INDICATIONS & USAGE
Dextroamphetamine
saccharate,amphetamine
aspartate,
dextroamphetamine sulfate and
amphetamine sulfate
tablets is indicated for
the treatment of Attention Deficit Hyperactivity
Disorder (ADHD) and Narcolepsy.
Attention Deficit Hyperactivity Disorder (ADHD)
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 Considerations
Specific
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 Program
Dextroamphetamine
saccharate,amphetamine
aspartate,
dextroamphetamine sulfate and
amphetamine sulfate
tablets 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 Use
The effectiveness ofdextroamphetamine
saccharate,amphetamine
aspartate,
dextroamphetamine sulfate and
amphetamine sulfate
tablets for long-term use has not been
systematically evaluated in
controlled trials. Therefore, the
physician who elects to usedextroamphetamine
saccharate, amphetamine
aspartate,
dextroamphetamine sulfate and
amphetamine sulfate
tablets for extended periods should
periodically reevaluate the long-term usefulness of the drug for the
individual patient.