Jane S. Ricciuti, RPh, MS

Disclosures

December 27, 2002

In This Article

ADHD Agents

Strattera
(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.

Initial treatment:

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.

    Drug-drug interactions - Dosing adjustment for use with a strong CYP2D6 Inhibitor (eg, paroxetine, fluoxetine, quinidine) in:

    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.

  • Reference

    Strattera (atomoxetine) Capsules labeling

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