DEXEDRINE is indicated in:

Narcolepsy

Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a 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.

Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses—particularly with the SPANSULE capsule form—should be avoided because of the resulting insomnia.

Narcolepsy: Usual dose is 5 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, DEXEDRINE may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until an 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 an optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. SPANSULE capsules may be used for once-a-day dosage wherever appropriate. With tablets, give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Attention Deficit Disorder with Hyperactivity: Not recommended for pediatric patients under 3 years of age.

In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily, by tablet; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.

In pediatric patients 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.

SPANSULE capsules may be used for once-a-day dosage wherever appropriate.

With tablets, 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.

DEXEDRINE SPANSULE capsules: Each capsule, with brown cap and clear body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted 5 mg and 3512 on the brown cap and is imprinted 5 mg and SB on the clear body. The 10-mg capsule is imprinted 10 mg—3513—on the brown cap and is imprinted 10 mg—SB—on the clear body. The 15-mg capsule is imprinted 15 mg and 3514 on the brown cap and is imprinted 15 mg and SB on the clear body. A narrow bar appears above and below 15 mg and 3514. Available: 5 mg, 10 mg, and 15 mg in bottles of 100. DEXEDRINE SPANSULE capsules are manufactured by Cardinal Health, Winchester, KY 40391.

Store at controlled room temperature between 20° and 25°C (68° and 77°F) [see USP].

Dispense in a tight, light-resistant container.

5 mg 100s: NDC 0007-3512-20
5 mg 90s: NDC 0007-3512-59
10 mg 100s: NDC 0007-3513-20
10 mg 90's: NDC 0007-3513-59
15 mg 100s: NDC 0007-3514-20
15 mg 90's NDC 0007-3514-59

DEXEDRINE Tablets: Triangular, orange, scored, debossed SKF and E19. Available: 5 mg in bottles of 100.

5 mg 100s: NDC 0007-3519-20

Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light-resistant container.

DEXEDRINE Tablets are manufactured by Abbott Laboratories, North Chicago, IL 60064. March 2007. FDA rev date: 5/1/2007

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