Instructions for Strattera (Atomoxetine)
Atomoxetine is a highly selective potent inhibitor of the transporter of presynaptic norepinephrine, its probable mechanism of action without direct effect on the carriers of serotonin and dopamine. Atomoxetine has minimal affinity for other noradrenergic receptors or other neurotransmitter vectors or receptors. Atomoxetine has two main oxidative metabolites: 4-hydroxyatomoxetine and N-desmethylatomoxetine. 4-hydroxyatomoxetine has the same efficacy as a norepinephrine carrier inhibitor as Strattera but, unlike the latter, this metabolite also has some inhibitory activity against the serotonin carrier.
However, this effect is usually minimal, as most 4-hydroxyatomoxetine is further metabolized and circulates in blood plasma at much lower concentrations (1% of atomoxetine concentration in active metabolizers (EM) and 0.1% of atomoxetine concentration in slow metabolizers (PM)). N-desmethylatomoxetine has a significantly lower pharmacological activity than atomoxetine. It circulates in the blood plasma at lower concentrations in active metabolizers and at concentrations comparable to those of the parent substance in low-equilibrium metabolizers
Atomoxetine is not a psychostimulant or amphetamine derivative. In a randomized, double-blind, placebo-controlled trial of addictogenic potential in adult patients, when comparing the effects of atomoxetine and placebo, atomoxetine was not associated with a reaction model indicating stimulant or euphoric properties.
The drug Strattera was tested in trials involving more than 4,000 children and adolescents with attention deficit hyperactivity disorder (ADHD). The efficacy of Strutter in treating ADHD was found in six randomized double-blind, placebo-controlled trials lasting six to nine weeks. The signs and symptoms of ADHD were assessed by comparing mean changes from the start to the end point for patients receiving Strutter and placebo. In each of the 6 studies with statistical significance, the predominance of efficiency over placebo relative to the reduction of signs and symptoms of ADHD has been demonstrated.
Furthermore, the efficacy of relative to the effect on symptoms was demonstrated in a 1-year placebo-controlled trial with more than 400 patients, conducted mainly in Europe (about 3 months of open acute treatment followed by 9 months of double-blind placebo-controlled supportive treatment). The proportion of patients with relapse after 1 year was 18.7% and 31.4% (Strattera and placebo respectively). After 1-year treatment with atomoxetine, patients who continued atomoxetine for an additional 6 months were less likely to relapse or partially resume symptoms compared to patients who stopped active treatment and switched to placebo (2% and 12%, respectively). Children and adolescents should periodically assess current rates during long-term treatment.
The drug Strattera was effective at a single daily dose or as a split dose administered in the morning and afternoon/early evening. A statistically significant reduction in the severity of ADHD symptoms compared to placebo was demonstrated by administering the drug once a day, according to teachers and parents.
Strattera does not exacerbate tics in patients with ADHD and associated motor tics or Tourette's syndrome
Pharmacokinetic measures of atomoxetine in children and adolescents are similar to those in adults. Pharmacokinetics of atomoxetine were not defined in children under the age of six.
Absorption: Atomoxetine is rapidly and almost completely absorbed after oral administration, reaching an average maximum concentration in blood plasma approximately one to two hours after administration of the dose. The absolute bioavailability of after oral administration was 63-94%, depending on differences in the patients' pre-systemic metabolism. can be administered with or without food.
- Treatment of attention deficit hyperactivity disorder (ADHD) in children over 6 years of age as part of a comprehensive
- treatment program.
Treatment must be performed by an ADHD specialist. The diagnosis must meet the criteria of the Diagnostic and Statistical Manual of Mental Disorders Revision IV (DSM-IV) or the ICD-10 Basic Principles.
For oral use. The drug Strattera can be used as a single daily dose in the morning with or without food. If the patient does not have a satisfactory clinical response when Strutter is administered as a single daily dose, it may be recommended to use it twice daily with a uniform dose distribution in the morning and afternoon or early evening.