Product Monograph ADDERALL XR
®
(mixed salts amphetamine extended-release capsules)
Template Date: June 2017 Page 4 of 42
PART I: HEALTH PROFESSIONAL INFORMATION
1 INDICATIONS
ADDERALL XR (mixed salts amphetamine extended-release capsules) is indicated for the
treatment of Attention Deficit Hyperactivity Disorder (ADHD) in:
Children (6 – 12 years of age)
Adolescents (13 – 17 years of age)
Adults (18 years of age or older)
A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive and/or inattentive
symptoms that caused 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 level of development, must cause clinically significant impairment (e.g., in social,
academic, or occupational functioning), and must be present in two or more settings (e.g.,
school or work, and at home). The symptoms must not be better accounted for by another
mental disorder. For the Inattentive Type, at least six 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 to follow through on tasks, poor organization, avoids tasks
requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-
Impulsive Type, at least six of the following symptoms 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 and hyperactive impulsive criteria must be met.
Special Diagnostic Considerations
The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate
diagnosis requires the use not only of medical but of special psychological, educational, and
social resources. Learning may or may not be impaired. The diagnosis must be based upon a
complete history and evaluation of the patient and not solely on the presence of the required
number of DSM-IV characteristics.
Need for Comprehensive Treatment Program
ADDERALL XR is indicated as an integral part of a total treatment program for ADHD that may
include other measures (psychological, educational, social) for patients with this syndrome.
Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not
intended for use in the patient who exhibits symptoms secondary to environmental factors
and/or other primary psychiatric disorders, including psychosis. Appropriate educational
placement is essential in patients with this diagnosis and psychosocial intervention is often
helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment
will depend upon the physician's assessment of the chronicity and severity of the patient’s
symptoms.
Long-Term Use
The effectiveness of ADDERALL XR for long-term use, i.e., for more than 3 weeks in children
aged 6 to 12 years and 4 weeks in adolescents aged 13 to 17 years, and adults, has not been
systematically evaluated in controlled trials. Therefore, the physician who elects to use
ADDERALL XR for extended periods should periodically re-evaluate the long-term usefulness of