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Dexedrine

Drug Description
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DEXEDRINE®
(dextroamphetamine sulfate)

SPANSULE® sustained-release capsules and Tablets

WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

DRUG DESCRIPTION

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.

Structural formula:

DEXEDRINE (dextroamphetamine sulfate) Structural formula illustration

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 prolonged period.

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 inactive ingredients.

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.

Brand Name: Dexedrine
Generic Name: Dextroamphetamine
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