Label: ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium delayed release capsules capsule, coated pellets

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 4, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis - Esomeprazole magnesium is indicated for the short-term treatment (4 to 8 weeks) in the healing and ...
  • 2 DOSAGE AND ADMINISTRATION
    Esomeprazole magnesium is supplied as delayed-release capsules, USP for oral administration. The recommended dosages are outlined in Table 1. esomeprazole magnesium should be taken at least one ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Esomeprazole magnesium delayed-release capsules, USP 20 mg – Light yellow to brown colored enteric coated pellets filled in size “4” hard gelatin capsule, opaque dark blue cap & opaque dark blue ...
  • 4 CONTRAINDICATIONS
    Esomeprazole magnesium is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Presence of Gastric Malignancy - In adults, symptomatic response to therapy with esomeprazole magnesium does not preclude the presence of gastric malignancy. Consider additional follow-up and ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2) ...
  • 7 DRUG INTERACTIONS
    7.1 Interference with Antiretroviral Therapy - Concomitant use of atazanavir and nelfinavir with proton pump inhibitors is not recommended.  Co-administration of atazanavir with proton pump ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies with esomeprazole magnesium in pregnant women. Esomeprazole is the S-isomer of omeprazole. Available epidemiologic ...
  • 10 OVERDOSAGE
    A single oral dose of esomeprazole at 510 mg/kg (about 124 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity ...
  • 11 DESCRIPTION
    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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H - +/K - +-ATPase in the gastric ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - The carcinogenic potential of esomeprazole magnesium was assessed using studies of omeprazole, of which esomeprazole is an enantiomer ...
  • 14 CLINICAL STUDIES
    14.1 Healing of Erosive Esophagitis - The healing rates of esomeprazole magnesium 40 mg, esomeprazole magnesium 20 mg, and omeprazole 20 mg (the approved dose for this indication) were evaluated ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Esomeprazole magnesium delayed-release capsules, USP 20 mg, are light yellow to brown colored enteric coated pellets filled in size “4” hard gelatin capsule, opaque dark blue cap & opaque dark ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Adverse Reactions - Advise patients to report to their healthcare provider if they experience any signs or symptoms ...
  • MEDICATION GUIDE
    Esomeprazole magnesium delayed-release capsules, USP - (es ″ oh mep′ ra zole mag nee′ zee um) Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules, USP ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    esomeprazole-20mg ...
  • INGREDIENTS AND APPEARANCE
    Product Information