STRATTERA - atomoxetine hydrochloride capsule
Physicians Total Care, Inc.
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder.
Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
1.1 Attention-Deficit/Hyperactivity Disorder (ADHD)
STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The efficacy of STRATTERA Capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
2.1 Acute Treatment
Dosing of children and adolescents 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 [see Clinical Studies (14)].
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. After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response. There are no data that support increased effectiveness at higher doses [see Clinical Studies (14)].
The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.
DOSAGE FORMS AND STRENGTHS
Each capsule contains atomoxetine HCl equivalent to 10 mg (Opaque White, Opaque White), 18 mg (Gold, Opaque White), 25 mg (Opaque Blue, Opaque White), 40 mg (Opaque Blue, Opaque Blue), 60 mg (Opaque Blue, Gold), 80 mg (Opaque Brown, Opaque White), or 100 mg (Opaque Brown, Opaque Brown) of atomoxetine.
DESCRIPTION
STRATTERA� (atomoxetine HCl) is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl is the R (-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N -Methyl-3-phenyl-3-(o -tolyloxy)-propylamine hydrochloride. The molecular formula is C17 H21 NO�HCl, which corresponds to a molecular weight of 291.82.
Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water.
STRATTERA capsules are intended for oral administration only.
Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. The capsule shells also contain one or more of the following:
FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
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.
