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Pharmacokinetics
Pharmacokinetic studies of ADDERALL XR (mixed salts amphetamine extended-release capsules) have been conducted in healthy adult and pediatric (aged 6-12 years) subjects, and adolescent (aged 13-17 years) and pediatric patients with ADHD.
ADDERALL XR capsules contain dextroamphetamine
(d-amphetamine) and levoamphetamine (l-amphetamine) salts in the ratio of 3:1.
ADDERALL XR demonstrates linear pharmacokinetics over the dose range of 20 to 60mg in adults and adolescents aged 13 to 17 years weighing greater than 75kg/165lbs, over the dose range of 10 to 40mg in adolescents weighing less than or equal to 75kg/165lbs and 5 to 30mg in children aged 6 to 12 years.
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There was no unexpected accumulation at steady state.
Comparison of the pharmacokinetics of d- and l-amphetamine after oral administration of ADDERALL XR in pediatric (aged 6-12 years) and adolescent (aged 13-17 years) ADHD patients and healthy adult volunteers indicates that body weight is the primary determinant of apparent differences in the pharmacokinetics of d- and l-amphetamine across the age range. Systemic exposure measured by area under the curve to infinity (AUC) and maximum plasma concentration (Cmax) decreased with increases in body weight, while oral volume of distribution (Vz/F), oral clearance (CL/F), and elimination half-life (t1/2) increased with
increases in body weight.
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. same day adderall prescription online
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. adderall for sale online
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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
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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 the drug for the individual patient (see
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