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Strattera Summary of Product Characteristics (SmPC)
Atomoxetine is rapidly and almost completely absorbed after oral administration, reaching Cmax approximately 1 to 2 hours after dosing
pharmacokinetics of atomoxetine in children and adolescents are
similar to those in adults. The pharmacokinetics of atomoxetine have
not been evaluated in children under six years of age.
studies have shown that atomoxetine capsules and oral solution are
rapidly and almost completely absorbed after oral administration,
reaching mean maximal observed plasma concentration (Cmax)
approximately 1 to 2 hours after dosing. The absolute bioavailability
of atomoxetine following oral administration ranged from 63% to 94%,
depending upon inter-individual differences in the modest first-pass
metabolism. Atomoxetine can be administered with or without food.
widely distributed and is extensively (98%) bound to plasma proteins,
undergoes biotransformation primarily through the cytochrome P450 2D6
(CYP2D6) enzymatic pathway. Individuals with reduced activity of this
pathway (poor metabolisers) represent about 7% of the Caucasian
population and have higher plasma concentrations of atomoxetine
compared with people with normal activity (extensive metabolisers).
For poor metabolisers, AUC of atomoxetine is approximately 10-fold
greater and Css,
max is about
5-fold greater than extensive metabolisers. The major oxidative
metabolite formed is 4-hydroxyatomoxetine that is rapidly
glucuronidated. 4-hydroxyatomoxetine is equipotent to atomoxetine but
circulates in plasma at much lower concentrations. Although
4-hydroxyatomoxetine is primarily formed by CYP2D6, in individuals
that lack CYP2D6 activity, 4-hydroxyatomoxetine can be formed by
several other cytochrome P450 enzymes, but at a slower rate.
Atomoxetine does not inhibit or induce CYP2D6 at therapeutic doses.
P450 Enzymes: Atomoxetine did not cause clinically significant
inhibition or induction of cytochrome P450 enzymes, including CYP1A2,
CYP3A, CYP2D6, and CYP2C9.
elimination half-life of atomoxetine after oral administration is 3.6
hours in extensive metabolisers and 21 hours in poor metabolisers.
Atomoxetine is excreted primarily as
mainly in the urine.
atomoxetine are linear over the range of doses studied in both
extensive and poor metabolisers.
impairment results in a reduced atomoxetine clearance, increased
atomoxetine exposure (AUC increased 2-fold in moderate impairment and
4-fold in severe impairment), and a prolonged half-life of parent
drug compared to healthy controls with the same CYP2D6 extensive
metaboliser genotype. In patients with moderate to severe hepatic
mean plasma concentrations for end-stage renal disease (ESRD)
subjects were generally higher than the mean for healthy control
subjects shown by Cmax
difference) increases. After adjustment for body weight, the
differences between the two groups are minimised. Pharmacokinetics
of atomoxetine and its metabolites in individuals with ESRD suggest
that no dose adjustment would be necessary.
Summary of Product Characteristics
Date of Last Review:November 02, 2018
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