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Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules USP are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole Magnesium Delayed-Release Capsules USP may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules USP are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole Magnesium Delayed-Release Capsules USP are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
Esomeprazole Magnesium Delayed-Release Capsules USP are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
Triple Therapy (Esomeprazole Magnesium Delayed-Release Capsules USP plus amoxicillin and clarithromycin): Esomeprazole Magnesium Delayed-Release Capsules USP, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Dosage and Administration (2) and Clinical Studies (14)].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the prescribing information for clarithromycin].
Esomeprazole Magnesium Delayed-Release Capsules USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
There is currently no drug history available for this drug.
The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001.) It has a molecular weight of 749.2 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:
(C17H18N3O3S)2 Mg • 2 H2O M.W. 749.2
The magnesium salt is an off-white to pale yellow colored crystalline powder. It contains 2 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.
Each Esomeprazole Magnesium Delayed-Release Capsule USP contains either 20 mg or 40 mg of esomeprazole (present as 21.69 mg or 43.38 mg esomeprazole magnesium dihydrate) in the form of enteric-coated granules. In addition, each delayed-release capsule contains the following inactive ingredients: FD&C blue #1, gelatin, hypromellose, methacrylic acid copolymer dispersion, polysorbate 80, propylene glycol, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide.