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(dextroamphetamine sulfate) SPANSULE® Sustained-release Capsules
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.
DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the compound d,1-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:
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 512 on the brown cap and is imprinted 5 mg and ap on the clear body. The 10-mg capsule is imprinted 10 mg—513—on the brown cap and is imprinted 10 mg—ap—on the clear body. The 15-mg capsule is imprinted 15 mg and 514 on the brown cap and is imprinted 15 mg and ap on the clear body. A narrow bar appears above and below 15 mg and 514. 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, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.
What are the possible side effects of dextroamphetamine (Dexedrine, Dexedrine Spansule, Dextrostat, Liquadd, ProCentra)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- fast or pounding heartbeats;
- feeling light-headed, fainting;
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure);...
What are the precautions when taking dextroamphetamine (Dexedrine)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as amphetamine or lisdexamfetamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (such as Raynaud's disease), certain mental/mood conditions (such as severe agitation, psychosis), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychotic disorder, suicidal thoughts), heart problems (including irregular heartbeat/rhythm, coronary artery disease, heart failure,...
Last reviewed on RxList: 12/19/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Dexedrine Information
Dexedrine - User Reviews
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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