ADHD AgentsStrattera (atomoxetine) Capsules
Manufacturer: Eli Lilly and Company
Drug Approval Classification: Original New Drug Application (Approval Date: 11/26/02)
Indication: Strattera (atomoxetine) is indicated for the treatment of ADHD.
Dosing: Strattera adolescent dosing is based on body weight.
Dosing of children and adolescents with up to 70 kg body weight: Strattera should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening.
No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day.
The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less.
Dosing of children and adolescents over 70 kg body weight and adults: Strattera should be initiated at a total daily dose of 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening.
Strattera may be taken with or without food.
In hepatic insufficiency (HI), dose adjustments are recommended as follows:
For patients with moderate HI (Child-Pugh Class B), initial and target doses should be reduced to 50% of the normal dose (for patients without HI).
For patients with severe HI (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of the normal dose.
Strattera can be discontinued without being tapered.
Strattera capsules are supplied in 5-, 10-, 18-, 25-, 40-, and 60-mg strengths.
Clinical Summary: Strattera, a selective norepinephrine reuptake inhibitor, reduces ADHD symptoms by blocking or slowing reabsorption of norepinephrine, a brain chemical considered important in regulating attention, impulsivity, and activity levels. Strattera is not a controlled substance, and in an abuse-potential study in adults, Strattera was not associated with stimulant or euphoriant properties.
Four randomized, double-blind, placebo-controlled clinical studies evaluated Strattera in 758 children and adolescents who met Diagnostic and Statistical Manual 4th edition (DSM-IV) criteria for ADHD. In all 4 trials, patients statistically improved on Strattera compared with placebo, based on the mean change from baseline to end point using an intent-to-treat analysis of the primary outcome measure (the investigator-administered and scored ADHD Rating Scale-IV Parent Version [ADHDRS] total score including hyperactive/impulsive and inattentive subscales).
Strattera was studied in 256 adult patients in 2 randomized, double-blind, placebo-controlled studies. Symptoms were statistically significantly improved in patients treated with Strattera compared with those receiving placebo.
The safety and efficacy of Strattera in pediatric patients younger than 6 years of age have not been established. The efficacy of Strattera beyond 9 weeks and safety beyond 1 year of treatment have not been systematically evaluated.
Adverse Effects: The following were the most commonly reported adverse events with atomoxetine administration by age group:
Children/adolescents: dyspepsia, nausea, vomiting, fatigue, decreased appetite, dizziness, and mood swings.
Adults: constipation, dry mouth, nausea, decreased appetite, dizziness, insomnia, decreased libido, ejaculatory problems, impotence, urinary hesitation and/or urinary retention and/or difficulty in micturition, and dysmenorrhea.
Pharmacokinetics: Atomoxetine is eliminated primarily by oxidative metabolism through the cytochrome P450 2D6 (CYP2D6) enzymatic pathway and subsequent glucuronidation. Atomoxetine has a half-life of 5 hours.
Children and adolescents up to 70 kg body weight. Strattera should be initiated at 0.5 mg/kg/day and only increased to the usual target dose of 1.2 mg/kg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.
Children and adolescents over 70 kg body weight and adults. Strattera should be initiated at 40 mg/day and only increased to the usual target dose of 80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.
Medscape Pharmacists. 2002;3(2) © 2002 Medscape
Cite this: December 2002 - Medscape - Dec 30, 2002.