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Amphetamine (Amphetamine) - Description and Clinical Pharmacology

 
 



DESCRIPTION

A single entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate.

EACH TABLET CONTAINS: 5 mg 7.5 mg 10 mg 12.5 mg 15 mg 20 mg 30 mg
Dextroamphetamine
   Saccharate
1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Amphetamine Aspartate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Dextroamphetamine
   Sulfate USP
1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Amphetamine Sulfate USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Total amphetamine
   base equivalence
3.13 mg 4.7 mg 6.3 mg 7.8 mg 9.4 mg 12.6 mg 18.8 mg

Inactive Ingredients: acacia, corn starch, lactose, magnesium stearate, and sucrose.

Colors:        ADDERALL 5 mg, 7.5 mg and 10 mg contain FD & C Blue #1.

                   ADDERALL 12.5 mg, 15 mg, 20 mg and 30 mg contain FD & C Yellow #6 as a color additive.

CLINICAL PHARMACOLOGY

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevation of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.

There is neither specific evidence which clearly establishes the mechanism whereby amphetamine produces mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

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