iron deficiency. This marks a significant milestone for pediatric iron deficiency treatment.

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Area of Science:

  • Pharmacology and Therapeutics
  • Pediatric Medicine
  • Gastroenterology

Background:

  • Ferric maltol (ACCRUFeR®) is an oral iron replacement therapy.
  • It was initially approved for adult iron deficiency and iron deficiency anemia in specific patient populations.

Purpose of the Study:

  • To summarize the development milestones of ferric maltol.
  • To highlight the recent pediatric indication expansion in the USA.

Main Methods:

  • Review of ferric maltol's development and regulatory history.
  • Analysis of clinical data supporting pediatric use.

Main Results:

  • Ferric maltol received US FDA approval for pediatric patients aged ≥10 years in December 2025.
  • A similar indication for adolescents aged ≥12 years is under evaluation in the EU.

Conclusions:

  • Ferric maltol's development has successfully led to its first pediatric approval for iron deficiency.
  • This expansion offers a new oral treatment option for pediatric patients with iron deficiency.