Adderall (Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate) - Indications and Dosage

INDICATIONS

ADDERALL^® 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

ADDERALL^® 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 of ADDERALL^® for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use ADDERALL^® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.

Attention Deficit Hyperactivity Disorder

Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Narcolepsy

Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6-12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

HOW SUPPLIED

ADDERALL^® 5 mg: A round, flat-faced beveled edge, white to off-white tablet, "5" embossed on one side with partial bisect and "AD" embossed on the other side (NDC 54092-371-01)

ADDERALL^® 7.5 mg: An oval, convex, blue tablet, "7.5" embossed on one side with a partial bisect and "AD" embossed on the other side with a full and partial bisect (NDC 54092-372-01)

ADDERALL^® 10 mg: A round, convex, blue tablet, "10" embossed on one side with a full and partial bisect and "AD" embossed on the other side (NDC 54092-373-01)

ADDERALL^® 12.5 mg: A round, flat-faced beveled edge, orange tablet, "12.5" embossed on one side and "AD" embossed on the other side with a full and partial bisect (NDC 54092-374-01)

ADDERALL^® 15 mg: An oval, convex, orange tablet, "15" embossed on one side with a partial bisect and "AD" embossed on the other side with a full and partial bisect (NDC 54092-375-01)

ADDERALL^® 20 mg: A round, convex, orange tablet, "20" embossed on one side with a full and partial bisect and "AD" embossed on the other side (NDC 54092-376-01)

ADDERALL^® 30 mg: A round, flat-faced beveled edge, orange tablet, "30" embossed on one side with a full and partial bisect and "AD" embossed on the other side (NDC 54092-377-01)

In bottles of 100 tablets.

Dispense in a tight, light-resistant container as defined in the USP.

Store at 25°C (77°F), excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]

Rx only.

002979

371 0107 005

Manufactured for: Shire US Inc.

725 Chesterbrook Blvd.

Wayne, PA 19087

Manufactured by: DSM Pharmaceuticals Inc.

        5900 NW Greenville Blvd.

        Greenville, NC 27834

Made in USA

1-800-828-2088

©2005 Shire US Inc.