Esomeprazole Strontium

Esomeprazole Strontium

Esomeprazole Strontium Recall

Get an alert when a recall is issued.

Questions & Answers

  • Question

    Please try and update the date that the medication is to become, or became commercially available at the pharmacy. Such as the newly released generic for Nexium, esomeprazole; it would be nice to know the FDA approval and also commercially available dates. Thanks!

    posted on February 25, 2015
  • Side Effects & Adverse Reactions

    There is currently no warning information available for this product. We apologize for any inconvenience.

    Legal Issues

    There is currently no legal information available for this drug.

    FDA Safety Alerts

    There are currently no FDA safety alerts available for this drug.

    Manufacturer Warnings

    There is currently no manufacturer warning information available for this drug.

    FDA Labeling Changes

    There are currently no FDA labeling changes available for this drug.

    Uses

    1.1 Treatment of Gastroesophageal Reflux Disease (GERD) in Adults

    Healing of Erosive Esophagitis

    Esomeprazole strontium is 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 strontium may be considered.

    Maintenance of Healing of Erosive Esophagitis

    Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.

    Symptomatic Gastroesophageal Reflux Disease

    Esomeprazole strontium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.

    1.2 Risk Reduction of NSAID-Associated Gastric Ulcer in Adults

    Esomeprazole strontium is 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 either due to their age (≥60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

    1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults

    Triple Therapy (esomeprazole strontium plus amoxicillin and clarithromycin): esomeprazole strontium, 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].

    1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome in Adults

    Esomeprazole strontium is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

    History

    There is currently no drug history available for this drug.

    Other Information

    The active ingredient in the proton pump inhibitor esomeprazole strontium delayed-release capsules is bis(5‑ methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) strontium tetrahydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. The molecular formula of esomeprazole strontium is (C17H18N3O3S)2·Sr·4H2O with molecular weight of 848.50. The structural formula is:

    Figure 1

    Structural Formula

    The strontium salt is a white or almost white crystalline powder. Each molecule contains 4 moles of water of solvation and is soluble in water.

    Esomeprazole strontium is supplied in delayed-release capsules. Each delayed-release capsule contains 24.65 mg esomeprazole strontium equivalent to 20 mg esomeprazole or 49.3 mg esomeprazole strontium equivalent to 40 mg esomeprazole, in the form of enteric-coated granules with the following inactive ingredients: calcium carbonate, hypromellose, methacrylic acid copolymer dispersion, mono- and diglycerides, polysorbate 80, sugar spheres, talc, triethyl citrate. The 24.65 mg capsule shells have the following inactive ingredients: gelatin, titanium dioxide, synthetic iron oxide. The 49.3 mg capsule shells have the following inactive ingredients: gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6.

    Each 24.65 mg capsule contains 2.6 mg of strontium. Each 49.3 mg capsule contains 5.1 mg of strontium.

    Esomeprazole Strontium Manufacturers


    • Amneal Pharmaceuticals, Llc
      Esomeprazole Strontium Capsule, Delayed Release [Amneal Pharmaceuticals, Llc]
    • Amneal Pharmaceuticals Of New York, Llc
      Esomeprazole Strontium Capsule, Delayed Release [Amneal Pharmaceuticals Of New York, Llc]

    Login To Your Free Account