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Pharmacokinetics and Safety of the MRI Contrast Agent Gadoversetamide Injection (OptiMARK) in Healthy Pediatric Subjects

Pharmacokinetics and Safety of the MRI Contrast Agent Gadoversetamide Injection (OptiMARK) in Healthy Pediatric Subjects

James F Baker, Linda C Kratz, Gary R Stevens, James H Wible Jr

Invest Radiol. 2004 Jun;39(6):334-9.

PMID: 15167099

Abstract:

Rationale and objective:
This clinical trial examined the pharmacokinetics of gadoversetamide, a magnetic resonance imaging contrast agent, in normal pediatric subjects.
Materials and methods:
Seventeen healthy pediatric subjects received a single intravenous injection of gadoversetamide (0.1 mmol/kg, 0.2 mL/kg). Sixteen subjects that were evaluable for pharmacokinetic analysis fell into 2 stratified age groups: 2 years to <5 years and 5 years to <18 years of age. Serum samples were analyzed for total gadolinium as a measure of gadoversetamide concentration.
Results:
Statistical analysis demonstrated significant (P < 0.05) age-related trends in the mean elimination half-life (t 1/2) of gadolinium with the older group having a slightly longer t 1/2 (1.39 hours) than the younger group (1.19 hours). No age-related changes occurred in volume of distribution or total body clearance, when normalized to body weight or body surface area.
Conclusions:
Based on this preliminary pharmacokinetic assessment, no adjustment from the approved adult gadoversetamide dose of 0.1 mmol/kg should be necessary for children aged 2 or older.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
CS31041718	Gadoversetamide Related Compound A			Price

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