Amphetamine (Amphetamine) - Indications and Dosage

INDICATIONS

Attention Deficit Disorder with Hyperactivity:    Adderall is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

IN NARCOLEPSY

DOSAGE AND ADMINISTRATION

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

Attention Deficit Disorder with Hyperactivity:    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: Blue double-scored tablet, debossed "AD" on one side and "5" on the other side
(NDC 54092-031-01)

ADDERALL® 7.5 mg: Blue double-scored tablet, debossed "AD" on one side and "7.5" on the other side
(NDC 54092-076-01)

ADDERALL® 10 mg: Blue double-scored tablet, debossed "AD" on one side and "10" on the other side
(NDC 54092-032-01)

ADDERALL® 12.5 mg: Orange double-scored tablet, debossed "AD" on one side and "12.5" on the other side
(NDC 54092-125-01)

ADDERALL® 15 mg: Orange double-scored tablet, debossed "AD" on one side and "15" on the other side
(NDC 54092-150-01)

ADDERALL® 20 mg: Orange double-scored tablet, debossed "AD" on one side and "20" on the other side
(NDC 54092-033-01)

ADDERALL® 30 mg: Orange double-scored tablet, debossed "AD" on one side and "30" on the other side
(NDC 54092-034-01)

In bottles of 100 tablets.

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

Store at 25°C (77°F) excursions 15-30°C (59-86°F).

Rx only.

MG #10185

Mfg. for:

Shire

Shire US Inc.

One Riverfront Place

Newport, KY 41071

Made in U.S.A.

1-800-828-2088

© 2002 Shire US Inc.

Rev 12/02