Product Description.:
LILLY 3250, 80 mg
capsule , brown white , oblong oblong
Black inkOpaque
(atomoxetine hydrochloride) Capsules for Oral Use
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].
DRUG DESCRIPTION
STRATTERA? (atomoxetine HCl) is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl is the R(-) isomer as determined by x-ray diffraction.
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.
INDICATIONS
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)
SIDE EFFECTS
Clinical Trials Experience
STRATTERA was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Child and Adolescent Clinical Trials
Reasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trials
In acute child and adolescent placebo-controlled trials, 3.0% (48/1613)of atomoxetine subjects and 1.4% (13/945) placebo subjects discontinued for adverse reactions. For all studies, (including open-label and long-term studies), 6.3%of extensive metabolizer (EM) patients and 11.2% of poor metabolizer (PM)patients discontinued because of an adverse reaction. Among STRATTERA-treated patients, irritability (0.3%, N=5) somnolence (0.3%, N=5) aggression (0.2%, N=4) nausea (0.2%, N=4) vomiting (0.2%, N=4) abdominal pain (0.2%, N=4) constipation (0.1%, N=2) fatigue (0.1%, N=2) feeling abnormal (0.1%,N=2) and headache (0.1%,N=2) were the reasons for discontinuation reported by more than 1 patient.
Seizures
STRATTERA has not been systematically evaluated in pediatric patients with seizure disorder as these patients were excluded from clinical studies during the product's premarket testing. In the clinical development program, seizures were reported in 0.2% (12/5073) of children whose average age was 10 years (range 6 to 16 years). In these clinical trials, the seizure risk among poor metabolizers was 0.3% (1/293) compared to 0.2% (11/4741) for extensive metabolizers.
