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Dexedrine (Dextroamphetamine Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

DEXEDRINE tablets are indicated in:

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

DOSAGE AND ADMINISTRATION

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.

Narcolepsy

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

Narcolepsy seldom occurs in pediatric patients under 12 years of age; however, when it does, DEXEDRINE tablets 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 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. 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.

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.

HOW SUPPLIED

DEXEDRINE tablets, 5 mg are pink, round compressed tablets debossed cor over 215 on one side and Bisect on the other side. They are supplied as follows:

            Bottles of 100 (NDC 52054-215-10)

DEXEDRINE tablets, 10 mg are pink, round compressed tablets debossed cor over 216 on one side and Quadrisect on the other side. They are supplied as follows:

            Bottles of 100 (NDC 52054-216-10)

Dispense in a tight container as defined in the USP.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

DEA Order Form Required.

Pharmacist: Medication Guide to be dispensed to patients.

LB # 896

Rev. May, 2014

Distributed by:
Amedra Pharmaceuticals LLC
Horsham, PA 19044

For additional copies of the printed patient information/medication guide, please visit www.amedrapharma.com or call 1-888-894-6528.

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