INDICATIONS
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules is
indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of Dextroamphetamine Saccharate, Amphetamine Asparate
Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release
Capsules in the treatment of ADHD was established on the basis of two controlled
trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to
17, and one controlled trial in adults who met DSM-IV
criteria for ADHD (see CLINICAL PHARMACOLOGY), along with
extrapolation from the known efficacy of ADDERALL, the
immediate-release formulation of this substance.
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive
symptoms that caused impairment and were present before age 7 years. The
symptoms must cause clinically significant impairment, e.g., in social,
academic, or occupational functioning, and 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. The Combined
Type requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic ConsiderationsSpecific etiology of this syndrome 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 child and not solely on the presence of the required number of
DSM-IV characteristics.
Need for Comprehensive Treatment ProgramDextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules 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 children with this
syndrome. Stimulants are not intended for use in the child who exhibits symptoms
secondary to environmental factors and/or other primary psychiatric disorders,
including psychosis. Appropriate educational placement is essential and
psychosocial intervention is often helpful. When remedial measures alone are
insufficient, the decision to prescribe stimulant medication will depend upon
the physician's assessment of the chronicity and severity of the child's
symptoms.
Long-Term UseThe effectiveness of Dextroamphetamine Saccharate, Amphetamine
Asparate Monohydrate, Dextroamphetamine Sulfate and, Amphetamine Sulfate
Extended-Release Capsules for long-term use, i.e., for more than 3 weeks in
children and 4 weeks in adolescents and adults, has not been systematically
evaluated in controlled trials. Therefore, the physician who elects to use
Dextroamphetamine Saccharate, Amphetamine Asparate Monohydrate,
Dextroamphetamine Sulfate and, Amphetamine Sulfate Extended-Release Capsules for
extended periods should periodically re-evaluate the long-term usefulness of the
drug for the individual patient.