Product Monograph Page 3
(atomoxetine capsules)PART I: HEALTH PROFESSIONAL INFORMATIONSUMMARY PRODUCT INFORMATION
Route of Administration
Dosage Form / Strength
Oral 10, 18, 25, 40, 60, 80 or 100 mg capsulesThe capsules also contain pregelatinized starch anddimethicone. The capsule shells contain gelatin,sodium lauryl sulfate, and other inactive ingredients.The capsule shells also contain one or more of thefollowing: FD&C Blue No. 2, synthetic yellow ironoxide, red iron oxide, titanium dioxide.
INDICATIONS AND CLINICAL USE
STRATTERA (atomoxetine hydrochloride) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and over, adolescents, andadults.A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentivesymptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable levelof development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and athome. The symptoms must not be better accounted for by another mental disorder. For the
type, at least 6 of the following symptoms must have persisted for at least 6 months:lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure tofollow through on tasks, poor organization, avoids tasks requiring sustained mental effort, losesthings, easily distracted, forgetful. For the
type, at least 6 of the followingsymptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat,inappropriate running/climbing, difficulty with quiet activities, “on the go,” excessive talking, blurting answers, can’t wait turn, intrusive. For a Combined Type diagnosis, both inattentive andhyperactive-impulsive criteria must be met.
Special Diagnostic Considerations
The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequatediagnosis requires the use not only of medical but also of special psychological, educational, andsocial resources. Learning may or may not be impaired. The diagnosis must be based upon acomplete history and evaluation of the patient and not solely on the presence of the requirednumber of DSM-IV characteristics.