INDICATIONS & USAGE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are 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 are 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 of
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
and for long-term use has not been systematically evaluated in controlled
trials. Therefore, the physician who elects to use
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
for extended periods should periodically re evaluate the long-term usefulness of the drug for the individual patient.