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The active ingredient in ADDERALL (esomeprazole magnesium) Delayed-Release Capsules is bis( 5-methoxy-2-[( S)-[( 4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate, a compound that inhibits gastric acid secre-tion. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S-and R-isomers. Its empirical formula is (C17 H18N3O3S) 2 Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis.

The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25° C and about 8 hours at 37° C.

ADDERALL is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions. ADDERALL also is indicated for reducing the risk of gastric (stomach) ulcers developing among at-risk patients on continuous non-steroidal anti-inflammatory drug (NSAID) therapy. Patients are considered to be at risk if they are 60 and over, or if they have a history of previous stomach ulcers. And now ADDERALL is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. Dosage regimens should be adjusted to individual patient needs.

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