Drug information of Atomoxetine

Atomoxetine

Drug group:

Selective norepinephrine reuptake inhibitor Treatment of ADHD, alone or combined with behavioral treatment, as an adjunct to psychological, educational, social, and other remedial measures in carefully selected adults1 11 and children ≥6 years of age.

Mechanism of effect

selective inhibition of the presynaptic norepinephrine transporter.

Pharmacodynamic

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

Pharmacokinetics

Rapidly absorbed following oral administration, with peak plasma concentration attained in approximately 1–2 hours Excreted mainly as metabolites in urine (80%) and in feces (<17%) Extensive metabolizers: about 5 hours

Drug indications

ADHD

Dosage

Children and adolescents weighing ≤70 kg: Initially, approximately 0.5 mg/kg daily Children and adolescents weighing >70 kg: Initially, 40 mg daily. Adults:Initially, 40 mg daily Maximum 100 mg daily

Drug contraindications

hypersensitivity to drug or its components. , Current or recent (within 2 weeks) therapy with MA , patients with pheochromocytoma , patients with glaucoma

Side effects

nausea , abdominal pain , decreased appetite , dizziness , vomiting , fatigue , irritability

Alerts

Suicidality Risk :Increased risk of suicidal thinking :Sensitivity Reactions Angioedema, urticaria, and rash reported rarely Severe Hepatic Injury Sudden Death and Serious Cardiovascular Events Precipitation of Psychotic Symptoms Orthostatic hypotension and syncope reported Peripheral Vascular Effects:Raynaud’s phenomenon Aggressive behavior and hostility frequently are observed in pediatric patients Risk of priapism

Points of recommendation

Risk of suicidal thinking. Hepatic dysfunction may rarely develop Importance of informing clinician immediately if adverse cardiovascular effects (e.g., chest pain, shortness of breath, fainting) occur Importance of taking atomoxetine exactly as prescribed Risk of priapism : Importance of seeking immediate medical attention if erection persists for >4 hours Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed

Pregnancy level

C

Related drugs

Paroxetine , lisdexamfetamine


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