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DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the compound
d,l-amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically,
dextroamphetamine is d-alpha-methylphenethylamine, and is present in all forms of
DEXEDRINE as the neutral sulfate.
SPANSULE capsules: Each SPANSULE sustained-release capsule is so prepared that an
initial dose is released promptly and the remaining medication is released gradually over a
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. Product reformulation in 1996 has caused a minor change in the color of the
time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&C
Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Blue No. 1 aluminum
lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, propylene glycol,
povidone, silicon dioxide, sodium lauryl sulfate, sugar spheres, and trace amounts of other
Tablets: Each triangular, orange, scored tablet is debossed SKF and E19 and contains
dextroamphetamine sulfate, 5 mg. Inactive ingredients consist of calcium sulfate, FD&C Yellow
No. 5 (tartrazine), FD&C Yellow No. 6, gelatin, lactose, mineral oil, starch, stearic acid, sucrose,
talc, and trace amounts of other inactive ingredients.
DEXEDRINE is indicated in:
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.
How To Take
The doctor may adjust the amount of drug taken by you
or your child until it is right for you or your child. From time to
time, the doctor may interrupt treatment to check you or your
child’s symptoms while you or your child are not taking the drug.
Your doctor may do regular checks of the blood, heart, and blood
pressure while taking DEXEDRINE®. Children should have their
height and weight checked often while taking DEXEDRINE®.
DEXEDRINE® treatment may be stopped if a problem is found
during these check-ups.
Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been
isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System: Psychotic episodes at recommended doses (rare), overstimulation,
restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache,
exacerbation of motor and phonic tics, and Tourette’s syndrome.
Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other
gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
Endocrine: Impotence, changes in libido.
Other serious side effects include:
• Slowing of growth (height and weight) in children
• Seizures, mainly in patients with a history of seizures
• Eyesight changes or blurred vision
Common side effects include:
• Fast heart beat
• Decreased appetite
• Trouble sleeping
• Stomach upset
• Weight loss
• Dry mouth
DEXEDRINE may affect your or your child’s ability to drive or do other dangerous activities.
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
DEXEDRINE (dextroamphetamine sulfate) is contraindicated in patients with:
• Advanced arteriosclerosis
• Symptomatic cardiovascular disease
• Moderate to severe hypertension
• Hypersensitivity or idiosyncrasy to sympathomimetic amines
• Agitated state
• History of drug abuse
• Hypersensitivity to DEXEDRINE or to any ingredient in the formulation or component of
the container. For complete listing, see the Dosage Forms, Composition and Packaging
section of the product monograph.
• Motor tics or with a family history of diagnosis of Tourette’s Syndrome (verbal tics).
• Concomitant treatment with MAO inhibitors or within 14 days following the withdrawal of