Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Pharmacotherapeutic group: paramagnetic contrast media
ATC code: V08CA02 (gadoteric acid).
Dotagraf is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing effect is mediated by gadoteric acid which is an ionic gadolinium complex composed out of Gadolinium oxide and 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA), and present as meglumine salt.
The paramagnetic effect (relaxivity) is determined from the effect on spin-lattice relaxation time (T1) about 3.4 mmol-1 ·L· sec-1 and on the spin-spin relaxation time (T2) about 4.27 mmol-1 · L· sec-1.
After intravenous administration gadoteric acid is quickly distributed in the extracellular fluids. The distribution volume was approx. 18 l which is approximately equal to the volume of extra-cellular fluid. Gadoteric acid does not bind to proteins like serum albumin.
Gadoteric acid is eliminated rapidly (89% after 6 h, 95% after 24 h) in unchanged form through the kidneys by glomerular filtration. Excretion via the faeces is negligible. No metabolites were detected. The elimination half life amounts to about 1.6 hours in patients with a normal renal function. In renally impaired patients, the elimination half life was increased to approximately 5 hours for a creatinine clearance between 30 and 60 ml/min and approximately 14 hours for a creatinine clearance between 10 and 30 ml/min.
In animal experiments it has been demonstrated that gadoteric acid can be removed by dialysis.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or toxicity to reproduction.
Animal studies have shown negligible (less than 1% of the administered dose) secretion of gadoteric acid in maternal milk.
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