Chemical Formulas
Pharmacodynamics
An exposure-response analysis
encompassing doses of atomoxetine (0.5, 1.2 or 1.8 mg/kg/day) or
placebo demonstrated atomoxetine exposure correlates with efficacy
as measured by the Attention-Deficit/Hyperactivity Disorder Rating
Scale-IV-Parent Version: Investigator administered and scored. The
exposure-efficacy relationship was similar to that observed between
dose and efficacy with median exposures at the two highest doses
resulting in near maximal changes from baseline [See Clinical
Studies].The
precise mechanism by which atomoxetine produces its therapeutic
effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is
unknown, but is thought to be related to selective inhibition of the
pre-synaptic norepinephrine transporter, as determined in ex vivo
uptake and neurotransmitter depletion studies.
The pharmacokinetics of
atomoxetine have been evaluated in more than 400 children and
adolescents in selected clinical trials, primarily using population
pharmacokinetic studies. Single-dose and steady-state individual
pharmacokinetic data were also obtained in children, adolescents,
and adults. When doses were normalized to a mg/kg basis, similar
half-life, Cmax, and AUC values were observed in children,
adolescents, and adults. Clearance and volume of distribution after
adjustment for body weight were also similar.
Human
Pharmacokinetics
He pharmacokinetics of
atomoxetine have been evaluated in more than 400 children and
adolescents in selected clinical trials, primarily using population
pharmacokinetic studies.
Single-dose and steady-state
individual pharmacokinetic data were also obtained in children,
adolescents, and adults. When doses were normalized to a mg/ kg
basis, similar half-life, Cmax, and AUC values were observed in
children, adolescents, and adults. Clearance and volume of
distribution after adjustment for body weight were also similar.
The pharmacokinetics of atomoxetine
have been evaluated in more than 400 children and adolescents in
selected clinical trials, primarily using population pharmacokinetic
studies.
Information
Associated with Product :
Dosage
Uses
Side Effects
Pharmacology
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